País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ranitidine hydrochloride
Flamingo Pharma (UK) Ltd
A02BA02
Ranitidine hydrochloride
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 5060464501951
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. DO NOT TAKE RANITIDINE FILM-COATED TABLETS: • if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ranitidine Film-coated Tablets if: • you have stomach cancer • you have kidney problems. You will need to take a different amount of Ranitidine Film-coated Tablets • you have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory (NSAID) medicines • you have a rare condition called acute porphyria • you are over 65 years old • you have lung disease • you are diabetic • you have any problems with your immune system. If you are not sure, talk to your doctor or pharmacist before taking Ranitidine Film-coated Tablets. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using this medicine. PACKAGE LEAFLET: INFORMATION FOR THE USER RANITIDINE 150 MG FILM-COATED TABLETS RANITIDINE 300 MG FILM-COATED TABLETS RANITIDINE HYDROCHLORIDE WHAT IS IN THIS LEAFLET: 1. What Ranitidine Film-coated Tablet is and what it is used for 2. What you need to know before you take Ranitidine Film-coated Tablets 3. How to take Ranitidine Film-coated Tablets 4. Possible side effects 5. How to store Ranitidine Film-coated Tablets 6. Contents of the pack and other information 1. WHAT RANITIDINE FILM-COATED TABLET IS AND WHAT IT IS USED FOR Ranitidine Film-coated Tablet contains a medicine called Leer el documento completo
OBJECT 1 RANITIDINE 300 MG TABLETS Summary of Product Characteristics Updated 08-Apr-2020 | Flamingo Pharma (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 Ranitidine 300 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 336 mg of Ranitidine hydrochloride equivalent to 300 mg of Ranitidine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated Tablet Yellow, capsule shaped, biconvex, beveled edge film coated tablets with breakline on one side and plain on other side. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Adults Ranitidine Film-coated Tablets are indicated for: • treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti- inflammatory agents. • treatment of duodenal ulcers associated with Helicobacter pylori infection. • treatment of post-operative ulcer • Zollinger-Ellison Leer el documento completo