Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets.
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets.
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets: White, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VCL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width). Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets: Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VDL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width). Copalia HCT 5 mg/160 mg/25 mg film-coated tablets: Yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VEL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width). Copalia HCT 10 mg/160 mg/25 mg film-coated tablets: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VHL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width). Copalia HCT 10 mg/320 mg/25 mg film-coated tablets: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VFL” on the other side. Approximate size: 19 mm (length) x 7.5 mm (width). |
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.
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. |
|
| Hydrochlorothiazide |
Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted. |
|
| 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, Amlodipine and Hydrochlorothiazide |
Combination of three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine that belongs to the calcium antagonist class and valsartan that belongs to the angiotensin II antagonist class of medicines and hydrochlorothiazide that belongs to the thiazide diuretics class of medicines. The combination of these substances has an additive antihypertensive effect. |
| List of Excipients |
|---|
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tabletsTablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) Copalia HCT 10 mg/160 mg/12.5 mg film-coated tabletsTablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) Copalia HCT 5 mg/160 mg/25 mg film-coated tabletsTablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) Copalia HCT 10 mg/160 mg/25 mg film-coated tabletsTablet core: Cellulose microcrystalline Coating: Hypromellose, substitution type 2910 (3 mPa.s) Copalia HCT 10 mg/320 mg/25 mg film-coated tabletsTablet 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: 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
Multipacks of 280 tablets, comprising 20 cartons, each containing 14 tablets.
PVC/PVDC perforated unit dose blisters for hospital use:
Pack sizes: 56, 98 or 280 film-coated tablets
Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets: EU/1/09/575/001-012
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets: EU/1/09/575/013-024
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets: EU/1/09/575/025-036
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets: EU/1/09/575/037-048
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets: EU/1/09/575/049-060
Date of first authorisation: 04 November 2009
Date of latest renewal: 04 July 2014
| Drug | Countries | |
|---|---|---|
| COPALIA HCT | Austria, Estonia, Croatia, Ireland, Lithuania, Poland |
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