Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
PANTOPRAZOLE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
A02BC02
PANTOPRAZOLE 40 mg
GASTRO-RESISTANT TABLET
PANTOPRAZOLE 40 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2010-05-18
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER PANTOPRAZOLE 40MG GASTRO-RESISTANT TABLETS Pantoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. WHAT IS IN THIS LEAFLET: 1. What Pantoprazole Tablets are and what they are used for 2. What you need to know before you take Pantoprazole Tablets 3. How to take Pantoprazole Tablets 4. Possible side effects 5. How to store Pantoprazole Tablets 6. Contents of the pack and other information 1. WHAT PANTOPRAZOLE TABLET ARE AND WHAT THEY ARE USED FOR Pantoprazole Tablets are selective “proton pump inhibitors”, which are medicines that reduce the amount of acid produced in your stomach. They are used for treating acid-related diseases of the stomach and intestine. PANTOPRAZOLE TABLETS ARE USED FOR TREATING: _Adults and adolescents 12 years of age and above:_ • Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. _Adults:_ • 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE TABLETS DO NOT TAKE PANTOPRAZOLE TABLETS: • If you are allergic to pantoprazole or to any of the other ingredi Leggi il documento completo
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERSITICS 1. NAME OF THE MEDICINAL PRODUCT Pantoprazole 40 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSTION One gastro-resistant tablet contains: 40 mg Pantoprazole (as pantoprazole sodium sesquihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. A yellow, oval, biconvex gastro-resistant tablet; plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and adolescents 12 years of age and above _ - Reflux oesophagitis. _Adults _ - Eradication of _Helicobacter pylori_ (_H. pylori_) in combination with appropriate antibiotic therapy in patients with _H. pylori_ associated ulcers. - Gastric and duodenal ulcer. - Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents 12 years of age and above: _ Reflux oesophagitis One pantoprazole 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to two tablets daily) especially when there has been no response to other treatment. A four week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further four weeks. _Adults: _ Eradication of _H. pylori_ in combination with two appropriate antibiotic: 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 Page 2 of 13 use and prescription of antibacterial agents. Depending upon the resistance patter, the following combinations can be recommended for the eradication of _H. pylori_: a) twice daily one Pantoprazole 40 mg gastro-resistant tablet + twice daily 1000 mg amoxicillin + twice daily 500 mg clarithromycin b) twice daily one Pantoprazole 40 mg gastro-resistan Leggi il documento completo