País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
Ranbaxy Ireland Limited
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
20 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESOMEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS ESOMEPRAZOLE 40MG GASTRO-RESISTANT TABLETS esomeprazole WHAT IS IN THIS LEAFLET: 1. What Esomeprazole gastro-resistant tablets are and what they are used for 2. What you need to know before you take Esomeprazole gastro-resistant tablets 3. How to take Esomeprazole gastro-resistant tablets 4. Possible side effects 5. How to store Esomeprazole gastro-resistant tablets 6. Contents of the pack and other information 1. WHAT ESOMEPRAZOLE GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE USED FOR Esomeprazole Tablets 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 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 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 Tablets can also be used to stop stomach ulcers or ulcers in the upper part of the gut (intestine) from forming if you are taking NSAIDs. • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). • Prolonged treatment after prevention of rebleeding of ulcers with intravenous Esomeprazole. READ ALL OF Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 20 mg esomeprazole as esomeprazole magnesium (amorphous). Excipient with known effect: Each tablet also contains not more than 27.45 mg Sucrose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet Light brick red to brown coloured, oval, biconvex, film-coated tablets with ‘E5’ debossed on one side and plain on other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esomeprazole Gastro-resistant tablets are indicated for: Gastroesophageal Reflux Disease (GORD) treatment of erosive reflux esophagitis long-term management of patients with healed esophagitis to prevent relapse symptomatic treatment of gastroesophageal reflux disease (GORD) IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR THE ERADICATION OF _HELICOBACTER PYLORI_ AND healing of _Helicobacter pylori _associated duodenal ulcer and 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. 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 esophagitis to prevent relapse HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 09/09/2014_ _CRN 2151993_ _page number: 1_ symptomatic treatment of gastro-oesophageal reflux disease (GORD) IN Leia o documento completo