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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)

Losec gastro-resistant tablets contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
Losec is used to treat the following conditions:
In adults:

• ‘Gastro-esophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and ≥ 10 kg

‘Gastro-esophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.


Do not take Losec:
• If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Losec.
• If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (for HIV infection).


If you are not sure, talk to your doctor or pharmacist before taking Losec.

Take special care with Losec:
Losec may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Losec or while you are taking it, talk to your doctor straight away:
• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
• You have severe liver problems.

If you take Losec on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Taking a proton pump inhibitor like Losec, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is because Losec can affect the way some medicines work and some medicines can have an effect on Losec.
Do not take Losec if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:
• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus).
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Losec.
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Losec.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infections)
• Tacrolimus (in cases of organ transplantation)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Losec treatment.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Losec to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Taking Losec with food and drink:
You can take your tablets with food or on an empty stomach.
Pregnancy and breast-feeding:
Before taking Losec, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Losec during this time.

Your doctor will decide whether you can take Losec if you are breastfeeding.


Driving and using machines:
Losec is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.


Important information about some of the ingredients of Losec:
Losec gastro-resistant tablets contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


Always take Losec exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition and how old you are.
The usual doses are given below.

Adults:
To treat symptoms of GERD such as heartburn and acid regurgitation:
• If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.
• The usual dose once the gullet has healed is 10 mg once a day.
• If your gullet has not been damaged, the usual dose is 10 mg once a day.


To treat ulcers in the upper part of the intestine (duodenal ulcer):
• The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.


To treat ulcers in the stomach (gastric ulcer):
• The usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.


To prevent the duodenal and stomach ulcers from coming back:
• The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
• The usual dose is 20 mg once a day for 4 to 8 weeks.


To prevent duodenal and stomach ulcers if you are taking NSAIDs:
• The usual dose is 20 mg once a day.


To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• The usual dose is 20 mg Losec twice a day for one week.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.


To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
• The usual dose is 60 mg daily.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Children:
To treat symptoms of GERD such as heartburn and acid regurgitation:
• Children over 1 year of age and with a body weight of more than 10 kg may take Losec. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• Children aged over 4 years may take Losec. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine:
• It is recommended that you take your tablets in the morning.
• You can take your tablets with food or on an empty stomach.
• Swallow your tablets whole with half a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you or your child have trouble swallowing the tablets:
• If you or your child have trouble swallowing the tablets:
- Break the tablet and disperse it in a spoonful of water (non-fizzy), any acidic fruit juice
(e.g. apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.

To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. Do not use milk or fizzy water. The solid pieces contain the medicine - do not chew or crush them.
If you take more Losec than you should:
- If you take more Losec than prescribed by your doctor, talk to your doctor or pharmacist straight away.
If you forget to take Losec :
- If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.


Like all medicines, Losec can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Losec and contact a doctor immediately:
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may occur with certain frequencies, which are defined as follows:

Very common:affects more than 1 user in 10
Common:affects 1 to 10 users in 100
Uncommon:affects 1 to 10 users in 1,000
Rare:affects 1 to 10 users in 10,000
Very rare:affects less than 1 user in 10,000
Not known:frequency cannot be estimated from the available data

Other side effects include:
Common side effects:
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects:

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.

Rare side effects:
• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects:
• Changes in blood count including agranulocytosis (lack of white blood cells)
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness.
• Enlarged breasts in men.

Not known:
• Inflammation in the gut (leading to diarrhoea).
• If you are on Losec for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Losec may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Store this blister in the original package or keep the bottle tightly closed in order to protect from moisture.
• Do not use Losec after the expiry date which is stated on the outer and inner pack after EXP. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


- The active substance is omeprazole. Losec gastro-resistant tablets contain omeprazole magnesium corresponding to 10 mg, 20 mg or 40 mg omeprazole.
- The other ingredients are cellulose microcrystalline, glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent, sugar spheres, synthetic paraffin (NF), macrogol (polyethylene glycol 6000), polysorbate 80, crospovidone, sodium hydroxide (for pH- adjustment), sodium stearyl fumarate, talc, triethyl citrate, iron oxide E172, titanium dioxide E171.


• Losec 10 mg gastro-resistant tablets are light-pink with on one side and 10 mg on the other side. • Losec 20 mg gastro-resistant tablets are pink wit on one side and 20 mg on the other side. • Losec 40 mg gastro-resistant tablets are dark red-brown with on one side and 40 mg on the other side. Pack sizes: • 10 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets. o Blisters of 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets. o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets. • 20 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140 , 200, 280 tablets. o Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of 560 tablets. o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets. • 40 mg: o HDPE bottles of 7, 14, 15, 28, 30, 100 tablets. o Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 100 tablets; hospital pack of 560 tablets. o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1tablets. Not all pack sizes may be marketed.

AstraZeneca AB
SE-151 85 Södertälje
Södertälje
Sweden
Tel: 0046855326000
Fax: 0046855254480


14 August , 2013
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

تحتوي أقراص لوسيك المقاومة لعصارة المعدة على مادة أميبرازول النشطة. وهي تنتمي إلى مجموعة من الأدوية يُطلق عليها "مثبطات ضخ البروتون". وهي تعمل على تقليل كمية الحمض الذي تفرزه المعدة.

يستخدم لوسيك في علاج الحالات التالية:

عند البالغين:

·             ’مرض الارتجاع المريئي المعدي (GERD). حيث يتسلل حمض من المعدة إلى المريء (الأنبوب الواصل بين الحلق والمعدة) وهو ما يسبب شعورًا بالألم والالتهاب والحرقة.

·             قرحات في الجزء العلوي من الأمعاء (قرحة الاثنى عشر) أو المعدة (قرحة المعدة).

·             قرحات ناتجة عن الإصابة ببكتيريا تسمى ’الملوية البوابية‘. إذا كنت تعاني من هذه الحالة، فقد يصف لك الطبيب مضادًا حيويًا لعلاج العدوى وإفساح المجال لعلاج القرحة.

·             القرحات الناتجة عن أدوية تسمى NSAID (أدوية مضادة للالتهابات غير الستيرويدية). يمكن استخدام لوسيك كذلك في إيقاف تكون القرحات إذا كنت تتناول أدوية NSAID.

