País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pantoprazole sodium sesquihydrate
Sandoz Ltd
A02BC02
Pantoprazole sodium sesquihydrate
40mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5050650057034
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 Leia o documento completo
OBJECT 1 PANTOPRAZOLE 40MG GASTRO-RESISTANT TABLETS Summary of Product Characteristics Updated 01-Jun-2022 | Sandoz Limited • 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 40 mg Gastro-resistant Tablets 2. Qualitative and quantitative composition Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate). Excipient with known effect: Each gastro-resistant tablet contains 2 microgram of azo colouring agent Ponceau 4R aluminium lake (E124). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet A yellow, oval coated tablet, approx.. 11.7 x 6.0 mm. 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 adults for: - Eradication of _Helicobacter pylori _(_H. pylori_) in combination with appropriate antibiotic therapy in patients with _H. pylori _associated u Leia o documento completo