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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)

Riapanta is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related disease of the stomach and intestine.

Riapanta is used to treat Adults and adolescents 12 years of age and above for:

-          Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitating of stomach acid.

 

Riapanta is used to treat adults for :

-          An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.

-          Stomach and duodenal ulcers

-          Zollinger-Ellison syndrome and other conditions producing too much acid in the stomach.


Do not take Riapanta

- If you are allergic (hypersensitive) to Pantoprazole or to any of the other ingredients of Riapanta (see section 6).

- If you are allergic to medicines containing other proton pump inhibitors.

Take special care with Riapanta

-          If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently, especially when you are taking Riapanta as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.

-          If you have reduced body stores or risk factors for reduced vitamin B12 and receive Riapanta long-term treatment. As with all acid reducing agents, Riapanta may lead to a reduced absorption of vitamin B12.

-          If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.

-          Taking a proton pump inhibitor like Riapanta, 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).

-          If you are on Riapanta 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, 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.

-          If you have ever had a skin reaction after treatment with a medicine similar to Riapanta  that reduces stomach acid.

-          If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole. Remember to also mention any other ill-effects like pain in your joints.

-          If you are due to have a specific blood test (Chromogranin A)

 

Tell your doctor immediately if you notice any of the following symptoms:

-          An unintentional loss of weight

-          Vomiting, particularly if repeated

-          Vomiting blood; this may appear as dark coffee grounds in your vomit

-          You notice blood in your stools; which may be black or tarry in appearance

-          Difficulty in swallowing or pain when swallowing

-          You look pale and feel weak (anaemia)

-          Chest pain

-          Stomach pain

-          Severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.

 

Your doctor may decide that you need some tests to rule out malignant disease because Riapanta also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.

 

If you take Riapanta 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.

 

Children and adolescents

Pantoprazole is not recommended for use in children as it has not been proven to work in children below 12 years of age.

 

Other Medicines and RIAPANTA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

 

Riapanta may influence the effectiveness of other medicines, so tell your doctor if you are taking:

-          Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotnib (used for certain types of cancer) because Riapanta may stop these and other medicines from working properly.

-          Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks.

-          Atazanavir (used to treat HIV-infection).

-          Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your Riapanta treatment because Riapanta  can increase levels of methotrexate in the blood.

-          Fluvoxamine (used to treat depression and other psychiatric diseases) – if you are taking fluvoxamine your doctor may reduce the dose.

-          Rifampicin (used to treat infections).

-          St John’s wort (Hypericum perforatum) (used to treat mild depression).

 

Pregnancy and breast-feeding

There are no adequate data from the use of Riapanta in pregnant women. Excretion into human milk has been reported.

 

If you are pregnant, or think you may be pregnant, or if you are breast-feeding, Ask your doctor or pharmacist for advice before taking any medicine.

 

you should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.

 

Driving and using machines

RIAPANTA has no or negligible influence on the ability to drive and use machines.

 

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.


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

 

Method of administration

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.

 

The recommended dose is :

 

Adults and adolescents 12 years of age and above:

-        To treat reflux oesophagitis:

The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take your medicine.

 

Adults:

-          For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy):

One tablet, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your Riapanta tablet. Take the first Riapanta tablet 1 hour before breakfast and the second Riapanta tablet 1 hour before your evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks.

 

 

-        For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled. Your doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.

-        For the long-term treatment of Zollinger-Ellison syndrome and of other conditions in which too much stomach acid is produced:

The recommended starting dose is usually two tablets a day.

Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, take the tablets in twice daily.

 

If your doctor prescribes a daily dosage of more than four tablets a day, you will be told exactly when to stop taking the medicine.

 

Patients with Kidney problems

If you have kidney problems, you should not take Riapanta for eradication of Helicobacter pylori.

 

Patients with Liver problems

If you suffer from severe liver problems, you should not take more than one tablet 20 mg Riapanta a day .

 

If you suffer from moderate or severe liver problems, you should not take Pantoprazole for eradication of Helicobacter pylori.

 

Use in children and adolescents

These tablets are not recommended for use in children below 12 years.

 

If you take more Riapanta than you should

Consult your doctor or pharmacist. There are no known symptoms of overdose.

 

If you forget to take your Riapanta

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

 

If you stop taking Riapanta

Do not stop taking the tablets without first talking to your doctor or pharmacist.

 

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


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

 

If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:

-          Serious allergic reactions (frequency rare may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s disease / angioedema), severe dizziness with very fast heartbeat and heavy sweating.

-          Serious skin conditions (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.

-          Other serious conditions (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys). possibly leading to kidney failure.

Other known side effects are:

-          Common (may affect up to 1 in 10 people)

Benign polyps in the stomach.

-          Uncommon (may affect up to 1 user in 100 people)

headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders. fracture in the hip, wrist or spine.

-          Rare (may affect up to 1 in 1,000 people)

distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.

-          Very Rare (may affect up to 1 in 10,000 people)

disorientation.

