Ranolazine Teva 750 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package 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 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.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed only for you. Do not give it 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, including if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ranolazine Teva is and what it is used for
2. What you need to know before taking Ranolazine Teva
3. How to take Ranolazine Teva
4. Possible side effects

5 Storage of Ranolazine Teva

1. Contents of the pack and other information

1. What Ranolazine Teva is and what it is used for

Ranolazine Teva is a medicine used in combination with other treatments for the management 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 during physical exertion or particularly intense activity.

You should consult a doctor if your symptoms worsen or do not improve.

2. What you need to know before taking Ranolazina Teva

Do not take Ranolazina Teva

• 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 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 elderly.
• If you have low body weight (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 Ranolazina Teva

Do not use 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 for 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 (hypericum), you must inform your doctor, as these medicines may reduce the effectiveness of ranolazine.
• Heart medicines 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 levels (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.

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

Taking Ranolazina Teva with food and drink

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

Pregnancy and breastfeeding

You must not take ranolazine during pregnancy unless your doctor has specifically told you that you may do so.

You must not take ranolazine while 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 medicine.

Driving and using machines

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

Ranolazine may cause adverse effects such as dizziness (common), 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 resolved.

Ranolazina Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet; therefore, it is essentially “sodium-free”.

3. How to take Ranolazine Teva

Follow exactly the instructions given by your doctor for taking this medicine. 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 in half, 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 that you 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, may instruct you to stop treatment with ranolazine.

Use in children and adolescents

Ranolazine must not be used in children and adolescents under 18 years of age.

If you take more Ranolazine Teva 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 department.

Take any remaining tablets with you, together 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, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ranolazine Teva

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.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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.

Other possible adverse effects are listed below:

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

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

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

• Altered sensation
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbances
• Sensory disturbances (touch or taste), tremors, fatigue or weakness, somnolence 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 flashes, 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 head spinning
• Stomach pain or discomfort, indigestion, dry mouth, gas

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

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Changes in the sense of smell, numbness of the 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 feet
• 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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Teva

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

Do not use this medicine after the expiry date stated on each blister strip and on the outer packaging after "CAD" or "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 in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ranolazine Teva

The active substance in Ranolazine Teva is ranolazine.

Ranolazine Teva 375 mg: Each tablet contains 375 mg of ranolazine.

Ranolazine Teva 500 mg: Each tablet contains 500 mg of ranolazine.

Ranolazine Teva 750 mg: Each tablet contains 750 mg of ranolazine.

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

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

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

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

Appearance of the product and contents of the container

Ranolazine Teva 375 mg prolonged-release tablets are light blue, film-coated, oval-shaped tablets marked with "375" on one side and flat on the other. The tablet is approximately 14.9 mm x 7.1 mm.

Ranolazine Teva 500 mg prolonged-release tablets are light orange, film-coated, oval-shaped tablets marked with "500" on one side and flat on the other. The tablet is approximately 16.5 mm x 8.0 mm.

Ranolazine Teva 750 mg prolonged-release tablets are white to off-white, film-coated, oval-shaped tablets marked with "750" on one side and flat on the other. The tablet is approximately 18.8 mm x 9.1 mm.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11 Edificio Albatros B, 1st floor
28108 Alcobendas (Madrid)
Spain

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

This medicinal product is authorised in the European Economic Area member states 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  Ranolazine Teva 375 mg prolonged-release tablets EFG
     Ranolazine Teva 500 mg prolonged-release tablets EFG
     Ranolazine Teva 750 mg prolonged-release tablets EFG

Italy   Ranolazina Teva

Date of the most recent review of this summary: November 2023

Other sources of information

Detailed information on this medicinal product 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 up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html