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  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

What Atectura Breezhaler is and how it works

Atectura Breezhaler contains two active substances called indacaterol and mometasone furoate.

 

Indacaterol belongs to a group of medicines called bronchodilators. It relaxes the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When it is taken regularly, it helps the small airways to remain open.

 

Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.

 

What Atectura Breezhaler is used for

Atectura Breezhaler is used regularly as treatment for asthma in adults and adolescents (12 years of age and older).

 

Asthma is a serious, long‑term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough.

 

You should use Atectura Breezhaler every day and not only when you have breathing problems or other symptoms of asthma. This will ensure that it controls your asthma properly. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.

 

If you have any questions about how Atectura Breezhaler works or why this medicine has been prescribed for you, ask your doctor.

 


Follow all the doctor’s instructions carefully.

 

a.       Do not use Atectura Breezhaler

-                 if you are allergic to indacaterol, mometasone furoate or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

 

b.      Take special care with Atectura Breezhaler

Talk to your doctor, pharmacist or nurse before using Atectura Breezhaler if any of the following applies to you:

-                 if you have heart problems, including an irregular or fast heartbeat.

-                 if you have thyroid gland problems.

-                 if you have ever been told you have diabetes or high blood sugar.

-                 if you suffer from seizures or fits.

-                 if you have a low level of potassium in your blood.

-                 if you have severe liver problems.

-           if you have tuberculosis (TB) of the lung, or any long‑standing or untreated infections.

 

During treatment with Atectura Breezhaler

Stop using this medicine and get medical help immediately if you have any of the following:

-                 tightness of the chest, coughing, wheezing or breathlessness immediately after using Atectura Breezhaler (signs the medicine is unexpectedly tightening the airways, known as paradoxical bronchospasm).

-                 difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction).

 

Children and adolescents

Do not give this medicine to children below 12 years of age because it has not been studied in this age group.

 

c.       Using other medicines and Atectura Breezhaler

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, tell your doctor or pharmacist if you are using:

-                 medicines that decrease the level of potassium in your blood. These include diuretics (which increase urine production and can be used to treat high blood pressure, e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines used for breathing problems (e.g. theophylline) or corticosteroids (e.g. prednisolone).

-                 tricyclic antidepressants or monoamine oxidase inhibitors (medicines used in the treatment of depression).

-                 any medicines that may be similar to Atectura Breezhaler (contain similar active substances); using them together may increase the risk of possible side effects.

-                 medicines called beta blockers used to treat high blood pressure or other heart problems (e.g. propranolol) or to treat glaucoma (e.g. timolol).

-                 ketoconazole or itraconazole (medicines used to treat fungal infections)

-                 ritonavir, nelfinavir or cobicistat (medicines used to treat HIV infection).

 

d.      Pregnancy and breast‑feeding

If you are pregnant or breast‑feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you whether you can use Atectura Breezhaler.

 

e.       Driving and using machines

It is unlikely that this medicine will affect your ability to drive and use machines.

 

f.        Important information about some of the ingredients of Atectura Breezhaler

Atectura Breezhaler contains lactose

This medicine contains about 25 mg of lactose per capsule. If you have been told by your doctor that you have an intolerance to some sugars, speak with your doctor before taking this medicine.

 


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

 

How much Atectura Breezhaler to inhale

There are three different strengths of Atectura Breezhaler capsules. Your doctor will decide which is best for you.

 

The usual dose is to inhale the content of one capsule each day. You only need to use the medicine once a day. Do not use more than your doctor tells you to use.

 

You should use Atectura Breezhaler every day, even when your asthma is not troubling you.

 

When to inhale Atectura Breezhaler

Inhale Atectura Breezhaler at the same time each day. This will help control your symptoms throughout the day and night. It will also help you to remember to use it.

 

How to inhale Atectura Breezhaler

-                 Atectura Breezhaler is for inhalation use.

-                 In this pack, you will find an inhaler and capsules that contain the medicine. The inhaler enables you to inhale the medicine in the capsule. Only use the capsules with the inhaler provided in this pack. The capsules should remain in the blister until you need to use them.

-                 Peel the backing away from the blister to open it, do not push the capsule through the foil.

-                 When you start a new pack, use the new inhaler supplied in this new pack.

-                 Dispose of the inhaler in each pack after all capsules in that pack have been used.

-                 Do not swallow the capsules.

-                 Please read the instructions for use on the other side of this leaflet for more information on how to use the inhaler.

 

If your symptoms do not improve

If your asthma is not getting better or if it gets worse after you have started using Atectura Breezhaler, talk to your doctor.

 

If you use more Atectura Breezhaler than you should

If you accidently inhale too much of this medicine, contact your doctor or hospital for advice immediately. You may need medical attention.

 

If you forget to use Atectura Breezhaler

If you forget to inhale a dose at the usual time, inhale one as soon as possible on that day. Then inhale the next dose at the usual time on the next day. Do not inhale two doses on the same day.

 

If you stop using Atectura Breezhaler

Do not stop using Atectura Breezhaler unless your doctor tells you to. Your asthma symptoms may come back if you stop using it.

 

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

 


Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

Some side effects could be serious

Stop using Atectura Breezhaler and get medical help immediately if you have any of the following:

 

Common: may affect up to 1 in every 10 people

-                 difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching and hives (signs of allergic reaction).

 

Uncommon: may affect up to 1 in every 100 people

-                 swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).

 

Other side effects

Other side effects include the following listed below. If these side effects become severe, please tell your doctor, pharmacist or nurse.

 

Very common: may affect more than 1 in 10 people

-                 sore throat

-                 runny nose

-                 sudden difficulty breathing and feeling of tightness in chest with wheezing or coughing

 

Common: may affect up to 1 in every 10 people

-                 voice alteration (hoarseness)

-                 blocked nose

-                 sneezing, cough

-                 headache

-                 pain in muscles, bones or joints (signs of musculoskeletal pain)

 

Uncommon: may affect up to 1 in every 100 people

-                 fast heart beat

-                 oral thrush (sign of candidiasis)

-                 high level of sugar in the blood

-                 muscle spasm

-                 skin itching

-                 rash

-                 clouding of the lens of your eyes (signs of cataract)

-                 blurred vision


-                 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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

-                 This medicinal product does not require any special temperature storage conditions.

-                 Store the capsules in the original blister in order to protect from light and moisture, and do not remove until immediately before use.

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

 


-                 The active substances are indacaterol (as acetate) and mometasone furoate.

 

Atectura Breezhaler 125 micrograms/62.5 micrograms

Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 80 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 62.5 micrograms of mometasone furoate.

 

Atectura Breezhaler 125 micrograms/127.5 micrograms

Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 127.5 micrograms of mometasone furoate.

 

Atectura Breezhaler 125 micrograms/260 micrograms

Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.

 

-                 The other ingredient is lactose monohydrate (see “Atectura Breezhaler contains lactose” in section 2).


In this pack, you will find an inhaler together with capsules in blisters. The capsules are transparent and contain a white powder. - Atectura Breezhaler 125 micrograms/62.5 micrograms capsules have a blue product code “IM150 80” printed above one blue bar on the body with a logo printed in blue and surrounded by two blue bars on the cap. - Atectura Breezhaler 125 micrograms/127.5 micrograms capsules have a grey product code “IM150 160” printed on the body with a logo printed in grey on the cap. - Atectura Breezhaler 125 micrograms/260 micrograms capsules have a black product code “IM150 320” printed above two black bars on the body with a logo printed in black and surrounded by two black bars on the cap. The following pack sizes are available: Single pack containing 30 x 1 hard capsules together with 1 inhaler.

The Marketing Authorization Holder for this Product is Novartis Pharma AG.

www.Novartis.com


This leaflet was last approved by EMA in 06/2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ما هو عقار أتكتورا بريزهيلير وكيف يعمل؟

يحتوي عقار أتكتورا بريزهيلير على مادتين فعَّالتين تُسميان إنداكاتيرول و موميتازون فيوروات.

