Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Esomeprazole magnesium
McDermott Laboratories Ltd., T/A Gerard Laboratories
A02BC; A02BC05
Esomeprazole magnesium
20 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; esomeprazole
Not marketed
2011-04-01
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ESOMEPRAZOLE MYLAN 20 MG GASTRO-RESISTANT HARD CAPSULES ESOMEPRAZOLE MYLAN 40 MG GASTRO-RESISTANT HARD CAPSULES esomeprazole 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 or nurse. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If any of the side effects gets serious, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Esomeprazole Mylan is and what it is used for 2. What you need to know before you take Esomeprazole Mylan 3. How to take Esomeprazole Mylan 4. Possible side effects 5. How to store Esomeprazole Mylan 6. Contents of the pack and other information 1. WHAT ESOMEPRAZOLE MYLAN IS AND WHAT IT IS USED FOR Esomeprazole Mylan contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Esomeprazole Mylan is used to treat the following conditions: Adults and young people aged 12 years and above ‘Gastro-oesophageal 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 stomach or upper part of the gut (intestine) that 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. Adults Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole Mylan can also be used to stop stomach ulcers from forming if you are taking NSAIDs. Too much acid in the stomach caused by a সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole Mylan 20 mg Gastro-resistant Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg esomeprazole (as esomeprazole magnesium). Excipient with known effect: Each capsule contains up to 45.58 mg sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant hard capsule White to cream coloured pellets filled in hard gelatin capsules of length 15.8 mm ± 0.4 mm and width 5.85 mm ± 0.03 (approx) with pink cap and pink body, imprinted with ‘Mylan’ over ‘EM 20’ in black ink on cap and body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esomeprazole Mylan is indicated for: Adults: GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) - Treatment of erosive reflux oesophagitis - Long-term management of patients with healed oesophagitis to prevent relapse - Symptomatic treatment of gastro-oesophageal reflux disease (GORD) IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN FOR THE ERADICATION OF_ HELICOBACTER PYLORI_ AND - Healing of_ Helicobacter pylori_ associated duodenal ulcer - Prevention of relapse of peptic ulcers in patients with_ Helicobacter pylori-_associated ulcers. PATIENTS REQUIRING CONTINUED NSAID THERAPY Healing of gastric ulcers associated with NSAID therapy. Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULCERS. TREATMENT OF ZOLLINGER ELLISON SYNDROME Adolescents from the age of 12 years GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) - Treatment of erosive reflux oesophagitis - Long-term management of patients with healed oesophagitis to prevent relapse - Symptomatic treatment of gastro-oesophageal reflux disease (GORD) IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED BY_ HELICOBACTER PYLORI._ H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ সম্পূর্ণ নথি পড়ুন