Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
RANITIDINE HYDROCHLORIDE
Ranbaxy (UK) Limited
75 Milligram
Tablets
2000-07-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellran 75mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 83.75 mg of Ranitidine Hydrochloride equivalent to 75 mg of Ranitidine. For excipients see 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bellran Tablets are indicated for the short-term symptomatic relief of acid indigestion and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly) and adolescents of 16 years of age and older._ One Bellran 75mg tablet should be taken when symptoms occur, day or night. Do not take more than two tablets in 24 hours. Patients will be instructed not to take the tablets for more than 2 weeks continuously. They must consult their doctor if symptoms deteriorate or persist after 2 weeks treatment. _Children under 16 years._ The tablets are not recommended for children under 16 years of age. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance ranitidine or to any of the excipients of the medicinal product. Bellran tablets should not be given to children under 16 years of age. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/12/2007_ _CRN 2044513_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product is not indicated if the patient presents with any of the following without first seeking their doctor’s advice: o Treatment with histamine (H 2 ) antagonists may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. If the patient has been diagnosed as having a gastric ulcer or in middle aged or older patients who have experienced Aqra d-dokument sħiħ