RANOLAZINE TEVA 375 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Ranolazina Teva

Do not take Ranolazina Teva

• If you are allergic to ranolazina or any of the other components 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 (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 ranolazina:

• If you have mild or moderate kidney problems.
• If you have mild liver problems.
• If you have ever had an electrocardiogram (ECG) alteration.
• 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 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 if you are taking ranolazina:

• Certain medications for the treatment of 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).

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

• Certain medications to treat a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medication used to prevent organ transplant rejection (cyclosporine), or if you are taking heart pills such as diltiazem or verapamil. These medications may cause a greater number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of treatment with ranolazina (see section 4). If you are taking these medications, your doctor may decide to give you a lower dose of ranolazina.
• Medications 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 remedy called hypericum or St. John's wort, you should inform your doctor because these medications may make ranolazina less effective.
• Heart medications that contain digoxin or metoprolol, as if you are taking this medication, your doctor may decide to change the dose while taking ranolazina.
• Certain medications to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and medications for the treatment of depression (e.g. imipramine, doxepin, amitriptyline), as these medications may alter your electrocardiogram (ECG).
• Certain medications for the treatment of depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medications to treat high blood cholesterol levels (e.g. simvastatin, lovastatin, atorvastatin). These medications may cause muscle pain and damage. Your doctor may decide to change the dose of this medication while taking ranolazina.
• Certain medications used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to change the dose of this medication while taking ranolazina.

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

Taking Ranolazina Teva with food and drinks

Ranolazina can be taken with or without food. While you are being treated with ranolazina, you should not drink grapefruit juice.

Pregnancy and breastfeeding

You should not take ranolazina if you are pregnant unless your doctor has told you that you can.

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

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

Driving and using machines

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

Ranolazina 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 notice any of these symptoms, do not drive or use machines until they have passed.

Ranolazina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet; this is essentially "sodium-free".

3. How to take Ranolazina Teva

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

Always 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 medication 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 ranolazina 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 indicate that you stop taking ranolazina.

Use in children and adolescents

Children and adolescents under 18 years of age should not take ranolazina.

If you take more Ranolazina Teva than you should

If you accidentally take more ranolazina 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 center.

Take the remaining tablets with you, 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, pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ranolazina Teva

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

• 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 the dose or indicate that you stop taking ranolazina.

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 (asthenia)

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
• Difficulty breathing, 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, alteration of the electrocardiogram (ECG)
• Swelling of the joints, pain in the limbs
• 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 side effects (may affect up to 1 in 1000 people):

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Alterations 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
• Tightness in the throat
• 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 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 is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ranolazina Teva

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

Do not use this medication after the expiration date that appears on each blister strip and on the outer packaging after "CAD or EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ranolazina Teva

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, methacrylic acid and ethyl acrylate copolymer, sodium hydroxide, magnesium stearate.

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

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

Ranolazina Teva 750 mg: The coating contains: poly(vinyl alcohol), titanium dioxide, macrogol 3350 and talc.

Appearance of the product and package contents

Ranolazina Teva 375 mg prolonged-release tablets are film-coated tablets of 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 of 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 of 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 and PVC/Aclar/PVC-Al blister packs containing 30, 60 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

Manufacturer

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

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

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

Austria Ranolazin ratiopharm 375 mg Retardtabletten

Ranolazin ratiopharm 500 mg Retardtabletten

Ranolazin ratiopharm 750 mg Retardtabletten

Denmark Ranolazin-ratiopharm 375 mg Retardtabletten

Ranolazin-ratiopharm 500 mg Retardtabletten

Ranolazin-ratiopharm 750 mg Retardtabletten

Spain Ranolazina Teva 375 mg prolonged-release tablets EFG

Ranolazina Teva 500 mg prolonged-release tablets EFG

Ranolazina Teva 750 mg prolonged-release tablets EFG

Italy Ranolazina Teva

Date of the last revision of this leaflet: November 2023

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medication 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