TEVETEN TABLET 600 mg

Indication

Treatment of essential hypertension.

Contra-indications

Known hypersensitivity to components of the product. Pregnancy and lactation. Severe hepatic impairment.

The concomitant use of Teveten™ with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology and method of administration

The recommended dose is 600 mg once daily, to be taken in the morning.

The dose may be increased to a maximum of 800 mg daily, depending on the blood pressure response, until satisfactory response is achieved. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment.

Doses up to 1200 mg per day, for 8 weeks, have been shown in clinical trials to be effective with no apparent dose relationship in the incidence of adverse experiences reported.

Teveten™ may be used alone or in combination with other antihypertensives, e.g. thiazide-type diuretics or calcium channel blockers, if a greater blood pressure lowering effect is required.

Teveten™ may be taken with or without food.

Elderly (> 75 years): As clinical experience is limited in patients over 75 years, a starting dose of 300 mg once daily is recommended.

Dosage in hepatically impaired patients: There is limited experience in patients with hepatic impairment (see section Contra-indications and section Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with mild to moderate hepatic impairment, a starting dose of 300 mg once daily is recommended.

Dosage in renally impaired patients: No dose adjustment is required in patients with creatinine clearance 60–80 ml/min. As clinical experience is limited in patients with creatinine clearance <60ml/min, a starting dose of 300mg once daily is recommended (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).