What this pack is
RANEXA is the brand name in this record; ranolazine prolonged-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
RANEXAGeneric nameranolazine prolonged-release tablets
How this medicine works
The U.S. label says the precise antianginal mechanism is not fully determined and records inhibition of the cardiac late sodium current at therapeutic concentrations; the EMA public overview explains a possible relaxation effect through reduced calcium-ion entry into heart-muscle cells. This only supports understanding stable angina, QT, interactions and monitoring. It cannot calculate a tablet count, emergency plan or substitution with nitroglycerin, a beta blocker or a calcium-channel blocker.
Read source: United States ↗Historical public record · reviewed 2026-08-30More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- RANEXA
- Source-scoped market brand names
- RANEXA · European UnionCurrent regulator record ↗Current central authorisation EMEA/H/C/000805; 375, 500 and 750 mg prolonged-release tablets.
- RANEXA · United StatesHistorical regulator record ↗Historical RLD products under NDA 021526 at 500 and 1000 mg are currently listed as Discontinued; old pack images identify only the dated label.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- ranolazine prolonged-release tablets
- Dosage-form class
- Ranolazine prolonged-release tablets: current EU 375/500/750 mg; historical U.S. 500/1000 mg. Swallow the tablet whole and do not crush, break or chew it. Milligram figures from different markets are not a self-conversion or multi-tablet assembly guide.
- Route
- Oral (prolonged-release tablet exact-product identity field; swallow whole)
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
5 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
EU · Current EU EMA product information (verified 30 Aug 2026)
Ranolazine 375 mg per tablet; EU prolonged-release tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- EMA EMEA/H/C/000805 · 375 mg
- Form and route
- RANEXA ranolazine prolonged-release tablet · oral; swallowed whole (product-identity field)
- Container
- EU product information lists multiple packs; this card does not infer the pack in hand
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- ranolazine
- 375 mgEU labelled strength per tablet; not an individual's tablet count, frequency, titration or switching instruction
- Labelled appearance
- pale blue · oval prolonged-release tablet · imprint 375Unscored; the cited label says to swallow it whole
EU · Current EU EMA product information (verified 30 Aug 2026)
Ranolazine 500 mg per tablet; EU prolonged-release tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- EMA EMEA/H/C/000805 · 500 mg
- Form and route
- RANEXA ranolazine prolonged-release tablet · oral; swallowed whole (product-identity field)
- Container
- EU product information lists multiple packs; this card does not infer the pack in hand
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- ranolazine
- 500 mgEU labelled strength per tablet; not an individual's tablet count, frequency, titration or switching instruction
- Labelled appearance
- light orange · oval prolonged-release tablet · imprint 500Unscored; the cited label says to swallow it whole
EU · Current EU EMA product information (verified 30 Aug 2026)
Ranolazine 750 mg per tablet; EU prolonged-release tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- EMA EMEA/H/C/000805 · 750 mg
- Form and route
- RANEXA ranolazine prolonged-release tablet · oral; swallowed whole (product-identity field)
- Container
- EU product information lists multiple packs; this card does not infer the pack in hand
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- ranolazine
- 750 mgEU labelled strength per tablet; not an individual's tablet count, frequency, titration or switching instruction
- Labelled appearance
- pale green · oval prolonged-release tablet · imprint 750Unscored; the cited label says to swallow it whole
United States label · U.S. DailyMed Gilead historical brand label (updated 26 Apr 2010; currently listed as Discontinued in the Orange Book)
Ranolazine 500 mg per tablet; 60-tablet bottle (historical U.S. brand label)
- Product code
- NDC 61958-1001-1
- Form and route
- RANEXA ranolazine film-coated extended-release tablet · oral; swallowed whole (historical U.S. product-identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- ranolazine
- 500 mghistorical labelled strength per tablet; not an individual's tablet count, frequency, titration or conversion to an EU strength
- Package
- 60 tablets per bottle
- Labelled appearance
- light orange · oblong, unscored extended-release tablet · imprint CVT500Unscored; the cited label says to swallow it whole
United States label · U.S. DailyMed Gilead historical brand label (updated 26 Apr 2010; currently listed as Discontinued in the Orange Book)
Ranolazine 1000 mg per tablet; 60-tablet bottle (historical U.S. brand label)
- Product code
- NDC 61958-1002-1
- Form and route
- RANEXA ranolazine film-coated extended-release tablet · oral; swallowed whole (historical U.S. product-identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- ranolazine
- 1000 mghistorical labelled strength per tablet; not an individual's tablet count, frequency, titration or conversion to an EU strength
- Package
- 60 tablets per bottle
- Labelled appearance
- pale yellow · oblong, unscored extended-release tablet · imprint CVT1000Unscored; the cited label says to swallow it whole
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
RANEXA label reading: swallow the prolonged-release tablet whole, and do not treat it as an acute-rescue medicine
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Current EU information and the historical U.S. brand label both say to swallow the tablet whole and not crush, break or chew it. Current EU strengths are 375, 500 and 750 mg, while historical U.S. strengths are 500 and 1000 mg; these figures are not a cross-market conversion table. RANEXA will not abate an acute angina episode. New, different, severe or persistent chest pain requires the established emergency plan and local emergency services.