-          Not known (frequency cannot be estimated from the available data)

Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood, decreased magnesium level in blood (see section 2), feeling of tingling, prickling, pins and needles, burning sensation or numbness, rash, possibly with pain in the joints.

 

Side effects identified through blood tests:

-          Uncommon (may affect up to 1 in 100 people)

an increase in liver enzymes

-          Rare (may affect up to 1 in 1,000 people)

an increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.

-          Very Rare (may affect up to 1 in 10,000 people)

a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.

 

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.


-          Keep out of the reach children.

-          Store below 30°C.

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

-          Do not use RIAPANTA after the expiry date which is stated on the blister or the package.

-          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.


COMPOSITION:

Tablets:

Each enteric coated tablet contains Pantoprazole Sodium Sesquihydrate (Ph Eur) equivalent to Pantoprazole 40 mg.

Other ingredients: Mannitol, Crospovidone, Anhydrous Sodium Carbonate, Hypromellosa, Calcium Stearate, Seal Coating( Opadry Clear) and Enteric Coating (ACRYL-EZE Yellow).


Light yellow colored, round biconvex enteric-coated tablets with RP and 101 on either side of the tablet. PACK: contains (15) or (30) enteric coated tablets of RIAPANTA. Hospital packs of RIAPANTA enteric coated tablets.

Medical and Cosmetic Products Company Ltd. (Riyadh Pharma)

P.O.Box 442, Riyadh 11411

Fax: +966 11 265 0505

Email: contact@riyadhpharma.com

For any information about this medicinal product, please contact the local representative of marketing authorisation holder:

Saudi Arabia

Marketing department

Riyadh

Tel: +966 11 265 0111

Email: marketing@riyadhpharma.com


11/2018
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ريابنتا هو " مثبط انتقائي لمضخة البروتون "، وهو دواء يقلل من كمية الحامض المنتجة في معدتك. فهو يستخدم لعلاج الأمراض ذات الصلة بحمض المعدة والأمعاء.

يستخدم ريابنتا لعلاج  البالغين والمراهقين بعمر 12 سنة فما فوق في حالات:

-        التهاب المريء الارتجاعي. التهاب المريء (الأنبوب الذي يربط الحلق إلى المعدة) مصحوبا بتقيؤ حمض المعدة.

يستخدم ريابنتا لعلاج  البالغين في حالات:

-        عدوى بكتيريا تسمى هيليكوباكتر بيلوري في المرضى الذين يعانون من قرحة الاثني عشر وقرحة المعدة بالاشتراك مع اثنين من المضادات الحيوية (علاج الإبادة). والهدف من ذلك هو التخلص من البكتيريا وبذلك يقلل من احتمال عودة هذه القرحة.

-        قرح المعدة والاثني عشر .

-        متلازمة زولينجر إليسون وغيرها من حالات إفراز الكثير من الحامض في المعدة.

لا تتناول ريابنتا

- إذا كنت تعاني من حساسية (التحسس) لبانتوبرازول أو إلى أي من المكونات الأخرى من ريابنتا (انظر القسم 6).

- إذا كان لديك حساسية من الأدوية الأخرى التي تحتوي على مثبطات مضخة البروتون.

عناية خاصة مع ريابنتا

-        إذا كان لديك مشاكل شديدة في الكبد. يرجى إخبار الطبيب إذا كان لديك في أي وقت مضى مشاكل في الكبد. وهو سوف يفحص انزيمات الكبد بشكل أكثر تكرارا، وخصوصا عندما تتناول ريابنتا كعلاج طويل الأمد. في حالة وجود ارتفاع في أنزيمات الكبد يجب أن توقف العلاج.

-        إذا كان لديك انخفاض بمخزون الجسم أو لديك أحد عوامل الخطر لانخفاض فيتامين B12 وتتناول ريابنتا كعلاج على المدى الطويل. كما هو الحال مع كل أدوية خفض الحمض، قد يؤدي ريابنتا إلى خفض امتصاص فيتامين B12.

-        إذا كنت تتناول مثبطات الإنزيم البروتيني لفيروس نقص المناعة البشرية مثل أتازانفير (لعلاج عدوى فيروس نقص المناعة البشري) في نفس الوقت مع بانتوبرازول ، اطلب من طبيبك المشورة.

-        قد يؤدي استخدام مثبط مضخة البروتون مثل ريابنتا ، وخاصة خلال فترة تزيد عن عام ، إلى زيادة خطر حدوث كسر في الورك أو المعصم أو العمود الفقري. أخبر طبيبك إذا كان لديك هشاشة العظام أو إذا كنت تتناول الكورتيزون (التي يمكن أن تزيد من خطر الإصابة بهشاشة العظام).