 

ينتمي إنداكاتيرول إلى مجموعة من الأدوية تسمى موسعات الشُّعب الهوائية. يُرخي العقار عضلات المسالك الهوائية الصغيرة في الرئتين. يساعد ذلك على فتح المسالك الهوائية، الأمر الذي يُسَهِّل من دخول الهواء إلى الرئتين وخروجه منهما. عند تناوُله بصفة منتظمة، يُساعِد العقار على إبقاء المسالك الهوائية الصغيرة مفتوحة.

 

ينتمي موميتازون فيوروات إلى مجموعة من الأدوية تسمى الكورتيكوستيرويدات (أو الستيرويدات). تحد الكورتيكوستيرويدات من تورُّم المسالك الهوائية الصغيرة بالرئتين وتهيُّجها (التهابها)، وهو ما يخفف مشاكل التَّنفس تدريجيًّا. تُساعد الكورتيكوستيرويدات أيضًا على الوقاية من نوبات الربو.

 

ما هي دواعي استعمال عقار أتكتورا بريزهيلير

يُستخدم عقار أتكتورا بريزهيلير بانتظام لعلاج الربو في البالغين والمراهقين (الذين يبلغون من العمر 12 عامًا فأكثر)

 

الربو هو مرض رئوي خطير وطويل الأمد تصبح فيه العضلات المحيطة بالمسالك الهوائية الأصغر حجمًا مشدودة (تضيُّق قصبي) وملتهبة. تظهر الأعراض ثم تختفي وتشمل ضيق النفس، أزيزًا بالصدر، ضيق الصدر وسعالًا.

يجب عليك استخدام عقار أتكتورا بريزهيلير كل يوم وألا يقتصر استخدامك له على الأوقات التي تُعاني فيها من مشاكل في التنفس أو غيرها من أعراض الربو. سيضمن ذلك تحكم العقار في الربو كما ينبغي. يُحظَر استخدام هذا الدَّواء لتخفيف نوبةٍ مفاجئةٍ من عُسْر التَّنَفُّس أو أزيز الصدر.

 

إذا كانت لديك أية أسئلة حول كيفية عمل عقار أتكتورا بريزهيلير أو لماذا تم وصف هذا الدواء لك، فاستشر طبيبك.

 

 

اتبع جميع تعليمات الطبيب بعناية.

 

‌أ.         موانع استعمال عقار أتكتورا بريزهيلير:

-          إذا كنت تعاني من حساسية تجاه إنداكاتيرول، موميتازون فيوروات أو تجاه أي مكون من المكونات الأخرى بهذا الدَّواء (المدرجة في قسم: 6). إذا كنت تعتقد أنك قد تكون لديك حساسية، فاستشر طبيبك.

 

‌ب.     الاحتياطات عند استعمال عقار أتكتورا بريزهيلير

تحدَّث إلى طبيبك أو الصيدلي أو الممرض(ة) قبل استخدام عقار أتكتورا بريزهيلير في الحالات الآتية:

-        في حال كنت تُعاني من مشاكل قلبية، من ضمنها عدم انتظام ضربات القلب أو تسارعها.

-        إذا كنت مصابًا بمشاكل في الغدة الدرقية.

-        في حال أُخبِرت سابقًا بأنك تعاني من مرض السُّكَّري أو ارتفاع مستوى السُّكَّر بالدَّم.

-        إذا كنت تعاني من نوبات صرع أو تشنجات.

-        في حال انخفاض مستوى البوتاسيوم في دمك.

-        إذا كانت لديك مشاكل شديدة بالكبد.

-        في حال كنت تعاني من السُّل الرئوي أو أي عدوى قائمة لفترة طويلة أو عدوى لم تُعالج.

 

أثناء العلاج بعقار أتكتورا بريزهيلير

توقف عن استخدام هذا الدَّواء واطلب المساعدة الطبية فورًا إذا أُصِبت بأيٍّ من الآتي:

-        ضيق بالصدر، أو سعال، أو أزيز بالصدر أو عُسْر التَّنَفُّس فور استخدام عقار أتكتورا بريزهيلير (علامات تشير إلى تسبب الدَّواء في تضيُّق غير متوقع في المسالك الهوائية؛ وتُعرَف هذه الحالة بالتشنُّج القصبي التناقضي).

-        صعوبة التَّنفس أو البلع، أو تورم اللسان أو الشفتين أو الوجه، أو الطفح الجلدي، أو الحكة والشرى (أرتكاريا) (علامات تشير إلى الإصابة بتفاعل حساسية).

 

الأطفال والمراهقون

لا تعطِ هذا الدَّواء للأطفال ممن تقل أعمارهم عن 12 عامًا؛ ذلك لأن هذا الدَّواء لم يخضع بعد للدراسة في هذه الفئة العمرية.

 

‌ج.      التداخلات الدوائية من أخذ هذا المستحضر مع أدوية أخرى أو أعشاب أو مكملات غذائية

يُرجى إبلاغ طبيبك أو الصيدلي الخاص بك إذا كنت تستخدم أو استخدمت مؤخرًا أو قد تستخدم أيَّة أدوية أخرى. على وجه الخصوص، أخبر الطبيب أو الصيدلي الخاص بك إذا كنت تستخدم أيًّا مما يلي:

-        أدوية خافضة لمستوى البوتاسيوم في الدَّم. تشمل هذه الأدوية مُدِرات البول (التي تزيد من إنتاج البول والتي يُمكن استخدامها لعلاج ارتفاع ضغط الدَّم، على سبيل المثال: هيدروكلوروثيازيد)، مُوَسِّعات الشُّعب الهوائية الأخرى مثل الميثيلزانثينات التي تُستخدم لعلاج مشاكل التنفس (على سبيل المثال: ثيوفيلين) أو الكورتيكوستيرويدات (على سبيل المثال: بريدنيزولون).

-        مضادات الاكتئاب ثلاثية الحلقات أو مثبطات أوكسيديز أحادي الأمين (أدوية تُستخدم لعلاج الاكتئاب).

-        أيَّة أدوية قد تكون مماثلة لعقار أتكتورا بريزهيلير (تحتوي على مواد فَعَّالة مماثلة)؛ فقد يزيد استخدام هذه الأدوية بمصاحبته من احتمالية التعرُّض لخطر الإصابة بالآثار الجانبية المُحتملة.

-        أدوية تُسمى حاصرات بيتا تُستخدم لعلاج ارتفاع ضغط الدَّم أو غيره من المشاكل القلبية (على سبيل المثال: بروبرانولول) أو لعلاج الزَرَق (المياه الزرقاء) (على سبيل المثال: تيمولول).

-        كيتوكونازول أو إتراكونازول (أدوية تُستخدم لعلاج العدوى الفطرية).

-        ريتونافير أو نيلفينافير أو كوبيسيستات (أدوية تُستخدم لعلاج عدوى فيروس نقص المناعة البشري).

 

‌د.           الحمل والرضاعة

إذا كنتِ حاملًا أو مرضعًا، أو تعتقدين أنكِ حامل أو تخططين لذلك، فاستشيري طبيبكِ قبل تناوُل هذا الدَّواء. سيناقشكِ طبيبكِ حول إمكانية استخدامكِ لعقار أتكتورا بريزهيلير.

 

‌ه.           تأثير أتكتورا بريزهيلير على القيادة واستخدام الآلات

‌و.          من غير المرجح أن يُؤثر هذا الدواء في قدرتك على القيادة واستخدام الآلات.

 

‌ز.          معلومات هامَّة حول بعض مكونات عقار أتكتورا بريزهيلير

يحتوي عقار أتكتورا بريزهيلير على اللاكتوز

يحتوي هذا الدَّواء على 25 مجم من اللاكتوز بكل كبسولة. إذا كان طبيبك قد أخبرك بأنك لا تتحمل بعض أنواع السكريات، فاتصل به قبل تناول هذا الدَّواء.

https://localhost:44358/Dashboard

استخدم هذا الدَّواء بالضبط كما أخبرك طبيبك أو الصيدلي الخاص بك. راجع طبيبك أو الصيدلي الخاص بك إذا لم تكن متأكدًا من كيفية الاستخدام.

 

ما الكمية التي ينبغي استنشاقها من عقار أتكتورا بريزهيلير؟

هناك ثلاثة تركيزات مختلفة من عقار أتكتورا بريزهيلير كبسولات سيقرر طبيبك التَّركيز الأفضل لحالتك.

