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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

It contains two medicines, salmeterol and fluticasone propionate:

·       Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours.

·       Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

The doctor has prescribed this medicine to help prevent breathing problems such as asthma.

You must use Seroflo Inhaler every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.

Seroflo inhaler helps to stop breathlessness and wheeziness coming on. However, Seroflo Inhaler should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast-acting ‘rescue’ inhaler with you


Do not take Seroflo inhaler

If you are allergic to salmeterol, fluticasone propionate or to the other ingredient Tetrafluoroethane (HFA-134a Propellant)

Warnings and precautions

Talk to your doctor or pharmacist before using Seroflo Inhaler if you have:

·       Heart disease, including an irregular or fast heart beat

·       Overactive thyroid gland

·       High blood pressure

·       Diabetes mellitus (Seroflo Inhaler may increase your blood sugar)

·       Low potassium in your blood

·       Tuberculosis (TB) now, or in the past, or other lung infections

Contact your doctor if you experience blurred vision or other visual disturbances

Other medicines and Seroflo inhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including medicines for asthma or any medicines obtained without a prescription. This is because Seroflo Inhaler may not be suitable to be taken with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use Seroflo Inhaler:

·       β blockers (such as atenolol, propranolol and sotalol). β blockers are mostly used for high blood pressure or other heart conditions.

·       Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for HIV treatment (such as ritonavir, cobicistat-containing products). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with Seroflo Inhaler, including irregular heartbeats, or may make side effects worse. Your doctor may wish to monitor you carefully if you are taking these medicines.

·       Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.

·       Diuretics, also known as ‘water tablets’ used to treat high blood pressure.

·       Other bronchodilators (such as salbutamol).

·       Xanthine medicines. These are often used to treat asthma

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Seroflo Inhaler is not likely to affect your ability to drive or use machines.

 


Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

·       Use your Seroflo inhaler every day, until your doctor advises you to stop. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure.

·       Do not stop taking Seroflo inhaler or reduce the dose of Seroflo inhaler without talking to your doctor first

·       Seroflo inhaler should be inhaled through the mouth into the lungs.

 

Adults and adolescents aged 12 years and over

 

·       Seroflo inhaler 25/125 - 2 puffs twice a day

·       Seroflo inhaler 25/250 - 2 puffs twice a day

 

Children 4 to 12 years of age

 

·       Seroflo inhaler is not recommended for use in children below 12 years of age.

 

Your symptoms may become well controlled using Seroflo inhaler twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

 

·       once at night - if you have night-time symptoms

·       once in the morning - if you have daytime symptoms.

 

It is very important to follow your doctor’s instructions on how many puffs to take and how often to take your medicine.

 

If you are using Seroflo inhaler for asthma, your doctor will want to regularly check your symptoms.

 

If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast-acting ‘reliever’ medicine. If any of these happen, you should continue to take Seroflo Inhaler but do not increase the number of puffs you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.

 

Instructions for use

 

·       Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Seroflo Inhaler properly or as prescribed may mean that it will not help your asthma as it should.

·       The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.

·       There is a counter on the back of the inhaler which tells you how many doses are left. Each time you press the canister, a puff of medicine is released and the counter will count down by one.

·       Take care not to drop the inhaler as this may cause the counter to count down.

 

Testing your inhaler

 

1.     When using your inhaler for the first time, test that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.

2.     To make sure that it works, shake it well, point the mouthpiece away from you and press the canister to release a puff into the air. Repeat these steps, shaking the inhaler before releasing each puff, until the counter reads 120. If you have not used your inhaler for a week or more, release two puffs of medicine into the air.

 

Using your inhaler

It is important to start to breathe as slowly as possible just before using your inhaler.

1.     Stand or sit upright when using your inhaler.

2.     Remove the mouthpiece cover (as shown in the first picture). Check inside and outside to make sure that the mouthpiece is clean and free of loose objects.

3.     Shake the inhaler 4 or 5 times to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.

4.     Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable.

5.     Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.

6.     Breathe in through your mouth slowly and deeply. Just after starting to breathe in, press firmly down on the top of the canister to release a puff of medicine. Do this while still breathing in steadily and deeply.

7.     Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable.

8.     Wait about half a minute between taking each puff of medicine and then repeat steps 3 to 7.

9.     Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help to stop you getting thrush and becoming hoarse.

10.     After use always replace the mouthpiece cover straight away to keep out dust. When the mouthpiece cover is fitted correctly it will ‘click’ into position. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.

 

Do not rush steps 4, 5, 6 and 7. It is important that you breathe in as slowly as possible just before using your inhaler. You should use your inhaler whilst standing in front of a mirror for the first few times. If you see "mist" coming from the top of your inhaler or the sides of your mouth, you should start again from step 3.

 

As with all inhalers, caregivers should ensure that children prescribed Seroflo Inhaler use correct inhalation technique, as described above.

 

If you or your child find it difficult to use the inhaler, either your doctor or nurse or other healthcare provider may recommend using a spacer device with your inhaler. Your doctor, nurse, pharmacist or other healthcare provider should show you how to use the spacer device with your inhaler and how to care for your spacer device and will answer any questions you may have. It is important that if you are using a spacer device with your inhaler that you do not stop using it without talking to your doctor or nurse first. It is also important that you do not change the type of spacer device that you use without talking to your doctor. If you stop using a spacer device or change the type of spacer device that you use your doctor may need to change the dose of medicine required to control your asthma. Always talk to your doctor before making any changes to your asthma treatment.

Older children or people with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece.

 

You should get a replacement when the counter shows the number 040. Stop using the inhaler when the counter shows 000 as any puffs left in the device may not be enough to give you a full dose. Never try to alter the numbers on the counter or detach the counter from the metal canister.

 

Cleaning your inhaler

 

To stop your inhaler blocking, it is important to clean it at least once a week.

To clean your inhaler:

·       Remove the mouthpiece cover.

·       Do not remove the metal canister from the plastic casing at any time.

·       Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

·       Replace the mouthpiece cover. It will ‘click’ into place when fitted correctly. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.

 

Do not put the metal canister in water.

 

If you use more Seroflo inhaler than you should

 

It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints.

 

If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seroflo Inhaler may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Seroflo inhaler

 

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

 

If you stop using Seroflo inhaler

 

It is very important that you take your Seroflo Inhaler every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Seroflo Inhaler. This could make your breathing worse.

 

In addition, if you suddenly stop taking Seroflo Inhaler or reduce your dose of Seroflo Inhaler this may (very rarely) cause you to have problems with your adrenal gland (adrenal insufficiency) which sometimes causes side effects.

 

These side effects may include any of the following:

 

·       Stomach pain

·       Tiredness and loss of appetite, feeling sick

·       Sickness and diarrhoea

·       Weight loss

·       Headache or drowsiness

·       Low levels of sugar in your blood

·       Low blood pressure and seizures (fits)

 

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.


Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Seroflo Inhaler to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Seroflo Inhaler. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using Seroflo Inhaler, stop using Seroflo Inhaler and tell your doctor straight away. Allergic reactions to Seroflo Inhaler are uncommon (they affect less than 1 person in 100).

Other side effects are listed below:

Very Common (affects more than 1 person in 10)

·       Headache - this usually gets better as treatment continues.

·       Increased number of colds have been reported in patients with COPD.

Common (affects less than 1 person in 10)

·       Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also, sore tongue and hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help. Your doctor may prescribe an anti-fungal medication to treat the thrush.

·       Aching, swollen joints and muscle pain.

·       Muscle cramps.

·       The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

·       Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems.

·       Bruising and fractures.

·       Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache)

·       A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp).

 

Uncommon (affects less than 1 person in 100)

·       Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.

·       Cataract (cloudy lens in the eye).

·       Very fast heartbeat (tachycardia).

·       Feeling shaky (tremor) and fast or uneven heartbeat (palpitations) - these are usually harmless and get less as treatment continues.

·       Chest pain.

·       Feeling worried (this effect mainly occurs in children).

·       Disturbed sleep.

·       Allergic skin rash.

Rare (affects less than 1 person in 1000)

·       Breathing difficulties or wheezing that get worse straight after taking Seroflo Inhaler. If this happens stop using your Seroflo Inhaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

·       Seroflo Inhaler may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:

·       Slowing of growth in children and adolescents

·       Thinning of the bones

·       Glaucoma

·       Weight gain

·       Rounded (moon shaped) face (Cushing’s Syndrome)

·       Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Seroflo Inhaler to control your asthma.

·       Behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).