-        إذا كنت تتناول ريابنتا لأكثر من ثلاثة أشهر فمن المحتمل أن مستويات المغنيسيوم في الدم قد تنخفض. تظهر مستويات منخفضة من المغنيسيوم على هيئة التعب ، وتقلصات العضلات اللاإرادية ، والارتباك ، والتشنجات ، والدوخة ، وزيادة معدل ضربات القلب. إذا ظهرت عليك أي من هذه الأعراض ، فالرجاء إخبار طبيبك على الفور. يمكن أن يؤدي انخفاض مستويات المغنيسيوم أيضًا إلى انخفاض مستويات البوتاسيوم أو الكالسيوم في الدم. قد يقرر طبيبك إجراء اختبارات دم منتظمة لمراقبة مستويات المغنسيوم.

-        إذا كنت قد عانيت من حساسية الجلد بعد العلاج باستخدام دواء مشابه لريابنتا الذي يقلل من حامض المعدة.

-        إذا ظهر طفح جلدي على بشرتك ، خاصة في المناطق المعرضة للشمس ، أخبر طبيبك بأسرع ما يمكن ، حيث قد تحتاج إلى إيقاف علاجك باستخدام ريابنتا. تذكر أيضًا ذكر أي آثار ضارة أخرى مثل ألم في مفاصلك.

-        إذا كان من المقرر إجراء اختبار دم محدد (الكروموجرانين A).

 

أخبر طبيبك فورا إذا لاحظت أي من الأعراض التالية:

-        خسارة الوزن غير المتعمدة.

-        القيء ، خاصة إذا تكرر.

-        القيء الدموي ؛ قد يبدو مثل القهوة الداكنة في القيء.

-        ملاحظة الدم في البراز. والذي قد يكون أسود أو مثل القطران في مظهره.

-        صعوبة البلع أو ألم عند البلع.

-        الشحوب والشعور بالضعف (فقر الدم).

-        ألم الصدر.

-        ألم المعدة.

-        الإسهال الشديد و / أو المستمر ، لأن هذا الدواء قد ارتبط بزيادة طفيفة في الإسهال المرتبط بالعدوى.

 

طبيبك قد يقرر أنك تحتاج بعض الاختبارات لاستبعاد الامراض الخبيثة لأن ريابنتا ايضاً يحد من اعراض السرطان وقد يتسبب في تأجيل التشخيص، إذا استمرت الاعراض لديك بالرغم من العلاج , المزيد من الفحوصات سيتم أخذها في الاعتبار.

 

إذا تناولت ريابنتا على مدى طويل (لمدة أطول من سنة واحد) فقد يبقيك الطبيب تحت الاختبارات بانتظام. لابد ان تخبر طبيبك عن اية اعراض جانبية جديدة او غير متوقعة.

 

الأطفال والمراهقون

لا ينصح باستخدام ريابنتا في الأطفال لأنه لم يثبت تأثيره في الأطفال دون سن 12 سنة من العمر.

 

ريابنتا و الأدوية الأخرى                                                                                         

قد يؤثر ريابنتا على مفعول الأدوية الأخرى، لذا اخبر طبيبك إذا كنت تتناول:

-          ادوية مثل كيتوكونازول، إتراكونازل، و بوساكونازول (تستخدم لعلاج العدوى الفطرية) أو إرلوتينب (يستخدم لعلاج أنواع معينة من السرطان) لان ريابنتا قد يمنع هذه الادوية و ادوية اخري من العمل بشكل صحيح.

-          وارفرين و فينبروكومون الذين يؤثران على ترقيق أو سماكة الدم. قد تحتاج الى اختبارات أكثر.

-          اتازنفير (لعلاج العدوى بفيروس نقص المناعة البشرية).

-          ميثوتريكسات (يستخدم لعلاج التهاب المفاصل الروماتويدي ، الصدفية ، والسرطان) - إذا كنت تستخدم الميثوتريكسيت ، قد يقوم طبيبك بإيقاف علاج ريابنتا مؤقتًا لأن ريابنتا يمكنه زيادة مستويات الميثوتريكسيت في الدم.

-          فلوفوكسامين (يستخدم لعلاج الاكتئاب والأمراض النفسية الأخرى) - إذا كنت تستخدم فلوفوكسامين قد يقلل الطبيب من الجرعة.

-          ريفامبيسين (يستخدم لعلاج العدوى).

-          نبتة سانت جون (هيبيريكم بيرفوراتم ) (تستخدم لعلاج الاكتئاب الخفيف).

 

الحمل والرضاعة الطبيعية

ليس هناك معلومات كافية لاستخدام ريابنتا في النساء الحوامل، قد وجد انه يفرز في لبن الام.

إذا كنتي حاملاً ، أو تعتقدين أنك حامل ، أو إذا كنت ترضعين طفلك ، فاطلبي من طبيبك أو الصيدلي نصيحة قبل تناول أي دواء.

يجب عليكي استخدام هذا الدواء فقط إذا اعتبر طبيبك فائدة لك أكبر من المخاطر المحتملة على الجنين أو الطفل الذي لم يولد بعد.

