מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Omeprazole
Wockhardt UK Ltd
A02BC01
Omeprazole
20mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE 20MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE 40MG 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 illnes 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 Omeprazole is and what it is used for 2. What you need to know before you take Omeprazole 3. How to take Omeprazole 4. Possible side effects 5. How to store Omeprazole 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR Omeprazole 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 is used to treat the following conditions: In adults: • ‘Gastro-oesophageal 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 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 the pancreas (Zollinger-Ell קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole 20mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of omeprazole. Excipient(s) with known effect: • Each 20mg capsule contains 102 to 116mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard (gastro-resistant capsule). Omeprazole 20 mg capsules: hard gelatine capsules with opaque yellow capsule containing off-white to cream-white spherical microgranules. 4.1 THERAPEUTIC INDICATIONS _ _ Omeprazole capsules is indicated for in: 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 Paediatric use _Children over 1 year of age and _ ≥ _ 10 kg _ • Treatment of reflux esophagitis •. Symptomatic treatment of heartburn and acid regurgitation in gastro- esophageal reflux disease _ _ _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 Adults _ _ _Treatment of duodenal ulcers _ The recommended dose in patients with an active duodenal ulcer is Omeprazole 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with poorly responsive duodenal ulce קרא את המסמך השלם