·       Uneven heart beat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Seroflo Inhaler unless the doctor tells you to stop.

·       A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.

Frequency not known, but may also occur:

·       Depression or aggression. These effects are more likely to occur in children.

·       Blurred vision

Reporting of suspected adverse reactions

 

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your <doctor, health care provider> <or> <pharmacist>.

 


·       Do not store above 30°C. Do not Freeze.

·       Keep this medicine out of the sight and reach of children.

·       Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

·       Use this product during 3 months from opining.

·       The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C, protect from direct sunlight. Do not pierce or burn the canister even when empty.

·       As with most inhaled medicinal products in pressurised canisters, the therapeutic effect of this medicinal product may decrease when the canister is cold.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate Ph.Eur.) and 125 or 250 micrograms of fluticasone propionate. The other ingredient is propellant HFA- 134a


Aluminium canister with a suitable metering valve and a polypropylene actuator with dust cap having dose indicator in a sealed pouch containing desiccant. Each container is filled to deliver 120 doses.

MARKETING AUTHORIZATION HOLDER: 

Sudair Pharma Company (SPC)

King Fahad road, Building 911- The First Round

Riyadh, Saudi Arabia

Tel: +966-11-920001432

Fax: +966-11-4668195

Email: info@sudairpharma.com

Mailing: P.O. Box 19047 Riyadh, Saudi Arabia

 

Manufacturer:

Cipla Ltd., Unit II

Plot No. L-139 to L-146,

Verna Industrial Estate, Verna,

Goa - 403722, India.

 

 


02/2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي سيروفلو على مادتين فعّاليتين وهما سالميتيرول و بروبيونات فلوتيكازون:

·       سالميتيرول هو دواء موسع للشعب الهوائية طويل المفعول. تساعد موسعات الشعب الهوائية على إبقاء الشعب الهوائية بالرئة مفتوحة. مما يسهل عملية دخول وخروج الهواء من وإلى الرئتين. ويستمر ّتأثير الدواء لمدة 12 ساعة على الأقل.

·        بروبيونات فلوتيكازون هو أحد الأدوية التي تنتمي إلى مجموعة أدوية الكورتيكوستيرويدات التي تعمل على تخفيف حدة التهاب وتهيج الرئتين.

تم وصف هذا الدواء من قبل الطبيب المعالج لك للمساعدة في الوقاية من مشاكل التنفس مثل مرض الربو.

يجب استخدام سيروفلو بخاخ يوميًا حسب توجيهات الطبيب المعالج لك. حيث سيساعد هذا الأمر على التأكد من أن الدواء يعمل بشكل صحيح في السيطرة على مرض الربو.

يساعد سيروفلو بخاخ على منع الإصابة بضيق التنفس والأزيز المصاحب له. ومع ذلك، لا ينبغي استخدام سيروفلو لتخيفيف حدة نوبات ضيق التنفس المفاجئة أو أزيز الصدر.

وإذا حدث ذلك فأنت بحاجة إلى استخدام دواء "مهدئ" سريع المفعول (دواء الاستنشاق الانقاذي)" مثل سالبوتامول احرص دائمًا على أن تصطحب معك بخاخ الربو سريع المفعول (دواء الاستنشاق الانقاذي) الخاص بك

لا تتناول سيروفلو بخاخ في الحالات الآتية:

إذا كنت تعاني من حساسية تجاه سالميترول أو بروبيونات فلوتيكازون أو تجاه أي من المكونات الأخرى التي تحتوي على رباعي فلورو الإيثان (أجهزة الاستنشاق بالجرعة المقننة أو الهيدروفلوروكان (HFA-134A  كمادة دافعة ))

 

 

تحذيرات واحتياطات

تحدث إلى الطبيب المعالج لك أو الصيدلي الخاص بك قبل استخدام سيروفلو بخاخ في الحالات التالية:

·       إذا كنت تعاني من مرض القلب، بما في ذلك عدم انتظام أو تسارع ضربات القلب

·       فرط نشاط الغدة الدرقية

·       ارتفاع ضغط الدم

·       مرض السُّكري (قد يزيد سيروفلو من مستوى السكر في الدم)

·       انخفاض نسبة البوتاسيوم في الدم

·       مرض السل (TB) حاليًا أو في الماضي أو التهابات أخرى بالرئة.

اتصل بالطبيب المعالج لك إذا شعرت بعدم وضوح في الرؤية أو عانيت من أي اضطرابات بصرية أخرى.

استخدام سيروفلو مع الأدوية الأخرى:

يُرجى إبلاغ الطبيب المعالج لك أو الصيدلي الخاص بك إذا كنت تتناول أو تناولت مؤخرًا أو قد تتناول أيَّة أدوية أخرى، بما في ذلك الأدوية الخاصة بعلاج الربو أو الأدوية التي حصلت عليها دون وصفة طبية. حيث قد لا يتناسب استخدام سيروفلو مع بعض الأدوية الأخرى.

أخبر الطبيب المعالج لك إذا كنت تتناول أيًّا من الأدوية التَّالية، قبل بدء استخدام سيروفلو:

·       حاصرات بيتا (مثل أتينولول وبروبرانولول وسوتالول) التي غالبًا ما تُستخدم لعلاج ارتفاع ضغط الدَّم أو الحالات الأخرى لعد انتظام ضربات القلب.

·       الأدوية التي تستخدم لعلاج حالات العدوى (مثل كيتوكونازول وايتراكونازول و اريثرومايسين) بما في ذلك بعض الأدوية التي تُستخدم لعلاج فيروس نقص المناعة البشرية HIV (مثل: ريتونافير والأدوية التي تحتوي على كوبيسيستات).  قد تزيد بعض هذه الأدوية من تركيزات فلوتيكازون بروبيونات وسالميتيرول في الجسم. يمكن أن يزيد هذا من خطر التعرض لآثار جانبية عند تناول عقارسالميتيرول وبروبيونات فلوتيكازون، والتي تشمل عدم انتظام ضربات القلب أو قد يؤدى إلى تدهور حالة الآثار الجانبية إلى الأسوأ. سوف يطلب الطبيب المعالج لك متابعة حالتك بعناية إذا كنت تتناول هذه الأدوية.

·       إذا كنت تستخدم أدوية الكورتيكوستيرويدات الأخرى (سواء عن طريق الفم أو الحقن). إذا قمت بتناول هذه الأدوية مؤخرًا، فقد يزيد ذلك من المخاطر المصاحبة لهذا الدواء مما يؤثر على الغدة الكظرية.

·       أدوية مدرات البول، التي تعرف أيضا باسم "أقراص الماء" والتي تُستخدم لعلاج ارتفاع ضغط الدم.

·       الأدوية الأخرى الموسعة للشعب الهوائية (مثل دواء سالبوتامول).

·       الأدوية التي تحتوي على زانثين. والتي غالبا ما تستخدم لعلاج الربو.

الحمل والرضاعة الطبيعية:

إذا كُنتِ حاملًا أو تمارسين الرضاعة الطبيعية، أو تعتقدين أنكِ قد تكونين حاملاً أو تخططين للحمل، فاستشيري الطبيب المعالج لكِ أو الصيدلي الخاص بكِ للحصول على النصيحة قبل استخدام هذا الدَّواء.

القيادة واستخدام الآلات:

من غير المحتمل أن يُؤثر سيروفلو على القدرة على قيادة السيارات أو استخدام الآلات.

https://localhost:44358/Dashboard

استخدم دائمًا هذا الدَّواء بالضبط كما أخبركِ الطبيب المعالج لك أو الصيدلي الخاص بك. يُرجى الرجوع إلى الطبيب المعالج لك أو الصيدلي الخاص بك إذا لم تكن متأكدًا من كيفية التَّناوُل.

·       ينبغي عليك استخدام سيروفلو يوميًا ما لم يخبرك الطبيب المعالج لك بإيقافه. لا تتناول أكثر من الجرعة الموصى بها. يُرجى الرجوع إلى الطبيب المعالج لك أو الصيدلي الخاص بك إذا لم تكن متأكدًا من كيفية التَّناوُل.

·       يحظر التوقف عن استخدام سيروفلو أو تقليل الجرعة دون التحدُّث إلى الطبيب المعالج لك أولًا.

·       يجب استنشاق سيروفلو عن طريق الفم بحيث ينتقل إلى الرئتين.

 

الاستخدام في المرضى من البالغين والمراهقين الذين تبلغ أعمارهم 12 عامًا فأكثر:

·       سيروفلو بخاخ 25/125 - (بختين) مرتين يوميًا.