·             الحمض الزائد جدًا بالمعدة الناتج عن تضخم البنكرياس (متلازمة زولينجر إليسون).

 

عند الأطفال:

الأطفال أكبر من عام واحد و ≥ 10 كجم

 

·             ’مرض الارتجاع المريئي المعدي‘ (GERD). حيث يتسلل حمض من المعدة إلى المريء (الأنبوب الواصل بين الحلق والمعدة) وهو ما يسبب شعورًا بالألم والالتهاب والحرقة.

قد تشمل أعراض الحالة عند الأطفال إفراغ محتوى المعدة في الفم (القلس) والشعور بالمرض (التقيؤ) وزيادة ضعيفة بالوزن.

 

الأطفال والمراهقون أكبر من 4 أعوام:

·             قرحات ناتجة عن الإصابة ببكتيريا تسمى ’الملوية البوابية‘. إذا عانى طفلك من هذه الحالة، فقد يصف الطبيب مضادات حيوية لعلاج العدوى وإفساح المجال لعلاج القرحة.

لا تتناول عقار لوسيك:

·             إذا كانت لديك حساسية (فرط حساسية) تجاه أوميبرازول أو أي من المكونات الأخرى لعقار لوسيك.

·             إذا كحساسية انت لديك تجاه الأدوية التي تحتوي على مثبطات ضخ البروتون الأخرى (مثل بانتوبرازول ولانسوبرازول ورابيبرازول وإيزومبرازول).

·             إذا كنت تتناول دواءً يحتوي على نيلفينافير (الخاص بعدوى الإيدز).

 

وإذا لم تكن متأكدًا، فتحدّث إلى طبيبك أو الصيدلي الخاص بك قبل تناول لوسيك.

 

توخّ الحرص الشديد عند تناول عقار لوسيك:

يمكن أن يؤدّي لوسيك إلى إخفاء أعراض ترتبط بأمراض أخرى. وبالتالي، إذا ما واجهت أيًا من الأعراض التالية قبل تناول لوسيك أو أثناء تناولك إياه، فتحدث إلى طبيبك على الفور:

·             فقدان الكثير من وزنك دون أي سبب والمعاناة من مشاكل في البلع.

·             الشعور بألم في المعدة أو عسر هضم.

·             بدأت بتقيّؤ الطعام أو الدم.

·             إخراج براز أسود (براز ملطخ بالدماء).

·             عانيت من إسهال شديد أو إسهال مستديم حيث يرتبط أوميبرازول بزيادة بسيطة في الإسهال المُعدي.

·             كنت تعاني من مشاكل شديدة في الكبد.

إذا كنت تتناول لوسيك على المدى الطويل (أطول من عام واحد)، فسيخضعك الطبيب للمراقبة المنتظمة. يجب عليك الإبلاغ عن أي حالات أو أعراض جديدة وغير طبيعية عند زيارتك للطبيب.

 

قد يسبب مثبط ضخ البروتون، عند تناوله لأكثر من عام، خطرًا بسيطًا على الورك أو الخصر أو العمود الفقري حيث تصبح قابلة للكسر بشكل بسيط. أخبر الطبيب إذا كنت تعاني من تخلخل العظام أو إذا كنت تتناول كورتيكوستيرويد (الذي يزيد من خطر تخلخل العظام).

 

تناول أدوية أخرى:

يرجى أن تخبر طبيبك أو الصيدلي الخاص بك إذا كنت تتناول أو تناولت مؤخرًا أي أدوية أخرى بما في ذلك الأدوية التي حصلت عليها دون وصفة طبية. ويعود ذلك إلى أنّ لوسيك قد يؤثر على طريقة عمل بعض الأدوية كما قد يكون لبعض الأدوية تأثير على لوسيك.

 

لا تتناول لوسيك إذا كنت تتناول دواءً آخر يحتوي على نيلفينافير (يُستخدَم لعلاج الإيدز).

 

أخبر طبيبك أو الصيدلي الخاص بك إذا كنت تتناول أيًا من الأدوية التالية:

·             كيتوكونازول أو إيتراكونازول أو بوزاكونازول أو فوريكونازول (المستخدمة في علاج حالات العدوى التي يتسبب فيها فطر معين).

·             ديجوكسين (المستخدم لعلاج مشاكل القلب).

·             الديازيبام (المستخدم في علاج القلق أو استرخاء العضلات أو الصرع).

·             الفنيتوين (المستخدم في الصرع). إذا كنت تتناول الفنيتوين، فسيقوم الطبيب بمراقبتك عند بدء وإيقاف تناول عقار لوسيك

·             الأدوية المستخدمة في تخثر الدم مثل وارفارين أو مثبطات فيتامين ك. قد يحتاج الطبيب إلى مراقبتك عند بدء أو إيقاف عقار لوسيك.

·             ريفامبيسين (المستخدم في علاج السل)

·             أتازانافير (المستخدم في علاج عدوى الإيدز)

·             تاكروليموس (المستخدم في حالات زراعة الأعضاء)

·             عشبه سانت جون (نبات هيوفاريقون) (المستخدم في علاج الاكتئاب البسيط)

·             سيلوستازول (المستخدم في علاج العرج المتقطع)

·             ساكينافير (المستخدم في علاج عدوى الإيدز)

·             كلوبيدوجريل (المستخدم في علاج جلطات الدم (الخثرات))

·             إيرلوتينيب (المستخدم في علاج السرطان).

·             ميثوتريكيست (علاج كيميائي يستخدم بجرعات كبيرة في علاج السرطان) – إذا كنت تتناول جرعة كبيرة من ميثوتريكيست، فقد يقوم الطبيب بإيقاف علاج لوسيك مؤقتًا.

 

إذا وصف طبيبك مضادًا حيويًا من نوع أموكسيسيلين وكلاريثرومايسين إلى جانب لوسيك لعلاج القرحات الناتجة عن عدوى الملولية البوابية، فسيكون من الهام جدًا أن تخبر الطبيب حول أي أدوية تتناولها.

 

تناول لوسيك مع الطعام والشراب:

يمكنك تناول الأقراص مع الطعام أو على معدة فارغة.

