Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
omeprazole 20 mg
Mylan S.A.S.
A02BC01
omeprazole
gastro-resistant hard capsule
Authorised
2012-07-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Omeprazole Mylan 20 mg gastro-resistant capsules, hard _ _ {Omeprazole} READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Omeprazole is and what it is used for 2. Before you take Omeprazole 3. How to take use Omeprazole 4. Possible side effects 5. How to store Omeprazole 6. Further information 1. WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR Omeprazole 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-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 intestines (duodenal ulcer) or stomach (gastric ulcer). • Ulcers which are also infected with a 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-steriodal anti inflammatory drugs). Omeprazole can also be use Soma hati kamili
Page 1 of 14 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Omeprazole Mylan 20 mg gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule, hard contains 20 mg omeprazole Each 20mg gastro-resistant capsule, hard contains 33.8 mg sucrose Each 20mg gastro-resistant capsule, hard contains 0.0029mg Tartrazine (E102) and 0.0104mg Allura red (E129). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsules, hard 20 mg capsule: capsule with dark pink opaque cap and white opaque body and marked ‘MYLAN’ over ‘OM20’ axially on both cap and body 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole 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,_ 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 of patients with healed reflux esophagitis - Treatment of symptomatic gastro-esophageal reflux disease, - Treatment of Zollinger-Ellison syndrome - Paedriatric 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 Page 2 of 14 _Children and adolescents over 4 years of age _ - In combination with antibiotics in the treatment of duodenal ulcer caused by _H. pylori_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _Treatment of duodenal ulcers _ The recommended Soma hati kamili