- Start with ‘prolonged/extended release’: do not crush, break or chew. An unscored tablet is not permission to split by feel, and a shared mg figure across markets does not permit assembling one market's larger strength from another's smaller tablets.
- RANEXA is a chronic stable-angina dossier, not a rescue substitute for sublingual nitroglycerin such as NITROSTAT. New, different, severe or persistent chest pain, or pain with breathing difficulty, sweating or fainting, requires immediate local emergency care; do not wait for a website or self-add a tablet.
- Strong CYP3A inhibitors such as clarithromycin, ketoconazole, itraconazole, voriconazole and some HIV protease inhibitors, and inducers such as rifampin, carbamazepine, phenytoin, phenobarbital and St John's wort, are priority review items. Do not try to solve them by self-separating doses by a few hours.
- Diltiazem, verapamil, fluconazole, erythromycin, ciclosporin and grapefruit can affect ranolazine exposure; digoxin, simvastatin, metformin and other medicines may also need joint review. This site does not decide co-use or dose reduction from two names.
- Ranolazine can prolong QT. A personal or family long-QT history, amiodarone, sotalol, certain antipsychotics or other QT-prolonging medicines, or fainting, palpitations or severe dizziness needs prompt clinical review; severe or persistent symptoms require immediate help.
- Older age, weight at or below 60 kg, reduced kidney function, liver problems or moderate-to-severe heart failure increases the importance of exposure and adverse-event review. Dizziness, weakness, constipation, nausea and fall risk must be handled with the full medicine list and monitoring plan, not self-stopping or switching.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkEMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-30
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- European Union / European Economic Area · 2
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeEMA: current EU product information and patient leaflet for RANEXA ranolazine 375/500/750 mg prolonged-release tablets ↗Current regulatory record · reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- EMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-30EMA: RANEXA (ranolazine) EU central-authorisation EPAR, public overview and pharmacovigilance entry ↗Current regulatory record · reviewed 2026-08-30
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-30DailyMed (NLM): historical U.S. Gilead brand label for RANEXA ranolazine 500/1000 mg extended-release tablets (updated 26 Apr 2010) ↗Historical public record · reviewed 2026-08-30
- FDA · United States · Regulatory product record or label archive · 2026-08-30FDA Drugs@FDA: RANEXA NDA 021526 application, historical RLD identity and discontinued status ↗reviewed 2026-08-30
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about RANEXA (ranolazine prolonged-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
RANEXA is the brand in this record and ranolazine prolonged-release tablets is the active-ingredient name. Check both with the dosage form (Ranolazine prolonged-release tablets: current EU 375/500/750 mg; historical U.S. 500/1000 mg. Swallow the tablet whole and do not crush, break or chew it. Milligram figures from different markets are not a self-conversion or multi-tablet assembly guide.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- EMA: current EU product information and patient leaflet for RANEXA ranolazine 375/500/750 mg prolonged-release tablets ↗Current regulatory record · reviewed 2026-08-30
- EMA: RANEXA (ranolazine) EU central-authorisation EPAR, public overview and pharmacovigilance entry ↗Current regulatory record · reviewed 2026-08-30
- DailyMed (NLM): historical U.S. Gilead brand label for RANEXA ranolazine 500/1000 mg extended-release tablets (updated 26 Apr 2010) ↗Historical public record · reviewed 2026-08-30
- FDA Drugs@FDA: RANEXA NDA 021526 application, historical RLD identity and discontinued status ↗reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How ranolazine works: it may reduce myocardial sodium/calcium loading, but the mechanism is not a personal selection rule
- Effects on late sodium current and QT are not evidence that more is better. Exposure varies with liver/kidney function, body weight and interacting medicines, so chest-pain frequency or one ECG number cannot direct self-increase.
