Leaflet:information for the patient

Ranolazine Teva 375 mg prolonged-release tablets EFG

Ranolazine Teva 500 mg prolonged-release tablets EFG

Ranolazine Teva 750 mg prolonged-release tablets EFG

Read this 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.
• 1. If you are unsure, consult yourdoctor,orpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor,even if they are not listed in this leaflet. See section 4.

1.What isRanolazine Tevaand what it is used for

2.What you need to knowbeforestarting totake Ranolazine Teva

3.How to take Ranolazine Teva

4.Possible side effects

5Storage of Ranolazine Teva

6.Contents of the pack and additional information

Ranolazina Teva is 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 Ranolazina Teva

• If you are allergic to ranolazine or any of the other ingredients of this medication (listed in section 6).
• If you have severe kidney problems.
• If you have moderate or severe liver problems.
• If you are taking certain medications to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (HIV/AIDS) (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:

• 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 medication or take other precautions.

Other medications and Ranolazina Teva

Do not use any of the following medications while taking ranolazine:

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

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

• Certain medications to treat bacterial infections (erythromycin) or fungal infections (fluconazole), a medication used to prevent organ transplant rejection (ciclosporin), or heart medications like diltiazem or verapamil. These medications 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 medications, your doctor may decide to give you a lower dose of ranolazine.
• Medications 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 a herbal remedy called St. John's Wort, inform your doctor because these medications may make ranolazine less effective.
• Heart medications containing digoxin or metoprolol, as your doctor may decide to change your dose while taking ranolazine.
• Certain medications to treat allergies (e.g. terfenadine, astemizole, or mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and medications to treat depression (e.g. imipramine, doxepin, or amitriptyline), as these medications may alter your electrocardiogram (ECG).
• Certain medications to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• Certain medications to treat high cholesterol levels in the blood (e.g. simvastatin, lovastatin, or atorvastatin). These medications may cause muscle pain and damage. Your doctor may decide to change the dose of this medication while you are taking ranolazine.
• Certain medications used to prevent organ transplant rejection (e.g. tacrolimus, ciclosporin, sirolimus, or everolimus), as your doctor may decide to change the dose of this medication while you are taking ranolazine.

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

Taking Ranolazina Teva 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

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

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

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

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.

Ranolazina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet; that is, it 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 Teva than you should

If you accidentally take more ranolazine tablets 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 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, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. .

If you forgot to take Ranolazine Teva

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.

Like all medicines, this medicine can 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 potentially 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 people):

• Constipation
• Dizziness
• Headache
• Nausea, vomiting
• Weakness (Astenia)

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

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disturbances
• Alterations in sensation (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up
• Dark urine, blood in the urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nasal bleeding
• Diplopia
• Excessive sweating, itching
• 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 people):

• Inability to urinate
• Abnormal liver function test values
• Acute renal failure
• Alterations in the sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweat, hives
• Coordination problems
• Low blood pressure when standing up
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Sensation of cold in 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.

Unknown frequency of side effects (cannot be estimated from available data):

• Mioclonus

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears oneach blister strip and on the outer part of the containerafter “CAD or EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubt,ask your pharmacisthow to dispose ofthe containers and unused medications.By doing so, you will help protect the environment.

Ranolazina Teva Composition

The active ingredient in Ranolazina Teva is ranolazina.

Ranolazina Teva 375 mg: Each tablet contains 375 mg of ranolazina.

Ranolazina Teva 500 mg: Each tablet contains 500 mg of ranolazina.

Ranolazina Teva 750 mg: Each tablet contains 750 mg of ranolazina.

The other components are:microcrystalline cellulose, hypromellose, ethyl acrylate and methacrylic acid copolymer, sodium hydroxide, magnesium stearate.

Ranolazina Teva 375 mg: The coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, and aluminum lake indigo carmine (E132).

Ranolazina Teva 500 mg: The coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide (E172), and red iron oxide (E172).

Ranolazina Teva 750 mg: The coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, and talc.

Appearance of the product and packaging contents

Ranolazina Teva 375 mg prolonged-release tablets are film-coated tablets with a light blue color, oval shape, marked with “375” on one side and flat on the other. The tablet is approximately 14.9 mm x 7.1 mm.

Ranolazina Teva 500 mg prolonged-release tablets are film-coated tablets with a light orange color, oval shape, marked with “500” on one side and flat on the other. The tablet is approximately 16.5 mm x 8.0 mm.

Ranolazina Teva 750 mg prolonged-release tablets are film-coated tablets with a white to off-white color, oval shape, marked with “750” on one side and flat on the other. The tablet is approximately 18.8 mm x 9.1 mm.

Ranolazina Teva is supplied in PVC/PVDC/Al blisters and PVC/Aclar/PVC-Al blisters containing 30, 60, or 100 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder andResponsible for Manufacturing

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible for Manufacturing

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

This medicinal productis authorized in the member states of the European Economic Area with the following names:

AustriaRanolazin ratiopharm 375 mg Retardtabletten

Ranolazin ratiopharm 500 mg Retardtabletten

Ranolazin ratiopharm 750 mg Retardtabletten

DenmarkRanolazin-ratiopharm 375 mg Retardtabletten

Ranolazin-ratiopharm 500 mg Retardtabletten

Ranolazin-ratiopharm 750 mg Retardtabletten

SpainRanolazina Teva 375 mg prolonged-release tablets EFG

Ranolazina Teva 500 mg prolonged-release tablets EFG

Ranolazina Teva 750 mg prolonged-release tablets EFG

ItalyRanolazina Teva

Last review date of thisleaflet:November 2023

Other sources of information

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html