Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
EPROSARTAN MESYLATE
Abbott Healthcare Products Ltd
EPROSARTAN MESYLATE
400 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TEVETEN 400 mg, film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains eprosartan mesylate equivalent to 400 mg eprosartan. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Oval, light to moderately pink film-coated tablet marked “5044” on one side and no inscription on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eprosartan is indicated for the treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is 600 mg eprosartan once daily. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment. Eprosartan may be used alone or in combination with other anti-hypertensives. In particular, addition of a thiazide-type diuretic such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown to have an additive effect with eprosartan. Eprosartan may be taken with or without food. Duration of treatment is not limited. GERIATRIC PATIENTS No dose adjustment is required in the elderly. DOSAGE IN HEPATICALLY IMPAIRED PATIENTS There is limited experience in patients with hepatic insufficiency _(see section 4.3, Contraindications)._ DOSAGE IN RENALLY IMPAIRED PATIENTS In patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min), the daily dose should not exceed 600 mg. PAEDIATRIC PATIENTS Teveten is not recommended for use in children and adolescents due to lack of data on safety and efficacy. 4.3 CONTRAINDICATIONS Known hypersensitivity to eprosartan or to any of the excipients. Severe hepatic impairment. IRISH MEDICINES BOARD ___________________________________________________________ Soma hati kamili