Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Procoralan 5 mg film-coated tablets.
Procoralan 7.5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Procoralan 5 mg film-coated tablets: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and Procoralan 7.5 mg film-coated tablets: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and |
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Excipient with known effect: Each film-coated tablet contains 63.91 mg lactose monohydrate.
Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Excipient with known effect: Each film-coated tablet contains 61.215 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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: Lactose monohydrate Film-coating: Hypromellose (E464) |
Aluminium/PVC blister packed in cardboard boxes.
Pack sizes Calendar packs containing 14, 28, 56, 84, 98, 100 or 112 film-coated tablets.
Not all pack sizes may be marketed.
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Procoralan 5 mg film-coated tablets: EU/1/05/316/001-007
Procoralan 7.5 mg film-coated tablets: EU/1/05/316/008-014
Date of first authorisation: 25/10/2005
Date of latest renewal: 31/08/2010
| Drug | Countries | |
|---|---|---|
| PROCORALAN | Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Tunisia, United Kingdom |
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on the other face. The tablet can be divided into equal doses.