·       سيروفلو بخاخ 25/250  - (بختين) مرتين يوميًا.

 

الاستخدام في المرضى من الأطفال الذين تتراوح أعمارهم من 4 إلى 12 عامًا

·       لا يُوصى باستخدام سيروفلو بخاخ في الأطفال أقل من عمر 12عامًا.

 

قد يساعد استخدام سيروفلو مرتين يوميًا على السيطرة على الأعراض التي تعاني منها. في هذه الحالة، قد يقرر الطبيب المعالج لك تقليل الجرعة الخاصة بك إلى مرة واحدة يوميًا. قد يتم تغيير الجرعة إلى:

·       مرة واحدة مساءً - إذا كنت تعاني من ظهور الأعراض أثناء الليل.

·       مرة واحدة صباحًا - إذا كنت تعاني من ظهور الأعراض أثناء النهار.

 

ومن المهم للغاية اتباع تعليمات الطبيب المعالج لك حول عدد البخات التي تتناولها من الدَّواء وعدد مرات تناوله.

 

إذا كنت تستخدم سيروفلو لعلاج مرض الربو، فربما يحتاج الطبيب المعالج لك لفحص الأعراض التي تعاني منها بشكل منتظم.

 

يُرجى إخبار الطبيب المعالج لك على الفور، إذا تدهورت حالة الربو أو زادت عملية التنفس لديك سوءً.

 

قد تشعر بزيادة أزيز الصدر عند التنفس أو كثيرًا ما تشعر بضيق الصدر أو قد تحتاج إلى استخدام دواء سريع المفعول لتخفيف الألم بجرعات زائدة. وإذا تعرضت لأيٍ مما سبق، فيتعين عليك الاستمرار في استخدام سيروفلو ولكن بدون زيادة عدد البخات التي تستنشقها. قد تتدهور حالة ضيق الصدر لديك، مما يؤدي إلى الإصابة بأمراض خطيرة. استشر الطبيب المعالج لك، فقد تحتاج إلى تناول علاج إضافي.

تعليمات الاستخدام

·       يجب أن يوضح الطبيب المعالج لك أو الممرض(ة) المتابع(ة) لحالتك أو الصيدلي الخاص بك كيفية استخدام جهاز الاستنشاق الخاص بك. يجب عليهم التحقق من كيفية استخدامك للدواء ومتابعتك من وقت لأخر. قد يؤدي عدم استخدام سيروفلو بطريقة صحيحة أو على النحو الموصوف إلى عدم علاج مرض الربو كما ينبغي.

·       يتوفر هذا الدواء في عبوة مضغوطة داخل غلاف مصنوع من البلاستيك مع الجزء الذي يوضع داخل الفم.

·       يوجد جهاز قياس في الجزء الخلفي لجهاز الاستنشاق يُخبرك بكمية الجرعات المتبقية. في كل مرة تضغط فيها على العبوة المضغوطة لتخرج بخة من الدواء سوف يقوم جهاز القياس بالعد التنازلي بمقدار البخة الواحدة.

·       احرص على عدم إسقاط جهاز الاستنشاق لأن هذا قد يُؤدى إلى قيام جهاز القياس بالعد التنازلي للبخات.

 

اختبار جهاز الاستنشاق الخاص بك.

 

1.     اختبر ما إذا كان جهاز الاستنشاق يعمل أم لا عند استخدامه لأول مرة. قم بإزالة غطاء الجزء الذي يوضع داخل الفم عن طريق الضغط برفق على الجانبين باستخدام الإبهام والسبابة ثم انزعه.

2.     للتأكد مما إذا كان يعمل الجهاز بشكل جيد، رجه جيدًا، ثم وجِّه الجزء الذي يوضع داخل الفم بعيدًا عنك واضغط على العبوة المضغوطة لتُخرج بخة في الهواء. كرر هذه الخطوات وحرك جهاز الاستنشاق قبل إخراج كل بخة، حتى يقرأ جهاز القياس رقم 120. إذا لم تقم باستخدام جهاز الاستنشاق الخاص بك لمدة أسبوع أو أكثر، قم أيضًا بإخراج بختين من الدواء في الهواء.

 

كيفية استخدام جهاز الاستنشاق

من المهم أخذ نفس عميق (شهيق) ببطء بقدر المستطاع قبل استخدام جهاز الاستنشاق.

1.     يمكنك استخدام جهاز الاستنشاق أثناء الوقوف أو الجلوس في وضع مستقيم.

2.     انزع غطاء الجزء الذي يوضع داخل الفم (كما هو مبين في الصورة الأولى). تأكد من نظافة الجزء الذي يوضع داخل الفم من الداخل والخارج وأنه نظيف وخالي من عدم وجود أي أجزاء مفكوكة بالجهاز.

3.     رج جهاز الاستنشاق 4 أو 5 مرات للتأكد من تثبيت أي أجزاء مفكوكة به وأن محتويات جهاز الاستنشاق مختلطة بشكل متساوِ.

4.     أمسك جهاز الاستنشاق في وضع قائم بحيث يكون الإبهام على القاعدة تحت الجزء الذي يوضع داخل الفم. قم بإخراج زفير قدر استطاعتك.

5.     ضع الجزء الذي يوضع داخل الفم في فمك بحيث يكون بين أسنانك. أطبق شفتيك حوله. لا تقوم بالضغط عليه بأسنانك.

6.     خذ نفس عميق ببطء عن طريق الفم. بعد اخذ نفس عميق فقط، اضغط على الجزء العلوي من العبوة المضغوطة بشدة لأسفل لإخراج بخة من الدواء. قم بذلك مع الاستمرار في أخذ شهيق بثبات وبعمق.

7.     احبس نفسك، ثم اخرج جهاز الاستنشاق من فمك وارفع اصبعك عن الجزء العلوي من جهاز الاستنشاق. استمر في حبس نفسك لبضعة ثواني أو لأطول فترة ممكنة.

8.     انتظر لمدة نصف دقيقة بين تناول كل بخة من الدواء ثم كرر هذه الخطوات من 3 إلى 7 مرة أخرى.

9.     بعد ذلك، قم بغسل فمك بالماء واخرجه من فمك و/أو اغسل اسنانك بالفرشاة.  فقد يساعد ذلك على الحد من الإصابة بالسلاق وخشونة الصوت.

10.  قم بإعادة تثبيت غطاء الجزء الذي يوضع داخل الفم دائمًا في مكانه فور الانتهاء من استخدامه للحفاظ عليه من الأتربة. عندما يتم تثبيت غطاء الجزء الذي يوضع داخل الفم بشكل صحيح، فسوف يصدر صوت صفير عند إدخاله في موضعه. وإذا لم يصدر غطاء الجزء الذي يوضع داخل الفم صوت صفير عند تثبيته في موضعه، قم بلفه في الاتجاه الآخر وحاول إغلاقه مرة أخرى. لا تضغط على الغطاء بشدة لأغلاقه.

 

لا تتعجل في تنفيذ الخطوات رقم 4 و5 و6 و7. من المهم أخذ نفس عميق (شهيق) ببطء بقدر المستطاع قبل استخدام جهاز الاستنشاق. يتعين عيك استخدام جهاز الاستنشاق الخاص بك أثناء الوقوف أمام المرآة عند استخدامه للمرات الأولى. يجب عليك أن تبدأ من الخطوة رقم 3، إذا رأيت "رزاز" يخرج من الجزء العلوي من جهاز الاستنشاق أو من جانبي فمك.

كما هو الحال مع جميع أجهزة الاستنشاق، يجب أن يتأكد مقدمي الرعاية الصحية من أن يقوم المرضى من الأطفال الذين تم وصف سيروفلو بخاخ لهم باستخدام تقنية الاستنشاق الصحيحة كما هو موضح أعلاه.

 

وإذا واجهت أنت أو طفلك صعوبة في استخدام جهاز الاستنشاق، فقد يوصى الطبيب المعالج لك أو الممرض(ة) المتابعة (ة) لحالتك أو مقدمي الرعاية الصحية باستخدام جهاز مباعدة مع جهاز الاستنشاق. يجب أن يُدربك الطبيب المعالج لك أو الممرض (ة) المتابع (ة) حالتك أو الصيدلي الخاص بك أو مقدمي الرعاية الصحية الآخرين على كيفية استخدام جهاز المباعدة مع جهاز الاستنشاق وكيفية المحافظة على جهاز المباعدة والرد على أي أسئلة يتم طرحها.

