Source: Health Sciences Authority (SG) Revision Year: 2023 Publisher: <u>France:</u> Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France <u>Singapore:</u> Servier Singapore Pte Ltd, 67 Ubi Avenue 1, #06-09 StarHub Green, Singapore 408942
Carivalan film-coated tablets 6.25 mg/5 mg.
Carivalan film-coated tablets 6.25 mg/7.5 mg.
Carivalan film-coated tablets 12.5 mg/5 mg.
Carivalan film-coated tablets 12.5 mg/7.5 mg.
Carivalan film-coated tablets 25 mg/5 mg.
Carivalan film-coated tablets 25 mg/7.5 mg.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White, hexagonal, film-coated tablet (6.25/5 mg) (longest diagonal 7.3 mm) engraved with CI2 on one face and Yellow, hexagonal, film-coated tablet (6.25/7.5 mg) (longest diagonal 7.3 mm) engraved with CI3 on one face and White, elliptic, film-coated tablet (12.5/5 mg) (10.6 mm x 5.3 mm) engraved with CI4 on one face and Yellow, elliptic, film-coated tablet (12.5/7.5 mg) (10.6 mm x 5.3 mm) engraved with CI5 on one face and White, octagonal, film-coated tablet (25/5 mg) (diameter 7.8 mm) engraved with CI6 on one face and Yellow, octagonal, film-coated tablet (25/7.5 mg) (diameter 7.8 mm) engraved with CI7 on one face and |
Each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Each film-coated tablet contains 12.5 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Each film-coated tablet contains 25 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Each film-coated tablet contains 25 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Excipient with known effect: lactose monohydrate (68.055 mg for Carivalan 6.25/5 mg, 65.360 mg for Carivalan 6.25/7.5 mg, 78.710 mg for Carivalan 12.5/5 mg, 76.015 mg for Carivalan 12.5/7.5 mg, 85.530 mg for Carivalan 25/5 mg and 82.835 mg for Carivalan 25/7.5 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Carvedilol |
Carvedilol is a vasodilatory non-selective beta-blocker, which reduces the peripheral vascular resistance by selective alpha1-receptor blockade and suppresses the renin-angiotensin system through non-selective beta-blockade. Plasma renin activity is reduced and fluid retention is rare. |
|
| Carvedilol and Ivabradine |
Carvedilol is a vasodilating non-selective beta-blocker, which reduces the peripheral vascular resistance by selective alpha 1-receptor blockade and suppresses the renin-angiotensin system through non-selective betablockade. Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation. |
|
| Ivabradine |
Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation. |
| List of Excipients |
|---|
|
Tablet core: Starch, Pregelatinised (maize) Tablet film-coating: Glycerol (E422) |
PVC/PVDC/aluminum blister packed in cardboard cartons: Calendar packs containing 14 or 56 film-coated tablets.
Not all pack sizes may be marketed.
France: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Singapore: Servier Singapore Pte Ltd, 67 Ubi Avenue 1, #06-09 StarHub Green, Singapore 408942
Carivalan film-coated tablets 6.25 mg/5 mg SIN15624P
Carivalan film-coated tablets 6.25 mg/7.5 mg SIN15625P
Carivalan film-coated tablets 12.5 mg/5 mg SIN15626P
Carivalan film-coated tablets 12.5 mg/7.5 mg SIN15627P
Carivalan film-coated tablets 25 mg/5 mg SIN15628P
Carivalan film-coated tablets 25 mg/7.5 mg SIN15629P
| Drug | Countries | |
|---|---|---|
| CARIVALAN | Lithuania, Romania, Singapore |
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on the other face.