 

القيادة واستخدام الآلات

ريابنتا ليس له تأثير يذكر على القدرة على قيادة واستخدام الآلات.

إذا استشعرت اعراض جانبية مثل الدوخة أو خلل بالرؤيا فلا يجب أن تقود أو تدير آلات.

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تناول دائما ريابنتا كما اخبرك طبيبك تماماً. لابد ان تتأكد مع طبيبك أو الصيدلي إذا لم تكن متأكداً.

 

طريقة الاستخدام :

تناول الأقراص قبل الوجبة  بساعة دون مضغها أو كسرها مع ابتلاعها كلها مع بعض الماء.

 

الجرعة الموصى بها هي:

 

البالغين والمراهقين بعمر 12 سنة وأكبر:

-        لعلاج ارتجاع المريء

الجرعة المعتادة هي قرص واحد يومياً. طبيبك قد يخبرك لزيادة الجرعة إلى 2 قرص يومياً. مدة العلاج لالتهاب المريء الارتجاعي هي ما بين 4 و 8 أسابيع. طبيبك سوف يخبرك المدة التي ستتناول بها علاجك

 

البالغين:

-        لعلاج العدوى ببكتيريا تسمى هليكوباكتر بيلوري  في المرضى الذين يعانون من قرحة الاثني عشر وقرحة المعدة في تركيبة مع اثنين من المضادات الحيوية (علاج ابادة العدوى).

قرص واحد مرتين يوميا مضافا لاثنين من المضادات الحيوية من أموكسيسيللين، كلاريثرومايسين أو مترونيدازول (أو تينيدازول) كل منهما يؤخذ مرتين يومياً مع ريابنتا. تناول اول قرص ريابنتا ساعة واحدة قبل الإفطار والقرص الثاني ساعة واحدة قبل وجبة المساء. اتبع تعليمات الطبيب وتأكد أنك قرأت النشرة المرفقة لهذه المضادات الحيوية. فترة العلاج الاعتيادية هي من أسبوع إلى أسبوعين .

 

-        لعلاج المعدة وقرحة الاثني عشر:

الجرعة المعتادة هي قرص واحد في اليوم. بعد استشارة طبيبك، يمكن مضاعفة الجرعة. طبيبك سيخبرك مدة  العلاج. فترة العلاج لقرحة المعدة عادة ما بين 4 و8 أسابيع. فترة العلاج لقرحة الاثنى عشر عادة ما بين 2 و4 أسابيع.

 

-        لعلاج طويل الأمد لحالات متلازمة زولينجر إليسون والحالات الأخرى التي يتم فيها إفراز الكثير من حمض المعدة:

الجرعة الموصى بها عادة هي قرصين يوميا.

تناول القرصين قبل وجبة الطعام بساعة. طبيبك قد يعدل في وقت لاحق الجرعة، اعتمادا على كمية الحمض المعدي التي تنتجها. إذا كان المنصوص عليه أكثر من قرصين يوميا، تناول الأقراص مرتين يوميا.

إذا وصف لك الطبيب جرعة يومية أكثر من أربعة أقراص يوميا، سوف يخبرك بالضبط متى تتوقف عن تناول الدواء.

 

المرضي بمشاكل في الكلى:

إذا كان لديك مشاكل في الكلى ,لا ينبغي أن تتناول ريابنتا للقضاء على هيليكوباكتر بيلوري.

 

المرضي بمشاكل في الكبد:

إذا كنت تعاني من مشاكل شديدة في الكبد ، يجب ألا تتناول أكثر من قرص 20 ملجم ريابنتا يوميا .

 

إذا كنت تعاني من مشاكل متوسطة أو شديدة في الكبد ، يجب ألا تتناول بانتوبرازول للقضاء على هيليكوباكتر بيلوري.

 

الاستخدام في الأطفال و المراهقين

لا ينصح بتناول هذه الاقراص في الأطفال أقل من 12 عاما.

 

إذا تناولت ريابنتا أكثر مما يجب

استشر طبيبك أو الصيدلي. لا توجد أعراض معروفة عن الجرعة الزائدة.

 

إذا نسيت أن تتناول ريابنتا

لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية. خذ الجرعة التالية، العادية في الوقت المعتاد.

 

إذا توقفت عن تناول ريابنتا

لا تتوقف عن تناول أقراص دون التحدث مع طبيبك أو الصيدلي.

 

إذا كان لديك أي أسئلة أخرى عن استخدام هذا المنتج، اسأل طبيبك أو الصيدلي.

مثل جميع الأدوية، يمكن أن تتسبب ريابنتا في آثار جانبية، على الرغم من أن الجميع لا تحدث لهم.

 

إذا حدث لك أي من الآثار الجانبية التالية، توقف عن تناول هذه الاقراص وأخبر طبيبك فورا، أو اتصل بقسم الحوادث في أقرب مستشفى اخاص بك:

-          الحساسية الخطيرة (نادرة  التكرار قد تؤثر على شخص واحد من كل 1000 شخص): تورم في اللسان و / أو الحلق، وصعوبة في البلع، وحساسية القش (طفح القراص)، وصعوبات في التنفس، تورم تحسسي في الوجه (مرض كوينكه / وذمة وعائية)، والدوخة الشديدة مع سرعة كبيرة لضربات القلب وكثرة التعرق.

