Ranolazine CINFA 500 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

ranolazine cinfa 375 mg prolonged-release tablets EFG

ranolazine cinfa 500 mg prolonged-release tablets EFG

ranolazine cinfa 750 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What ranolazine cinfa is and what it is used for.
2. What you need to know before taking ranolazine cinfa.
3. How to take ranolazine cinfa.
4. Possible adverse effects.
5. How to store ranolazine cinfa.
6. Contents of the pack and other information.

1. What is ranolazine cinfa and what is it used for

Ranolazine is a medicine used in combination with other medicines for the treatment of angina pectoris, a condition that causes chest pain or discomfort felt anywhere in the upper half of the body between the neck and the upper abdomen, often occurring after physical exertion or particularly intense activity.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before taking ranolazine cinfa

Do not take ranolazine cinfa

• If you are allergic to ranolazine or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney problems.
• If you have moderate or severe liver problems.
• If you are taking certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Warnings and precautions

Talk to your doctor before starting treatment with ranolazine cinfa:

• If you have mild or moderate kidney problems.
• If you have mild liver problems.
• If you have ever had an abnormal electrocardiogram (ECG).
• If you are elderly.
• If you are underweight (60 kg or less).
• If you have heart failure.

If any of these apply to you, your doctor may decide to prescribe a lower dose of the medicine or take other precautions.

Other medicines and ranolazine cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take any of the following medicines if you are taking ranolazine:

• Certain medicines used to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Tell your doctor or pharmacist before taking ranolazine if you are using:

• Certain medicines to treat a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or heart medications such as diltiazem or verapamil. These medicines may increase the likelihood of adverse effects such as dizziness, nausea, or vomiting, which are possible side effects of ranolazine treatment (see section 4). If you are taking these medicines, your doctor may decide to prescribe a lower dose of ranolazine.
• Medicines used to treat epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine, or phenobarbital); if you are taking rifampicin to treat an infection (e.g. tuberculosis); or if you are taking the herbal remedy St. John’s wort. Inform your doctor, as these medicines may make ranolazine less effective.
• Heart medications containing digoxin or metoprolol, as your doctor may need to adjust the dose of these medicines while you are taking ranolazine.
• Certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, amitriptyline), as these medicines may affect your electrocardiogram (ECG).
• Certain medicines used to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• Certain medicines used to treat high blood cholesterol (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle damage. Your doctor may decide to adjust the dose of these medicines while you are taking ranolazine.
• Certain medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), in which case your doctor may decide to adjust the dose of these medicines while you are taking ranolazine.

Taking ranolazine cinfa with food and drink

Ranolazine may be taken with or without food. While taking ranolazine, you must not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

You should not take ranolazine during pregnancy unless your doctor has specifically instructed you to do so.

Breastfeeding

You should not take ranolazine while breastfeeding. Consult your doctor if you are breastfeeding.

Driving and using machines

No studies have been conducted on the effects of ranolazine on the ability to drive or operate machinery. Ask your doctor whether you can drive or operate machinery.

Ranolazine may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), and coordination problems (rare), which may affect your ability to drive or operate machinery. If you experience any of these symptoms, do not drive or operate machinery until they have resolved.

ranolazine cinfa contains sodium

Ranolazine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, i.e., essentially “sodium-free”.

3. How to take ranolazine cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Always swallow the tablets whole with water. Do not chew, suck, crush, or split the tablets, as this may affect how the medicine is released in your body.

The initial dose for adults is one 375 mg tablet twice daily. After a period of 2 to 4 weeks, your doctor may increase the dose to achieve the desired effect. The maximum dose of ranolazine is 750 mg twice daily.

It is important to inform your doctor if you experience adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or, if this is not sufficient, advise you to stop treatment with ranolazine.

Use in children and adolescents

Children and adolescents under 18 years of age must not take ranolazine.

If you take more ranolazine cinfa than you should

If you accidentally take more ranolazine tablets than prescribed or take tablets of a higher dose than recommended by your doctor, it is important to inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency center. Take any remaining tablets with you, along with the blister pack and the outer container, so that hospital staff can easily identify what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take ranolazine cinfa

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose (less than 6 hours away). Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

You must stop taking ranolazine and contact your doctor immediately if you experience the following symptoms of angioedema, a rare but potentially serious condition:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives or difficulty breathing

Inform your doctor if you experience frequent adverse effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or instruct you to stop taking ranolazine.