 

الجرعة المُعتادة هي استنشاق محتوى كبسولة واحدة كل يوم. يتعين عليك استخدام الدَّواء مرة واحدة في اليوم فقط. لا تستخدم كمية أكبر من تلك التي أخبرك طبيبك باستخدامها.

 

يجب عليك استخدام عقار أتكتورا بريزهيلير كل يوم، حتى وإن لم يسبب لك الربو مشاكل.

 

متى تستنشق عقار أتكتورا بريزهيلير؟

قم باستنشاق عقار أتكتورا بريزهيلير في نفس الوقت من كل يوم. سيُساعِد ذلك على التحكم بأعراضك ليلًا ونهارًا. سيُساعِدك ذلك أيضًا على تذكر استخدامه.

 

كيفية استنشاق عقار أتكتورا بريزهيلير

-        عقار أتكتورا بريزهيلير للاستخدام عن طريق الاستنشاق.

-        ستجد في هذه العبوة جهاز استنشاق وكبسولات تحتوي على الدَّواء. يُمكِّنك جهاز الاستنشاق من استنشاق الدَّواء الموجود بالكبسولة. لا تستخدم الكبسولات إلا مع جهاز الاستنشاق المتوفر في هذه العبوة. يجب أن تظل الكبسولات في الشريط حتى تحتاج استخدامها.

-        لا تدفع الكبسولة عبر الرقاقة المعدنية لإخراجها من الشريط، بل قم بإزالة الغطاء بعيدًا عن الشريط لفتحها

-        عند البدء في استخدام عبوة جديدة، استخدم جهاز الاستنشاق الجديد المتوفر في هذه العبوة الجديدة.

-        تخلص من جهاز الاستنشاق الموجود في كل عبوة بعد استخدام جميع الكبسولات الموجودة في تلك العبوة.

-        لا تبتلع الكبسولات.

-        يُرجى قراءة تعليمات الاستخدام الموجودة بالجانب الآخر من هذه النَّشرة للاطلاع على مزيد من المعلومات حول كيفية استخدام جهاز الاستنشاق.

 

في حال لم تتحسن أعراضك

إذا لم يتحسن الربو أو إذا تفاقمت حالتك بعد بدء استخدام عقار أتكتورا بريزهيلير، فتحدَّث إلى طبيبك.

 

إذا استخدمت كمية أكثر مما يجب من عقار أتكتورا بريزهيلير

إذا استنشقت كمية أكبر مما يجب من هذا الدَّواء بطريق الخطأ، فاتصل بطبيبك أو بالمستشفى فورًا للحصول على المشورة. فقد تحتاج إلى عناية طبية.

 

إذا أغفلت استخدام عقار أتكتورا بريزهيلير

إذا أغفلت استنشاق إحدى الجرعات في الموعد المُعتاد، فاستنشق جرعةً في أسرع وقت ممكن في ذلك اليوم. قم باستنشاق الجرعة التَّالية في الوقت المعتاد من اليوم التالي. لا تستنشق جرعتين في اليوم نفسه.

 

إذا توقفت عن استخدام عقار أتكتورا بريزهيلير

لا تتوقف عن استخدام عقار أتكتورا بريزهيلير ما لم يخبرك طبيبك بذلك. قد تعاود أعراض الربو الظهور إذا توقفت عن استخدامه.

 

إذا كانت لديك أية أسئلة إضافية حول استخدام هذا الدَّواء، فاستشر طبيبك أو الصيدلي الخاص بك.

 

مثله مثل كافة الأدوية، قد يُسبب هذا الدَّواء أثارًا جانبية، على الرَّغم من عدم حدوثها لدى الجميع.

 

بعض الأثار الجانبية قد تكون خطيرة

توقف عن استخدام عقار أتكتورا بريزهيلير واحصل على المساعدة الطبية فورًا إذا أُصِبت بأيٍّ من الآتي:

 

شائعة: قد تُؤثر على ما يصل إلى شخص واحد من بين كل 10 أشخاص

-                 صعوبة التَّنفس أو البلع، أو تورم اللسان أو الشفتين أو الوجه، أو الطفح الجلدي، أو الحكة والشرى (أرتكاريا) (علامات تشير إلى الإصابة بتفاعل حساسية).

 

غير شائعة: قد تُؤثر على ما يصل إلى شخص واحد من بين كل 100 شخص

-                 تورُّم يصيب اللسان أو الشفتين أو الوجه أو الحَلْق بشكل أساسي (علامات مُحتَمَلة للإصابة بالوذمة الوعائية).

 

الآثار الجانبية الأخرى

تشمل الأثار الجانبية الأخرى ما يلي من المدرج أدناه. إذا أصبحت هذه الآثار الجانبية شديدة، يُرجى إخبار طبيبك، أو الصيدلي، أو الممرض(ة) الخاص(ة) بك.

 

شائعة جدًّا: قد تُؤثر على أكثر من شخص واحد من بين كل 10 أشخاص

-                 التهاب الحلق

-                 سيلان الأنف

-                 حالة مفاجئة من صعوبة التَّنَفُّس والشعور بضيق في الصدر مع أزيز بالصدر أو سعال

 

شائعة: قد تُؤثر على ما يصل إلى شخص واحد من بين كل 10 أشخاص

-                 تغيُّر الصوت (بحة في الصوت)

-                 انسداد الأنف

-                 عطس وسعال

-                 صداع

-                 ألم بالعضلات أو العظام أو المفاصل (علامات آلام العضلات والعظام)

 

غير شائعة: قد تُؤثر على ما يصل إلى شخص واحد من بين كل 100 شخص

-                 تسارع نبضات القلب

-                 سُلاَق فموي (علامة تشير إلى الإصابة بالكانديدا)

-                 ارتفاع مستويات السُّكَّرِ في الدَّم

-                 تقلصات عضلية

-                 حكة بالجلد

-                 طفح جلدي

-                 تعتُّم عدستي العينين (علامة تشير إلى الإصابة بالمياه البيضاء)

-                 عدم وضوح الرؤية

-                 يُحفظ هذا الدَّواء بعيدًا عن رؤية ومُتناوَل الأطفال.

-                 لا تستخدم هذا الدَّواء بعد تاريخ انتهاء الصلاحية المدون على العبوة والشريط بعد كلمة “EXP”. يُشير تاريخ انتهاء الصَّلاحية إلى اليوم الأخير من ذلك الشهر.

-                 هذا المنتج الدوائي لا يحتاج إلى أية شروط خاصة فيما يتعلق بدرجة حرارة التخزين.

-                 تُحفَظ الكبسولات داخل الشريط الأصلي، لحمايتها من الضوء والرطوبة، ويجب ألا تُزال منه إلا قبل استخدامها مباشرةً.

-                 لا تتخلص من الأدوية عن طريق إلقائها في مياه الصَّرف. استشر الصيدلي الخاص بك عن كيفية التَّخلص من الأدوية التي لم تَعُد تستخدمها. ستساعد هذه الإجراءات في الحفاظ على البيئة.

 

-        المواد الفعَّالة هي إنداكاتيرول (في هيئة أسيتات) و موميتازون فيوروات.

عقار أتكتورا بريزهيلير 125 ميكروجرامًا/62.5 ميكروجرام

تحتوي كل كبسولة على 173 ميكروجرام إنداكاتيرول أسيتات (ما يُعادِل 150 ميكروجرام إنداكاتيرول) و80 ميكروجرام موميتازون فيوروات. تُعادِل الجرعة المُتلقاة (الجرعة التي تغادر قطعة الفم الخاصة بجهاز الاستنشاق) 125 ميكروجرام إنداكاتيرول و62.5 ميكروجرام موميتازون فيوروات.

 

عقار أتكتورا بريزهيلير 125 ميكروجرامًا/127.5 ميكروجرام

تحتوي كل كبسولة على 173 ميكروجرام إنداكاتيرول أسيتات (ما يُعادِل 150 ميكروجرام إنداكاتيرول) و160 ميكروجرام موميتازون فيوروات. تُعادِل الجرعة المُتلقاة (الجرعة التي تغادر قطعة الفم الخاصة بجهاز الاستنشاق) 125 ميكروجرام إنداكاتيرول و127.5 ميكروجرام موميتازون فيوروات.

