Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE PH. EUR.
Pinewood Laboratories Ltd,
OMEPRAZOLE PH. EUR.
10 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER LOSEPINE 10 MG GASTRO-RESISTANT TABLETS LOSEPINE 20 MG GASTRO-RESISTANT TABLETS 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. WHAT IS IN THIS LEAFLET: 1. What Losepine is and what it is used for 2. What you need to know before you take Losepine 3. How to take Losepine 4. Possible side effects 5. How to store Losepine 6. Contents of the pack and other information 1. WHAT LOSEPINE IS AND WHAT IT IS USED FOR Losepine gastro-resistant tablets 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. Losepine 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 Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losepine 10 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 10 mg of omeprazole. Excipients: each tablet contains 104.5 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Oval red-brown tablet (length 9.8 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losepine gastro-resistant tablets 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 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 in adults _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is Losepine 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 treatmen Belgenin tamamını okuyun