The following is a list of other possible adverse effects you may experience:

Frequent adverse effects (may affect up to 1 in 10 patients):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Weakness

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbances
• Sensory disturbances (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness upon standing
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nosebleeds
• Double vision
• Excessive sweating, itching
• Feeling of swelling or puffiness
• Hot flushes, low blood pressure
• Increased levels of a substance called creatinine, increased blood urea, increased platelet or white blood cell counts, electrocardiogram (ECG) abnormalities
• Joint swelling, limb pain
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Ringing in the ears and/or sensation of dizziness
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Changes in sense of smell, numbness of mouth or lips, hearing loss
• Cold sweats, rash
• Coordination problems
• Drop in blood pressure upon standing
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Cold sensation in hands and legs
• Hives, skin allergic reactions
• Impotence
• Inability to walk due to balance problems
• Inflammation of the pancreas or intestine
• Memory loss
• Throat tightness
• Low sodium levels in blood (hyponatremia), which may cause fatigue and confusion, muscle twitching, cramps, and coma

Adverse effects with unknown frequency (cannot be estimated from available data):

• Myoclonus

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ranolazine cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of ranolazine cinfa

The active substance is ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg of ranolazine.

The other components are:

Tablet core: Microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide (E524), hypromellose (E464), magnesium stearate (E470b).

Film coating AquaPolish P-white: hypromellose (E464), hydroxypropylcellulose (E463), polyethylene glycol 8000 (E1521), titanium dioxide (E171).

Appearance of the product and contents of the pack

The 375 mg tablets are white, film-coated, oblong, convex tablets, measuring 15 mm x 7.2 mm, with the inscription “375” engraved on one side.

The 500 mg tablets are white, film-coated, oblong, convex tablets, measuring 16.5 mm x 8.0 mm, with the inscription “500” engraved on one side.

The 750 mg tablets are white, film-coated, oblong, convex tablets, measuring 19 mm x 9.2 mm, with the inscription “750” engraved on one side.

Ranolazina cinfa is packaged in PVC/PVDC/aluminum blisters contained in cardboard boxes with 30, 60 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Ranolazine ELC 375 mg / 500 mg / 750 mg prolonged-release tablets

Austria: Ranolazin ELC 375 mg /500 mg/ 750 mg Retardtabletten

Bulgaria: Ranolazine ELC 375 mg /500 mg/ 750 mg ???????? ? ???????? ????????????

Cyprus: Ranolazine ELC 375 mg /500 mg / 750 mg Δισκ?ο παρατεταμ?νης αποδ?σμευσης

Estonia: Ranolazine ELC

Croatia: Ranolazin ELC 375 mg /500 mg/ 750 mg tabletes produljenim oslobadanjem

Ireland: Ranolazine 375 mg /500 mg/ 750 mg Prolonged-release tablet

Lithuania: Ranolazine ELC 375 mg /500 mg/750 mg pailginto atpalaidavimo tabletes

Portugal: Ranolazine ELC

Romania: Ranolazina ELC Group s.r.o. 375 mg /500 mg/750 mg comprimate cu eliberare prelungita

Slovenia: Ranolazin ELC Group 375 mg/ 500 mg/ 750 mg tablete s podaljšanim sproščanjem

Italy: Ranolazina ELC

Spain: Ranolazina Cinfa 375 mg/ 500 mg/ 750 mg comprimidos de liberación prolongada EFG

Greece: RANOLAZINE/GENEPHARM

Date of the most recent review of this leaflet: 05/2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

Ranolazina cinfa 375 mg prolonged-release tablets EFG

Detailed and up-to-date information about this medicinal product is available by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88005/P_88005.html

QR code link: https://cima.aemps.es/cima/dochtml/p/88005/P_88005.html

Ranolazina cinfa 500 mg prolonged-release tablets EFG

Detailed and up-to-date information about this medicinal product is available by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88006/P_88006.html

QR code link: https://cima.aemps.es/cima/dochtml/p/88006/P_88006.html

Ranolazina cinfa 750 mg prolonged-release tablets EFG

Detailed and up-to-date information about this medicinal product is available by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88007/P_88007.html

QR code link: https://cima.aemps.es/cima/dochtml/p/88007/P_88007.html