מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
ESOMEPRAZOLE
Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland
A02BC05
ESOMEPRAZOLE 20 mg
GASTRO-RESISTANT TABLET
ESOMEPRAZOLE 20 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2014-11-10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ESOMEPRAZOLE BRILLPHARMA 20 MG GASTRO-RESISTANT TABLETS ESOMEPRAZOLE BRILLPHARMA 40 MG GASTRO-RESISTANT TABLETS Esomeprazole 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 Esomeprazole is and what it is used for 2. What you need to know before you take Esomeprazole 3. How to take this Esomeprazole 4. Possible side effects 5. How to store Esomeprazole 6. Contents of the pack and other information 1. WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR The name of your medicine is Esomeprazole Gastro-Resistant Tablets. 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 ADOLESCENTS AGED 12 YEARS AND OVER • ‘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). This medicine can also be used to stop stomach ulcers from forming if you are taking NSAIDs. • Too much acid in the stomach caused by a growth in קרא את המסמך השלם
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole Brillpharma 20 mg Gastro-Resistant Tablets Esomeprazole Brillpharma 40 mg Gastro-Resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg of esomeprazole (as magnesium dihydrate). Excipients with known effect: Each gastro-resistant tablet contains 8.74 mg sucrose and 37.35 mg lactose monohydrate approximately. Each gastro-resistant tablet contains 40 mg of esomeprazole (as magnesium dihydrate). Excipients with known effect: Each gastro-resistant tablet contains 17.48 mg sucrose and 74.70 mg lactose monohydrate approximately. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet (tablet) Light pink coloured oval shaped, bevel edged tablets debossed with ‘H’ on one side and ‘186’ on the other side. The tablet dimensions are 14.2mm x 7.1mm. Pink coloured oval shaped, bevel edged tablets debossed with ‘H’ on one side and ‘187’ on the other side. The tablet dimensions are 16.2mm x 8.1mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Esomeprazole tablets are indicated in adults for: • 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 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. Page 2 of 17 -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 קרא את המסמך השלם