Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Pantoprazole
KRKA, d.d., Novo mesto
A02BC; A02BC02
Pantoprazole
40 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; pantoprazole
Marketed
2009-03-13
PACKAGE LEAFLET: INFORMATION FOR THE USER NOLPAZA 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 Nolpaza is and what it is used for 2. What you need to know before you take Nolpaza 3. How to take Nolpaza 4. Possible side effects 5. How to store Nolpaza 6. Contents of the pack and other information 1. WHAT NOLPAZA IS AND WHAT IT IS USED FOR Nolpaza 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. NOLPAZA IS USED FOR: _Adults and adolescents 12 years of age and above: _ - Treating 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: _ - 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 NOLPAZA DO NOT TAKE NOLPAZA - if you are allergic to pantoprazole, sorbitol or any of the other ingredients of this medicine (listed in section 6); - if you are allergic to medicines containing other proton pump inhibitors. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before taking Lire le document complet
Health Products Regulatory Authority 24 January 2024 CRN00F2N0 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nolpaza 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate). Excipient with known effect: - sorbitol: 36 mg/tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. A light brownish yellow, oval, slightly biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and adolescents 12 years of age and above _ - Reflux oesophagitis. _Adults_ - 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 _ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_ Reflux oesophagitis One tablet of Nolpaza per day. In individual cases the dose may be doubled (increase to 2 tablets Nolpaza daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. _ADULTS_ Eradication of _H. pylori _in combination with two appropriate antibiotics In _H. pylori _positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of _H. pylori_: a) twice daily one tablet Nolpaza + twice daily 1000 mg amoxicillin + twice daily 500 mg clarithromycin Health Products Regulatory Au Lire le document complet