País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE
Merck Serono Limited
Tablets
1997-11-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Emcoretic Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg Bisoprolol fumarate and 12.5 mg Hydrochlorothiazide. For excipients, see 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Circular, biconvex, pink, film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION METHOD OF ADMINISTRATION: Oral. ADULTS: One tablet daily. In patients with moderate to severe impairment of renal (creatinine clearance < 20ml/min) or liver function the dose should be reduced. ELDERLY: As for adults. CHILDREN: There is no paediatric experience with bisoprolol and it is not therefore recommended for children. 4.3 CONTRAINDICATIONS It should not be used in cases of untreated or decompensated cardiac failure, cardiogenic shock, sinoatrial block, second or third degree AV block, marked bradycardia (heart rate less than 50 beats/min), acute myocardial infarction, severe asthma, patients with a known hypersensitivity to hydrochlorothiazide, severe renal or hepatic failure, hypokalaemia or hyponatraemia. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Emcoretic can be administered with caution to patients with obstructive respiratory disorders provided that adequate supervision is maintained. If increased airways resistance develops consideration must be given to discontinuation of the -blocker, depending on the degree of airways resistance and the benefit derived from -blockade. Use with care in patients with a prolonged PR conduction interval, poor cardiac reserve and peripheral circulatory IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 01/12/2005_ _CRN 2017412_ _page number: 1_ disturbances, suc Leia o documento completo