 

 

الحمل والرضاعة:

قبل تناول لوسيك أخبري طبيبك إذا كنتِ حاملاً أو تعتزمين الحمل. سيقرر الطبيب إمكانية تناول لوسيك خلال هذه الفترة.

 

سيقرر الطبيب إمكانية تناول لوسيك إذا كنتِ ترضعين طبيعيًا.

 

 

القيادة واستخدام الآلات:

من غير المرجح أن يؤثر لوسيك على قدرتك على القيادة أو استخدام أي أدوات أو آلات. قد تحدث بعض الآثار الجانبية مثل الدوار والاضطرابات البصرية (انظر قسم  4). عند الإصابة بهذه الأعراض، يجب تجنب القيادة أو تشغيل الآلات.

 

معلومات هامة حول بعض مكونات لوسيك:

تحتوي أقراص لوسيك المقاومة لعصارة المعدة على السكروز. إذا أخبرك الطبيب أنّك لا تحتمل بعض أنواع السكر، فعليك الاتصال به قبل تناول هذا المنتج الطبي.

https://localhost:44358/Dashboard

عليك تناول لوسيك دائمًا وفقًا لتوجيهات الطبيب. يتعيّن عليك التحقق من طبيبك أو الصيدلي الخاص بك إذا لم تكن متأكّدًا.

 

سيخبرك الطبيب عن كمية الأقراص التي تتناولها وطول فترة تناولها. وسيعتمد هذا على الحالة والعمر.

الجرعات العادية موضحة بالأسفل.

 

البالغون:

عليك تناول لوسيك دائمًا وفقًا لتوجيهات الطبيب. يتعيّن عليك التحقق من طبيبك أو الصيدلي الخاص بك إذا لم تكن متأكّدًا.

 

سيخبرك الطبيب عن كمية الأقراص التي تتناولها وطول فترة تناولها. وسيعتمد هذا على الحالة والعمر.

الجرعات العادية موضحة بالأسفل.

 

البالغون:

 

لعلاج أعراض GERD مثل الحرقة وقلس الأحماض:

·             إذا اكتشف الطبيب تضرر أنبوب توصيل الطعام (المريء) بشكل بسيط، فإن الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا لفترة  4- 8 أسابيع. قد يخبرك الطبيب بأن تتناول جرعة 40 ملغ لفترة 8 أسابيع أخرى إذا لم يعالج المريء حتى تلك الفترة.

·             الجرعة الاعتيادية بمجرد علاج المريء هي 10 ملغ مرة واحدة يوميًا.

·             إذا لم يتضرر المريء، فإن الجرعة الاعتيادية هي 10 ملغ مرة واحدة يوميًا.

 

لعلاج القرحات في الجزء العلوي من الأمعاء (قرحة الاثنى عشر):

·             الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا لفترة أسبوعين. قد يخبرك الطبيب أن تتناول نفس الجرعة لفترة أسبوعين إضافيين إذا لم تعالج القرحة حتى وقتها.

·             إذا لم تعالج القرحة بشكل كامل، يمكن زيادة الجرعة إلى 40 ملغ مرة واحدة يوميًا لفترة 4 أسابيع.

 

لعلاج أعراض GERD مثل الحرقة وقلس الأحماض:

·             إذا اكتشف الطبيب تضرر أنبوب توصيل الطعام (المريء) بشكل بسيط، فإن الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا لفترة  4- 8 أسابيع. قد يخبرك الطبيب بأن تتناول جرعة 40 ملغ لفترة 8 أسابيع أخرى إذا لم يعالج المريء حتى تلك الفترة.

·             الجرعة الاعتيادية بمجرد علاج المريء هي 10 ملغ مرة واحدة يوميًا.

·             إذا لم يتضرر المريء، فإن الجرعة الاعتيادية هي 10 ملغ مرة واحدة يوميًا.

 

لعلاج القرحات في الجزء العلوي من الأمعاء (قرحة الاثنى عشر):

·             الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا لفترة أسبوعين. قد يخبرك الطبيب أن تتناول نفس الجرعة لفترة أسبوعين إضافيين إذا لم تعالج القرحة حتى وقتها.

·             إذا لم تعالج القرحة بشكل كامل، يمكن زيادة الجرعة إلى 40 ملغ مرة واحدة يوميًا لفترة 4 أسابيع.

لعلاج القرحات في المعدة (قرحة المعدة):

·             الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا لفترة 4 أسابيع. قد يخبرك الطبيب أن تتناول نفس الجرعة لفترة 4 أسابيع إضافية إذا لم تعالج القرحة حتى وقتها.

·             إذا لم تعالج القرحة بشكل كامل، يمكن زيادة الجرعة إلى 40 ملغ مرة واحدة يوميًا لفترة 8 أسابيع.

 

لمنع قرحات المعدة والاثنى عشر من العودة:

·             الجرعة الاعتيادية هي 10 ملغ أو 20 ملغ مرة واحدة يوميًا. قد يزيد الطبيب الجرعة إلى 40 ملغ مرة واحدة يوميًا.

 

لعلاج قرحات المعدة والاثنى عشر الناتجة عن أدوية NSAID (أدوية مضادة لالتهاب غير الستيرويدية):

·             الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا لفترة تتراوح ما بين 4 و8 أسابيع.

 

لمنع قرحات المعدة والاثنى عشر إذا كنت تتناول أدوية NSAID:

·             الجرعة الاعتيادية هي 20 ملغ مرة واحدة يوميًا.

 

لعلاج القرحات الناتجة عن عدوى الملوية البوابية ولمنعها من العودة مرة أخرى:

·             الجرعة الاعتيادية هي 20 ملغ من لوسيك مرتين يوميًا لفترة أسبوع واحد.

·             سيخبرك الطبيب أن تتناول اثنين من المضادات الحيوية من بين أموكسيسيلين وكلاريثرومايسين ومترونيدازول.

 

لعلاج الحمض الزائد جدًا بالمعدة الناتج عن تضخم البنكرياس (متلازمة زولينجر إليسون):

·             الجرعة الاعتيادية هي 60 ملغ يوميًا.

·             سيقوم الطبيب بتعديل الجرعة حسب الاحتياجات وسيقرر فترة احتياجك للدواء.

