Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pantoprazole sodium sesquihydrate
Torrent Pharma (UK) Ltd
A02BC02
Pantoprazole sodium sesquihydrate
20mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5060623370497
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Pantoprazole 20 mg Gastro-resistant Tablets are and what they are used for 2. What you need to know before you take Pantoprazole 20 mg Gastro-resistant Tablets 3. How to take Pantoprazole 20 mg Gastro-resistant Tablets 4. Possible side effects 5. How to store Pantoprazole 20 mg Gastro-resistant Tablets 6. Contents of the pack and other information 1. WHAT PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE USED FOR Pantoprazole 20 mg Gastro-resistant Tablets contains the active substance pantoprazole. Pantoprazole 20 mg Gastro-resistant Tablets 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. PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS IS USED TO TREAT: _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. _Pantoprazole is used to treat adults for: _ _ _ - Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patie Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet_ _contains 20 mg of pantoprazole (as sodium sesquihydrate). Excipient with known effect: Each gastro-resistant tablet contains 19.06 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Yellow to ochre elongated coated_ _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 _Recommended dose _ Adults and adolescents 12 years of age and above. Symptomatic gastro-oesophageal reflux disease. The recommended oral dose is one gastro-resistant tablet Pantoprazole 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, taking one tablet 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 Pantoprazole 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoprazole 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 Прочетете целия документ