Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
PANTOPRAZOLE
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
A02BC02
PANTOPRAZOLE 20 mg
GASTRO-RESISTANT TABLET
PANTOPRAZOLE 20 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Authorised
2011-03-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PANTOPRAZOLE MYLAN PHARMACEUTICALS 20 MG GASTRO-RESISTANT TABLETS (PANTOPRAZOLE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. - You should not take this medicine for more than 4 weeks without consulting a doctor. WHAT IS IN THIS LEAFLET: 1. What Pantoprazole is and what it is used for 2. What you need to know before you take Pantoprazole 3. How to take Pantoprazole 4. Possible side effects 5. How to store Pantoprazole 6. Contents of the pack and other information. 1. WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR Pantoprazole contains the active substance pantoprazole, which blocks the ‘pump’ that produces stomach acid. Hence it reduces the amount of acid in your stomach. Pantoprazole is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults. Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation). You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with Pantoprazole, but this medicine is not meant to bring immediate relief. It may be necessary to take the tablets for 2-3 consecutive days to relieve the symptoms. You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. 2. WHAT YO Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pantoprazole Mylan Pharmaceuticals 20 mg Gastro-resistant Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet _ _ contains 22.550 mg of pantoprazole sodium sesquihydrate, equivalent to 20 mg of pantoprazole. Excipient with known effect Each tablet contains less than 23 mg of sodium, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Dark yellow film coated, oval, approximately 4.3 mm x 8.4 mm, biconvex tablet that is blank on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended oral dose is one gastro-resistant tablet (Pantoprazole 20 mg) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued. The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. _ _ _Special populations _ No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function. _Paediatric population_ Pantoprazole is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. Method of administration Pantoprazole 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients (listed in section 6.1). Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significan Přečtěte si celý dokument