-          الأمراض الجلدية الخطيرة (التكرار غير معروف: لا يمكن تقدير التكرار من البيانات المتاحة): ظهور تقرحات في الجلد  وتدهور سريع في الحالة العامة، وتآكل (بما في ذلك نزيف طفيف) في العينين والأنف والفم / الشفتين أو الأعضاء التناسلية (متلازمة ستيفنز جونسون، متلازمة ايل، حمامي متعددة الأشكال) وحساسية للضوء.

-          حالات أخرى خطيرة (التكرار غير معروف: لا يمكن تقدير التكرار من البيانات المتاحة): اصفرار الجلد أو بياض العينين (أضرار جسيمة للخلايا الكبدية، واليرقان) أو الحمى والطفح الجلدي، والكلى الكبيرة في بعض الأحيان مع التبول المؤلم وآلام أسفل الظهر (التهاب خطير في الكلى).محتمل أن تؤدي الى فشل كلوي .

 

الآثار الجانبية الأخرى المعروفة هي:

-          شائعة (قد تؤثر على شخص واحد من كل 10 أشخاص)

الاورام الحميدة في المعدة.

-          غير شائعة (قد تؤثر على شخص واحد من كل 100 شخص)

الصداع؛ الدوخة؛ الإسهال. الشعور بالمرض والقيء. الانتفاخ والغازات (الريح)؛ الإمساك؛ فم جاف؛ آلام في البطن وعدم الراحة. الطفح الجلدي، طفح ، هياج؛ الحكة. الشعور بالضعف، والانهاك أو لست على ما يرام عموما. اضطرابات النوم. كسر في الورك والمعصم أو العمود الفقري.

-          نادرة (قد تؤثر على شخص واحد من كل 1000 شخص)

تشويه أو انعدام تام لحاسة التذوق. اضطرابات في الرؤية مثل عدم وضوح الرؤية؛ ألم في المفاصل. آلام في العضلات. تغيرات الوزن. رفع درجة حرارة الجسم. ارتفاع في درجة الحرارة؛ تورم في الأطراف (وذمة محيطية)؛ ردود فعل تحسسية. كآبة؛ تضخم الثدي عند الذكور.

-          نادرة جدا (قد تؤثر على شخص واحد  من كل 10,000شخص)

الارتباك.

-          غير معروفة (لا يمكن تقدير التكرار من البيانات المتاحة)

الهلوسة، والارتباك (وخصوصا في المرضى الذين لديهم تاريخ من هذه الأعراض)؛ انخفاض مستوى الصوديوم في الدم. انخفاض مستوى المغنيسيوم في الدم (انظر القسم 2) ، الشعور بوخز ، ، دبابيس وإبر ، حرقان أو خدر ، طفح جلدي ، ربما مع ألم في المفاصل.

الآثار الجانبية التي تم تحديدها من خلال اختبارات الدم:

-          غير شائعة (قد تؤثر على شخص واحد من كل 100 شخص)

زيادة في إنزيمات الكبد

-          نادرة (قد تؤثر على شخص واحد من كل 1000 شخص)

زيادة البيليروبين. زيادة مستويات الدهون في الدم. انخفاض حاد في خلايا الدم البيضاء الحبيبية، ويرتبط مع ارتفاع في درجة الحرارة.

-          نادرة جدا (قد تؤثر على شخص واحد  من كل 10,000شخص)

انخفاض في عدد الصفائح الدموية، مما قد يؤدي إلى نزف أو كدمة أكثر من المعتاد. انخفاض في عدد خلايا الدم البيضاء، مما قد يؤدي إلى التهابات متكررة. نقص غير طبيعي مستمر في عدد خلايا الدم الحمراء والبيضاء، وكذلك الصفائح الدموية.

 

تحدث مع طبيبك، الصيدلي أو الممرض إذا لاحظت أي من الأثار الجانبية، وهذا يشمل الأثار الجانبية المحتملة الغير مدرجة في هذه النشرة.

-          يحفظ بعيدا عن متناول ومرأى الاطفال

-          يحفظ في درجة حرارة أقل من 30 درجة مئوية

-          يحفظ في العبوة الأصلية للحماية من الضوء والرطوبة

-          لا تستخدم ريابنتا بعد تاريخ انتهاء الصلاحية المدون على العبوة، التاريخ يرجع إلى آخر يوم في هذا الشهر

-          يجب ألا يتم التخلص من الأدوية من خلال مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي كيفية التخلص من الأدوية التي لم تعد مطلوبة. سوف تساعد هذه التدابير لحماية البيئة.

