Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ranitidine hydrochloride
Omega Pharma Ltd
A02BA02
Ranitidine hydrochloride
75mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 5000123109647 5000347087042
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. IN THIS LEAFLET: 1. What Zantac 75 is and what it is used for 2. What you need to know before you take Zantac 75 3. How to take Zantac 75 4. Possible side effects 5. How to store Zantac 75 6. Contents of the pack and other information 1. What Zantac 75 is and what it is used for ZANTAC 75 IS USED TO TREAT AND PREVENT INDIGESTION AND HEARTBURN FOR UP TO 12 HOURS. THE STOMACH PRODUCES ACID WHICH HELPS TO DIGEST FOOD. SOMETIMES YOUR STOMACH PRODUCES TOO MUCH ACID WHICH CAN CAUSE INDIGESTION AND HEARTBURN. THE ACTIVE INGREDIENT IS RANITIDINE HYDROCHLORIDE WHICH IS A MEDICINE CALLED AN 'H2-BLOCKER’. IT WORKS BY PREVENTING YOUR STOMACH FROM PRODUCING TOO MUCH ACID. You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. 2. What you need to know before you take Zantac 75 DO NOT TAKE ZANTAC 75: • if you are ALLERGIC TO RANITIDINE OR ANY OF THE OTHER INGREDIENTS OF THIS MEDICINE (listed in section 6). • if you are UNDER 16 YEARS. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zantac 75. • if you have KIDNEY or LIVER PROBLEMS • if you have PORPHYRIA (too much of the pigment called porphyrin which may discolour the urine) • if you have UNINTENDED WEIGHT LOSS ASSOCIATED WITH ACID INDIGESTION • if you are MIDDLE-AGED or older with NEW or RECENTLY CHANGED INDIGESTION symptoms • if you have PERSISTENT STOMACH PAIN • if you are under REGULAR MEDICAL SUPERVISION • if yo Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zantac 75 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ranitidine hydrochloride 84mg (equivalent to ranitidine 75mg) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, five-sided, biconvex, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity. For prevention of acid indigestion, indigestion, hyperacidity and heartburn associated with consuming food and drink. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral Posology _ _ _Adults (including the elderly) and children 16 years of age and older: _ Swallow one Zantac 75 tablet whole, with a drink of water, as soon as you have symptoms. If symptoms persist for more than one hour or return, take another tablet. Do not take more than four tablets in 24 hours. For prevention of acid indigestion, indigestion, hyperacidity and heartburn associated with consuming food and drink, swallow one tablet with water, half to one hour beforehand. Patients will be advised not to take the tablets for more than 2 weeks continuously and to consult their doctor if symptoms get worse or persist after 2 weeks treatment. _Children under 16 years _ Not recommended for children under 16 years of age. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Treatment with a histamine H 2 -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 (creatinine clearance less than 50 ml/min). Zantac 75 is not suitable for these patients without medical supervision. Patients who are taking non-steroidal anti-inflammatory drugs especially in those with a history Baca dokumen lengkapnya