 

وإذا كنت تستخدم جهاز المباعدة مع جهاز الاستنشاق، فمن المهم ألا تتوقف عن استخدامه دون استشارة الطبيب المعالج لك أو الممرض (ة) المتابع (ة) لحالتك أولاً. ومن المهم أيضًا ألا تقوم بتغيير نوع جهاز المُباعدة الذي تستخدمه دون استشارة الطبيب المعالج لك. وإذا توقفت عن استخدام جهاز المُباعدة أو قمت بتغيير نوع الجهاز الذي تستخدمه، فقد يحتاج الطبيب المعالج لك إلى تغيير جرعة الدواء المطلوبة للسيطرة على مرض الربو. استشر دائمًا الطبيب المعالج لك قبل إجراء أية تغييرات على علاج مرض الربو.

 

قد يجد الأطفال الأكبر سنًا أو الأشخاص ذو الأيدي الضعيفة أن استخدام جهاز الاستنشاق أسهل عند حمله بكلا اليدين.  ضع إصبعي السبابة على الجزء العلوي من جهاز الاستنشاق، وإصبعى الإبهام أسفل الجزء الذي يوضع داخل الفم.

 

يجب عليك الحصول على عبوة بديلة عندما يُظهر جهاز القياس رقم 040. توقف عن استخدام جهاز الاستنشاق عندما يُظهر جهاز القياس رقم 000، حيث أن أي بخة تتواجد في الجهاز قد لا تكون كافية لإعطائك جرعة كاملة. لا تحاول أبدًا تغيير الأرقام الظاهرة على جهاز القياس أو فصل جهاز القياس من العبوة المعدنية.

 

كيفية تنظيف جهاز الاستنشاق الخاص بك:

لإزالة انسداد جهاز الاستنشاق، فمن المهم أن تقوم بتنظيف جهاز الاستنشاق الخاص بك علي الأقل مرة أسبوعيًا. 

 

يمكنك تنظَّيف جهاز الاستنشاق على النحو التالي:

·       انزع غطاء الجزء الذي يوضع داخل الفم.

·       لا تُخرِج العبوة المعدنية من الغلاف المصنوع من البلاستيك أبدًا.

·       امسح الجزء الذي يوضع داخل الفم من الداخل والخارج والغلاف المصنوع من البلاستيك باستخدام قطعة قماش نظيفة وجافة.

·       قم بإعدة وضع غطاء الجزء الذي يوضع داخل الفم. سوف يُصدر الغطاء صوت صفير، عندما يتم تثبيته في مكانه بطريقة صحيح. فإذا لم يُصدر غطاء الجزء الذي يوضع داخل الفم صوت صفير عند تثبيته في موضعه، قم بلفه في الاتجاه الآخر وحاول تركيبه مرة أخرى. لا تضغط على الغطاء بشدة لأغلاقه.

 

لا تضع العبوة المعدنية في الماء.

 

إذا استخدمت كمية أكبر مما يجب من سيروفلو:

من الضروري استخدام جهاز الاستنشاق وفقًا لتعليمات الطبيب. تحدث إلى الطبيب المعالج لك أو الصيدلي الخاص بك إذا استخدمت جرعة أكبر من الجرعة الموصى بها عن طريق الخطأ. حيث قد تُلاحظ تسارع ضربات القلب بشكلِ أكثر من المعتاد وقد تشعر برعشة. قد تعاني أيضًا من دوخة وصداع وضعف العضلات وألم المفاصل.

 

استشر الطبيب المعالج لك أو الصيدلي الخاص بك للحصول على النصيحة إذا استخدمت جرعات كبيرة لفترة طويلة من الوقت. حيث أن استخدام جرعات كبيرة من دواء سيروفلو بخاخ قد تقلل من كمية هرمونات الستيرويد التي تنتجها الغدة الكظرية.

 

إذا نسيت استخدام سيروفلو:

لا تتناول جرعة مضاعفة لتعويض جرعة أغفلتها. فقط تناول الجرعة التَّالية في الوقت المُعتاد.

 

إذا توقفت عن استخدام سيروفلو:

من المهم للغاية استخدام سيروفلو بخاخ يوميًا حسب توجيهات الطبيب. استمر في تناول سيروفلو ما لم يخبرك الطبيب المعالج لك بإيقاف العلاج. لا تتوقف عن تناول الجرعة الموصوفة لك من سيروفلو أو تقليلها فجأة. فقد يؤدى ذلك إلى تفاقم مشاكل التنفس لديك.

بالإضافة إلى ذلك، قد يؤدي إيقاف سيروفلو فجأة أو تقليل الجرعة الموصوفة لك إلى حدوث اضطرابات بالغدة الكظرية "قصور الغدة الكظرية" (عَرَض نادر جدًّا) والذي قد يؤدي أحيانًا إلى ظهور بعض الآثار الجانبية:

 

قد تشمل هذه الآثار الجانبية أي مما يلي:

·       ألم بالمعدة

·       إرهاق وفقدان الشهية وشعور بالإعياء.

·       إعياء وإسهال

·       فقدان الوزن

·       صداع أو نعاس

·       انخفاض مستويات السكر بالدم

·       انخفاض ضغط الدم ونوبات تشنج

 

عندما يكون جسمك تحت ضغط ناتج، على سبيل المثال، عن الإصابة بحمى أوكدمات (كحادث سيارة)، عدوى، أو عقب إجراء جراحة، قد تتفاقم قصور الغدة الكظرية مما يؤدي إلى الإصابة ببعض الآثار الجانبية المذكورة أعلاه.

 

إذا عانيت من أية آثار جانبية، تحدَّث إلى الطبيب المعالج لك أو الصيدلي الخاص بك. للوقاية من هذه الأعراض، قد يصف الطبيب المعالج لك أدوية أخرى من الكورتيكوستيرويدات على شكل أقراص (مثل عقار بريدنيزولون).

 

إذا كانت لديك أية أسئلة إضافية متعلقة باستخدام هذا الدواء، فاستشر الطبيب المعالج لك أو الممرض (ة) المتابع (ة) لحالتك أو الصيدلي الخاص بك.

مثله مثل كافة الأدوية، قد يُسبب هذا الدَّواء آثارًا جانبية، على الرغم من عدم حدوثها لجميع المرضى. للحد من فرص الإصابة باالأثار الجانبية، سوف يصف الطبيب المعالج لك جرعة أقل من سيروفلو بخاخ للسيطرة على مرض الربو.

تفاعلات حساسية: إذا كنت تعاني من تفاعلات حساسية، قد تلاحظ أحيانًا تفاقم مشاكل التنفس لديك فور استخدام بريكوال.

قد تعاني من أزيز شديد أثناء التنفس وسعال أو ضيق في التنفس. وقد تُلاحظ أيضًا ظهور حكة وطفح جلدي (شرى) وتورم (عادة ما يكون في الوجه أو الشفتين أو اللسان أو الحلق) أو قد تشعر فجأة بتسارع ضربات القلب لديك أو قد تشعر بدوار ودوخة (والتي قد تؤدي إلى الإصابة بهبوط أو فقدان الوعي).

إذا أُصِبت بأي من هذه الأعراض أو ظهرت فجأة بعد بدء استخدام سيروفلو، يجب إيقاف استخدام الدواء وأخبر الطبيب المعالج لك على الفور. إذا كنت تعاني من تفاعلات حساسية تجاه سيروفلو وهي آثار جانبية غير شائعة (تُؤثر على أقل من مريض واحد من بين كل 100 مريض).

آثار جانبية أخرى مدرجة أدناه:

آثار جانبية شائعة جدًّا (تؤثر على أكثر من مريض واحد من بين كل 10 مرضى)

·       صداع، وعادة ما يتحسن ويتم علاجه بالمواظبة على العلاج.

·       تم الإبلاغ عن وجود حالات كثيرة من الإصابة بإلانفلونزا في المرضى الذين يعانون من مرض الانسداد الرئوي المزمن.

آثار جانبية شائعة (تؤثر على أقل من مريض واحد من بين كل 10 مرضى)

·       سُلاَق/ عدوى فطرية (التهابات وظهور بقع لونها أصفر فاتح) بالفم والحلق. بالإضافة إلى، التهابات باللسان وخشونة الصوت وتهيج الحلق. قد يساعد غسل الفم بالماء واخراجه على الفور و/أو تنظيف الأسنان بعد تناول كل جرعة من الدواء، على الوقاية من هذه العدوى. وقد يصف الطبيب المعالج لك دواء مضاد للفطريات لعلاج مرض السُلاَق.

