Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pantoprazole sodium sesquihydrate
Dr Reddy's Laboratories (UK) Ltd
A02BC02
Pantoprazole sodium sesquihydrate
40mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
PATIENT INFORMATION LEAFLET PANTOPRAZOLE 40 MG GASTRO-RESISTANT TABLETS pantoprazole (as sodium sesquihydrate) The name of this medicine is Pantoprazole 40 mg Gastro-Resistant Tablets, which will be referred to as Pantoprazole Tablets throughout this leaflet. 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 further questions, ask your doctor or your 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 pharmacist. IN THIS LEAFLET: 1. What Pantoprazole Tablets are and what they are used for 2. Before you take Pantoprazole Tablets 3. How to take Pantoprazole Tablets 4. Possible side effects 5. How to store Pantoprazole Tablets 6. Further information 1. WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR 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. PANTOPRAZOLE IS USED FOR TREATING: _Adults and adolescents 12 years of age and above:_ Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. _Adults_: An infection with a bacterium called _Helicobacter pylori _in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning. Stomach and duodenal ulcers. Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach. 2. BEFORE YOU TAKE PANTOPRAZOLE TABLETS DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU: ARE ALLERGIC (HYPERSENSITIVE) to PANTOPRAZOLE, or to any of Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg of pantoprazole (as 45.16 mg pantoprazole sodium sesquihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Elliptical, biconvex, dark yellow gastro-resistant tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Pantoprazole is indicated for use in adults and adolescents 12 years of age and _ _above for: _ -Reflux oesophagitis. _Pantoprazole is indicated in adult 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 _ _ _Adults and adolescents 12 years of age and above _ Reflux oesophagitis One Pantoprazole 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to 2 Pantoprazole 40 mg tablets 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) Pantoprazole 40 mg gastro-resistant tablet twice daily one + twice daily 1000 mg amoxicillin + twice daily 500 mg clarithromy Citiți documentul complet