التّركيب:

يحتوي كل قرص مغلف تغليف معوي على بانتوبرازول صوديوم سيسكويهيدريت (دستور الأدوية الأوروبي) ما يعادل بانتوبرازول 40ملجم.

المواد الإضافية: مانيتول، كروس بوفيدون، صوديوم كاربونيت لامائي، هيبروميللوز، كالسيوم ستيريت، غلاف (أوبادري شفاف) وغلاف معوي (أكرايل-EZE أصفر).

أقراص مغلفة تغليف معوي ثنائية التحدب ذات لون أصفر فاتح ، مع وجود RP و 101 على جانبي القرص.

 

العبوة: عبوات تحتوي على 15 أو 30 قرص مغلف تغليفاً معوياً من ريابنتا

            عبوات للمستشفيات أقراص مغلفة تغليفاً معوياً من ريابنتا

شركة المنتجات الطبية والتجميلية المحدودة ( الرياض فارما)

ص.ب. 442 الرياض 11411

فاكس: 966112650505+

البريد الإلكتروني: contact@riyadhpharma.com

لأية معلومات عن هذا المنتج الطبي، يرجى الاتصال على  صاحب الترخيص والتسويق:

المملكة العربية السعودية

قسم التسويق

الرياض

تلفون: 966112650111+

البريد الإلكتروني: marketing@riyadhpharma.com

11/2018
 Read this leaflet carefully before you start using this product as it contains important information for you

Riapanta 40 mg enteric coated tablets

Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate). For the full list of excipients, see section 6.1.

Enteric-coated tablets, Light yellow colored, round biconvex enteric-coated tablets with RP and 101 on either side of the tablet.

Riapanta is indicated for use in adults and adolescents 12 years of age and above for:

- Reflux oesophagitis.

Riapanta is indicated in adults for:

- Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pyloriassociated ulcers.

- Gastric and duodenal ulcer.

- Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions.


Posology

Adults and adolescents 12 years of age and above

 

Reflux oesophagitis

One tablet of Riapanta per day. In individual cases the dose may be doubled (increase to 2 tablets Riapanta daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

Adults

Eradication of H. pylori in combination with two appropriate antibiotics

In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:

a) Twice daily one tablet Riapanta

+ twice daily 1000 mg amoxicillin

+ twice daily 500 mg clarithromycin

b) Twice daily one tablet Riapanta

+ twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole)

+ twice daily 250 - 500 mg clarithromycin

c) Twice daily one tablet Riapanta

+ twice daily 1000 mg amoxicillin

+ twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole)

In combination therapy for eradication of H. pylori infection, the second Riapanta tablet should be taken 1 hour before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged for a further 7 days to a total duration of up to two weeks. If, to ensure healing of the ulcers, further treatment with Riapanta is indicated, the dose recommendations for duodenal and gastric ulcers should be considered.

If combination therapy is not an option, e.g. if the patient has tested negative for H. pylori, the following dose guidelines apply for Riapanta monotherapy:

 

Treatment of gastric ulcer

One tablet of Riapanta per day. In individual cases the dose may be doubled (increase to 2 tablets of Riapanta daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

 

Treatment of duodenal ulcer

One tablet of Riapanta per day. In individual cases the dose may be doubled (increase to 2 tablets of Riapanta daily) especially when there has been no response to other treatment. A duodenal ulcer generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.

 

Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

For the long-term management of Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions patients should start their treatment with a daily dose of 80 mg (2 tablets of Pantoprazole 40 mg). Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.

Treatment duration in Zollinger-Ellison syndrome and other pathological hyper secretory conditions is not limited and should be adapted according to clinical needs.

 

Patients with hepatic impairment

A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole) should not be exceeded in patients with severe liver impairment. Pantoprazole must not be used in combination treatment for eradication of H. pylori in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of Pantoprazole in combination treatment of these patients (see section 4.4).

 

Patients with renal impairment

No dose adjustment is necessary in patients with impaired renal function. Pantoprazole must not be used in combination treatment for eradication of H. pylori in patients with impaired renal function since currently no data are available on the efficacy and safety of Pantoprazole in combination treatment for these patients (see section 5.2).

 

Older people

No dose adjustment is necessary in older people (see section 5.2).

 

Paediatric population

Riapanta is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in the age group (see section 5.2).

Method of administration

Oral use

The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.


Hypersensitivity to the active substance, substituted benzimidazoles, any of the other excipients listed in section 6.1.

Hepatic impairment

In patients with severe liver impairment, the liver enzymes should be monitored regularly during treatment with Riapanta, particularly on long-term use. In the case of a rise of the liver enzymes, the treatment should be discontinued (see section 4.2).

 

Combination therapy

In the case of combination therapy, the summaries of product characteristics of the respective medicinal products should be observed.

 

Gastric malignancy

Symptomatic response to Riapanta may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.

Further investigation is to be considered if symptoms persist despite adequate treatment.

 

Co-administration with HIV protease inhibitors

Co-administration of Riapanta is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).

