Prospect: Information for the Patient

Ranolazine Cinfa 375 mg Extended-Release Tablets EFG

Ranolazine Cinfa 500 mg Extended-Release Tablets EFG

Ranolazine Cinfa 750 mg Extended-Release Tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

Ranolazineis a medication used in combination with others for the treatment of angina pectoris, a disease that causes chest pain or discomfort felt in any part of the upper half of the body between the neck and the upper abdomen, often after physical exercise or particularly intense activity.

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

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 using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (acquired immunodeficiency syndrome) (protease inhibitors), depression (nefazodone) or heart rhythm disturbances (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 abnormal electrocardiogram (ECG).
• If you are an elderly person.
• If you are underweight (60 kg or less).
• If you have heart failure.

If you are in any of these cases, your doctor may decide to give you a lower dose of the medicine or take other precautions.

Other medicines and ranolazine cinfa

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medicine.

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 (acquired immunodeficiency syndrome) (protease inhibitors), depression (nefazodone) or heart rhythm disturbances (e.g. quinidine, dofetilide or sotalol).

Inform 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 (ciclosporin), 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 ranolazine treatment (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 to treat an infection

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

• Heart medicines containing digoxin or metoprolol, as if you are taking this medicine, your doctor may decide to change your dose while taking ranolazine.
• Certain medicines for allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disturbances (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 the treatment of depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medicines used to treat high cholesterol levels in the blood (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 you are taking ranolazine.
• Certain medicines used for the prevention of organ transplant rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus), so your doctor may decide to change the dose of this medicine while you are taking ranolazine.

Taking ranolazine cinfa with food and drinks

Ranolazine can be taken with or without food. While you are taking ranolazine, do not drink grapefruit juice.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Do not take ranolazine if you are breastfeeding. Consult your doctor if you are breastfeeding.

Driving and operating machinery

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

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

ranolazine cinfa contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The initial dose for adults is one 375 mg tablet taken 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 taken twice a day.

It is essential to inform your doctor if you experience side effects such as dizziness, nausea, or vomiting. Your doctor may reduce the dose or, if that is not sufficient, instruct you to stop taking ranolazine treatment.

Use in children and adolescents

Children and adolescents under 18 years old should not take ranolazine.

If you take more Ranolazine Cinfa than you should

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

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

If you forgot to take Ranolazine Cinfa

If you forgot to take a dose, take it as soon as you remember, except if it is almost time to take the next dose (less than 6 hours). Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Swelling in the face, tongue, or throat
• Difficulty swallowing
• Hives or difficulty breathing

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

The following are other side effects you may experience:

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

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

Infrequent side effects(may affect up to 1 in 100 patients):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disturbances
• Alterations in senses (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nasal bleeding
• Diplopia
• Excessive sweating, pruritus
• Sensation of swelling or heaviness
• Hot flashes, low blood pressure
• Increased levels of a substance called creatinine, urea in the blood, platelet or white blood cell counts, electrocardiogram (ECG) alteration
• Joint swelling, limb pain
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Tinnitus in the ears and/or sensation of the head spinning
• Abdominal pain or discomfort, indigestion, dry mouth, gas

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

• Inability to urinate
• Liver function test abnormalities
• Acute renal failure
• Alterations in sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweat, urticaria
• Coordination problems
• Low blood pressure when standing up
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Sensation of cold hands and feet
• Hives, skin allergic 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 may cause fatigue and confusion, muscle contractions, cramps, and coma.

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

• Mioclono

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of ranolazine cinfa

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

The other components are:

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

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

Appearance of the product and contents of the package

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

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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Austria: Ranolazine ELC 375 mg /500 mg/ 750 mg Retard tablets

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: Ranolazine 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: Ranolazine ELC Group s.r.o. 375 mg /500 mg/750 mg comprimate cueliberare prelungita

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

Italy: Ranolazine ELC

Spain: Ranolazine Cinfa 375 mg/ 500 mg/ 750 mg prolonged-release tablets EFG

Greece: RANOLAZINE/GENEPHARM

Last review date of this leaflet:05/2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

Ranolazine cinfa 375 mg prolonged-release tablets EFG

You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information on 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 updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information on 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 updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information on 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