RANOLAZINE CINFA 500 mg PROLONGED-RELEASE TABLETS

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 tabletsEFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is ranolazine cinfa and what is it used for.
2. What you need to know before you take ranolazine cinfa.
3. How to take ranolazine cinfa.
4. Possible side effects.
5. Storage of 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, which is a disease that causes chest pain or discomfort that can be felt anywhere in the upper half of the body between the neck and the upper part of the abdomen, often after physical exercise or particularly intense activity.

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

2. What you need to know before you take ranolazine cinfa

Do not take ranolazine cinfa

• If you are allergic to ranolazine or 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 for bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide or sotalol).

Warnings and precautions

Consult your doctor before starting to take ranolazine cinfa:

• If you have mild or moderate kidney problems.
• If you have mild liver problems.
• If you have ever had an electrocardiogram (ECG) abnormality.
• If you are an elderly person.
• If you are a person of low weight (60 kg or less).
• If you have heart failure.

If you are in any of these situations, your doctor may decide to give you 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 take any other medicines.

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

• Certain medicines for the treatment of bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (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 for treating bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine used to prevent organ rejection after a transplant (cyclosporin), or if you are taking heart tablets such as diltiazem or verapamil. These medicines may cause a higher number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of treatment with ranolazine (see section 4). If you are taking these medicines, your doctor may decide to give you a lower dose of ranolazine.
• Medicines for the treatment of epilepsy or other neurological disorders (e.g. phenytoin, carbamazepine or phenobarbital); if you are taking rifampicin for the treatment of an infection (e.g. tuberculosis); or if you are taking a herbal medicine called St. John's Wort, you should inform your doctor because these medicines may make ranolazine less effective.

(e.g. tuberculosis); or if you are taking a herbal medicine called St. John's Wort, you should inform your doctor because these medicines may make ranolazine less effective.

• Medicines for the heart that contain digoxin or metoprolol, as if you are taking this medicine, your doctor may decide to change the dose while taking ranolazine.
• Certain medicines for treating allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and medicines for the treatment of depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may alter your electrocardiogram (ECG).
• Certain medicines for treating depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medicines for treating high blood cholesterol levels (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and damage. Your doctor may decide to change the dose of this medicine while taking ranolazine.
• Certain medicines used to prevent organ rejection after a transplant (e.g. tacrolimus, cyclosporin, sirolimus, everolimus), so your doctor may decide to change the dose of this medicine while taking ranolazine.

Taking ranolazine cinfa with food and drinks

Ranolazine can be taken with or without food. While being treated with ranolazine, you should not drink grapefruit juice.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take ranolazine if you are pregnant unless your doctor has told you to.

Breast-feeding

Do not take ranolazine if you are breast-feeding. Ask your doctor for advice if you are breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Ask your doctor if you can drive or use machines.

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

ranolazine cinfa contains sodium

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

3. How to take ranolazine cinfa

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with water. Do not chew, suck or crush the tablets or divide them in half, as this may affect the way the medicine is released in your body.

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

It is important that you inform your doctor if you experience side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or tell you to stop taking ranolazine.

Use in children and adolescents

Children and adolescents under 18 years should not take ranolazine.

If you take more ranolazine cinfa than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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). Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must stop taking ranolazine and consult your doctor immediately if you experience the following symptoms of angioedema, which is a rare but serious disorder:

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

Tell your doctor if you experience frequent side effects such as dizziness, nausea or vomiting. Your doctor may reduce the dose or tell you to stop taking ranolazine.

The following are other side effects that you may experience:

Frequent side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disorders
• Sensory disturbances (touch or taste), tremors, fatigue or weakness, somnolence or lethargy, weakness or fainting, dizziness when standing up
• Dark urine, blood in the urine, difficulty urinating
• Dehydration
• Breathing difficulties, cough, nosebleeds
• Double vision
• Excessive sweating, itching
• Feeling of swelling or bloating
• Hot flashes, low blood pressure
• Increased levels of a substance called creatinine, urea in the blood, platelet or white blood cell counts in the blood, altered electrocardiogram (ECG)
• Swollen joints, pain in the limbs
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Ringing in the ears and/or sensation of the head spinning
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare side effects(may affect up to 1 in 1,000 people):

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Disturbances in the sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweats, rash
• Coordination problems
• Low blood pressure when standing up
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Feeling of cold in hands and feet
• Hives, allergic skin reactions
• Impotence
• Inability to walk due to balance problems
• Pancreatitis or intestinal inflammation
• Memory loss
• Throat tightness
• Low sodium levels in the blood (hyponatremia) that can cause fatigue and confusion, muscle contractions, cramps, and coma.

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

• Myoclonus

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website (https://www.notificaram.es). By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are:

Core of the tablet:Microcrystalline cellulose (E460), methacrylic acid - ethyl acrylate copolymer (1:1), sodium hydroxide (E524), hypromellose (E464), magnesium stearate (E470b).

AquaPolish P-white coating:Hypromellose (E464), hydroxypropylcellulose (E463), macrogol 8000 (E1521), titanium dioxide (E171).

Appearance of the product and pack contents

The 375 mg tablets are white, oblong, convex, film-coated tablets, 15 mm x 7.2 mm in size, with "375" engraved on one side.

The 500 mg tablets are white, oblong, convex, film-coated tablets, 16.5 mm x 8.0 mm in size, with "500" engraved on one side.

The 750 mg tablets are white, oblong, convex, film-coated tablets, 19 mm x 9.2 mm in size, with "750" engraved on one side.

Ranolazine cinfa is packaged in PVC/PVDC/aluminum blisters in cardboard boxes containing 30, 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Ranolazine ELC 375 mg / 500 mg/ 750 mg tabletten met verlengde afgifte

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 cueliberare prelungita

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

Italy: Ranolazina ELC

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

Greece: RANOLAZINE/GENEPHARM

Date of last revision of this leaflet:05/2022

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

Ranolazine cinfa 375 mg prolonged-release tablets EFG

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the 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 to: https://cima.aemps.es/cima/dochtml/p/88005/P_88005.html

Ranolazine cinfa 500 mg prolonged-release tablets EFG

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the 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 to: https://cima.aemps.es/cima/dochtml/p/88006/P_88006.html

Ranolazine cinfa 750 mg prolonged-release tablets EFG

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the 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 to: https://cima.aemps.es/cima/dochtml/p/88007/P_88007.html