Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: KRKA, d.d., Novo mesto, ล marjeลกka cesta 6, 8501 Novo mesto, Slovenia
Treatment of essential hypertension in adults.
Reduction of cardiovascular morbidity in adults with:
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 (see section 5.1).
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.
Limited experience is available in patients with severe renal impairment or haemodialysis. A lower starting dose of 20 mg is recommended in these patients (see section 4.4). No posology adjustment is required for patients with mild to moderate renal impairment.
Tolura is contraindicated in patients with severe hepatic impairment (see section 4.3). In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
No dose adjustment is necessary for elderly patients.
The safety and efficacy of Tolura in children and adolescents aged below 18 years have not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
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 administration (see section 6.6).
Tolura tablets cannot be divided, therefore they are not suitable for patients who require a dose of 20 mg of telmisartan for the treatment of hypertension or for patients with severe renal impairment or haemodialysis. For these patients, an equivalent product with the same active ingredient is available.
There is limited information available with regard to overdose in humans.
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Telmisartan is not removed by haemodialysis. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Management depends on the time since ingestion and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.
3 years.
Do not store above 30ยฐC.
Store in the original package in order to protect from light.
OPA/Al/PVC Al blister. Each blister contains 7 or 10 tablets.
Pack sizes: 14, 28, 30, 56, 84, 90, 98 and 100 tablets in a box.
Not all pack sizes may be marketed.
No special requirements.
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