Twynsta Dosage/Direction for Use

Posology: 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 (see Interactions).
Add on therapy: TWYNSTA 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
TWYNSTA 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
TWYNSTA 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with TWYNSTA 40 mg/5 mg.
TWYNSTA 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on TWYNSTA 40 mg/10 mg or TWYNSTA 80 mg/5 mg.
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 TWYNSTA 40 mg/5 mg 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 TWYNSTA 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 dosage regimens are recommended in the elderly, but increase of dosage should take place with care (see Precautions).
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 (see also Precautions).
No posology adjustment is required for patients with mild to moderate renal impairment.
Hepatic impairment: TWYNSTA is contraindicated in patients with severe hepatic impairment (see Contraindications).
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 (see Precautions).
Paediatric population: The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established. No data are available.
Methods of administration: Oral use.
TWYNSTA can be taken with or without food. It is recommended to take TWYNSTA with some liquid.