 

Influence on vitamin B12 absorption

In patients with Zollinger-Ellison syndrome and other pathological hyper secretory conditions requiring long-term treatment, Riapanta, 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 or if respective clinical symptoms are observed.

 

Long term treatment

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

 

Gastrointestinal infections caused by bacteria

Treatment with Riapanta may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.

 

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like Riapanta 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 medicinal products that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

 

Bone fractures

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 older people or in the 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.

 

Sub-acute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping Riapanta. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

 

Interference with Laboratory Tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Riapanta treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.


Medicinal products with pH-Dependent Absorption Pharmacokinetics

Because of profound and long lasting inhibition of gastric acid secretion, Riapanta may interfere with the absorption of other medicinal products where gastric pH is an important determinant of oral availability, e.g. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicine such as erlotinib.

 

HIV protease inhibtiors

Co-administration of Riapanta is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir due to significant reduction in their bioavailability (see section 4.4).

If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A pantoprazole dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitors may need to be adjusted.

 

Coumarin anticoagulants (phenprocoumon or warfarin)

Co-administration of Riapanta with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with Riapanta and warfarin or phenprocoumon may need to be monitored for increase in INR and prothrombin time.

Methotrexate

Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of Riapanta may need to be considered.

 

Other interactions studies

Pantoprazole is extensively metabolized in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4.

Interaction studies with medicinal products also metabolized with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl oestradiol, did not reveal clinically significant interactions.

An interaction of pantoprazole with other medicinal products or compounds, which are metabolized using the same enzyme system, cannot be excluded.

Results from a range of interaction studies demonstrate that pantoprazole does not affect the metabolism of active substances metabolised by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol), or does not interfere with p-glycoprotein related absorption of digoxin.

There were no interactions with concomitantly administered antacids.

Interaction studies have also been performed by concomitantly administering pantoprazole with the respective antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically relevant interactions were found.

Medicinal products that inhibit or induce CYP2C19:

Inhibitors of CYP2C19 such as fluvoxamine could increase the systemic exposure of Riapanta. A dose reduction may be considered for patients treated long-term with high doses of Riapanta, or those with hepatic impairment.

Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St John´s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.


Pregnancy

A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Riapanta.

Animal studies have shown reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Riapanta during pregnancy.

 

Breast-feeding

Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from Pantoprazole therapy taking into account the benefit of breast-feeding for the child, and the benefit of Pantoprazole therapy for the woman.

 

Fertility

There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).


Riapanta has no or negligible influence on the ability to drive and 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 machines.


Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1 % of patients.

The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification:

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).

For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience

Frequency

Common

Uncommon

Rare

Very rare

Not known

System Organ Class

Blood and lymphatic system disorders

  

Agranulocytosis

Thrombocytopenia; Leukopenia; Pancytopenia

 

Immune system disorders

  

Hypersensitivity (including anaphylactic reactions and anaphylactic shock)

  

Metabolism and nutrition disorders

  

Hyperlipidaemias and lipid increases (triglycerides, cholesterol); Weight changes

 

Hyponatraemia; Hypomagnesaemia (see section 4.4); Hypocalcaemia (1); Hypokalaemia

Psychiatric disorders

 

Sleep disorders

Depression (and all aggravations)

Disorientation (and all aggravations)

Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)

Nervous system disorders

 

Headache; Dizziness

Taste disorders

 

Paraesthesia

Eye disorders

  

Disturbances in vision / blurred vision

  

Gastrointestinal disorders

Fundic gland polyps (benign)

Diarrhoea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort

   

Hepatobiliary disorders

 

Liver enzymes increased (transaminases, γ-GT)

Bilirubin increased

 

Hepatocellular injury; Jaundice; Hepatocellular failure

Skin and sub-cutaneous tissue disorders

 

Rash / exanthema / eruption; Pruritus

Urticaria; Angioedema

 

Stevens-Johnson syndrome; Lyell syndrome; Erythema multiforme; Photosensitivity; Sub-acute cutaneous lupus erythematosus (see section 4.4)

Musculoskeletal and connective tissue disorders

 

Fracture of the hip, wrist or spine (see section 4.4)

Arthralgia; Myalgia

 

Muscle spasm (2)

Renal and urinary disorders

    

Interstitial nephritis (with possible progression to renal failure)

Reproductive system and breast disorders

  

Gynaecomastia

  

General disorders and administration site conditions

 

Asthenia, fatigue and malaise

Body temperature increased; Oedema peripheral

  

1. Hypocalcemia in association with hypomagnesemia

2. Muscle spasm as a consequence of electrolyte disturbance

Reporting of suspected adverse reactions

 

To report any side effects

-       National Pharmacovigilance and Drug Safety Center (NPC)

oFax: +966-11-205-7662

oTo call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340

oToll-free: 8002490000

oE-mail: npc.drug@sfda.gov.sa

oWebsite: www.sfda.gov.sa/npc


There are no known symptoms of overdose in man.

Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated.

