Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Twynsta 40 mg/5 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Blue and white oval shaped two layer tablets of approximately 14 mm length engraved with the product code A1 and the company logo on the white layer. |
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Excipient(s) with known effect: Each tablet contains 168.64 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Amlodipine |
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. |
|
| Telmisartan |
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting. |
|
| Telmisartan and Amlodipine |
Combination of two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. |
| List of Excipients |
|---|
|
Colloidal anhydrous silica |
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.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
EU/1/10/648/001 (14 tablets)
EU/1/10/648/002 (28 tablets)
EU/1/10/648/003 (30 × 1 tablets)
EU/1/10/648/004 (56 tablets)
EU/1/10/648/005 (90 × 1 tablets)
EU/1/10/648/006 (98 tablets)
EU/1/10/648/007 (360 (4 × 90 × 1) tablets)
Date of first authorisation: 07 October 2010
Date of latest renewal: 20 August 2015
| Drug | Countries | |
|---|---|---|
| TWYNSTA | Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Nigeria, Poland, Romania, Singapore, Tunisia, United States, South Africa |
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