 

عقار أتكتورا بريزهيلير 125 ميكروجرامًا/260 ميكروجرامًا

تحتوي كل كبسولة على 173 ميكروجرام إنداكاتيرول أسيتات (ما يُعادِل 150 ميكروجرام إنداكاتيرول) و320 ميكروجرام موميتازون فيوروات. تُعادِل الجرعة المُتلقاة (الجرعة التي تغادر قطعة الفم الخاصة بجهاز الاستنشاق) 125 ميكروجرام إنداكاتيرول و260 ميكروجرام موميتازون فيوروات.

-        المُكَوِّن الآخر هو اللاكتوز أحادي الهيدرات (انظر "يحتوي عقار أتكتورا بريزهيلير على اللاكتوز" في قسم 2).

 

ستجد في هذه العبوة جهاز استنشاق بمصاحبة كبسولات موجودة في شرائط. الكبسولات شفافة وتحتوي على مسحوق أبيض.

-        لعقار أتكتورا بريزهيلير 125 ميكروجرامًا/62.5 ميكروجرام كبسولات رمز أزرق خاص بالمُنتَج "IM150‑80" مطبوع فوق شريط أزرق على الجسم مع شعار مطبوع باللون الأزرق ومُحاط بشريطين أزرقين على الغطاء.

-        لعقار أتكتورا بريزهيلير 125 ميكروجرامًا/127.5 ميكروجرام كبسولات رمز رمادي خاص بالمُنتَج "IM150‑160" مطبوع على الجسم مع شعار مطبوع باللون الرمادي على الغطاء.

-        لعقار أتكتورا بريزهيلير 125 ميكروجرامًا/260 ميكروجرامًا كبسولات رمز أسود خاص بالمُنتَج "IM150‑320" مطبوع فوق شريطين أسودين على الجسم مع شعار مطبوع باللون الأسود ومُحاط بشريطين أسودين على الغطاء.

 

تتوافر أحجام العبوات التالية:

عبوة واحدة تحتوي على 30 × 1 كبسولة صلبة مع جهاز استنشاق واحد.

مالك حق التسويق لهذا المنتج هي شركة نوفارتس فارما إيه جي.

www.Novartis.com

تم آخر اعتماد لهذه النَّشرة من قِبَل منظمة الأدوية الأوروبية في 06/2020
 Read this leaflet carefully before you start using this product as it contains important information for you

Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules

Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 62.5 mcg of mometasone furoate. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 127.5 mcg of mometasone furoate. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 260 mcg of mometasone furoate. Excipient(s) with known effect Each capsule contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150 80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150 160” printed in grey on the body and with the product logo printed in grey on the cap. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150 320” printed in black above two black bars on the body and with the product logo printed in black and surrounded by two black bars on the cap.

Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short‑acting beta2‑agonists.


Posology

 

Adults and adolescents aged 12 years and over

The recommended dose is one capsule to be inhaled once daily.

 

Patients should be given the strength containing the appropriate mometasone furoate dosage for the severity of their disease and should be regularly reassessed by a healthcare professional.

 

The maximum recommended dose is 125 mcg/260 mcg once daily.

 

Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the day. If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.

 

Special populations

Elderly population

No dose adjustment is required in elderly patients (65 years of age or older) (see section 5.2).

 

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2).

 

Hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for the use of the medicinal product in patients with severe hepatic impairment, therefore it should be used in these patients only if the expected benefit outweighs the potential risk (see section 5.2).

 

Paediatric population

The posology in patients 12 years of age and older is the same posology as in adults. The safety and efficacy in paediatric patients below 12 years of age have not been established. No data are available.

 

Method of administration

 

For inhalation use only. The capsules must not be swallowed.

 

The capsules must be administered only using the inhaler provided (see section 6.6) with each new prescription.

 

Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.

 

The capsules must only be removed from the blister immediately before use.

 

After inhalation, patients should rinse their mouth with water without swallowing (see sections 4.4 and 6.6).

 

For instructions on use of the medicinal product before administration, see section 6.6.

 


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

Deterioration of disease

 

This medicinal product should not be used to treat acute asthma symptoms, including acute episodes of bronchospasm, for which a short‑acting bronchodilator is required. Increasing use of short‑acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.

 

Patients should not stop treatment without physician supervision since symptoms may recur after discontinuation.

 

It is recommended that treatment with this medicinal product should not be stopped abruptly. If patients find the treatment ineffective, they should continue treatment but must seek medical attention. Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy. Sudden and progressive deterioration in the symptoms of asthma is potentially life‑threatening and the patient should undergo urgent medical assessment.

 

Hypersensitivity

 

Immediate hypersensitivity reactions have been observed after administration of this medicinal product. If signs suggesting allergic reactions occur, in particular angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.

 

Paradoxical bronchospasm

 

As with other inhalation therapy, administration of this medicinal product may result in paradoxical bronchospasm, which can be life‑threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.

 

Cardiovascular effects of beta agonists

 

Like other medicinal products containing beta2‑adrenergic agonists, this medicinal product may produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure and/or symptoms. If such effects occur, treatment may need to be discontinued.

 

This medicinal product should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2‑adrenergic agonists.

 

Patients with unstable ischaemic heart disease, a history of myocardial infarction in last 12 months, New York Heart Association (NYHA) class III/IV left ventricular failure, arrhythmia, uncontrolled hypertension, cerebrovascular disease or history of long QT syndrome and patients being treated with medicinal products known to prolong QTc were excluded from studies in the indacaterol/mometasone furoate clinical development programme. Thus safety outcomes in these populations are considered unknown.

 

While beta2‑adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, the clinical significance of these observations is unknown.

 

Long‑acting beta2‑adrenergic agonists (LABA) or LABA‑containing combination products such as Atectura Breezhaler should therefore be used with caution in patients with known or suspected prolongation of the QT interval or who are being treated with medicinal products affecting the QT interval.

 

Hypokalaemia with beta agonists

 

Beta2‑adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe asthma hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias (see section 4.5).

 

Clinically relevant hypokalaemia has not been observed in clinical studies of indacaterol/mometasone furoate at the recommended therapeutic dose.

 

Hyperglycaemia

 

Inhalation of high doses of beta2‑adrenergic agonists and corticosteroids may produce increases in plasma glucose. Upon initiation of treatment, plasma glucose should be monitored more closely in diabetic patients.

 

This medicinal product has not been investigated in patients with Type I diabetes mellitus or uncontrolled Type II diabetes mellitus.

 

Prevention of oropharyngeal infections

 

In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose.

 

Systemic effects of corticosteroids

 

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.

 

Possible systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, glaucoma, and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is therefore important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

 

Visual disturbance may be reported with systemic and topical (including intranasal, inhaled and intraocular) corticosteroid use. Patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances, 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.

 

This medicinal product should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.

 

Excipients

 

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose‑galactose malabsorption should not take this medicinal product.

 


No specific interaction studies were conducted with indacaterol/mometasone furoate. Information on the potential for interactions is based on the potential for each of the monotherapy components.

 

Medicinal products known to prolong the QTc interval

 

Like other medicinal products containing a beta2‑adrenergic agonist, this medicinal product should be administered with caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants or medicinal products known to prolong the QT interval, as any effect of these on the QT interval may be potentiated. Medicinal products known to prolong the QT interval may increase the risk of ventricular arrhythmia (see sections 4.4 and 5.1).

 

Hypokalaemic treatment

 

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids or non‑potassium‑sparing diuretics may potentiate the possible hypokalaemic effect of beta2‑adrenergic agonists (see section 4.4).

 

Beta‑adrenergic blockers

 

Beta‑adrenergic blockers may weaken or antagonise the effect of beta2‑adrenergic agonists. Therefore, this medicinal product should not be given together with beta‑adrenergic blockers unless there are compelling reasons for their use. Where required, cardioselective beta‑adrenergic blockers should be preferred, although they should be administered with caution.

 

Interaction with CYP3A4 and P‑glycoprotein inhibitors

 

Inhibition of CYP3A4 and P‑glycoprotein (P‑gp) has no impact on the safety of therapeutic doses of Atectura Breezhaler.

