Description
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) or
• type 2 diabetes mellitus with documented target organ damage
DOSAGE
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 medicinal products that lower blood pressure may be necessary.
Elderly
No dose adjustment is necessary for elderly patients.
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. Telmisartan is not removed from blood by hemofiltration and is not dialyzable.
Hepatic impairment
Micardis 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.
Paediatric population
The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
Method of administration
Telmisartan tablets are for once-daily oral administration and should be swallowed whole with liquid, with or without food.
Precautions to be taken before handling or administering the medicinal product.
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 administration.
PREGNANCY AND LACTATION
The use of angiotensin II receptor antagonists,for example telmisartan, is not recommended during the first trimester of pregnancy. The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy.
Telmisartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
SIDE EFFECTS
Anaemia, Hyperkalaemia, Insomnia, depression, Syncope, Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, Pruritus, hyperhidrosis, rash, Chest pain, asthenia (weakness)
ACTIVE INGREDIENT
telmisartan