·       حكة والتهاب المفاصل وألم العضلات.

·       تشنج العضلات.

·       تم الإبلاغ عن الآثار الجانبية التالية لدي المرضي الذين يعانون من مرض الانسداد الرئوي المزمن.

·       التهاب رئوي و التهاب الشعب الهوائية (عدوى الرئة). أخبر طبيبك إذا لاحظت أيًّا من الآثار الجانبية التالية: زيادة إفراز البلغم، تغير لون البلغم، حمّى، ارتعاش، زيادة السعال، زيادة مشاكل التنفس.

·       الإصابة بكدمات وكسور.

·       التهاب الجيوب الأنفية (شعور بالتوتر أو تجمد الأنف والخدين وخلف العينين، وأحيانا مع آلام الخفقان).

·       انخفاض كمية البُوتاسيوم في الدم (قد تشعر بعدم انتظام ضربات القلب، ضعف بالعضلات، تشنجات)

آثار جانبية غير شائعة (تؤثر على أقل من مريض واحد من بين كل 100 مريض)

·       زيادة مستويات السكر (الجلوكوز) في الدم (فرط سكر الدم). إذا كنت مصابًا بمرض السُّكَّرِي، فقد تحتاج إلى متابعة مستوى السكر بالدم بشكل أكبر كما يمكن أن يتطلب الأمر تعديل علاج السكر الخاص بك.

·       إعتام عدسة العين (وجود غمام بعدسة العين).

·       تسارع ضربات القلب (عدم انتظام ضربات القلب).

·       شعور بالإهتزاز (رعشة) مع تسارع أو عدم انتظام ضربات القلب (خفقان) - عادة ما تكون هذه الأعراض خطيرة ولكنها تقل مع استمرار العلاج.

·       ألم في الصدر.

·       شعور بالقلق (يحدث بشكل شائع في المرضى من الأطفال).

·       اضطراب النوم.

·       طفح جلدي تحسسي.

آثار جانبية نادرة (تؤثر على أقل من مريض واحد من بين كل 1000 مريض)

·       تفاقم مشاكل التنفس أو أزير الصدر فور استخدام سيروفلو. عند حدوث ذلك، توقف عن استخدام سيروفلو. استخدم جهاز الاستنشاق "المهديء" سريع المفعول الخاص بك ليساعدك على التنفس وأخبر الطبيب المعالج لك على الفور.

·       قد يؤثر سيروفلو على معدل الإنتاج الطبيعي للهرمونات الستيرويدية في جسمك، خاصةً إذا قمت بتناول جرعات عالية طويلة المدى. تتضمن الآثار الجانبية ما يلي:

·       بطء نمو المرضى من الأطفال والمراهقين.

·       هشاشة العظام.

·       زَّرَق/ مياه زرقاء بالعين (الجلوكوما).

·       زيادة الوزن

·       (متلازمة كوشينج) ("هو حدوث تورم تدريجي للوجه على شكل مستدير، نتيجة لتراكم الدهون الزائدة على جانبي الوجه وهذا يمكن أن يشير لوجه القمر وغالباً ما يكون مرتبطاً بالبدانة")

·       سوف يقوم الطبيب المعالج لك بفحص حالتك بانتظام للكشف عن ظهور أي من هذه الآثار ومعالجتها والتأكد من تناولك جرعة أقل من سيروفلو بخاخ للتحكم في مرض الربو.

·       تغيرات سلوكية، مثل النشاط غير العادي (فرط النشاط والحركة) وسرعة الانفعال (تُحدث هذه الآثار بشكل شائع في المرضى من الأطفال).

·       عدم انتظام ضربات القلب أو زيادة ضربات القلب (اضطرابات نظم القلب). أخبر الطبيب المعالج لك، ولا تقم بإيقاف العلاج بسيروفلو بخاخ مالم يخبرك الطبيب المعالج لك بذلك.

·       عدوى فطرية في المريء قد تؤدي إلى صعوبات في البلع.

آثار جانبية غير معروف معدل تكرارها ولكنها قد تحدث أيضًا:

·       اكتئاب أو عدوانية.  من المرجح حدوث مثل هذه الآثار بشكل شائع في المرضى من الأطفال.

·       عدم وضوح الرؤية.

الإبلاغ عن الآثار الجانبية المُشتبَه بها

 

إذا أصبحت أيٍّ من هذه الآثار الجانبية خطيرة، أو إذا لاحظت أية آثار جانبية غير المُدرجة في هذه النشرة، فيُرجى إبلاغ الطبيب المعالج لك أو مقدم الرعاية الصحية أو الصيدلي الخاص بك.

 

·       يحفظ في درجة حرارة لا تتجاوز ٣٠ درجة مئوية، ولا يُعرض للتجميد.

·       يُحفظ هذا الدَّواء بعيدًا عن رؤية ومتناول الأطفال.

·       لا تستعمل هذا الدَّواء بعد انتهاء تاريخ الصَّلاحية المدون على الملصق والعبوة الكرتونية بعد كلمة "EXP". يُشير تاريخ انتهاء الصلاحية إلى اليوم الأخير من ذلك الشهر.

·       يتم استخدام المستحضر خلال ٣ شهور من فتح العبوة.

·       تحتوي العبوة علي سائل مضغوط. لا تُعرض العبوة لدرجات حرارة تزيد عن ٥٠ درجة مئوية ولا تعرضها لأشعة الشمس المباشرة. ولا تحاول فتح أو ثقب أو حرق العبوة حتى عندما تبدو فارغة.

·       كما هو الحال مع معظم منتجات الاستنشاق الطبية الموردة في عبوات مضغوطة، قد يقل التأثير العلاجي لهذه المنتجات الطبية عند تبريد العبوة.

لا تتخلص من أي أدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. استشر الصيدلي الخاص بك عن كيفية التَّخلص من الأدوية التي لم تعد تستخدمها. ستساعد هذه الإجراءات في الحفاظ على البيئة.

تحتوى كل جرعة مُقاسة (جرعة مقننة) على ٢٥ ميكرو جرام من سالميتيرول (سالميتيرول كسينافواتي وفقًا لدستور الأدوية الأوروبي) و ١٢٥ أو ٢٥٠ ميكرو جرام من بروبيونات فلوتيكازون. المادة الفعّالة الآخرى هى: رباعي فلورو الإيثان (أجهزة الاستنشاق بالجرعة المقننة أو الهيدروفلوروكان (HFA-134A كمادة دافعة))

شكل سيروفلو بخاخ ومحتويات العبوة:

يتوفر في شكل عبوة مصنوعة من الألومنيوم مزودة بصمام قياس أوتوماتي ومشغل صمام مصنوع من مادة البولي بروبيلين مع غطاء واق من الغبار والجسيمات الصغيرة مثبت به مؤشر الجرعة الذي يخبرك بعدد الجرعات المتبقية في المستنشق بشكل تقريبي معبأ في كيس أو علبة محكمة الإغلاق يحتوي على مادة مُجفِّفَة.

مالك حق التسويق

شركة سدیر للأدویة

طریق الملك فھد- مبنى 8006 - الدور الرابع

الریاض – المملكة العربیة السعودیة

ھاتف: 0096611920001432

فاكس: 00966114668195

ايميل: info@sudairpharma.com

 

تم التصنيع من قبل

سيبلا ليميتد، الوحدة رقم 2

بلوت رقم ال-139 الى ال-146

منطقة فيرنا الصناعية ، فيرنا، غوا - 403722، الهند

فبراير 2021
 Read this leaflet carefully before you start using this product as it contains important information for you

Seroflo Inhaler 25 mcg/125 mcg inhaler Seroflo Inhaler 25 mcg/250 mcg inhaler

- Seroflo Inhaler (25/125mcg) Each actuation delivers: Salmeterol (as Salmeterol Xinafoate Ph.Eur.) ……...25 mcg Fluticasone Propionate BP ……………………125mcg Suspended in Propellant HFA-134a…………………………q. s - Seroflo Inhaler(25/250mcg) Each actuation delivers: Salmeterol (as Salmeterol Xinafoate Ph.Eur.) ……...25 mcg Fluticasone Propionate BP ……………………250mcg Suspended in Propellant HFA-134a…………………………q. s

Aerosol for inhalation A white color powder is obtained after opening the container

Seroflo inhaler is indicated in the regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate:

-       patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short- acting β2 agonist

or

-       patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonist


Posology

Route of administration: Inhalation use.

Patients should be made aware that Seroflo Inhaler must be used daily for optimum benefit, even when asymptomatic.