 

Inhibition of the key contributors of indacaterol clearance (CYP3A4 and P‑gp) or mometasone furoate clearance (CYP3A4) raises the systemic exposure of indacaterol or mometasone furoate up to two‑fold.

 

Due to the very low plasma concentration achieved after inhaled dosing, clinically significant interactions with mometasone furoate are unlikely. However, there may be a potential for increased systemic exposure to mometasone furoate when strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, nelfinavir, ritonavir, cobicistat) are co‑administered.

 

Other long‑acting beta2‑adrenergic agonists

 

The co‑administration of this medicinal product with other medicinal products containing long‑acting beta2‑adrenergic agonists has not been studied and is not recommended as it may potentiate adverse reactions (see sections 4.8 and 4.9).

 


Pregnancy

 

There are insufficient data from the use of Atectura Breezhaler or its individual components (indacaterol and mometasone furoate) in pregnant women to determine whether there is a risk.

 

Indacaterol was not teratogenic in rats and rabbits following subcutaneous administration (see section 5.3). In animal reproduction studies with pregnant mice, rats and rabbits, mometasone furoate caused increased foetal malformations and decreased foetal survival and growth.

 

Like other medicinal products containing beta2‑adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.

 

This medicinal product should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.

 

Breast‑feeding

 

There is no information available on the presence of indacaterol or mometasone furoate in human milk, on the effects on a breast‑fed infant, or on the effects on milk production. Other inhaled corticosteroids similar to mometasone furoate are transferred into human milk. Indacaterol (including its metabolites) and mometasone furoate have been detected in the milk of lactating rats.

 

A decision must be made whether to discontinue breast‑feeding or to discontinue/abstain from therapy, taking into account the benefit of breast‑feeding for the child and the benefit of therapy for the woman.

 

Fertility

 

Reproduction studies and other data in animals did not indicate a concern regarding fertility in either males or females.


This medicinal product has no or negligible influence on the ability to drive and use machines.


Summary of the safety profile

 

The most common adverse reactions over 52 weeks were asthma (exacerbation) (26.9%), nasopharyngitis (12.9%), upper respiratory tract infection (5.9%) and headache (5.8%).

 

Tabulated list of adverse reactions

 

Adverse drug reactions (ADRs) are listed by MedDRA system organ class (Table 1). The frequency of the ADRs is based on the PALLADIUM study. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

 

Table 1 Adverse reactions

 

System organ class

Adverse reactions

Frequency category

Infections and infestations

Nasopharyngitis

Very common

Upper respiratory tract infection

Common

Candidiasis*1

Uncommon

Immune system disorders

Hypersensitivity*2

Common

Angioedema*3

Uncommon

Metabolism and nutrition disorders

Hyperglycaemia*4

Uncommon

Nervous system disorders

Headache*5

Common

Eye disorders

Vision blurred

Uncommon

Cataract*6

Uncommon

Cardiac disorders

Tachycardia*7

Uncommon

Respiratory, thoracic and mediastinal disorders

Asthma (exacerbation)

Very common

Oropharyngeal pain*8

Common

Dysphonia

Common

Skin and subcutaneous tissue disorders

Rash*9

Uncommon

Pruritus*10

Uncommon

Musculoskeletal and connective tissue disorders

Musculoskeletal pain*11

Common

Muscle spasms

Uncommon

*              Indicates grouping of preferred terms (PTs):

1 Oral candidiasis, oropharyngeal candidiasis.

2 Drug eruption, drug hypersensitivity, hypersensitivity, rash, rash erythematous, rash pruritic, urticaria.

3 Allergic oedema, angioedema, periorbital swelling, swelling of eyelid.

4 Blood glucose increased, hyperglycaemia.

5 Headache, tension headache.

6 Cataract, cataract cortical.

7 Heart rate increased, tachycardia, sinus tachycardia, supraventricular tachycardia.

8 Oral pain, oropharyngeal discomfort, oropharyngeal pain, throat irritation, odynophagia.

9 Drug eruption, rash, rash erythematous, rash pruritic.

10 Anal pruritus, eye pruritus, nasal pruritus, pruritus, pruritus genital.

11 Back pain, musculoskeletal pain, myalgia, neck pain, musculoskeletal chest pain.

 

To report any side effect(s):

•   Saudi Arabia

 

-   Saudi Food and Drug Authority National Pharmacovigilance Center (NPC):

o Fax: +966112057662

o Call NPC at +966-11-2038222, Exts: 2317-2356-2340.

o Toll free phone: 8002490000

o SFDA call center: 19999

o E-mail: npc.drug@sfda.gov.sa

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

 

-   Patient Safety Department Novartis Consulting AG - Saudi Arabia:

o Toll Free Number: 8001240078

o Phone: +966112658100

o Fax: +966112658107

o Email: adverse.events@novartis.com

 

•    Other GCC States:

-  Please contact the relevant competent authority.

 


General supportive measures and symptomatic treatment should be initiated in cases of suspected overdose.

 

An overdose will likely produce signs, symptoms or adverse effects associated with the pharmacological actions of the individual components (e.g. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia, suppression of hypothalamic pituitary adrenal axis function).

 

Use of cardioselective beta blockers may be considered for treating beta2‑adrenergic effects, but only under the supervision of a physician and with extreme caution, since the use of beta2‑adrenergic blockers may provoke bronchospasm. In serious cases, patients should be hospitalised.

 


Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK14

 

Mechanism of action

 

This medicinal product is a combination of indacaterol, a long‑acting beta2‑adrenergic agonist (LABA), and mometasone furoate, an inhaled synthetic corticosteroid (ICS).

 

Indacaterol

The pharmacological effects of beta2‑adrenoceptor agonists, including indacaterol, are at least in part attributable to increased cyclic‑3’, 5’‑adenosine monophosphate (cyclic AMP) levels, which cause relaxation of bronchial smooth muscle.

 

When inhaled, indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a partial agonist at the human beta2‑adrenergic receptor with nanomolar potency. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action.

 

Although beta2‑adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1‑receptors are the predominant receptors in the human heart, there are also beta2‑adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors.

 

Mometasone furoate

Mometasone furoate is a synthetic corticosteroid with high affinity for glucocorticoid receptors and local anti‑inflammatory properties. In vitro, mometasone furoate inhibits the release of leukotrienes from leukocytes of allergic patients. In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL‑1, IL‑5, IL‑6 and TNF‑alpha. It is also a potent inhibitor of leukotriene production and of the production of the Th2 cytokines IL‑4 and IL‑5 from human CD4+ T‑cells.

 

Pharmacodynamic effects

 

The pharmacodynamic response profile of this medicinal product is characterised by rapid onset of action within 5 minutes after dosing and sustained effect over the 24‑hour dosing interval, as evidenced by improvements in trough forced expiratory volume in the first second (FEV1) improvements versus comparators 24 hours after dosing.

 

No tachyphylaxis to the lung function benefits of this medicinal product was observed over time.

 

QTc interval

The effect of this medicinal product on the QTc interval has not been evaluated in a thorough QT (TQT) study. For mometasone furoate, no QTc‑prolonging properties are known.

 

Clinical efficacy and safety

 

Two phase III randomised, double‑blind studies (PALLADIUM and QUARTZ) of different durations evaluated the safety and efficacy of Atectura Breezhaler in adult and adolescent patients with persistent asthma.

 

The PALLADIUM study was a 52‑week pivotal study evaluating Atectura Breezhaler 125 mcg/127.5 mcg once daily (N=439) and 125 mcg/260 mcg once daily (N=445) compared to mometasone furoate 400 mcg once daily (N=444) and 800 mcg per day (given as 400 mcg twice daily) (N=442), respectively. A third active control arm included subjects treated with salmeterol/fluticasone propionate 50 mcg/500 mcg twice daily (N=446). All subjects were required to have symptomatic asthma (ACQ‑7 score ≥1.5) and were on asthma maintenance therapy using an inhaled synthetic corticosteroid (ICS) with or without LABA for at least 3 months prior to study entry. At screening, 31% of patients had history of exacerbation in the previous year. At study entry, the most common asthma medications reported were medium dose of ICS (20%), high dose of ICS (7%) or low dose of ICS in combination with a LABA (69%).