 

الأطفال:

لعلاج أعراض GERD  مثل الحرقة و قلس الأحماض :

  • الأطفال الذين يبلغون من العمر عاماً و  وزن أجسامهم أكثر من 10 كيلوجرامات بأمكانهم تناول لوسيك. جرعة الأطفال تعتمد على وزن الطفل وسيقرر الطبيب الجرعة الصحيحة.

 

لعلاج القرحات الناتجة عن عدوى الملوية البوابية ولمنعها من العودة مرة أخرى:

  • الأطفال بعمر 4 سنوات بامكانهم تناول لوسيك. جرعة الأطفال تعتمد على وزن الطفل وسيقرر الطبيب الجرعة الصحيحة.
  • سوف يصف الطبيب أيضاً مضادين حيويين اسمهما أموكسيسيلين وكلاريثرومايسين لطفلك.

 

تناول هذا الدواء:

·             يوصى بتناول الأقراص في الصباح.

·             يمكنك تناول الأقراص مع الطعام أو على معدة فارغة.

·             ابتلع القرص كاملاً مع نصف كوب من الماء. لا تقم بمضغ القرص أو سحقه. وهذا لأن القرص يحتوي على تغليف معوي يمنع تفتت القرص بفعل أحماض المعدة. من الهام عدم إتلاف التغليف.

 

 

ماذا يحدث إذا عانيت أو عانى طفلك من مشاكل عند بلع الأقراص:

·             إذا عانيت أو عانى طفلك من مشاكل عند بلع الأقراص:

-        اكسر القرص وأذبه في ملء ملعقة من المياه (ليست غازية) أو أي عصير فواكه حمضي (مثل التفاح أو البرتقال أو الأناناس) أو عصير التفاح.

-        حرك الخليط دائمًا قبل الشرب (لن يكون الخليط صافيًا). ثم اشرب الخليط مباشرًة أو خلال فترة 30 دقيقة.

-        للتحقق من شرب كل الدواء، اغسل الكوب الزجاجي جيدًا بمقدار نصف كوب مياه واشربه. لا تستخدم الحليب أو المياه الغازية. لا تمضغ أو تكسر الأجزاء الصلبة الموجودة في الدواء.

 

إذا تناولت جرعة من لوسيك أكثر مما ينبغي:

إذا تناولت جرعة لوسيك أكثر من الجرعة الموصوفة من الطبيب، فتحدث إلى الطبيب أو الصيدلي على الفور.

 

إذا نسيت تناول لوسيك:

إذا نسيت تناول إحدى الجرعات، فتناولها بمجرد تذكُرك. ومع ذلك، إذا كان وقت الجرعة التالية قد اقترب للغاية، فلا تتناول الجرعة التي نسيتها. لا تتناول جرعة مزدوجة لتعويض جرعة فائتة.

كما هو الحال في جميع الأدوية ، يمكن أن يتسبّب لوسيك في حدوث آثار جانبية على الرغم من أنها لا تصيب جميع المستخدمين.

 

الآثار الجانبية التالية نادرة ولكنها خطرة، اذا لاحظت أيّاً منها فتوقف عن تناول عقار لوسيك واتصل على الطبيب على الفور:

·             حدوث نوبات مفاجئة من أزيز الصدر وتورم الشفتين واللسان والحلق أو الجسم أو طفح جلدي أو إغماء أو صعوبات في البلع (تفاعل تحسسي حاد).

·             احمرار الجلد مع ظهور بثور أو تقشر. وقد يكون هناك أيضًا بثور حادة ونزيف في الشفتين والعينين والفم والأنف والأعضاء التناسلية. قد يكون هذا مؤشر لمرض ’متلازمة ستيفنز - جونسون‘ أو ’تقشر الأنسجة المتمونة البشروية التسممي‘.

·             جلد مصفر وبول قاتم اللون وتعب وهي قد تكون أعراض لمشاكل في الكبد.

 

قد تحدث بعض الآثار الجانبية بدرجات متفاوتة وتكون كما يلي:

شائعة جدًا:

تؤثر في عدد مستخدم واحد من أصل 10

شائعة:

تؤثّر في عدد يتراوح من مستخدم إلى عشرة مستخدمين من أصل 100

غير شائعة:

تؤثّر في عدد يتراوح من مستخدم إلى عشرة مستخدمين من أصل 1000

نادرة:

تؤثّر في عدد يتراوح من مستخدم إلى عشرة مستخدمين من أصل 10000

نادرة جدًا:

تؤثر في عدد أقل من مستخدم واحد من أصل 10000

غير معروفة:

لا يمكن تقدير تكرارها من البيانات المتوفرة

 

تشمل الآثار الجانبية الأخرى ما يلي:

آثار جانبية شائعة:

·             الصداع.

·             يؤثر على المعدة أو الأمعاء: إسهال، ألم في المعدة، إمساك، ريح (انتفاخ البطن).

·             شعور بالمرض (غثيان) أو كونك مريضًا (تقيؤ).

 

آثار جانبية غير شائعة:

·             تورم القدم والكاحل.

·             اضطراب النوم (الأرق).

·             دوار، شعور بالوخز مثل "الدبابيس والإبر"، شعور بالنعاس.

·             شعور بالدوار.

·             تغييرات في اختبار الدم التي تجري للتحقق من عمل الكبد.

·             طفح جلدي وطفح جلدي كتلي (الشري) وحكة في الجلد.

·             الشعور بالاعتلال أو نقص الطاقة بشكل عام.

 

آثار جانبية نادرة:

·             مشاكل في الدم مثل انخفاض عدد الخلايا البيضاء أو الصفائح الدموية. يمكن أن يتسبب ذلك في الضعف أو الرضوض أو قد يزيد احتمالية الإصابة بعدوى.

·             التفاعلات التحسسية وتكون شديدة في بعض الأحيان وتشمل تورم الشفاه واللسان والحلق وحمى ونوبة.

·             مستويات منخفضة من الصوديوم في الدم. يمكن أن يتسبب ذلك في الضعف والإصابة بالمرض (التقيؤ) والتشنجات.

·             شعور بالهياج أو الارتباك أو الاكتئاب.

·             تغييرات في حاسة التذوق.

·             مشاكل إبصار مثل عدم وضوح الرؤية.