Patients should be regularly reassessed by a doctor, so that the strength of Seroflo Inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone. As an alternative, patients requiring a long- acting β2 agonist could be titrated to Seroflo inhaler given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning.

Patients should be given the strength of Seroflo  Inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Seroflo Inhaler 25 microgram/50 microgram strength is not appropriate for adults and children with severe asthma. [AA1] If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.

 

Recommended Doses:

Adults and adolescents 12 years and older:

-       Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily.

or

-       Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.

A short-term trial ofSeroflo Inhaler may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential. In these cases, the recommended initial dose is two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important.

A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. In general inhaled corticosteroids remain the first line treatment for most patients. Seroflo Inhaler is not intended for the initial management of mild asthma. It is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-combination can be used in patients with severe asthma.

 

Paediatric population

Children 4 years and older:

The maximum licensed dose of fluticasone propionate delivered by Seroflo Inhaler in children is 100 micro-gram twice daily.

The safety and efficacy of Seroflo Inhaler in children aged under 4 years has not been established (see Section 5.a).

Children <12 years old may have difficulties synchronising aerosol actuation with inspiration of breath.

Use of a spacer device with Seroflo Inhaler is recommended in patients who have, or are likely to have difficulties to coordinate actuation with inspiration.

A suitable spacer device can be used (depending on National Guidance). Limited data are available that demonstrate an increase in systemic exposure when different spacer devices are used. (see section 4d).

Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. Patients should continue to use the same make of spacer device as switching between spacer devices can result in changes in the dose delivered to the lungs (see section 4d).

Re-titration to the lowest effective dose should always follow the introduction or change of a spacer device.

Special patient groups

There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Seroflo Inhaler in patients with hepatic impairment.

Instructions for Use

Patients should be instructed in the proper use of their inhaler (see patient information leaflet)

During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in a vertical position.

 

Testing the inhaler:

 

Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, hold the inhaler between the fingers and thumb with their thumb on the base, below the mouthpiece and release puffs into the air until the counter reads 120 to make sure that it works. The inhaler should be shaken immediately before releasing each puff. If the inhaler has not been used for a week or more the mouthpiece cover should be removed, the patient should shake the inhaler well and should release two puffs into the air. Each time the inhaler is activated the number on the counter will count down by one.

 

Use of the inhaler:

 

1.     Patients should remove the mouthpiece cover by gently squeezing the sides of the cover

2.     Patients should check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.

3.     Patients should shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed

4.     Patients should hold the inhaler upright between fingers and thumb with their thumb on the base, below the mouthpiece.

5.     Patients should breathe out as far as is comfortable and then place the mouthpiece in their mouth between their teeth and close their lips around it, Patients should be instructed not to bite the mouth piece.

6.     Just after starting to breathe in through their mouth, patients should press firmly down on the top of the inhaler to release Seroflo Inhaler, while still breathing in steadily and deeply.

7.     While holding their breath, patients should take the inhaler from their mouth and take their finger from the top of the inhaler. Patients should continue holding their breath for as long as is comfortable.

8.     To take a second inhalation, patients should keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.

9.     Patients should immediately replace the mouthpiece cover in the correct orientation by firmly pushing and snapping the cap into position. This does not require excessive force, the cover should click into position.

 

IMPORTANT 

Patients should not rush stages 5, 6 and 7. It is important that patients start to breathe in as slowly as possible just before operating their inhaler. Patients should practise in front of a mirror for the first few times. If they see "mist" coming from the top of their inhaler or the sides of their mouth they should start again from stage 3.

 

Patients should rinse their mouth out with water and spit out, and/or brush their teeth after each dose of medicine, in order to minimise the risk of oropharyngeal candidiasis and hoarseness.

 

Patients should get a replacement when the indicator shows the number ‘40’ and the colour on the dose indicator will change from green to red. Stop using the inhaler when the indicator shows ‘0’ as any puffs left in the device may not be enough to give you a full dose. Never try to alter the numbers on the indicator or detach the indicator from the actuator. The indicator cannot be reset and is permanently attached to the actuator.

 

Cleaning (also detailed in patient information leaflet):

 

Your inhaler should be cleaned at least once a week.

 

1.     Remove the mouth piece cover.

2.     Do not remove the canister from the plastic casing.

3.     Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

4.     Replace the mouthpiece cover in the correct orientation. This does not require excessive force, the cover should click into position.

 DO NOT PUT THE METAL CANISTER IN WATER


Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

Seroflo Inhaler Evohaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times.

Patients should not be initiated on Seroflo Inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

Serious asthma-related adverse events and exacerbations may occur during treatment with Seroflo Inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Seroflo Inhaler.

Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a physician.

Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment. Consideration should be given to increasing corticosteroid therapy.

Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Seroflo Inhaler. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Seroflo Inhaler should be used (see section 4.b).

Treatment with Seroflo inhaler should not be stopped abruptly due to risk of exacerbation. Therapy should be down-titrated under physician supervision.

As with all inhaled medication containing corticosteroids, Seroflo Inhaler should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway. Appropriate treatment should be promptly instituted, if indicated.

Rarely, Seroflo Inhaler may cause cardiac arrhythmias e.g. supraventricular tachycardia, extra systoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Seroflo Inhaler should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalemia or patients predisposed to low levels of serum potassium.

There have been very rare reports of increases in blood glucose levels (see section 4.h) and this should be considered when prescribing to patients with a history of diabetes mellitus.

As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Seroflo Inhaler  should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Pediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000 micrograms. Situations, which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Systemic absorption of salmeterol and fluticasone propionate is largely through the lungs. As the use of a spacer device with a metered dose inhaler may increase drug delivery to the lungs it should be noted that this could potentially lead to an increase in the risk of systemic adverse effects. Single dose pharmacokinetic data have demonstrated that the systemic exposure to salmeterol and fluticasone propionate may be increased as much as two-fold when the Aero Chamber Plus spacer device is used with Seroflo Inhaler as compared with the Volumatic spacer device.

The benefits of inhaled fluticasone propionate therapy should minimize the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Therefore, these patients should be treated with special care and adrenocortical function regularly monitored. Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk. This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered. The extent of the adrenal impairment may require specialist advice before elective procedures.

Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.e).

There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in a 3-year study in patients with Chronic Obstructive Pulmonary Disease (COPD) receiving salmeterol and fluticasone propionate as a fixed-dose combination administered via the Diskus/Accuhaler compared with placebo (see section 4.h). In a 3-year COPD study, older patients, patients with a lower body mass index (<25kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment. Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD as the clinical features of such infections and exacerbation frequently overlap. If a patient with severe COPD has experienced pneumonia the treatment with Seroflo Inhaler should be re- evaluated. The safety and efficacy of Seroflo Inhaler has not been established in patients with COPD and therefore Seroflo Inhaleris not indicated for use in the treatment of patients with COPD.

Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol. This may lead to an increase in the incidence of systemic effects (e.g. prolongation in the QTc interval and palpitations). Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment (see section 4.e).

Visual disturbance 

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Pediatric Population 

Children and adolescents <16years taking high doses of fluticasone propionate (typically ≥ 1000 micrograms/day) may be at particular risk. Systemic effects may occur, particularly at high doses prescribed for long periods. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents and more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Consideration should be given to referring the child or adolescent to a pediatric respiratory specialist.

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective control of asthma is maintained


β adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective β blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Potentially serious hypokalaemia may result from β2 agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.

Concomitant use of other β adrenergic containing drugs can have a potentially additive effect.

Fluticasone Propionate 

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome CYP3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.

In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome CYP3A4 inhibitor) 100 mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred-fold, resulting in markedly reduced serum cortisol concentrations. Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. Cases of Cushing's syndrome and adrenal suppression have been reported. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side effects.

In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone. Co-treatment with other potent CYP3A inhibitors, such as itraconazole and cobicistat-containing products, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic side effects. Combinations should be avoided unless the benefit outweighs the potential increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Salmeterol 

Potent CYP3A4 inhibitors 

Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4-fold Cmax and 15-fold AUC). This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4).

Clinically significant effects were not seen on blood pressure, heart rate, blood glucose and blood potassium levels. Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.

The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment. There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir).

Moderate CYP 3A4 inhibitors 

Co-administration of erythromycin (500 mg orally three times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC). Co-administration with erythromycin was not associated with any serious adverse effects.


Fertility 

There are no data in humans. However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility.

