What Ranexa contains
The active substance in Ranexa is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
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The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Depending on the tablet strength, the tablet coatings also contain:
375 mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132) 500 mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)
What Ranexa looks like and contents of the pack
Ranexa prolonged-release tablets are oval shaped tablets.
The 375 mg tablets are pale blue and are engraved with CVT375 or 375 on one side. The 500 mg tablets are light orange and are engraved with CVT500 or 500 on one side. The 750 mg tablets are pale green and are engraved with CVT750 or 750 on one side.
Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles. Not all pack-sizes may be marketed.
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Manufacturer
Brecon Pharmaceuticals Ltd
Pharos House, Wye Valley Business Park
Hay-on-Wye
Hereford HR3 5PG
United Kingdom
or
Fine Foods N.T.M. SpA
Via dell?Artigianato 8/10
24041 Brembate (BG)
Italy
or
Menarini - Von Heyden GmbH
Leipziger Stra?e 7-13
01097 Dresden
Germany
or
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
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BelgiëBelgiqueBelgien Menarini Benelux NVSA TélTel 32 02 721 4545 LuxembourgLuxemburg Menarini Benelux NVSA TélTel 32 02 721 4545
- . 359 2 96 00 860 Magyarország Berlin-ChemieA. Menarini Kft. Tel. 36 23501301
eská republika Berlin-ChemieA.Menarini Ceska republika s.r.o. Tel 420 272 937 381 Malta Menarini International Operations Luxembourg S.A. Tel 352 264976
Danmark Berlin-ChemieA.Menarini Danmark ApS Tlf 4548 217 110 Nederland Menarini Benelux NVSA Tel 32 02 721 4545
Deutschland Berlin-Chemie AG Tel 49 0 30 67070 Norge Menarini International Operations Luxembourg S.A. Tlf 352 264976
Eesti OÜ Berlin-Chemie Menarini Eesti Tel 372 667 5001 Österreich A. Menarini Pharma GmbH. Tel 43 1 879 95 85-0
MENARINI HELLAS AE 30 210 8316111-13 Polska Berlin-ChemieMenarini Polska Sp. z o.o. Tel. 48 22 566 21 00
España Laboratorios Menarini S.A. Tel 34-93 462 88 00 Portugal A. Menarini Portugal Farmacêutica, S.A. Tel 351 210 935 500
France MENARINI France Tél 33 01 45 60 77 20 România Berlin-Chemie Menarini Group Tel 40 211 232 34 32
Ireland A. Menarini Pharmaceuticals Ltd Tel 353 1 284 6744 Slovenija Berlin-Chemie AG, Podrunica Ljubljana Tel 386 01 300 2160
Ísland Menarini International Operations Luxembourg S.A. Sími 352 264976 Slovenská republika Berlin-Chemie AG - obchodné zastúpenie v SR Tel 421 2 544 30 730
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SuomiFinland Berlin-ChemieA.Menarini Suomi OY PuhTel 358 403 000 760 Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel 39-055 56801
MENARINI HELLAS AE 30 210 8316111-13 Sverige Menarini International Operations Luxembourg S.A. Tel 352 264976
Latvija SIA Berlin-ChemieMenarini Baltic Tel 371 67103210 United Kingdom A. Menarini Pharma U.K. S.R.L. Tel 44 01628 856400
Lietuva
UAB ?BERLIN-CHEMIE MENARINI
BALTIC?
Tel: +370 52 691 947
This leaflet was last approved in (MM/YYYY).
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