Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE
Abbott Healthcare Products Ltd
600/12.5 Milligram
Film Coated Tablet
2005-01-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teveten Plus 600 mg/12.5 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains eprosartan mesylate equivalent to 600 mg eprosartan and 12.5 mg hydrochlorothiazide. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet. Butterscotch-coloured, capsule-shaped film-coated tablets. The inscription of the tablet is ‘5147’ on one side and no inscription on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. Teveten Plus 600 mg/12.5 mg is indicated in patients whose blood pressure is not adequately controlled on eprosartan alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is one tablet Teveten Plus 600 mg/12.5 mg once daily, which should be taken in the morning. The switch from eprosartan monotherapy to the fixed combination can be considered after 8 weeks of blood pressure stabilization. Teveten Plus 600 mg/12.5 mg can be taken with or without food. ELDERLY No dose adjustment is required in the elderly, although limited information is available in this population. CHILDREN As safety and efficacy of administration to children have not been established, treatment of children and adolescents < 18 years with Teveten Plus 600 mg/12.5 mg is not recommended. HEPATIC IMPAIRMENT The use of Teveten Plus in patients with mild to moderate hepatic impairment is not recommended since there is currently only limited experience of eprosartan mesylate in this patient group. In patients with severe hepatic impairment Teveten Plus is contraindicated _(see sections 4.3 and 4.4)._ RENAL IMPAIRMENT In patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min) dose adjustment Read the complete document