Pregnancy 

A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformities or feto/neonatal toxicity related to Salmeterol and fluticasone propionate inhaler. Animal studies have shown reproductive toxicity after administration of β2 adrenoreceptor agonists and glucocorticosteroids (see section 5.3).

Administration of Seroflo Inhaler to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.

Breast-feeding 

It is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk.

Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats.

A risk to breastfed new-borns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Seroflo Inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.


Salmeterol and fluticasone propionate inhaler has no or negligible influence on the ability to drive and use machines.


The type and severity of adverse reactions associated with each of the compounds (salmeterol and fluticasone propionate), may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.

Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and not known (cannot be estimated from the available data). Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account.

System Organ Class

Adverse Event

Frequency

Infections & Infestations

Candidiasis of the mouth and throat

Pneumonia

Bronchitis

Oesophageal candidiasis

Common

Common1,3

Common1,3

Rare

Immune System Disorders

Hypersensitivity reactions with the following manifestations:

Cutaneous hypersensitivity reactions

Angioedema (mainly facial and oropharyngeal oedema)

Respiratory symptoms (dyspnoea)

Respiratory symptoms (bronchospasm)

Anaphylactic reactions including anaphylactic shock

 Uncommon

Rare

 

Uncommon

Rare

Rare

Endocrine Disorders

Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density

Rare4

Metabolism & Nutrition Disorders

Hypokalaemia

Hyperglycaemia

Common3

Uncommon4

Psychiatric Disorders

Anxiety

Sleep disorders

Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children)

Depression, aggression (predominantly in children)

Uncommon

Uncommon

Rare
 

 

Not Known

Nervous System Disorders

Headache

Tremor

Very Common1

Uncommon

Eye disorder

Cataract

Glaucoma

Vision, blurred

Uncommon

Rare4

Not known4

Cardiac Disorders

Palpitations

Tachycardia

Cardiac arrhythmias (including supraventricular tachycardia and extra systoles).

Atrial fibrillation

Angina pectoris

Uncommon

Uncommon

Rare
 

 

Uncommon

Uncommon

Respiratory, Thoracic & Mediastinal Disorders

Nasopharyngitis

Throat irritation

Hoarseness/dysphonia

Sinusitis

Paradoxical bronchospasm

Very Common2,3

Common

Common

Common1,3

Rare4

Skin and subcutaneous tissue disorders

Contusions

Common1,3

Musculoskeletal & Connective Tissue Disorders

Muscle cramps

Traumatic fractures

Arthralgia

Myalgia

Common

Common1,3

Common

Common

1. Reported commonly in placebo

2. Reported very commonly in placebo

3. Reported over 3 years in a COPD study

4. See section 4d

 

Description of selected adverse reactions

The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Seroflo Inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the oesophagus can occur in some patients. Both hoarseness and incidence of mouth and throat candidiasis may be relieved by rinsing the mouth with water and/or brushing the teeth after using the product. Symptomatic mouth and throat candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Seroflo Inhaler.

Paediatric population

Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents (see section 4.4). Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability.

To reports any side effect(s):

Saudi Arabia:

·       The National Pharmacovigilance Centre (NPC):

 

-       SFDA Call Center: 19999

-       E-mail: npc.drug@sfda.gov.sa

-       Website: https://ade.sfda.gov.sa/

 

Other GCC States:

-       Please contact the relevant competent authority.


There are no data available from clinical trials on overdose with Seroflo Inhaler, however data on overdose with both drugs are given below:

The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. If salmeterol and fluticasone propionate therapy has to be withdrawn due to overdose of the β agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. Additionally, hypokalaemia can occur and therefore serum potassium levels should be monitored. Potassium replacement should be considered.

Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.

Chronic overdose of inhaled fluticasone propionate: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary. When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose. Refer to section 4.4: risk of adrenal suppression.

In cases of both acute and chronic fluticasone propionate overdose, salmeterol and fluticasone propionate therapy should be continued at a suitable dosage for symptom control.


Pharmacotherapeutic Group: Adrenergics in combination with corticosteroids or other drugs, excl. Anticholinergics.

ATC Code: R03AK06

Mechanism of action and pharmacodynamic effects

Seroflo Inhaler contains salmeterol and fluticasone propionate which have differing modes of action.

The respective mechanisms of action of both drugs are discussed below.

Salmeterol:

Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.

Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.

Fluticasone propionate:

Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti- inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.

Clinical efficacy and safety

Salmeterol and Fluticasone Propionate Asthma clinical trials

A twelve-month study (Gaining Optimal Asthma Control, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of Seroflo Inhaler versus inhaled corticosteroid (Fluticasone Propionate) alone to determine whether the goals of asthma management were achievable. Treatment was stepped up every 12 weeks until **total control was achieved or the highest dose of study drug was reached. GOAL showed more patients treated with Seroflo Inhaler achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose

*Well controlled asthma was achieved more rapidly with Seroflo Inhaler than with ICS alone. The time on treatment for 50% of subjects to achieve a first individual well controlled week was 16 days for Seroflo Inhaler compared to 37 days for the ICS group. In the subset of steroid naive asthmatics, the time to an individual well controlled week was 16 days in theSeroflo Inhaler treatment compared to 23 days following treatment with ICS.

 

The overall study results showed:

Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over 12 months

Pre-Study Treatment

Salmeterol/FP

FP

WC

TC

WC

TC

No ICS (SABA alone)

78%

50%

70%

40%

Low dose ICS (≤500 microgram BDP or equivalent/day)

75%

44%

60%

28%

Medium dose ICS (>500 to 1000 microgram BDP or equivalent/day)

62%

29%

47%

16%

Pooled results across the 3 treatment levels

71%

41%

59%

28%

 

*Well controlled asthma; less than or equal to 2 days with symptom score greater than 1 (symptom score 1 defined as 'symptoms for one short period during the day') SABA use on less than or equal to 2 days and less than or equal to 4 occasions/week, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy

**Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy.

The results of this study suggest that Seroflo Inhaler 50/100 microgram bd may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see Dosage and Method of Administration).

A double blind, randomised, parallel group study in 318 patients with persistent asthma aged ≥18 years evaluated the safety and tolerability of administering two inhalations twice daily (double dose) of Seroflo Inhaler for two weeks. The study showed that doubling the inhalations of each strength of Seroflo Inhalerr for up to 14 days resulted in a small increase in β agonist-related adverse events (tremor; 1 patient [1%] vs 0, palpitations; 6 [3%] vs 1 [<1%], muscle cramps; 6[3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid-related adverse events (e.g. oral candidiasis; 6 [6%] vs 16 [8%], hoarseness; 2 [2%] vs 4 [2%]) compared to one inhalation twice daily. The small increase in β agonist-related adverse events should be taken into account if doubling the dose of Seroflo Inhaler is considered by the physician in adult patients requiring additional short-term (up to 14 days) inhaled corticosteroid therapy.

 

Asthma

The Salmeterol Multi-center Asthma Research Trial (SMART) 

The Salmeterol Multi-center Asthma Research Trial (SMART) was a 28-week US study that evaluated the safety of salmeterol compared to placebo added to usual therapy in adult and adolescent subjects. Although there were no significant differences in the primary endpoint of the combined number of respiratory-related deaths and respiratory-related life-threatening experiences, the study showed a significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated with salmeterol versus 3 deaths out of 13,179 patients on placebo). The study was not designed to assess the impact of concurrent inhaled corticosteroid use, and only 47% of subjects reported ICS use at baseline.

Safety and efficacy of salmeterol-FP versus FP alone in asthma

Two multi-centre 26-week studies were conducted to compare the safety and efficacy of salmeterol-FP versus FP alone, one in adult and adolescent subjects (AUSTRI trial), and the other in paediatric subjects 4-11 years of age (VESTRI trial). For both studies, enrolled subjects had moderate to severe persistent asthma with history of asthma-related hospitalisation or asthma exacerbation in the previous year. The primary objective of each study was to determine whether the addition of LABA to ICS therapy (salmeterol-FP) was non-inferior to ICS (FP) alone in terms of the risk of serious asthma related events (asthma-related hospitalisation, endotracheal intubation, and death). A secondary efficacy objective of these studies was to evaluate whether ICS/LABA (salmeterol-FP) was superior to ICS therapy alone (FP) in terms of severe asthma exacerbation (defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or an in-patient hospitalisation or emergency department visit due to asthma that required systemic corticosteroids).

A total of 11,679 and 6,208 subjects were randomized and received treatment in the AUSTRI and VESTRI trials, respectively. For the primary safety endpoint, non-inferiority was achieved for both trials (see Table below).

