IKOREL Tablet Ref.[9306] Active ingredients: Nicorandil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Ikorel 10 mg Tablets

or

Nicorandil 10 mg Tablets.

Pharmaceutical Form

Tablets.

Off-white, round tablets with facetted edge, scored on one side and with inscription “IK10” on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 10 mg nicorandil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nicorandil

Nicorandil is a derivative of the niacinamide that is structurally combined with an organic nitrate. It provides a dual mode of action leading to relaxation of vascular smooth muscle. Nicorandil is a potassium-channel opener that causes vasodilatation of arterioles and large coronary arteries. Its nitrate-like properties produce venous vasodilation through stimulation of guanylate cyclase. Nicorandil has a direct effect on coronary arteries without leading to a steal phenomenon. The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.

List of Excipients

Maize starch
Croscarmellose sodium
Stearic acid (E570)
Mannitol (E421)

Pack sizes and marketing

For each blister strip, there are:

  • 10 cavities containing Ikorel tablets, and
  • 1 bigger cavity containing a silica gel desiccant capsule positioned at one end of the strip.

Each cavity containing an Ikorel tablet is connected with the desiccant capsule by a channel.

The desiccant capsule must not be swallowed.

The blister pack is sealed with the aluminium cover foil on the removal side.

Pack sizes available are: 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0327

Date of first authorisation: 12 August 1992
Date of latest renewal: 06 May 2005

Drugs

Drug Countries
IKOREL Australia, France, Ireland, Netherlands, New Zealand, Turkey, United Kingdom

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