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ranolazine

Ranexa (previously Latixa) · ATC code C01EB18

Also known as: Ranolazin · Brand names: Ranexa, Rande, Ranogelan, Ranolazin Accord, Ranolazin Genericon, Ranolazin Hcs, Ranolazin Ratiopharm, Halibrell, Labigat, Ranola, Ranozek, Roxaza, Anjilex, Latixa, Razina

Key facts
Active substance
ranolazine
ATC code
C01EB18
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ranexa 375 mg prolonged-release tablets · Ranexa 500 mg prolonged-release tablets · Ranexa 750 mg prolonged-release tablets
Marketing authorisation holder
Menarini International Operations Luxembourg S.A. (MIOL)
Information as of
2026-10-27

Key facts

Ranolazine (Ranexa) is an antianginal agent. It is used in adults as add-on therapy for stable angina pectoris when first-line antianginal therapies are inadequate or not tolerated.

What it is used for

  • Add-on symptomatic treatment of stable angina pectoris in adults inadequately controlled by or intolerant to first-line antianginal therapies (e.g. beta-blockers and/or calcium antagonists)

Dosing

  • Prolonged-release tablets of 375 mg, 500 mg and 750 mg; swallowed whole, with or without food
  • Initial dose 375 mg twice daily; after 2–4 weeks 500 mg twice daily, then according to response up to a maximum of 750 mg twice daily
  • With adverse events (e.g. dizziness, nausea, vomiting), down-titration to 500 mg or 375 mg twice daily may be needed
  • Careful titration with moderate CYP3A4 or P-gp inhibitors, mild to moderate renal impairment (creatinine clearance 30–80 ml/min), mild hepatic impairment, the elderly, weight ≤ 60 kg and CHF NYHA Class III–IV

Contraindications

  • Severe renal impairment (creatinine clearance < 30 ml/min)
  • Moderate or severe hepatic impairment
  • Potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin)
  • Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone
  • Hypersensitivity

Important warnings

  • Caution with factors increasing exposure; with several combined, frequent monitoring, dose reduction or discontinuation
  • Dose-related QTc prolongation; caution with long QT syndrome or QT-prolonging drugs
  • Not to be used with CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, St. John's Wort) – lack of efficacy expected
  • Renal function should be checked at regular intervals

Side effects

  • Generally mild to moderate, often within the first 2 weeks
  • Common: dizziness, headache, constipation, vomiting, nausea, asthenia
  • Uncommon, among others: syncope, hypotension, visual disturbance, tinnitus
  • Rare: acute renal failure, angioedema, pancreatitis, hyponatremia

Interactions

  • CYP3A4 and P-gp inhibitors increase ranolazine levels; grapefruit juice is a potent CYP3A4 inhibitor
  • Ranolazine may increase levels of simvastatin, lovastatin, ciclosporin, tacrolimus, sirolimus, everolimus and digoxin; rhabdomyolysis reported with simvastatin
  • Metoprolol and other CYP2D6 substrates: exposure may be increased
  • Metformin and other OCT2 substrates: increased exposure

Pregnancy and breastfeeding

  • Limited data; embryo toxicity in animals; not to be used in pregnancy unless clearly necessary
  • Should not be used during breast-feeding

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • RandeDay Zero Ehf · 1 register entry
  • RanogelanG.L. Pharma Gmbh · 1 register entry
  • Ranolazin AccordAccord Healthcare B.V. · 2 register entries
  • Ranolazin GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Ranolazin HcsHcs Bvba · 1 register entry
  • Ranolazin RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • HalibrellHexal Ag · 1 register entry
  • LabigatPharmathen S.A. · 1 register entry
  • RandeDay Zero Ehf · 1 register entry
  • RanolaHexal Ag · 1 register entry
  • Ranolazin1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Ratiopharm Gmbh, Stadapharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Zentiva Pharma Gmbh, Accord Healthcare B.V., Aliud Pharma Gmbh, Elpen Pharmaceutical Co. Inc., Intas Third Party Sales 2005, S.L., Abdi Farma Gmbh, Betapharm Arzneimittel Gmbh, Tad Pharma Gmbh · 16 register entries
  • RanozekAdamed Pharma S.A. · 1 register entry
  • RoxazaElpen Pharmaceutical Co. Inc. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AnjilexNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LatixaMENARİNİ İLAÇ SANAYİ VE TİC. A.Ş. · 4 register entries
  • RazinaALİ RAİF İLAÇ SAN. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 21 more European countries
Bulgaria
Равена
Croatia
Halibrell, Lasokun, Ranolazin Accord, Ranolazin Hcs, Ranolazin Krka, Tezulix
Cyprus
Ranolazine Accord, Ranolazine Remedica, Roxaza
Czechia
Ranolazine Umedica
Denmark
Labigat
Estonia
Halibrell, Ralik, Ranolazine, Tezulix
France
Ranolazine Micro Labs
Greece
Labigat, Lakosun, Lasokun, Lazela, Ranange, Ranoheart, Ranolazine Genepharm, Ranolazine Rafarm, Ranolazine Sandoz, Renofrin, Roxaza, Tezulix
Iceland
Ranexa
Ireland
Ranolazine Accord, Ranolazine Clonmel, Ranolazine Krka
Italy
Labigat, Ranolazina Accord, Ranolazina Doc, Ranolazina Eg, Ranolazina Krka, Ranolazina Pensa, Ranolazina Sandoz, Ranolazina Teva, Ranolazina Zentiva, Ranozek, Ranva
Latvia
Halibrell, Lasokun, Ranolazine, Ranozek, Tezulix
Liechtenstein
Ranexa
Lithuania
Halibrell, Lasokun, Ranogelan, Ranolazine Accord, Ranolazine Stada, Tezulix
Netherlands
Lazela, Ranogelan, Ranolazine Elc, Ranolazine Stada, Ranozek, Renofrin
Norway
Ranexa
Poland
Ralik, Ranolazine Aurovitas, Ranozek
Portugal
Ranolazina Adamed, Ranolazina Bluepharma, Ranolazina Ciclum, Ranolazina Generis, Ranolazina Krka, Ranolazina Tolife, Ranolazina Zentiva
Romania
Ranolazina Atb
Slovenia
Halibrell, Ranolazin Stada, Tezulix
Spain
Labigat, Ranolazina Alter, Ranolazina Aurovitas, Ranolazina Cinfa, Ranolazina Intas, Ranolazina Krka, Ranolazina Normon, Ranolazina Olpha, Ranolazina Pensa, Ranolazina Stada, Ranolazina Teva, Ranozek

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Ranexa (previously Latixa) – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.