Indications, posology and method of administration
THERAPEUTIC INDICATIONS
- Hypertension:
Treatment of essential hypertension in adults.
- Cardiovascular prevention:
Reduction of cardiovascular morbidity in adults with:
+ Manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease).
+ Type 2 diabetes mellitus with documented target organ damage.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
- Treatment of essential hypertension:
The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment.
- Cardiovascular prevention:
The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Patients with renal impairment
Limited experience is available in patients with severe renal impairment or haemodialysis. A lower starting dose of 20 mg is recommended in these patients.
No posology adjustment is required for patients with mild to moderate renal impairment.
Patients with hepatic impairment
Telmisartan is contraindicated in patients with severe hepatic impairment.
In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily.
Elderly patients
No dose adjustment is necessary for elderly patients.
Paediatric population
The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established.
Use in this population is not recommended.
Method of administration:
Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets. Tablets should be taken out of the blister shortly before.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- Second and third trimester of pregnancy.
- Lactating women.
- Biliary obstructive disorders.
- Severe hepatic impairment.
The concomitant use of telmisartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
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