 

The primary objective of the study was to demonstrate superiority of either Atectura Breezhaler 125 mcg/127.5 mcg once daily over mometasone furoate 400 mcg once daily or Atectura Breezhaler 125 mcg/260 mcg once daily over mometasone furoate 400 mcg twice daily in terms of trough FEV1 at week 26.

 

At week 26, Atectura Breezhaler 125 mcg/127.5 mcg and 125 mcg/260 mcg once daily both demonstrated statistically significant improvements in trough FEV1 and Asthma Control Questionnaire (ACQ‑7) score compared to mometasone furoate 400 mcg once or twice daily, respectively (see Table 2). Findings at week 52 were consistent with week 26.

 

Atectura Breezhaler 125 mcg/127.5 mcg and 125 mcg/260 mcg once daily both demonstrated a clinically meaningful reduction in the annual rate of moderate or severe exacerbations (secondary endpoint), compared to mometasone furoate 400 mcg once and twice daily (see Table 2).

 

Results for the most clinically relevant endpoints are described in Table 2.

 

Lung function, symptoms and exacerbations

 

Table 2       Results of primary and secondary endpoints in PALLADIUM study at weeks 26 and 52

 

Endpoint

Time point/
Duration

Atectura Breezhaler1

vs MF2

Atectura Breezhaler1

vs SAL/FP3

 

 

 

Medium dose vs

medium dose

High dose vs

high dose

High dose vs

high dose

 

Lung function

Trough FEV14

Treatment difference

P value

(95% CI)

Week 26

(primary endpoint)

211 ml

<0.001

(167, 255)

132 ml

<0.001

(88, 176)

36 ml

0.101

(‑7, 80)

 

Week 52

209 ml

<0.001

(163, 255)

136 ml

<0.001

(90, 183)

48 ml

0.040

(2, 94)

 

Mean morning peak expiratory flow (PEF)*

Treatment difference

(95% CI)

Week 52

30.2 l/min

(24.2, 36.3)

28.7 l/min

(22.7, 34.8)

13.8 l/min

(7.7, 19.8)

 

Mean evening peak expiratory flow (PEF)*

Treatment difference

(95% CI)

Week 52

29.1 l/min

(23.3, 34.8)

23.7 l/min

(18.0, 29.5)

9.1 l/min

(3.3, 14.9)

 

Symptoms

ACQ‑7

Treatment difference

P value

(95% CI)

Week 26

(key secondary endpoint)

‑0.248

<0.001

(‑0.334, ‑0.162)

‑0.171

<0.001

(‑0.257, ‑0.086)

‑0.054

0.214

(‑0.140, 0.031)

 

Week 52

‑0.266

(‑0.354, ‑0.177)

‑0.141

(‑0.229, ‑0.053)

0.010

(‑0.078, 0.098)

 

ACQ responders (percentage of patients achieving minimal clinical important difference (MCID) from baseline with ACQ ≥0.5)

Percentage

Week 26

76% vs 67%

76% vs 72%

76% vs 76%

 

Odds ratio

(95% CI)

Week 26

1.73

(1.26, 2.37)

1.31

(0.95, 1.81)

1.06

(0.76, 1.46)

 

Percentage

Week 52

82% vs 69%

78% vs 74%

78% vs 77%

 

Odds ratio

(95% CI)

Week 52

2.24

(1.58, 3.17)

1.34

(0.96, 1.87)

1.05

(0.75, 1.49)

 

Percentage of rescue medication free days*

Treatment difference

(95% CI)

Week 52

8.6

(4.7, 12.6)

9.6

(5.7, 13.6)

4.3

(0.3, 8.3)

 

Percentage of days with no symptoms*

Treatment difference

(95% CI)

Week 52

9.1

(4.6, 13.6)

5.8

(1.3, 10.2)

3.4

(‑1.1, 7.9)

 

Annualised rate of asthma exacerbations**

Moderate or severe exacerbations

AR

Week 52

0.27 vs 0.56

0.25 vs 0.39

0.25 vs 0.27

 

RR

(95% CI)

Week 52

0.47

(0.35, 0.64)

0.65

(0.48, 0.89)

0.93

(0.67, 1.29)

 

Severe exacerbations

AR

Week 52

0.13 vs 0.29

0.13 vs 0.18

0.13 vs 0.14

 

RR

(95% CI)

Week 52

0.46

(0.31, 0.67)

0.71

(0.47, 1.08)

0.89

(0.58, 1.37)

 

*          Mean value for the treatment duration

**           RR <1.00 favours indacaterol/mometasone furoate.

1           Atectura Breezhaler medium dose: 125 mcg/127.5 mcg od; high dose: 125 mcg/260 mcg od.

2                 MF: mometasone furoate medium dose: 400 mcg od; high dose: 400 mcg bid (content doses).

Mometasone furoate 127.5 mcg od and 260 mcg od in Atectura Breezhaler are comparable to mometasone furoate 400 mcg od and 800 mcg per day (given as 400 mcg bid).

3                 SAL/FP: salmeterol/fluticasone propionate high dose: 50 mcg/500 mcg bid (content dose).

4                 Trough FEV1: the mean of the two FEV1 values measured at 23 hours 15 min and 23 hours 45 min after the evening dose.

Primary endpoint (trough FEV1 at week 26) and key secondary endpoint (ACQ‑7 score at week 26) were part of confirmatory testing strategy and thus controlled for multiplicity. All other endpoints were not part of confirmatory testing strategy.

RR = rate ratio, AR = annualised rate

od = once daily, bid = twice daily

 

 

Pre‑specified pooled analysis

 

Atectura Breezhaler 125 mcg/260 mcg once daily was also studied as an active comparator in another phase III study (IRIDIUM) in which all subjects had a history of asthma exacerbation requiring systemic corticosteroids in the past year. A pre‑specified pooled analysis across the IRIDIUM and PALLADIUM studies was conducted to compare Atectura Breezhaler 125 mcg/260 mcg once daily to salmeterol/fluticasone 50 mcg/500 mcg twice daily for the endpoints of trough FEV1 and ACQ‑7 at week 26 and annualised rate of exacerbations. The pooled analysis demonstrated that Atectura Breezhaler improved trough FEV1 by 43 ml (95% CI: 17, 69) and ACQ‑7 score by ‑0.091 (95% CI: ‑0.153, ‑0.030) at week 26 and reduced the annualised rate of moderate or severe asthma exacerbations by 22% (RR: 0.78; 95% CI: 0.66, 0.93) and of severe exacerbations by 26% (RR: 0.74; 95% CI: 0.61, 0.91) versus salmeterol/fluticasone.

 

The QUARTZ study was a 12‑week study evaluating Atectura Breezhaler 125 mcg/62.5 mcg once daily (N=398) compared to mometasone furoate 200 mcg once daily (N=404). All subjects were required to be symptomatic and on asthma maintenance therapy using a low‑dose ICS (with or without LABA) for at least 1 month prior to study entry. At study entry, the most common asthma medications reported were low‑dose ICS (43%) and LABA/low‑dose ICS (56%). The primary endpoint of the study was to demonstrate superiority of Atectura Breezhaler 125 mcg/62.5 mcg once daily over mometasone furoate 200 mcg once daily in terms of trough FEV1 at week 12.

 

Atectura Breezhaler 125 mcg/62.5 mcg once daily demonstrated a statistically significant improvement in baseline trough FEV1 at week 12 and Asthma Control Questionnaire (ACQ‑7) score compared to mometasone furoate 200 mcg once daily.

 

Results for the most clinically relevant endpoints are described in Table 3.

 

Table 3       Results of primary and secondary endpoints in QUARTZ study at week 12

 

Endpoints

Atectura Breezhaler low dose* vs

MF low dose**

Lung function

Trough FEV1 (primary endpoint)***

Treatment difference

P value

(95% CI)

182 ml

<0.001

(148, 217)

Mean morning peak expiratory flow (PEF)

Treatment difference

(95% CI)

27.2 l/min

(22.1, 32.4)

Evening peak expiratory flow (PEF)

Treatment difference

(95% CI)

26.1 l/min

(21.0, 31.2)

Symptoms

ACQ‑7 (key secondary endpoint)

Treatment difference

P value

(95% CI)

‑0.218

<0.001

(‑0.293, ‑0.143)

Percentage of patients achieving MCID from baseline with ACQ ≥0.5

Percentage

Odds ratio

(95% CI)

75% vs 65%

1.69

(1.23, 2.33)

Percentage of rescue medication free days

Treatment difference

(95% CI)

8.1

(4.3, 11.8)

Percentage of days with no symptoms

Treatment difference

(95% CI)

2.7

 (‑1.0, 6.4)

*        Atectura Breezhaler low dose: 125/62.5 mcg od.