·             الشعور المفاجئ بعسر التنفس أو قصور التنفس (التشنج القصبي).

·             جفاف الفم.

·             التهاب داخل الفم.

·             الإصابة بعدوى تُسمى "القلاع" والتي يمكن أن تؤثّر في الأمعاء والتي يتسبب فيها فطر معين.

·             مشاكل في الكبد وتشمل اليرقان الذي قد يسبب اصفرار الجلد وإخراج بول قاتم وشعورًا بالتعب.

·             تساقط الشعر (الصلع).

·             طفح جلدي عند التعرض لأشعة الشمس.

·             ألم المفاصل (ألم مفصلي) أو ألم العضلات (ألم عضلي).

·             مشاكل شديدة في الكلية (التهاب الكلى الخلالي).

·             زيادة التعرّق.

 

آثار جانبية نادرة جدًا:

·             تغييرات في عدد كرات الدم ويشمل ندرة المحببات (نقص كرات الدم البيضاء)

·             عدوانية.

·             رؤية أمور غير موجودة أو الشعور بها أو سماعها (هلاوس).

·             مشاكل شديدة في الكبد تؤدي إلى فشل كبدي والتهاب في المخ.

·             ظهور مفاجئ لطفح جلدي أو تبثر أو تقشر الجلد. قد يرتبط ذلك بحمى شديدة وألم مفاصل (حمامي متعدد الأشكال، متلازمة ستيفنز - جونسون، تقشّر الأنسجة المتموّتة البَشْروية التسممي)

·             ضعف عضلي.

·             تضخم الثديين لدى الرجال.

 

غير معروفة:

·             التهاب الأمعاء (يؤدي إلى إسهال).

·             إذا كنت تتناول عقار لوسيك لأكثر من ثلاثة أشهر، فقد تقل مستويات الماغنسيوم في الدم. ويمكن التعرف على نقص مستويات الماغنسيوم من خلال الشعور التعب أو تقلصات عضلية لاإرادية أو توهان أو اختلاجات أو دوار أو زيادة سرعة ضربات القلب. إذا عانيت من أي من تلك الأعراض، فيرجى إخبار طبيبك على الفور. يمكن أن يؤدي نقص مستويات الماغنسيوم كذلك إلى نقص مستويات البوتاسيوم أو الكالسيوم في الدم. قد يقرر الطبيب إجراء اختبارات منتظمة للدم لمراقبة مستويات الماغنسيوم.

 

في حالات نادرة جدًا قد يؤثر لوسيك على خلايا الدم البيضاء مما يؤدي إلى نقص المناعة. إذا كنت تعاني من الإصابة بأعراض مثل الحمى مع انخفاض حاد في الحالة العامة أو حمى مع أعراض عدوى محلية، مثل ألم في الرقبة، أو في الحلق أو الفم أو صعوبات في التبول، فيجب استشارة الطبيب في أقرب وقت ممكن بحيث يمكن السيطرة على نقص خلايا الدم البيضاء (المحببة) من خلال فحص الدم. من الأهمية بمكان أن تحصل على معلومات بشأن علاجك في هذا الوقت.

 

لا تقلق بشأن قائمة الآثار الجانبية المحتملة هذه. فقد لا تصاب بأي منها. إذا ازدادت خطورة أي من الآثار الجانبية، أو إذا لاحظت ظهور أي آثار جانبية غير مذكورة في هذه النشرة، فيُرجى إعلام طبيبك أو الصيدلي الخاص بك.

·             احفظ العقار بعيدًا عن متناول الأطفال ورؤيتهم.

·             لا يُحفظ في درجة حرارة أعلى من ٢٥ درجة مئوية.

·             خزّن هذا الشريط في العبوة الأصلية. أو حافظ على العبوة مغلقة بإحكام لحماية الدواء من الرطوبة.

·             لا تستخدم لوسيك بعد تاريخ انتهاء صلاحيته المدون على العبوة من الخارج ومن الداخل. يشير تاريخ انتهاء الصلاحية إلى آخر يوم في الشهر المدوّن.

·             لا تتخلص من الأدوية عبر مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي الخاص بك عن كيفية التخلص من الأدوية التي لم تعد تحتاج إليها. حيث تساعد هذه الإجراءات في حماية البيئة.

 

 

-              المادة النشطة هي أوميبرازول. تحتوي أقراص لوسيك المقاومة لعصارة المعدة على أوميبرازول ماغنسيوم يعادل 10 ملغ ,  20 ملغ أو 40 ملغ أوميبرازول.

-              المكونات الأخرى هي السيليلوز بلوري مكروي وأحادي ستيرات الغليسرول 40‑55 وهيدروكسي بروبيل السيليلوز وهايبروميلوز وستيارات الماغنسيوم ومحلول حمض الميثاكريليك - بوليمر إيثيل أكريليت المشترك (1:1) 30 في المائة وكرات سكرية وبارافين اصطناعي وماكروجول (متعدد إيثيلين الغليكول 6000) وبوليسوربات 80 والكروسبوفيدون وهيدروكسيد الصوديوم (لضبط درجة الحموضة والقاعدية pH) وفومارات ستيريل الصوديوم والتلك وسترات ثلاثي الإيثيل وأكسيد الحديد E172 وثاني أكسيد التيتانيوم E171.‏

