Cilzec-A Dosage/Direction for Use

The recommended dose of this medicinal product is one tablet per day.
The maximum recommended dose is one tablet 80 mg telmisartan/10 mg amlodipine per day. This medicinal product is indicated for long term treatment.
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects.
Add on therapy: Telmisartan + Amlodipine (Cilzec-A) may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Telmisartan + Amlodipine (Cilzec-A) once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Replacement therapy: Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Telmisartan + Amlodipine (Cilzec-A) containing the same component doses in one tablet once daily.
Elderly (> 65 years): No dose adjustment is necessary for elderly patients. Little information is available in the very elderly patients.
Normal amlodipine dose regimens are recommended in the elderly, but increase of dose should take place with care.
Renal impairment: Limited experience is available in patients with severe renal impairment or haemodialysis. Caution is advised when using telmisartan/amlodipine in such patients as amlodipine and telmisartan are not dialysable.
No posology adjustment is required for patients with mild to moderate renal impairment.
Hepatic impairment: Telmisartan + Amlodipine (Cilzec-A) is contraindicated in patients with severe hepatic impairment.
In patients with mild to moderate hepatic impairment telmisartan/amlodipine should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily.
Paediatric population: The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established. No data are available.
Method of administration: Oral use: Telmisartan + Amlodipine (Cilzec-A) can be taken with or without food.
It is recommended to take Telmisartan + Amlodipine (Cilzec-A) with some liquid.