Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Pantoprazole
KRKA, d.d., Novo mesto
A02BC; A02BC02
Pantoprazole
20 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 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nolpaza 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate). Excipient with known effect: - sorbitol: 18 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_ Symptomatic gastro-oesophageal reflux disease. For long-term management and prevention of relapse in reflux oesophagitis. _Adults _ 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_ Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one gastro-resistant tablet Nolpaza 20 mg 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, when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment. Long-term management and prevention of relapse in reflux oesophagitis For long-term management, a maintenance dose of one gastro-resistant tablet Nolpaza 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Nolpaza 40 mg is available for this case. After healing of the relapse the dose can be reduced again to 20 mg pantoprazole. _ADULTS_ Prevention of gastroduodenal ulcers induced by non-selective Lire le document complet