• أقراص لوسيك 10 ملغ المقاومة لعصارة المعدة بلون زهري فاتح ومطبوع على أحد جانبيها و10 ملغ على الجانب الآخر. • أقراص لوسيك 20 ملغ المقاومة لعصارة المعدة بلون زهري ومطبوع على أحد جانبيها و20 ملغ على الجانب الآخر. • أقراص لوسيك 40 ملغ المقاومة لعصارة المعدة بلون أحمر غامق ومطبوع على أحد جانبيها و 40 ملغ على الجانب الآخر. أحجام العبوات: • 10 ملغ: o عبوات HDPE تحتوي على 7, 14, 15, 28 , 30 , 50 أو 100 قرص , عبوات المستشفيات تحتوي 140 قرص. o شرائط تحتوي على 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90 أو 100 قرص , عبوات المستشفيات تحتوي 560 قرص. o شرائط الجرعة الواحدة المثقبة (عبوات المستشفيات) تحتوي 25 × 1, 28 × 1, 50 × 1 أو 56 × 1 أقراص. • 20 ملغ: o عبوات HDPE تحتوي على 7, 14, 15, 28 , 30 ,50 , 56 أو 100 قرص , عبوات المستشفيات تحتوي 140, 200 أو 280 قرص. o شرائط تحتوي على 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98 أو 100 قرص , عبوات المستشفيات تحتوي 560 قرص. o شرائط الجرعة الواحدة المثقبة (عبوات المستشفيات) تحتوي 25 × 1, 28 × 1, 50 × 1, 56 × 1 أو 100 × 1 أقراص. • 40 ملغ: o عبوات HDPE تحتوي على 7, 14, 15, 28 , 30 أو 100 قرص o شرائط تحتوي على 5, 7, 14, 15, 25, 28, 30, 50, 56, 60 أو 100 قرص , عبوات المستشفيات تحتوي 560 قرص. o شرائط الجرعة الواحدة المثقبة (عبوات المستشفيات) تحتوي 25 × 1, 28 × 1 أو 50 × 1 أقراص. ليس بالضرورة ان تكون جميع العبوات مسوّقة.

 

AstraZeneca AB

SE-151 85 Södertälje

Södertälje

Sweden

14 اغسطس 2013
 Read this leaflet carefully before you start using this product as it contains important information for you

Losec 10 mg gastro-resistant tablets Losec 20 mg gastro-resistant tablets

10 mg: Each gastro-resistant tablet contains 10.3 mg omeprazole magnesium equivalent to 10 mg omeprazole. 20 mg: Each gastro-resistant tablet contains 20.6 mg omeprazole magnesium equivalent to 20 mg omeprazole. Excipient: 10 mg: Each gastro-resistant tablet contains 19–20 mg sucrose. 20 mg: Each gastro-resistant tablet contains 19–20 mg sucrose. For a full list of excipients, see section 6.1.

Gastro-resistant tablet. Losec 10 mg gastro-resistant tablets: Light-pink, oblong, biconvex, film-coated tablets engraved with on one side and 10 mg on the other side containing enteric coated pellets. Losec 20 mg gastro-resistant tablets: Pink, oblong, biconvex, film-coated tablets, engraved with on one side and 20 mg on the other side containing enteric coated pellets.

Losec gastro-resistant tablets are indicated for:

Adults
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
• Treatment of reflux esophagitis
• Long-term management of patients with healed reflux esophagitis
• Treatment of symptomatic gastro-esophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

 

Paediatric use
Children over 1 year of age and ≥ 10 kg
• Treatment of reflux esophagitis
• Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease
Children and adolescents over 4 years of age
• In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori

 


Posology in adults
Treatment of duodenal ulcers
The recommended dose in patients with an active duodenal ulcer is Losec 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with poorly responsive duodenal ulcer Losec 40 mg once daily is recommended and healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcers
For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. pylori eradication is not possible the recommended dose is Losec 20 mg once daily. In some patients a daily dose of 10 mg may be sufficient. In case of therapy failure, the dose can be increased to 40 mg.

Treatment of gastric ulcers
The recommended dose is Losec 20 mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period. In patients with poorly responsive gastric ulcer Losec 40 mg once daily is recommended and healing is usually achieved within eight weeks.

Prevention of relapse of gastric ulcers
For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is Losec 20 mg once daily. If needed the dose can be increased to Losec 40 mg once daily.

H. pylori eradication in peptic ulcer disease
For the eradication of H. pylori the selection of antibiotics should consider the individual patient’s drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.

• Losec 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week, or
• Losec 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each twice daily for one week, or
• Losec 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or
tinidazole 500 mg), both three times a day for one week.

In each regimen, if the patient is still H. pylori positive, therapy may be repeated.
Treatment of NSAID-associated gastric and duodenal ulcers

For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is Losec
20 mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
For the prevention of NSAID associated gastric ulcers or duodenal ulcers in patients at risk (age> 60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is Losec 20 mg once daily.

Treatment of reflux esophagitis
The recommended dose is Losec 20 mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.
In patients with severe esophagitis Losec 40 mg once daily is recommended and healing is usually achieved within eight weeks.

Long-term management of patients with healed reflux esophagitis
For the long-term management of patients with healed reflux esophagitis the recommended dose is Losec 10 mg once daily. If needed, the dose can be increased to Losec 20-40 mg once daily.

Treatment of symptomatic gastro-esophageal reflux disease
The recommended dose is Losec 20 mg daily. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered. Continuously treatment in 2-3 days may be required in order to get relief of symptom. Most patients get full relief of the heartburn within 7 days. When full relief of symptom is attained the treatment should be discontinuated.
If symptom control has not been achieved after 4 weeks treatment with Losec 20 mg daily, further investigation is recommended.

Treatment of Zollinger-Ellison syndrome
In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated. The recommended initial dose is Losec 60 mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of Losec 20–120 mg daily. When dose exceed Losec 80 mg daily, the dose should be divided and given twice daily.

Posology in children
Children over 1 year of age and ≥ 10 kg

Treatment of reflux esophagitis


Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease
The posology recommendations are as follows:

AgeWeightPosology
≥ 1 year of age10-20 kg10 mg once daily. The dose can be increased to 20 mg once daily if needed
≥ 2 years of age> 20 kg20 mg once daily. The dose can be increased to 40 mg once daily if needed

Reflux esophagitis: The treatment time is 4–8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease: The treatment time is 2–4 weeks. If symptom control has not been achieved after 2–4 weeks the patient should be investigated further.

Children and adolescents over 4 years of age

Treatment of duodenal ulcer caused by H. pylori
When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.

The posology recommendations are as follows:

WeightPosology
15-30 kgCombination with two antibiotics: Losec 10 mg, amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administrated together two times daily for one week
31-40 kgCombination with two antibiotics: Losec 20 mg, amoxicillin 750 mg and clarithromycin
7.5 mg/kg body weight are all administrated two times daily for one week
> 40 kgCombination with two antibiotics: Losec 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administrated two times daily for one week.

Special populations
Impaired renal function
Dose adjustment is not needed in patients with impaired renal function (see section 5.2).