Serious Asthma-Related Events in the 26-Week AUSTRI and VESTRI Trials

 

AUSTRI

VESTRI

Salmeterol-FP

(n = 5,834)

FP Alone

(n = 5,845)

Salmeterol-FP

(n = 3,107)

FP Alone

(n = 3,101)

Composite endpoint (Asthma-related hospitalization, endotracheal intubation, or death)

34 (0.6%)

33 (0.6%)

27 (0.9%)

21 (0.7%)

Salmeterol-FP/FP Hazard ratio (95% CI)

1.029

(0.638-1.662) a

 

1.285

(0.726-2.272) b

 

Death

0

0

0

0

Asthma-related hospitalisation

34

33

27

21

Endotracheal intubation

0

2

0

0

a.             If the resulting upper 95% CI estimate for the relative risk was less than 2.0, then non-inferiority was concluded.

b.            If the resulting upper 95% CI estimate for the relative risk was less than 2.675, then non-inferiority was concluded.

 

For the secondary efficacy endpoint, reduction in time to first asthma exacerbation for salmeterol-FP relative to FP was seen in both studies, however only AUSTRI met statistical significance:

 

AUSTRI

VESTRI

Salmeterol-FP

(n = 5,834)

FP Alone

(n = 5,845)

Salmeterol-FP

(n = 3,107)

FP Alone

(n = 3,101)

Number of subjects with an asthma exacerbation

480 (8%)

597 (10%)

265 (9%)

309 (10%)

Salmeterol-FP/FP Hazard ratio (95% CI)

0.787

(0.698, 0.888)

0.859

(0.729, 1.012)

Paediatric population:

In trial SAM101667, in 158 children aged 6 to 16 years with symptomatic asthma, the combination of salmeterol/fluticasone propionate is equally efficacious to doubling the dose of fluticasone propionate regarding symptom control and lung function. This study was not designed to investigate the effect on exacerbations.

In a trial, which randomized children aged 4 to 11 years [n=428], salmeterol/fluticasone propionate Diskus (50/100 microgram, one inhalation twice daily) was compared with salmeterol/fluticasone propionate MDI (25/50 microgram, two inhalations twice daily) over a 12-week treatment period. The adjusted mean change from baseline in mean morning peak expiratory flow over Weeks 1-12 was 37.7L/min in the Diskus group and 38.6L/min in the MDI group. Improvements were also seen in both treatment groups on rescue and symptom free days and nights.

A multi-centre 8-week, double-blind, study was conducted to evaluate the safety and efficacy of salmeterol-FP metered dose inhaler (25/50 micrograms, 1 or 2 inhalations twice daily) versus FP (50 micrograms, 1 or 2 inhalations twice daily) alone in Japanese paediatric (6-month to 4 years of age) patients with infantile bronchial asthma. Ninety-nine percent (148/150) and ninety-five percent (142/150) of patients randomised to receive salmeterol-FP or FP alone, respectively, completed the double-blind period of the study. The safety of long-term treatment with salmeterol-FP metered dose inhaler (25/50 micrograms, 1 or 2 inhalations twice daily) was evaluated in a 16-week, open-label,extension treatment period. Ninety-three percent (268/288) completed the extension period. The study failed to meet its primary efficacy endpoint of mean change from baseline in total asthma symptom score (double blind period). No statistically significant superiority in favour of salmeterol-FP to FP was demonstrated (95% Cl [-2.47; 0.54], p=0.206). There are no obvious differences in the safety profile between salmeterol-FP and FP alone (8-week double-blind period); moreover, no new safety signals were identified with administration of salmeterol-FP in the 16-week open-label extension period. However, the data about efficacy and safety of salmeterol-FP are insufficient to establish the benefit/risk balance of salmeterol-FP in children under 4 years old.

Fluticasone propionate containing medications in asthma during pregnancy 

An observational retrospective epidemiological cohort study utilising electronic health records from the United Kingdom was conducted to evaluate the risk of MCMs following first trimester exposure to inhaled FP alone and salmeterol-FP relative to non-FP containing ICS. No placebo comparator was included in this study.

Within the asthma cohort of 5362 first trimester ICS-exposed pregnancies, 131 diagnosed MCMs were identified; 1612 (30%) were exposed to FP or salmeterol-FP of which 42 diagnosed MCMs were identified. The adjusted odds ratio for MCMs diagnosed by 1 year was 1.1 (95%CI: 0.5 – 2.3) for FP exposed vs non-FP ICS exposed women with moderate asthma and 1.2 (95%CI: 0.7 – 2.0) for women with considerable to severe asthma. No difference in the risk of MCMs was identified following first trimester exposure to FP alone versus salmeterol-FP. Absolute risks of MCM across the asthma severity strata ranged from 2.0 to 2.9 per 100 FP-exposed pregnancies which is comparable to results from a study of 15,840 pregnancies unexposed to asthma therapies in the General Practice Research Database (2.8 MCM events per 100 pregnancies).


When salmeterol and fluticasone propionate were administered in combination by the inhaled route, the pharmacokinetics of each component were similar to those observed when the drugs were administered separately. For pharmacokinetic purposes, therefore each component can be considered separately.

Salmeterol

Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects. In addition, there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram/mL or less) achieved after inhaled dosing.

Fluticasone propionate

The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 5 to 11% of the nominal dose depending on the inhalation device used. In patients with asthma a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.

Systemic absorption occurs mainly through the lungs and is initially rapid then prolonged. The remainder of the inhaled dose may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and pre-systemic metabolism, resulting in oral availability of less than 1%. There is a linear increase in systemic exposure with increasing inhaled dose.

The disposition of fluticasone propionate is characterised by high plasma clearance (1150 mL/min), a large volume of distribution at steady-state (approximately 300 L) and a terminal half-life of approximately 8 hours.

Plasma protein binding is 91%.

Fluticasone propionate is cleared very rapidly from the systemic circulation. The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4. Other unidentified metabolites are also found in the faeces.

The renal clearance of fluticasone propionate is negligible. Less than 5% of the dose is excreted in urine, mainly as metabolites. The main part of the dose is excreted in faeces as metabolites and unchanged drug.

Paediatric population

The effect of 21 days of treatment with Seroflo Inhaler 25/50 microgram (2 inhalations twice daily with or without a spacer) or salmeterol and fluticasone propionate dry powder inhaler 50/100 microgram (1 inhalation twice daily) was evaluated in 31 children aged 4 to 11 years with mild asthma. Systemic exposure to fluticasone propionate was similar for Seroflo Inhaler with spacer (107 pg hr/mL [95% CI: 45.7, 252.2]) and salmeterol and fluticasone propionate dry powder inhaler (138 pg hr/mL [95% CI: 69.3, 273.2]), but lower for Seroflo Inhaler (24 pg hr/mL [95% CI: 9.6, 60.2]). Systemic exposure to salmeterol was similar for Seroflo Inhaler,Seroflo Inhaler with spacer, and salmeterol and fluticasone propionate dry powder inhaler (126 pg hr/mL [95% CI: 70, 225], 103 pg hr/mL [95% CI: 54, 200], and 110 pg hr/mL [95% CI: 55, 219], respectively).


The only safety concerns for human use derived from animal studies of salmeterol and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.

In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations). However, these animal experimental results do not seem to be relevant for man given recommended doses. Animal studies with salmeterol have shown embryofetal toxicity only at high exposure levels. Following co-administration, increased incidences of transposed umbilical artery and incomplete ossification of occipital bone were found in rats at doses associated with known glucocorticoid-induced abnormalities. Neither salmeterol xinafoate or fluticasone propionate have shown any potential for genetic toxicity.

The non-CFC propellant, norflurane, has been shown to have no toxic effect at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.


Tetrafluoroethane (HFA-134a Propellant)


Not applicable.


24 months

Replace the mouthpiece cover firmly and snap it into position.

The canister contains a pressurised liquid. Store below 30°C. Do not freeze. Do not pierce the canister.

As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold.

 

Use this product during 3 months from opining.


Aluminium canister with a suitable metering valve and a polypropylene actuator with dust cap having dose indicator in a sealed pouch containing desiccant.

Each container is filled to deliver 120 doses


No special requirements.


Sudair Pharma Company (SPC) King Fahad road, Building 911- The First Round Riyadh, Saudi Arabia Tel: +966-11-920001432 Fax: +966-11-4668195 Email: info@sudairpharma.com Mailing: P.O. Box 19047 Riyadh, Saudi Arabia

Jan. 2021
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