Source: European Medicines Agency (EU) | Revision Year: 2019 | Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Ranexa 375 mg prolonged-release tablets.
Pale blue oval-shaped tablet engraved with 375 on one side.
Each tablet contains 375 mg of ranolazine.
For the full list of excipients see section 6.1.
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.
Excipients for all ranolazine prolonged-release tablets:
Methacrylic acid-ethyl acrylate copolymer (1:1)
Additional excipients for 375 mg tablet:
Blue #2/Indigo carmine aluminium lake (E132)
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.
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
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
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.