País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pantoprazole sodium sesquihydrate
DE Pharmaceuticals
A02BC02
Pantoprazole sodium sesquihydrate
20mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PANTOPRAZOLE 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 Pantoprazole is and what it is used for 2. What you need to know before you take Pantoprazole 3. How to take Pantoprazole 4. Possible side effects 5. How to store Pantoprazole 6. Contents of the pack and other information. 1. WHAT PANTOPRAZOLE IS AND WHAT IT IS 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: _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 cause 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 PANTOPRAZOLE DO NOT TAKE PANTOPRAZOLE - if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to medicines containing other proton pump inhibitors. - if you are taking medicines for the Leia o documento completo
OBJECT 1 PANTOPRAZOLE 20MG GASTRO-RESISTANT TABLETS Summary of Product Characteristics Updated 26-Mar-2020 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Pantoprazole 20 mg gastro-resistant tablets 2. Qualitative and quantitative composition Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate 22.58 mg) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet Elliptical, biconvex, light 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: • Symptomatic gastro-oesophageal reflux disease. • Long-term management and prevention of relapse in reflux oesophagitis. Pantoprazole is indicated for use in adults for: • Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for Leia o documento completo