Country: Malta
Language: English
Source: Medicines Authority
OMEPRAZOLE
Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany
A02BC01
OMEPRAZOLE 10 mg
GASTRO-RESISTANT CAPSULE
OMEPRAZOLE 10 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2011-06-03
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER OMEPRAZOLE ARISTO 10 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE ARISTO 20 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE ARISTO 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 Aristo is and what it is used for 2. What you need to know before you take Omeprazole Aristo 3. How to take Omeprazole Aristo 4. Possible side effects 5. How to store Omeprazole Aristo 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE ARISTO IS AND WHAT IT IS USED FOR Omeprazole Aristo 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 Aristo 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 Aristo can also be used to stop ulcers from forming if you are taking NSAIDs. Read the complete document
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Omeprazole Aristo 10 mg gastro-resistant capsules, hard Omeprazole Aristo 20 mg gastro-resistant capsules, hard Omeprazole Aristo 40 mg gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Omeprazole Aristo 10 mg: one capsule contains 10 mg of omeprazole. Omeprazole Aristo 20 mg: one capsule contains 20 mg of omeprazole. Omeprazole Aristo 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 Aristo 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 Aristo 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 Aristo 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 ulc Read the complete document