RANEXA Prolonged-release tablet Ref.[7346] Active ingredients: Ranolazine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Product name and form

Ranexa 375 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Pale blue oval-shaped tablet engraved with 375 on one side.

Qualitative and quantitative composition

Each tablet contains 375 mg of ranolazine.

For the full list of excipients see section 6.1.

Active Ingredient Description

Ranolazine may have some antianginal effects by inhibition of the late sodium current in cardiac cells. This reduces intracellular sodium accumulation and consequently decreases intracellular calcium overload. Ranolazine, via its action to decrease the late sodium current, is considered to reduce these intracellular ionic imbalances during ischaemia. This reduction in cellular calcium overload is expected to improve myocardial relaxation and thereby decrease left ventricular diastolic stiffness.

List of Excipients

Excipients for all ranolazine prolonged-release tablets:

Carnauba wax
Magnesium stearate
Methacrylic acid-ethyl acrylate copolymer (1:1)
Microcrystalline cellulose
Sodium hydroxide
Titanium dioxide

Additional excipients for 375 mg tablet:

Polysorbate 80
Blue #2/Indigo carmine aluminium lake (E132)

Pack sizes and marketing

PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Marketing authorization dates and numbers

60 tablets in blister pack: EU/1/08/462/001
60 tablets in bottle: EU/1/08/462/002
30 tablets in blister pack: EU/1/08/462/007
100 tablets in blister pack: EU/1/08/462/008

Date of first authorisation: 09 July 2008
Date of last renewal: 06 March 2013


Drug Countries
RANEXA Austria, Cyprus, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

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