**        MF: mometasone furoate low dose: 200 mcg od (content dose).

Mometasone furoate 62.5 mcg in Atectura Breezhaler od is comparable to mometasone furoate 200 mcg od (content dose).

***    Trough FEV1: the mean of the two FEV1 values measured at 23 hours 15 min and 23 hours 45 min after the evening dose.

od = once daily, bid = twice daily

 

Paediatric population

 

In the PALLADIUM study, which included 106 adolescents (12‑17 years old), the improvements in trough FEV1 at week 26 were 0.173 litres (95% CI: ‑0.021, 0.368) for Atectura Breezhaler 125 mcg/260 mcg once daily vs mometasone furoate 800 mcg (i.e. high doses) and 0.397 litres (95% CI: 0.195, 0.599) for Atectura Breezhaler 125 mcg/127.5 mcg once daily vs mometasone furoate 400 mcg once daily (i.e. medium doses).

 

In the QUARTZ study, which included 63 adolescents (12‑17 years old), the Least Square means treatment difference for trough FEV1 at day 85 (week 12) was 0.251 litres (95% CI: 0.130, 0.371).

 

For the adolescent subgroups, improvements in lung function, symptoms and exacerbation reductions were consistent with the overall population.

 

The European Medicines Agency has deferred the obligation to submit the results of studies with indacaterol/mometasone furoate in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).

 


Absorption

 

Following inhalation of Atectura Breezhaler, the median time to reach peak plasma concentrations of indacaterol and mometasone furoate was approximately 15 minutes and 1 hour, respectively.

 

Based on the in vitro performance data, the dose of each of the monotherapy components delivered to the lung is expected to be similar for the indacaterol/mometasone furoate combination and the monotherapy products. Steady‑state plasma exposure to indacaterol and mometasone furoate after inhalation of the combination was similar to the systemic exposure after inhalation of indacaterol maleate or mometasone furoate as monotherapy products.

 

Following inhalation of the combination, the absolute bioavailability was estimated to be about 45% for indacaterol and less than 10% for mometasone furoate.

 

Indacaterol

Indacaterol concentrations increased with repeated once‑daily administration. Steady state was achieved within 12 to 14 days. The mean accumulation ratio of indacaterol, i.e. AUC over the 24‑h dosing interval on day 14 compared to day 1, was in the range of 2.9 to 3.8 for once‑daily inhaled doses between 60 and 480 mcg (delivered dose). Systemic exposure results from a composite of pulmonary and gastrointestinal absorption; about 75% of systemic exposure was from pulmonary absorption and about 25% from gastrointestinal absorption.

 

Mometasone furoate

Mometasone furoate concentrations increased with repeated once‑daily administration via the Breezhaler inhaler. Steady state was achieved after 12 days. The mean accumulation ratio of mometasone furoate, i.e. AUC over the 24‑h dosing interval on day 14 compared to day 1, was in the range of 1.61 to 1.71 for once‑daily inhaled doses between 62.5 and 260 mcg as part of the indacaterol/mometasone furoate combination.

 

Following oral administration of mometasone furoate, the absolute oral systemic bioavailability of mometasone furoate was estimated to be very low (<2%).

 

Distribution

 

Indacaterol

After intravenous infusion the volume of distribution (Vz) of indacaterol was 2,361 to 2,557 litres, indicating an extensive distribution. The in vitro human serum and plasma protein binding were 94.1 to 95.3% and 95.1 to 96.2%, respectively.

 

Mometasone furoate

After intravenous bolus administration, the Vd is 332 litres. The in vitro protein binding for mometasone furoate is high, 98% to 99% in concentration range of 5 to 500 ng/ml.

 

Biotransformation

 

Indacaterol

After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting for about one third of total drug‑related AUC over 24 hours. A hydroxylated derivative was the most prominent metabolite in serum. Phenolic O‑glucuronides of indacaterol and hydroxylated indacaterol were further prominent metabolites. A diastereomer of the hydroxylated derivative, an N‑glucuronide of indacaterol, and C‑ and N‑dealkylated products were further metabolites identified.

 

In vitro investigations indicated that UGT1A1 was the only UGT isoform that metabolised indacaterol to the phenolic O‑glucuronide. The oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6 and CYP3A4. CYP3A4 is concluded to be the predominant isoenzyme responsible for hydroxylation of indacaterol. In vitro investigations further indicated that indacaterol is a low‑affinity substrate for the efflux pump P‑gp.

 

In vitro the UGT1A1 isoform is a major contributor to the metabolic clearance of indacaterol. However, as shown in a clinical study in populations with different UGT1A1 genotypes, systemic exposure to indacaterol is not significantly affected by the UGT1A1 genotype.

 

Mometasone furoate

The portion of an inhaled mometasone furoate dose that is swallowed and absorbed in the gastrointestinal tract undergoes extensive metabolism to multiple metabolites. There are no major metabolites detectable in plasma. In human liver microsomes mometasone furoate is metabolised by CYP3A4.

 

Elimination

 

Indacaterol

In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via urine was generally lower than 2% of the dose. Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour. Compared with the serum clearance of indacaterol of 18.8 to 23.3 litres/hour, it is evident that renal clearance plays a minor role (about 2 to 6% of systemic clearance) in the elimination of systemically available indacaterol.

 

In a human ADME study in which indacaterol was given orally, the faecal route of excretion was dominant over the urinary route. Indacaterol was excreted into human faeces primarily as unchanged parent substance (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% of the dose). Mass balance was complete with ≥90% of the dose recovered in the excreta.

 

Indacaterol serum concentrations declined in a multi‑phasic manner with an average terminal half‑life ranging from 45.5 to 126 hours. The effective half‑life, calculated from the accumulation of indacaterol after repeated dosing, ranged from 40 to 52 hours which is consistent with the observed time to steady state of approximately 12 to 14 days.

 

Mometasone furoate

After intravenous bolus administration, mometasone furoate has a terminal elimination T½ of approximately 4.5 hours. A radiolabelled, orally inhaled dose is excreted mainly in the faeces (74%) and to a lesser extent in the urine (8%).

 

Interactions

 

Concomitant administration of orally inhaled indacaterol and mometasone furoate under steady‑state conditions did not affect the pharmacokinetics of either active substance.

 

Linearity/non‑linearity

 

Systemic exposure of mometasone furoate increased in a dose proportional manner following single and multiple doses of Atectura Breezhaler 125 mcg/62.5 mcg and 125 mcg/260 mcg in healthy subjects. A less than proportional increase in steady‑state systemic exposure was noted in patients with asthma over the dose range of 125 mcg/62.5 mcg to 125 mcg/260 mcg. Dose proportionality assessments were not performed for indacaterol as only one dose was used across all dose strengths.

 

Paediatric population

 

Atectura Breezhaler may be used in adolescent patients (12 years of age and older) at the same posology as in adults.

 

Special populations

 

A population pharmacokinetic analysis in patients with asthma after inhalation of indacaterol/mometasone furoate indicated no significant effect of age, gender, body weight, smoking status, baseline estimated glomerular filtration rate (eGFR) and FEV1 at baseline on the systemic exposure to indacaterol and mometasone furoate.

 

Patients with renal impairment

Due to the very low contribution of the urinary pathway to total body elimination of indacaterol and mometasone furoate, the effects of renal impairment on their systemic exposure have not been investigated (see section 4.2).

 

Patients with hepatic impairment

The effect of indacaterol/mometasone furoate has not been evaluated in subjects with hepatic impairment. However, studies have been conducted with the monotherapy components (see section 4.2).