Impaired hepatic function
In patients with impaired hepatic function a daily dose of 10–20 mg may be sufficient (see section 5.2).

Elderly (> 65 years old)
Dose adjustment is not needed in the elderly (see section 5.2).

Method of administration
It is recommended to take Losec tablets in the morning, swallowed whole with half a glass of water. The tablets must not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food Patients can break the tablet and disperse it in a spoonful of non-carbonated water and if so wished, mix with some fruit juices or applesauce. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes)and always be stirred just before drinking and rinsed down with half a glass of water. DO NOT USE milk or carbonated water. The enteric-coated pellets must not be chewed.


Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients. Omeprazole like other proton pump inhibitors must not be used concomitantly with nelfinavir (see section 4.5).

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like omeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Interference with laboratory tests
Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped five days before CgA measurements.

Some children with chronic illnesses may require long-term treatment although it is not recommended.

Losec gastro-resistant tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter (see section 5.1).

As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Especially, patients over 55 years taking any ‘over-the-counter’ (OTC, non-prescription) indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.

Patients should be instructed to consult a doctor if:

• They have had previous gastric ulcer or gastrointestinal surgery
• They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
• They have jaundice or severe liver disease.
• They are aged over 55 years with new or recently changed symptoms.

Patients should not take omeprazole as a preventative medication.


Effects of omeprazole on the pharmacokinetics of other active substances

Active substances with pH dependent absorption
The decreased intragastric acidity during treatment with omeprazole might increase or decrease the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, atazanavir
The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.

Concomitant administration of omeprazole with nelfinavir is contraindicated (see section 4.3).
Co-administration of omeprazole (40 mg once daily) reduced mean nelvinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75-90%. The interaction may also involve CYP2C19 inhibition.

Concomitant administration of omeprazole with atazanavir is not recommended (see section 4.4). Concomitant administration of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a 75% decrease of the atazanavir exposure. Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300 mg/ritonavir
100 mg once daily.

Digoxin
Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported. However caution should be exercised when omeprazole is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should be then be reinforced.

Clopidogrel
In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together. In another study it was shown that administering clopidogrel and omeprazole at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19. Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from observational and clinical studies.

Other active substances
The absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and thus clinical efficacy may be impaired. For posaconazole and erlotinib concomitant use should be avoided.

Active substances metabolised by CYP2C19
Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising enzyme. Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol
Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.

Phenytoin
Monitoring phenytoin plasma concentration is recommended during the first two weeks after initiating omeprazole treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending omeprazole treatment.

Unknown mechanism

Saquinavir
Concomitant administration of omeprazole with saquinavir/ritonavir resulted in increased plasma levels up to approximately 70% for saquinavir associated with good tolerability in HIV-infected patients.

Tacrolimus
Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and dosage of tacrolimus adjusted if needed.

Methotrexate
When given together with proton pump inhibitors, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of omeprazole may need to be considered.

Effects of other active substances on the pharmacokinetics of omeprazole

Inhibitors of CYP2C19 and/or CYP3A4
Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit
CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased omeprazole serum levels by decreasing omeprazole’s rate of metabolism. Concomitant voriconazole treatment resulted in more than doubling of the omeprazole exposure. As high doses of omeprazole have been well-tolerated adjustment of the omeprazole dose is not generally required. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4
Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St John’s wort) may lead to decreased omeprazole serum levels by increasing omeprazole’s rate of metabolism.


Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can be used during pregnancy.


Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.


Losec is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machinery.


The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.


The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing. None was found to be dose-related. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency categories are defined according to the following convention: 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), Not known (cannot be estimated from the available data).

SOC/frequencyAdverse reaction
Blood and lymphatic system disorders
Rare:Leukopenia, thrombocytopenia
Very rare:Agranulocytosis, pancytopenia
Immune system disorders
Rare:Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Metabolism and nutrition disorders
Rare:Hyponatraemia
Not know:Hypomagnesaemia
Psychiatric disorders
Uncommon:Insomnia
Rare:Agitation, confusion, depression
Very rare:Aggression, hallucinations

 

Nervous system disorders
Common:Headache
Uncommon:Dizziness, paraesthesia, somnolence
Rare:Taste disturbance
Eye disorders
Rare:Blurred vision
Ear and labyrinth disorders
Uncommon:Vertigo
Respiratory, thoracic and mediastinal disorders
Rare:Bronchospasm
Gastrointestinal disorders
Common:Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting
Rare:Dry mouth, stomatitis, gastrointestinal candidiasis
Not known:Microscopic colitis
Hepatobiliary disorders
Uncommon:Increased liver enzymes
Rare:Hepatitis with or without jaundice
Very rare:Hepatic failure, encephalopathy in patients with pre-existing liver disease
Skin and subcutaneous tissue disorders
Uncommon:Dermatitis, pruritus, rash, urticaria
Rare:Alopecia, photosensitivity
Very rare:Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Musculoskeletal and connective tissue disorders
UncommonFracture of the hip, wrist or spine
Rare:Arthralgia, myalgia
Very rare:Muscular weakness
Renal and urinary disorders
Rare:Interstitial nephritis
Reproductive system and breast disorders
Very rare:Gynaecomastia
General disorders and administration site conditions
Uncommon:Malaise, peripheral oedema
Rare:Increased sweating

Paediatric population
The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive esophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long term data regarding the effects of omeprazole treatment on puberty and growth.


There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.


The symptoms described in connection to omeprazole overdose have been transient, and no serious outcome has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is symptomatic.


Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC01

Mechanism of action
Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted
mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.


Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+
K+-ATPase - the acid pump. This effect on the final step of the gastric acid formation process is
dose-dependent and provides for highly effective inhibition of both basal acid secretion and stimulated acid secretion, irrespective of stimulus.

Pharmacodynamic effects
All pharmacodynamic effects observed can be explained by the effect of omeprazole on acid secretion.
Effect on gastric acid secretion
Oral dosing with omeprazole once daily provides for rapid and effective inhibition of daytime and night- time gastric acid secretion with maximum effect being achieved within 4 days of treatment. With omeprazole 20 mg, a mean decrease of at least 80% in 24-hour intragastric acidity is then maintained in duodenal ulcer patients, with the mean decrease in peak acid output after pentagastrin stimulation being about 70% 24 hours after dosing.


