Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
OMEPRAZOLE
Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
A02BC01
OMEPRAZOLE 20 mg
GASTRO-RESISTANT HARD CAPSULE
OMEPRAZOLE 20 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2013-11-22
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT USER Omeprazole 20 mg Gastro-Resistant capsules, hard Omeprazole 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Omeprazole capsule is and what it is used for 2. What you need to know before you take Omeprazole capsule 3. How to take Omeprazole capsule 4. Possible side effects 5. How to store Omeprazole capsule 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE CAPSULE IS AND WHAT IT IS USED FOR Omeprazole capsule 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 capsule 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 capsule can also be used to stop ulcers from forming if you are taking NSAIDs. • Too much acid in the stomach caused by a growth in Leggi il documento completo
Page 1 of 15 1. NAME OF THE MEDICINAL PRODUCT Omeprazole 20 mg gastro ‐ resistant capsules, hard Omeprazole 40 mg gastro ‐ resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Omeprazole 20 mg: each gastro-resistant capsule, hard contains 20 mg omeprazole. Omeprazole 40 mg: each gastro-resistant capsule, hard contains 40 mg omeprazole. Excipients with known effect: 20 mg: each gastro-resistant capsule, hard contains 7,9 mg of lactose anhydrous and approximate 149,6 mg of sucrose. 40 mg: each gastro-resistant capsule, hard contains 15,84 mg lactose anhydrous and approximate 299,2 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard Omeprazole 20 mg Hard gelatine capsules nº 2 (length=18.0 mm), with green body and cap, containing enteric coated pellets of white or slightly yellow colour. Omeprazole 40 mg Hard gelatine capsules nº 0 (length=21.7mm), with blue purple body and cap, containing enteric coated pellets of white or slightly yellow colour. 4. CLINICAL PARTICULARS _4.1 THERAPEUTIC INDICATIONS _ Omeprazole is indicated in adults and children aged over 1 year of age and ≥ 10 kg. _ _ Omeprazole gastro-resistant capsules, hard 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 patients at risk • Treatment of reflux esophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-esophageal reflux disease • Treatment of Zollinger-Ellison syndrome Page 2 of 15 Paediatric population _Children over 1 year of age and ≥ 10 kg _ • Treatment of reflux esophagitis • Symptomatic treatment of heartburn and acid Leggi il documento completo