Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Treatment of essential hypertension in adults:
Add on therapy:
Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone.
Replacement therapy:
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.
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 section 4.5).
Twynsta 40 mg/5 mg 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 Twynsta 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses in one tablet once daily.
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 (see section 4.4).
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 section 4.4). No posology adjustment is required for patients with mild to moderate renal impairment.
Twynsta is contraindicated in patients with severe hepatic impairment (see section 4.3). 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 section 4.4).
The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established. No data are available.
Oral use.
Twynsta can be taken with or without food. It is recommended to take Twynsta with some liquid.
Twynsta 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).
Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects. The most prominent manifestations of telmisartan overdose are expected to be hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported. Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
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 overdose of both telmisartan and amlodipine.
Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position with elevation of extremities, with salt and volume replacement given quickly. Supportive treatment should be instituted.
Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Amlodipine is not dialysable and telmisartan is not removed from blood by hemofiltration and not dialysable.
3 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from light and moisture.
Remove the tablets from the blister only directly prior to intake.
Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 14, 28, 56, 98 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in a carton containing 30 × 1, 90 × 1 tablets and multipacks containing 360 (4 packs of 90 × 1) tablets.
Not all pack sizes may be marketed.
No special requirements.
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