Oral dosing with omeprazole 20 mg maintains an intragastric pH of ≥ 3 for a mean time of 17 hours of the 24-hour period in duodenal ulcer patients.


As a consequence of reduced acid secretion and intragastric acidity, omeprazole dose-dependently reduces/normalizes acid exposure of the esophagus in patients with gastro-esophageal reflux disease.
The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) of omeprazole and not to the actual plasma concentration at a given time.


No tachyphylaxis has been observed during treatment with omeprazole.

Effect on H. pylori
H. pylori
is associated with peptic ulcer disease, including duodenal and gastric ulcer disease. H. pylori is a major factor in the development of gastritis. H. pylori together with gastric acid are major factors in the development of peptic ulcer disease. H. pylori is a major factor in the development of atrophic gastritis which is associated with an increased risk of developing gastric cancer.

Eradication of H. pylori with omeprazole and antimicrobials is associated with high rates of healing and long-term remission of peptic ulcers
Dual therapies have been tested and found to be less effective than triple therapies. They could, however, be considered in cases where known hypersensitivity precludes use of any triple combination.

Other effects related to acid inhibition
During long-term treatment gastric glandular cysts have been reported in a somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.


Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.


Chromogranin A (CgA) also increases due to decreased gastric acidity. This CgA modifying effect can not be demonstrated five days after stopping treatment with PPIs.

Paediatric use
In a non-controlled study in children (1 to 16 years of age) with severe reflux esophagitis, omeprazole at doses of 0.7 to 1.4 mg/kg improved esophagitis level in 90% of the cases and significantly reduced reflux symptoms. In a single-blind study, children aged 0–24 months with clinically diagnosed gastro-esophageal reflux disease were treated with 0.5, 1.0 or 1.5 mg omeprazole/kg. The frequency of vomiting/regurgitation episodes decreased by 50% after 8 weeks of treatment irrespective of the dose.

Eradication of H. pylori in children
A randomised, double blind clinical study (Héliot study) concluded that omeprazole, in combination with two antibiotics (amoxicillin and clarithromycin), was safe and effective in the treatment of H. pylori infection in children age 4 years old and above with gastritis: H. pylori eradication rate: 74.2%
(23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin. However, there was no evidence of any clinical benefit with respect to dyspeptic symptoms. This study does not support any information for children aged less than 4 years.


Absorption
Omeprazole and omeprazole magnesium are acid labile and are therefore administered orally as
enteric-coated granules in capsules or tablets. Absorption of omeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose. Absorption of omeprazole takes place in the small intestine and is usually completed within 3-6 hours. Concomitant intake of food has no influence on the bioavailability. The systemic availability (bioavailability) from a single oral dose of omeprazole is approximately 40%. After repeated once-daily administration, the bioavailability increases to about 60%.

Distribution
The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight. Omeprazole is 97% plasma protein bound.


Bioequivalence between Losec capsules and Losec gastro-resistant tablets, based on both area under the omeprazole plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of omeprazole, has been demonstrated for all doses, 10 mg and 20 mg.

Distribution
The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight. Omeprazole is 97% plasma protein bound.
Bioequivalence between Losec capsules and Losec gastro-resistant tablets, based on both area under the omeprazole plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of omeprazole, has been demonstrated for all doses, 10 mg and 20 mg.

Approximately 3% of the Caucasian population and 15-20% of Asian populations lack a functional CYP2C19 enzyme and are called poor metabolisers. In such individuals the metabolism of omeprazole is probably mainly catalysed by CYP3A4. After repeated once-daily administration of 20 mg omeprazole, the mean AUC was 5 to 10 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were also higher, by 3 to 5 times. These findings have no implications for the posology of omeprazole.

Excretion
The plasma elimination half-life of omeprazole is usually shorter than one hour both after single and repeated oral once-daily dosing. Omeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration. Almost 80% of an oral dose of omeprazole is excreted as metabolites in the urine, the remainder in the faeces, primarily originating from bile secretion.


The AUC of omeprazole increases with repeated administration. This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration. This time- and dose- dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulphone).
No metabolite has been found to have any effect on gastric acid secretion.

Special populations


Impaired hepatic function
The metabolism of omeprazole in patients with liver dysfunction is impaired, resulting in an increased AUC. Omeprazole has not shown any tendency to accumulate with once-daily dosing.


Impaired renal function
The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, are unchanged in patients with reduced renal function.


Elderly
The metabolism rate of omeprazole is somewhat reduced in elderly subjects (75-79 years of age).


Paediatric patients
During treatment with the recommended doses to children from the age of 1 year, similar plasma concentrations were obtained as compared to adults. In children younger than 6 months, clearance of omeprazole is low due to low capacity to metabolise omeprazole.


Gastric ECL-cell hyperplasia and carcinoids, have been observed in life-long studies in rats treated with omeprazole. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition. Similar findings have been made after treatment with H2-receptor antagonists, proton pump inhibitors and after partial fundectomy. Thus, these changes are not from a direct effect of any individual active substance.


Cellulose microcrystalline,

Glycerol monostearate 40-55,

Hydroxypropylcellulose,

Hypromellose,
Magnesium stearate,
Methacrylic acid – Ethyl acrylate copolymer (1:1) dispersion 30 per cent,

Sugar spheres,
Synthetic paraffin (NF),
Macrogol (polyethylene glycol 6000),

Polysorbate 80,
Crospovidone,
Sodium hydroxide (for pH-adjustment),

Sodium stearyl fumarate,
Talc,
Triethyl citrate,

Iron oxide E172,
Titanium dioxide E171


Not applicable.


3 years.

Do not store above 25°C.
Bottle: Keep the container tightly closed in order to protect from moisture.

Blister: Store in the original package in order to protect from moisture.


HDPE bottle: with a tight fitting polypropylene screw-cap equipped with a desiccant capsule.

10 mg: 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets.
20 mg: 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140, 200, 280 tablets.


Aluminium blister.
10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of, 560 tablets.


Perforated unit dose blister (hospital pack): 10 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets.
20 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets.

Not all pack sizes may be marketed.


No special requirements.


AstraZeneca AB 151 85 Södertälje

2012-12-10
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