Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Astellas Pharma Co. Ltd
OMEPRAZOLE
20 Milligram
Capsules Gastro-Resistant
Withdrawn
2014-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ULCID 20 MG GASTRO-RESISTANT CAPSULES OMEPRAZOLE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 symptoms 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 the leaflet. See section 4. IN THIS LEAFLET: 1. What Ulcid is and what it is used for 2. What you need to know before you take Ulcid 3. How to take Ulcid 4. Possible side effects 5. How to store Ulcid 6. Contents of the pack and other information 1 . WHAT ULCID IS AND WHAT IS IT USED FOR Ulcid gastro-resistant capsules 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. This allows the ulcers to heal and eases the pain. Ulcid is used to treat the following conditions: IN ADULTS: • ’Gastro-oesophagitis reflux disease’ (GORD).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). • Prevention of relapse of duodenal and gastric ulcers. • 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 ul Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ulcid 20 mg gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 20 mg of omeprazole. Excipient: Each gastro-resistant capsule contains 116mg lactose monohydrate. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard (capsule) Opaque, white hard capsules marked with imprint '20' on the body and 'OM' on the cap. The capsules contain gastro- resistant microtablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ulcid gastro-resistant 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 for _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 oesophagitis • Long-term management of patients with healed reflux oesophagitis • Treatment of symptomatic gastro-oesophageal reflux disease • Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and_ _10 kg_ • Treatment of reflux oesophagitis • Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophagitis reflux disease (GORD) _Children and adolescents over 4 years of age_ • In combination with antibiotics in treatment of duodenal ulcer caused by _H. pylori_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Adults _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is Ulcid 20 mg once daily. In most patients healing IRISH MEDICINES BOARD _______ Les hele dokumentet