Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
pantoprazolnatriumseskvihydrat
Orion Corporation
A02BC02
pantoprazole sodium sesquihydrate
20 mg
Enterotablett
mannitol Hjälpämne; pantoprazolnatriumseskvihydrat 22,556 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 7 tabletter; Blister, 14 tabletter; Blister, 15 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Blister, 500 tabletter; Burk, 500 tabletter; Burk, 280 tabletter; Burk, 14 tabletter; Burk, 56 tabletter; Burk, 60 tabletter; Burk, 98 tabletter; Burk, 100 tabletter
Godkänd
2018-01-24
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PANTOPRAZOL ORION 20 MG GASTRO-RESISTANT TABLETS pantoprazole 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 Pantoprazol Orion is and what it is used for 2. What you need to know before you take Pantoprazol Orion 3. How to take Pantoprazol Orion 4. Possible side effects 5. How to store Pantoprazol Orion 6. Contents of the pack and other information 1. WHAT PANTOPRAZOL ORION IS AND WHAT IT IS USED FOR Pantoprazol Orion contains the active substance pantoprazole. Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. Pantoprazol Orion is used to treat _adults and adolescents 12 years of age and above for_ : • symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro- oesophageal reflux disease caused by reflux of acid from the stomach • long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return _adults for_ : • preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOL ORION DO NOT TAKE PANTOPRAZOL ORION if you are allergic to pantoprazole or any of the other ingredients of this medicine (li Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pantoprazol Orion 20 mg gastro-resistant tablets Pantoprazol Orion 40 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains pantoprazole sodium sesquihydrate equivalent to 20 mg or 40 mg pantoprazole. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet (tablet). 20 mg: Light yellow, oval, biconvex tablets, 8.7 mm x 4.5 mm. 40 mg: Yellow, oval, biconvex tablets, 11.9 mm x 6.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pantoprazol Orion 20 mg is indicated in • _adults and adolescents 12 years of age and above for_ : symptomatic gastro-oesophageal reflux disease long-term management and prevention of relapse in reflux oesophagitis. • _adults for_ prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti- inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4). Pantoprazol Orion 40 mg is indicated in • _adults and adolescents 12 years of age and above for_ : reflux oesophagitis • _adults for_ Eradication of _Helicobacter pylori_ ( _H. pylori_ ) in combination with appropriate antibiotic therapy in patients with _H. pylori_ associated ulcers Gastric and duodenal ulcer Zollinger-Ellison Syndrome and other pathological hypersecretory conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology PANTOPRAZOL ORION 20 MG Adults and adolescents 12 years of age and above _Symptomatic gastro-oesophageal reflux disease_ The recommended oral dose is one 20 mg tablet per day. Symptom relief is generally accomplished within 2–4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, taking one tablet when required. A switch to continuous therapy may be considered in case Läs hela dokumentet