Ranolazine Pensa 375 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ranolazina pensa 375 mg prolonged-release tablets EFG

Ranolazina pensa 500 mg prolonged-release tablets EFG

Ranolazina pensa 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ranolazina pensa is and what it is used for
2. What you need to know before taking Ranolazina pensa
3. How to take Ranolazina pensa
4. Possible side effects
5. How to store Ranolazina pensa
6. Contents of the pack and other information

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

Ranolazine is a medicine used in combination with other medications for the treatment of angina pectoris, a condition that causes chest pain or discomfort felt anywhere from the neck to the upper abdomen in the upper half of the body, often occurring during physical exertion or particularly intense activity.

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

2. What you need to know before taking Ranolazina pensa

Do not take Ranolazina pensa

• If you are allergic to ranolazine or to any of the other ingredients of this medicine listed in section 6 of this leaflet.
• 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 are of 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 pensa

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

• 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 Ranolazina pensa 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 risk 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 used 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 the herbal remedy St. John’s wort (hypericum), you must inform your doctor, as these medicines may reduce the effectiveness of ranolazine.
• Heart medications 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), and medicines used to treat depression (e.g. imipramine, doxepine, amitriptiline), 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 (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), as 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 pensa with food and drink

Ranolazina pensa may be taken with or without food. While taking this medicine, you must not drink grapefruit juice.

Pregnancy

Do not take this medicine during pregnancy unless your doctor has told you that you may do so.

Breast-feeding

Do not take this medicine while breast-feeding. Consult your doctor if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, talk to 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 performed. Ask your doctor whether you can drive or use machines.

Ranolazine may cause side 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 pensa contains sodium

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

3. How to take Ranolazina pensa

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, split, or cut the tablets, 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, advise you to stop taking ranolazine.

Use in children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

If you take more Ranolazina pensa than you should

If you accidentally take more ranolazine tablets than prescribed or take tablets with 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, along with the blister pack (aluminum sheet containing the tablets) and the outer packaging, so that hospital staff can easily identify what you have taken.

If you forget to take Ranolazina pensa

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 a missed dose.

4. Possible adverse effects

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

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

• 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.

The following is a list of other adverse effects you may experience:

Frequent adverse effects (occur in 1 to 10 out of every 100 users):

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

Uncommon adverse effects (occur in 1 to 10 out of every 1,000 users):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, visual disturbances
• Sensory disturbances (touch or taste), tremors, fatigue or weakness, drowsiness 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 flushes, 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 dizziness
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare adverse effects (occur in 1 to 10 out of every 10,000 users):

• Inability to urinate
• Abnormal liver laboratory values
• Acute kidney failure
• Changes in sense of smell, numbness of mouth or lips, hearing loss
• Cold sweat, rash
• Coordination problems
• Drop in blood pressure upon standing
• Decreased level of consciousness or loss of consciousness
• Disorientation
• Cold sensation in hands and legs
• Hives, skin allergic reactions
• Impotence
• Inability to walk due to balance problems
• Inflammation of the pancreas or intestine
• Memory loss
• Tightness in the throat
• Low sodium levels in blood (hyponatremia), which may cause fatigue and confusion, muscle twitching, cramps, and coma

Adverse effects with frequency not known (cannot be estimated from available data):

• Myoclonus

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ranolazine Pensa

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on each tablet blister strip and on the outer packaging and bottle after EXP.

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 and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ranolazina pensa

The active substance in Ranolazina pensa is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg of ranolazine.

The other components are: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide, hypromellose, magnesium stearate.

Coating excipients: hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide (E171).

Appearance of Ranolazina pensa and contents of the pack

Ranolazina pensa 375 mg prolonged-release tablets EFG

Coated tablets, white or almost white, oblong, biconvex, with the imprint "375" engraved on one side.

Ranolazina pensa 500 mg prolonged-release tablets EFG

Coated tablets, white or almost white, oblong, biconvex, with the imprint "500" engraved on one side.

Ranolazina pensa 750 mg prolonged-release tablets EFG

Coated tablets, white or almost white, oblong, biconvex, with the imprint "750" engraved on one side.

Ranolazina pensa 375 mg, 500 mg, and 750 mg are supplied in boxes containing 30 or 60 tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Spain: Ranolazina pensa 375 mg, 500 mg, 750 mg prolonged-release tablets EFG

Italy: Ranolazina Pensa

Portugal: Ranolazina toLife

Date of the most recent revision of this leaflet: November 2023

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