País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pantoprazole (pantoprazole sodium sesquihydrate)
Advance Pharma GmbH
pantoprazole (pantoprazole sodium sesquihydrate)
40mg
tablets gastro-resistant
Prescription
_Panto-Denk 40_ Gastro-resistant tablet – oral use Active substance: pantoprazole Proton pump inhibitor PACKAGE LEAFLET: INFORMATION FOR THE USER 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 – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharma- cist. IN THIS LEAFLET: 1. What Panto-Denk 40 is and what it is used for 2. Before you take Panto-Denk 40 3. How to take Panto-Denk 40 4. Possible side effects 5. How to store Panto-Denk 40 6. Further information 1. WHAT PANTO-DENK 40 IS AND WHAT IT IS USED FOR Panto-Denk 40 is a medicine that reduces the production of stomach acid (selective proton pump inhibitor). PANTO-DENK 40 IS USED – to treat duodenal ulcers, – to treat stomach ulcers, – to treat moderate and severe forms of reflux oesophagitis (inflammation of the gullet), – for the long-term treatment of conditions asso- ciated with excess stomach acid production (e.g. Zollinger-Ellison syndrome), – in combination with antibiotics in the treat- ment of an infection caused by _Helicobacter_ _pylori._ This is a bacterial infection, which can cause inflammation of the stomach. It can also cause ulcers in the stomach or duodenum. Treating _Helicobacter pylori_ infection helps to heal these conditions and prevent them from returning. 2. BEFORE YOU TAKE PANTO-DENK 40 DO NOT TAKE PANTO-DENK 40 – if you are allergic (hypersensitive) to panto - prazole, soya, peanuts or any of the other ingredients of Panto-Denk 40, – if you are taking medicines with the active substance atazanavir (used to treat HIV in - fections). – in combined therapy of _Helicobacter pylori,_ when you suffer from moderate or severely reduced kidney or liver functi Leia o documento completo
Page: 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Panto-Denk 40 _ _ _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gastro-resistant tablet contains 40 mg pantoprazole (equivalent to 45.1 mg pantoprazole sodium 1.5 H 2 O). Excipients: 1 tablet contains 76.85 mg maltitol (see section 4.4). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablets Yellow, oval tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Duodenal ulcer - Gastric ulcer - Moderate and severe forms of reflux oesophagitis - Long-term treatment of Zollinger-Ellison syndrome and other disorders associated with pathological hypersecretion of gastric acid - Eradication of _Helicobacter pylori_ , in combination with antibiotics in patients with duodenal ulcer or gastric ulcer 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS AGED 12 YEARS AND OLDER _ _ Moderate and severe forms of reflux oesophagitis The recommended dose for reflux oesophagitis is 1 Panto-Denk 40 gastro-resistant tablet dai- ly. In individual cases, especially in patients yet to respond to therapy with other medicinal prod- ucts, the dose can be doubled (i.e. 2 Panto-Denk 40 gastro-resistant tablets daily). ADULTS Page: 2 of 11 Gastric and duodenal ulcers For monotherapy with Panto-Denk 40, the following dosing guidelines apply: For gastroduodenal ulcers, the dose is 1 Panto-Denk 40 gastro-resistant tablet daily. In individual cases, especially in patients yet to respond to therapy with other medicinal prod- ucts, the double dose can be given (an increase to 2 Panto-Denk 40 gastro-resistant tablets daily). Zollinger-Ellison syndrome For the long-term therapy of Zollinger-Ellison syndrome and other disorders associated with pathological hypersecretion of gastric acid, the recommended starting dose is 80 mg daily (2 Panto-Denk 40 tablets).Thereafter, the dosage can be individually adjusted to the extent of gastric acid secretion. At dosages of more than 80 mg daily, the daily dose should be Leia o documento completo