 

Indacaterol

Patients with mild and moderate hepatic impairment showed no relevant changes in Cmax or AUC of indacaterol, nor did protein binding differ between mild and moderate hepatic impaired subjects and their healthy controls. No data are available for subjects with severe hepatic impairment.

 

Mometasone furoate

A study evaluating the administration of a single inhaled dose of 400 mcg mometasone furoate by dry powder inhaler to subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment resulted in only 1 or 2 subjects in each group having detectable peak plasma concentrations of mometasone furoate (ranging from 50 to 105 pcg/ml). The observed peak plasma concentrations appear to increase with severity of hepatic impairment; however, the numbers of detectable levels (assay lower limit of quantification was 50 pcg/ml) were few.

 

Other special populations

There were no major differences in total systemic exposure (AUC) for both compounds between Japanese and Caucasian subjects. Insufficient pharmacokinetic data are available for other ethnicities or races.

 


The non‑clinical assessments of each monotherapy and of the combination product are presented below.

 

Indacaterol and mometasone furoate combination

 

The findings during the 13‑week inhalation toxicity studies were predominantly attributable to the mometasone furoate component and were typical pharmacological effects of glucocorticoids. Increased heart rates associated with indacaterol were apparent in dogs after administration of indacaterol/mometasone furoate or indacaterol alone.

 

Indacaterol

 

Effects on the cardiovascular system attributable to the beta2‑agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs. Mild irritation of the nasal cavity and larynx was seen in rodents.

 

Genotoxicity studies did not reveal any mutagenic or clastogenic potential.

 

Carcinogenicity was assessed in a two‑year rat study and a six‑month transgenic mouse study. Increased incidences of benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent with similar findings reported for other beta2‑adrenergic agonists. No evidence of carcinogenicity was seen in mice.

 

All these findings occurred at exposures sufficiently in excess of those anticipated in humans.

 

Following subcutaneous administration in a rabbit study, adverse effects of indacaterol with respect to pregnancy and embryonal/foetal development could only be demonstrated at doses more than 500‑fold those achieved following daily inhalation of 150 mcg in humans (based on AUC0‑24 h).

 

Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri‑ and post‑natal developmental rat study at an exposure 14‑fold higher than in humans treated with indacaterol. Indacaterol was not embryotoxic or teratogenic in rats or rabbits.

 

Mometasone furoate

 

All observed effects are typical of the glucocorticoid class of compounds and are related to exaggerated pharmacological effects of glucocorticoids. Mometasone furoate showed no genotoxic activity in a standard battery of in vitro and in vivo tests.

 

In carcinogenicity studies in mice and rats, inhaled mometasone furoate demonstrated no statistically significant increase in the incidence of tumours.

 

Like other glucocorticoids, mometasone furoate is a teratogen in rodents and rabbits. Effects noted were umbilical hernia in rats, cleft palate in mice and gallbladder agenesis, umbilical hernia and flexed front paws in rabbits. There were also reductions in maternal body weight gains, effects on foetal growth (lower foetal body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in mice. In studies of reproductive function, subcutaneous mometasone furoate at 15 mcg/kg prolonged gestation and difficult labour occurred, with a reduction in offspring survival and body weight.

 


Capsule content

 

Lactose monohydrate

 

Capsule shell

 

Gelatin

Printing ink


Not applicable.


24 months.

Store in the original package in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions.


Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel.

 

PA/Alu/PVC – Alu perforated unit‑dose blister. Each blister contains 10 hard capsules.

 

Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules

 

Single pack containing 10 x 1 or 30 x 1 hard capsules, together with 1 inhaler.

Multipacks containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.

Multipacks containing 150 (15 packs of 10 x 1) hard capsules and 15 inhalers.

 

Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules

 

Single pack containing 10 x 1 or 30 x 1 hard capsules, together with 1 inhaler.

Multipacks containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.

Multipacks containing 150 (15 packs of 10 x 1) hard capsules and 15 inhalers.

 

Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules

 

Single pack containing 10 x 1 or 30 x 1 hard capsules, together with 1 inhaler.

Multipacks containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.

Multipacks containing 150 (15 packs of 10 x 1) hard capsules and 15 inhalers.

 

Not all pack sizes may be marketed.


The inhaler provided with each new prescription should be used. The inhaler in each pack should be disposed of after all capsules in that pack have been used.

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

Instructions for handling and use

 

Please read the full Instructions for Use before using the Atectura Breezhaler.

 

Insert

Pierce and release

Inhale deeply

Check capsule is empty

Arrow: Down: 1

Arrow: Down: 2

Arrow: Down: 3

Arrow: Down: Check

 

 

 

 

 

 

 

 

 

 

 

Step 1a:

Pull off cap

Step 2a:

Pierce capsule once

Hold the inhaler upright.

Pierce capsule by firmly pressing both side buttons at the same time.

Step 3a:

Breathe out fully

Do not blow into the inhaler.

Check capsule is empty

Open the inhaler to see if any powder is left in the capsule.

You should hear a noise as the capsule is pierced.

Only pierce the capsule once.

If there is powder left in the capsule:

·         Close the inhaler.

·         Repeat steps 3a to 3d.

Step 1b:

Open inhaler

Step 2b:

Release side buttons

Step 3b:

Inhale medicine deeply

Hold the inhaler as shown in the picture.

Place the mouthpiece in your mouth and close your lips firmly around it.

Do not press the side buttons.

Powder  Empty

remaining


 

Breathe in quickly and as deeply as you can.

During inhalation you will hear a whirring noise.

You may taste the medicine as you inhale.

Step 1c:

Remove capsule

Separate one of the blisters from the blister card.

Peel open the blister and remove the capsule.

Do not push the capsule through the foil.

Do not swallow the capsule.

 

Step 3c:

Hold breath

Hold your breath for up to 5 seconds.

 

 

Step 3d:

Rinse mouth

Rinse your mouth with water after each dose and spit it out.

Remove empty capsule

Put the empty capsule in your household waste.

 

Close the inhaler and replace the cap.

Step 1d:

Insert capsule

Never place a capsule directly into the mouthpiece.

 

 

 

Important Information

·   Atectura Breezhaler capsules must always be stored in the blister card and only removed immediately before use.

·   Do not push the capsule through the foil to remove it from the blister.

·   Do not swallow the capsule.

·   Do not use the Atectura Breezhaler capsules with any other inhaler.

·   Do not use the Atectura Breezhaler inhaler to take any other capsule medicine.

·   Never place the capsule into your mouth or the mouthpiece of the inhaler.

·   Do not press the side buttons more than once.

·   Do not blow into the mouthpiece.

·   Do not press the side buttons while inhaling through the mouthpiece.

·   Do not handle capsules with wet hands.

·   Never wash your inhaler with water.

Step 1e:

Close inhaler

Mouthpiece

 

Your Atectura Breezhaler Inhaler pack contains:

·         One Atectura Breezhaler inhaler

·        

Capsule chamber

Mouthpiece

One or more blister cards, each containing 10 Atectura Breezhaler capsules to be used in the inhaler

 

 
 

Cap

 

 

 

Base

Side buttons

Screen

Blister

Inhaler base

Blister card

Inhaler

 

Frequently Asked Questions

 

Why didn’t the inhaler make a noise when I inhaled?

The capsule may be stuck in the capsule chamber. If this happens, carefully loosen the capsule by tapping the base of the inhaler. Inhale the medicine again by repeating steps 3a to 3d.

 

What should I do if there is powder left inside the capsule?

You have not received enough of your medicine. Close the inhaler and repeat steps 3a to 3d.

 

I coughed after inhaling – does this matter?

This may happen. As long as the capsule is empty you have received enough of your medicine.

 

I felt small pieces of the capsule on my tongue – does this matter?

This can happen. It is not harmful. The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once.

Cleaning the inhaler

Wipe the mouthpiece inside and outside with a clean, dry, lint‑free cloth to remove any powder residue. Keep the inhaler dry. Never wash your inhaler with water.

Disposing of the inhaler after use

Each inhaler should be disposed of after all capsules have been used. Ask your pharmacist how to dispose of medicines and inhalers that are no longer required.

 

 


The Marketing Authorization Holder for this Product is Novartis Pharma AG. www.Novartis.com

06/2020 by EMA
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