Riik: Malta
keel: inglise
Allikas: Medicines Authority
RANITIDINE
Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland
A02BA02
RANITIDINE 75 mg
FILM-COATED TABLET
RANITIDINE 75 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2006-09-18
70 11 9 11 11 11 70 9 Please read all of this leaflet carefully before you start to take this medicine because it contains important information for you. This medicine is available without prescription. However, you still need to take Zantac 75 tablets carefully to get the best results from them. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve after 14 days. • If any of the side effects get serious or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Zantac 75 tablets are and what are they used for 2. Before you take Zantac 75 tablets 3. How to take Zantac 75 tablets 4. Possible side effects 5. How to store Zantac 75 tablets 6. Further information 1. WHAT ZANTAC 75 TABLETS ARE AND WHAT ARE THEY USED FOR Each tablet contains 75mg of ranitidine (as hydrochloride). Ranitidine belongs to a group of medicines known as histamine H2 antagonists. The stomach contains hydrochloric acid which helps to digest your food. Sometimes your stomach produces too much acid. This excess acid can lead to the conditions known as heartburn and dyspepsia (acid indigestion). Zantac 75 tablets are for the short-term relief of the symptoms of heartburn, excess acid and dyspepsia (acid indigestion). 2. BEFORE YOU TAKE ZANTAC 75 TABLETS DO NOT TAKE ZANTAC 75 TABLETS: • if you are allergic to ranitidine or any of the other ingredients listed in Section 6. • if you suffer from a rare condition called porphyria. TAKE SPECIAL CARE AND CONSULT YOUR DOCTOR BEFORE YOU TAKE ZANTAC 75 TABLETS: • if you are middle aged or older and have acid indigestion symptoms for the first time or symptoms that have recently changed. • if you have been told you have a peptic ulcer (“stomach” or “duodenal”). • if you have unintended weight loss associated with dyspepsia. • if you have kidney or liver problems. • if you suffer from l Lugege kogu dokumenti
HEALTH PRODUCTS REGULATORY AUTHORITY _Date Printed 21/07/2017_ _CRN 2194481_ _page number: 1_ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zantac 75mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zantac 75 contains 75mg ranitidine as ranitidine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (Tablet). Five sided biconvex, pink film coated tablet with Z engraved on one side and 75 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The short-term symptomatic relief of acid indigestion and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE IN ADULTS (INCLUDING THE ELDERLY) AND CHILDREN 16 YEARS OF AGE OR OLDER: One Zantac 75 tablet should be taken when symptoms appear, day or night. Maximum intake in 24 hours: 2 tablets (150mg). The maximum treatment period is two weeks. It is not necessary to take the tablets with food. Patients are advised to consult their doctor or pharmacist if symptoms persist, get worse or continue for 14 days. CHILDREN: Not recommended for children under 16 years of age. 4.3 CONTRAINDICATIONS Known hypersensitivity to any component of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment (creatine clearance less than 50ml/min). Ranitidine products are not suitable for these patients without medical supervision. Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria. HEALTH PRODUCTS REGULATORY AUTHORITY _Date Printed 21/07/2017_ _CRN 2194481_ _page number: 2_ The following patients are advised to seek their doctor’s advice before taking ranitidine products: Patients with renal impairmen Lugege kogu dokumenti