Země: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
OMEPRAZOLE
Amneal Pharma Europe Limited
A02BC01
OMEPRAZOLE
GASTRO-RESISTANT CAPSULE
OMEPRAZOLE 20 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Authorised
2011-06-03
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER OMEPRAZOLE AMNEAL 10 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE AMNEAL 20 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE AMNEAL 40 MG GASTRO-RESISTANT CAPSULES, HARD Omeprazole 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 only. 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. IN THIS LEAFLET: 1. What Omeprazole Amneal is and what it is used for 2. What you need to know before you take Omeprazole Amneal 3. How to take Omeprazole Amneal 4. Possible side effects 5. How to store Omeprazole Amneal 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE AMNEAL IS AND WHAT IT IS USED FOR Omeprazole Amneal 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. Omeprazole Amneal 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). Omeprazole Amneal can also be used to stop ulcers from forming if you are taking NSAIDs. T Přečtěte si celý dokument
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Omeprazole Amneal 10 mg gastro-resistant capsules, hard Omeprazole Amneal 20 mg gastro-resistant capsules, hard Omeprazole Amneal 40 mg gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Omeprazole Amneal 10 mg: one capsule contains 10 mg of omeprazole. Omeprazole Amneal 20 mg: one capsule contains 20 mg of omeprazole. Omeprazole Amneal 40 mg: one capsule contains 40 mg of omeprazole. Excipient: Lactose monohydrate. Each 10 mg capsule contains 1 mg of lactose monohydrate Each 20 mg capsule contains 2 mg of lactose monohydrate Each 40 mg capsule contains 4 mg of lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard Omeprazole Amneal 10 mg: Pink / Pink, size ‘3’ hard gelatin capsules imprinted with ‘E’ on pink cap and ‘65’ on pink body with black ink filled with white to off-white granules covered with a gastro-resistant coating. Omeprazole Amneal 20 mg: Reddish brown / Pink, size ‘1’ hard gelatin capsules imprinted with ‘E’ on Reddish brown cap and ‘67’ on pink body with black ink filled with white to off-white granules covered with a gastro-resistant coating. Omeprazole Amneal 40 mg: Reddish brown / Reddish brown, size ‘0’ hard gelatin capsules imprinted with ‘E’ on Reddish brown cap and ‘69’ on Reddish brown body with black ink filled with white to off-white granules covered with a gastro-resistant coating. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole capsules 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 p Přečtěte si celý dokument