As pantoprazole is extensively protein bound, it is not readily dialysable.

In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.


Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC02

Mechanism of action

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.

Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.

Pharmacodynamic effects

The fasting gastrin values increase under pantoprazole. On short-term use, in most cases they do not exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. An excessive increase, however, occurs only in isolated cases. As a result, a mild to moderate increase in the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during long-term treatment (simple to adenomatoid hyperplasia). However, according to the studies conducted so far, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as were found in animal experiments (see section 5.3) have not been observed in humans.

An influence of a long term treatment with pantoprazole exceeding one year cannot be completely ruled out on endocrine parameters of the thyroid according to results in animal studies.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours.

Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.


Absorption

Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 40 mg oral dose. On average at about 2.5 h p.a. the maximum serum concentrations of about 2 - 3 µg/ml are achieved, and these values remain constant after multiple administration.

Pharmacokinetics does not vary after single or repeated administration. In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration.

The absolute bioavailability from the tablet was found to be about 77 %. Concomitant intake of food had no influence on AUC, maximum serum concentration and thus bioavailability. Only the variability of the lag-time will be increased by concomitant food intake.

 

Distribution

Pantoprazole's serum protein binding is about 98 %. Volume of distribution is about 0.15 l/kg.

 

Biotransformation

The substance is almost exclusively metabolized in the liver. The main metabolic pathway is demethylation by CYP2C19 with subsequent sulphate conjugation; other metabolic pathway includes oxidation by CYP3A4.

 

Elimination

Terminal half-life is about 1 hour and clearance is about 0.1 l/h/kg. There were a few cases of subjects with delayed elimination. Because of the specific binding of pantoprazole to the proton pumps of the parietal cell the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secretion).

Renal elimination represents the major route of excretion (about 80 %) for the metabolites of pantoprazole, the rest is excreted with the faeces. The main metabolite in both the serum and urine is desmethylpantoprazole which is conjugated with sulphate. The half-life of the main metabolite (about 1.5 hours) is not much longer than that of pantoprazole.

 

Special populations

 

Poor metabolisers

Approximately 3 % of the European population lack a functional CYP2C19 enzyme and are called poor metabolisers. In these individuals the metabolism of pantoprazole is probably mainly catalysed by CYP3A4. After a single-dose administration of 40 mg pantoprazole, the mean area under the plasma concentration-time curve was approximately 6 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were increased by about 60 %. These findings have no implications for the posology of pantoprazole.

 

Renal impairment

No dose reduction is recommended when Riapanta is administered to patients with impaired renal function (including dialysis patients). As with healthy subjects, pantoprazole's half-life is short. Only very small amounts of pantoprazole are dialyzed. Although the main metabolite has a moderately delayed half-life (2 - 3 h), excretion is still rapid and thus accumulation does not occur.

 

Hepatic impairment

Although for patients with liver cirrhosis (classes A and B according to Child) the half-life values increased to between 7 and 9 h and the AUC values increased by a factor of 5 - 7, the maximum serum concentration only increased slightly by a factor of 1.5 compared with healthy subjects.

 

Older people

A slight increase in AUC and Cmax in elderly volunteers compared with younger counterparts is also not clinically relevant.

 

Paediatric population

Following administration of single oral doses of 20 or 40 mg pantoprazole to children aged 5 - 16 years AUC and Cmaxwere in the range of corresponding values in adults.

Following administration of single i.v. doses of 0.8 or 1.6 mg/kg pantoprazole to children aged 2 - 16 years there was no significant association between pantoprazole clearance and age or weight. AUC and volume of distribution were in accordance with data from adults.


Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.

In the two-year carcinogenicity studies in rats neuroendocrine neoplasms were found. In addition, squamous cell papillomas were found in the fore stomach of rats. The mechanism leading to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels occurring in the rat during chronic high-dose treatment. In the two-year rodent studies an increased number of liver tumours was observed in rats and in female mice and was interpreted as being due to pantoprazole's high metabolic rate in the liver.

A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg). The occurrence of these neoplasms is associated with the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver. As the therapeutic dose in man is low, no harmful effects on the thyroid glands are expected.

In animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg.

Investigations revealed no evidence of impaired fertility or teratogenic effects.

Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation. As a result, concentration of pantoprazole in the foetus is increased shortly before birth.


Mannitol

Crospovidone

Anhydrous sodium carbonate

Hypromellose

Calcium stearate

Seal Coating Opadry clear

Enteric Coating (ACRYL-EZE Yellow)


None known.


3 years

Store below 30° C.


polypropylene tracer pack with HDPE Cap containing either 15 or 30 enteric coated tablets.


Not applicable.


Medical and Cosmetic Products Company Ltd. (Riyadh Pharma) P.O.Box 442, Riyadh 11411 Fax: +966 11 265 0505 Email: contact@riyadhpharma.com For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department Riyadh Tel: +966 11 265 0111 Email: marketing@riyadhpharma.com

11/2018
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