- EMA information notes that known CYP2D6 metaboliser status may inform professional caution when several risk factors coexist, but this is not a recommendation for whole-genome screening in everyone. The site does not use a genetic result to select, increase, reduce or stop RANEXA for an individual.
- Long-term stable-angina action and acute chest-pain response are different. A mechanism that sounds like ‘improving blood flow’ does not turn an extended-release tablet into a rescue medicine or justify stopping an established emergency or long-term plan.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- EMA: RANEXA (ranolazine) EU central-authorisation EPAR, public overview and pharmacovigilance entry ↗Current regulatory record · reviewed 2026-08-30
- EMA: current EU product information and patient leaflet for RANEXA ranolazine 375/500/750 mg prolonged-release tablets ↗Current regulatory record · reviewed 2026-08-30
- DailyMed (NLM): historical U.S. Gilead brand label for RANEXA ranolazine 500/1000 mg extended-release tablets (updated 26 Apr 2010) ↗Historical public record · reviewed 2026-08-30
- FDA Drugs@FDA: RANEXA NDA 021526 application, historical RLD identity and discontinued status ↗reviewed 2026-08-30
- FDA: RANEXA NDA 021526 original approval letter (27 Jan 2006; extended-release dissolution requirements) ↗reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
RANEXAranolazine prolonged-release tablets
This page links to public primary-source material for RANEXA. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approved RANEXA 500 mg extended-release tablets
The NDA 021526 original approval letter retained multiple dissolution time points to establish extended-release product performance; this is not an individual splitting or dosing schedule.
FDA: RANEXA NDA 021526 original approval letter (27 Jan 2006; extended-release dissolution requirements) ↗FDA approved the historical 1000 mg strength
Current Orange Book data list both 500 and 1000 mg product rows as Discontinued and not RS.
FDA Drugs@FDA: RANEXA NDA 021526 application, historical RLD identity and discontinued status ↗EU central marketing authorisation
The current EMA EPAR lists RANEXA (previously Latixa), ranolazine and EMEA/H/C/000805, with Menarini International Operations Luxembourg S.A. as the current holder.
EMA: RANEXA (ranolazine) EU central-authorisation EPAR, public overview and pharmacovigilance entry ↗
MARKET SCOPE
Market-record boundary
European Union
Current central authorisation; 375, 500 and 750 mg prolonged-release tabletsEMA authorisation and product information do not establish national pharmacy stock, purchasing eligibility, individual suitability or conversion to historical U.S. strengths.
United States
Historical 500 and 1000 mg RLD products currently listed as DiscontinuedTwo 60-tablet bottle panels in the 2010 DailyMed label are retained only for historical identity and appearance review, not ongoing marketing or supply.
Mainland China, Japan and other markets
Current market records not establishedNo local brand, approval, strength, pack, supply, originator/generic relationship or interchangeability is inferred from EU or U.S. material.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Can a RANEXA prolonged-release tablet be split or crushed?
The cited current EU information and historical U.S. brand label both say to swallow the tablet whole and not crush, break or chew it. Do not assemble strengths from tablet portions or multiple tablets. For swallowing difficulty, have the actual pack reviewed rather than changing the tablet structure.
Can an extra RANEXA tablet be taken during chest pain?
A website cannot make that decision. The U.S. label explicitly says RANEXA will not abate an acute angina episode. New, different, severe or persistent chest pain requires the established emergency plan, local emergency services and disclosure of the full medicine list.
Does everyone need whole-genome screening before RANEXA?
The cited EMA information does not recommend whole-genome screening for everyone. It only notes that already-known CYP2D6 status may help professional caution when several exposure risk factors coexist. Any testing decision belongs with the clinical team after reviewing medicines, liver/kidney function, weight, ECG and history.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.