Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
esomeprazolmagnesiumtrihydrat
Grünenthal GmbH
A02BC05
magnesium trihydrate
20 mg
Enterotablett
natriumlaurilsulfat Hjälpämne; sockersfärer Hjälpämne; esomeprazolmagnesiumtrihydrat 22,3 mg Aktiv substans
Apotek
Receptbelagt
Esomeprazol
Förpacknings: Burk, 1 x 28 tabletter; Burk, 1 x 5 tabletter; Burk, 1 x 14 tabletter; Burk, 1 x 56 tabletter; Burk, 1 x 60 tabletter; Burk, 1 x 100 tabletter; Burk, 1 x 30 tabletter; Burk, 1 x 140 (5 x 28) tabletter; Burk, 1 x 2 tabletter; Burk, 1 x 7 tabletter; Burk, 1 x 15 tabletter; Blister, 1 x 15 tabletter; Blister, 1 x 28 tabletter; Blister, 1 x 30 tabletter; Blister, 1 x 140 tabletter; Blister, 1 x 56 tabletter; Blister, 1 x 14 tabletter; Blister, 1 x 60 tabletter; Blister, 1 x 98 tabletter; Blister, 1 x 3 tabletter; Blister, 1 x 7 tabletter; Blister, 50 x 1 tabletter (endos); Blister, 25 x 1 tabletter (endos); Blister, 100 x 1 tabletter (endos); Blister, 7 x 1 tabletter (endos); Blister, 1 x 90 tabletter
Godkänd
2000-10-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AXIAGO 20 MG GASTRO-RESISTANT TABLETS AXIAGO 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 Axiago is and what it is used for 2. What you need to know before you take Axiago 3. How to take Axiago 4. Possible side effects 5. How to store Axiago 6. Contents of the pack and other information 1. WHAT AXIAGO IS AND WHAT IT IS USED FOR Axiago 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. Axiago is used to treat the following conditions: Adults ‘Gastroesophageal 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 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. Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Axiago 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 the pancreas (Zollinger-Ellison syndrome). Prolonged treatment after prevention of rebleeding of ulcers with intravenous Axiago. Adolescents Läs hela dokumentet
1 Produktinformationen för Axiago 20 mg, 40 mg enterotablett, MTnr 16312, 16315, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 2 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT AXIAGO 20 mg gastro-resistant tablets AXIAGO 40 mg gastro-resistant tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium trihydrate). Excipients: Axiago 20 mg: Sucrose 28 mg. Axiago 40 mg: Sucrose 30 mg. For a full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Gastro-resistant tablet 20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A/EH on the other side. 40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A/EI on the other side. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Axiago tablets are indicated for: Adults GASTROESOPHAGEAL REFLUX DISEASE (GERD) - treatment of erosive reflux esophagitis - long-term management of patients with healed esophagitis to prevent relapse - symptomatic treatment of gastroesophageal reflux disease (GERD) 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. PROLONGED TREATMENT AFTE Läs hela dokumentet