Each tablet BOSAGAS 80 contains:
Active ingredient:
Telmisartan | 80 mg |
Excipients: Lactose monohydrate, sodium carbonate, povidone K30, sodium croscarmellose, magnesium stearate.
Hypertension: Telmisartan could be used as a monotherapy or in combination with other antihypertensive drugs.
Angiotensin II receptor blockers could replace ACE-inhibitors in treatment of heart failure (official indication) or diabetic nephropathy.
DOSAGE AND ADMINISTRATION
Administration: Telmisartan tablets are for once-daily oral administration and should be taken, with or without food.
Dosage
Adults: 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. The dose of telmisartan can be increased to a maximum of 80 mg once daily if needed. Alternatively, telmisartan may be used in combination with thiazide-type diuretics. 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.
Renal impairment: No dose adjustment is necessary for patients with renal impairment.
Hepatic impairment: In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily
Elderly: No dose adjustment is necessary for elderly.
Children: The safety and efficacy of Telmisartan in children and adolescents aged below 18 years have not been established.
CONTRAINDICATIONS
Hypersensitivity to any of the excipients.
Pregnancy and lactation.
Severe renal impairment
Severe hepatic impairment. Biliary obstructive disorders
WARNINGS AND PRECAUTIONS
Monitoring of serum potassium is recommended, especially in the elderly and in patients with renal impairment. Reduce the starting dose in these patients.
Aortic and mitral valve stenosis.
Obstructive hypertrophic cardiomyopathy
Severe congestive heart failure.
Intravascular hypovolemia (volume and sodium depleted by vomiting, diarrhoea, long term diuretic therapy, haemodialysis, dietary salt restriction) may increase the risk of symptomatic hypotension.
Such conditions should be corrected before the administration of telmisartan or reduced dose and closely monitored while administration.
Active gastric ulcer disease or other gastrointestinal disorders
Mild to moderate hepatic impairment
Renal artery stenosis.
Mild to moderate renal impairment
When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as telmisartan.
SHELF-LIFE
36 months from the manufacturing date.