CORLENTOR Film-coated tablet Ref.[6952] Active ingredients: Ivabradine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Product name and form

Corlentor 5 mg film-coated tablets.

Corlentor 7.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Corlentor 5 mg film-coated tablets: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and “S” on the other face. The tablet can be divided into equal doses.

Corlentor 7.5 mg film-coated tablets: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and “S” on the other face.

Qualitative and quantitative composition

Corlentor 5 mg film-coated tablets:* One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).

Excipient with known effect: 63.91 mg lactose monohydrate.

Corlentor 7.5 mg film-coated tablets:* One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).

Excipient with known effect: 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

Core:

Lactose monohydrate
Magnesium stearate (E470B)
Maize starch
Maltodextrin
Silica, colloidal anhydrous (E551)

Film-coating:

Hypromellose (E 464)
Titanium dioxide (E171)
Macrogol 6000
Glycerol (E422)
Magnesium stearate (E470B)
Yellow iron oxide (E172)
Red iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Marketing authorization dates and numbers

Corlentor 5 mg film-coated tablets: EU/1/05/317/001-007
Corlentor 7.5 mg film-coated tablets: EU/1/05/317/008-014

Date of first authorisation: 25/10/2005
Date of latest renewal: 31/08/2010

Drugs

Drug Countries
CORLENTOR Austria, Estonia, Spain, Ireland, Italy, Lithuania, Netherlands, Poland, Romania

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