Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Copalia 5 mg/80 mg film-coated tablets.
Copalia 5 mg/160 mg film-coated tablets.
Copalia 10 mg/160 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Copalia 5 mg/80 mg film-coated tablets: Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side. Approximate size: diameter 8.20 mm. Copalia 5 mg/160 mg film-coated tablets: Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width). Copalia 10 mg/160 mg film-coated tablets: Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width). |
Copalia 5 mg/80 mg film-coated tablets: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan.
Copalia 5 mg/160 mg film-coated tablets: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Copalia 10 mg/160 mg film-coated tablets: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of
valsartan.
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. |
|
| Valsartan |
Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist. It acts selectively on the AT1-receptor subtype, which is responsible for the known actions of angiotensin II. |
|
| Valsartan and Amlodipine |
Combination of two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. |
| List of Excipients |
|---|
|
Copalia 5 mg/80 mg film-coated tablets: Tablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) Copalia 5 mg/160 mg film-coated tablets: Tablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) Copalia 10 mg/160 mg film-coated tablets: Tablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) |
PVC/PVDC blisters. One blister contains 7, 10 or 14 film-coated tablets. Pack sizes: 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets and multipacks containing 280 (4 × 70 or 20 × 14) film-coated tablets.
PVC/PVDC perforated unit dose blisters. One blister contains 7, 10 or 14 film-coated tablets.
Pack sizes: 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Copalia 5 mg/80 mg film-coated tablets:
EU/1/06/372/001
EU/1/06/372/002
EU/1/06/372/003
EU/1/06/372/004
EU/1/06/372/005
EU/1/06/372/006
EU/1/06/372/007
EU/1/06/372/008
EU/1/06/372/025
EU/1/06/372/026
EU/1/06/372/027
EU/1/06/372/034
EU/1/06/372/037
Copalia 5 mg/160 mg film-coated tablets:
EU/1/06/372/009
EU/1/06/372/010
EU/1/06/372/011
EU/1/06/372/012
EU/1/06/372/013
EU/1/06/372/014
EU/1/06/372/015
EU/1/06/372/016
EU/1/06/372/028
EU/1/06/372/029
EU/1/06/372/030
EU/1/06/372/035
EU/1/06/372/038
Copalia 10 mg/160 mg film-coated tablets:
EU/1/06/372/017
EU/1/06/372/018
EU/1/06/372/019
EU/1/06/372/020
EU/1/06/372/021
EU/1/06/372/022
EU/1/06/372/023
EU/1/06/372/024
EU/1/06/372/031
EU/1/06/372/032
EU/1/06/372/033
EU/1/06/372/036
EU/1/06/372/039
Date of first authorisation: 16 January 2007
Date of latest renewal: 21 November 2011
| Drug | Countries | |
|---|---|---|
| COPALIA | Austria, Germany, Estonia, Spain, Croatia, Ireland, Lithuania, Netherlands, Poland, South Africa |
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