Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pantoprazole sodium sesquihydrate
Accord-UK Ltd
A02BC02
Pantoprazole sodium sesquihydrate
40mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5012617017697
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. • The full name of this medicine is Pantoprazole 40mg Gastro-resistant Tablets but within the leaflet it will be referred to as Pantoprazole tablets. WHAT IS IN THIS LEAFLET: 1 WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE TABLETS 3 HOW TO TAKE PANTOPRAZOLE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE PANTOPRAZOLE TABLETS 6 CONTENTS OF THE PACK AND OTHER 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 TABLETS ARE 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 _Heliobacter _ _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 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 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE TABLETS DO NOT TAKE PANTOPRAZOLE TABLETS IF YOU • are ALLERGIC TO PANTOPRAZOLE or an Διαβάστε το πλήρες έγγραφο
OBJECT 1 PANTOPRAZOLE 40MG GASTRO-RESISTANT TABLETS Summary of Product Characteristics Updated 15-Mar-2022 | 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 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 40 mg gastro-resistant tablets 2. Qualitative and quantitative composition Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate 45.16 mg) For the 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 _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 adolescent Διαβάστε το πλήρες έγγραφο