RANOLAZINE PENSA 375 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Ranolazine Pensa

Do not take Ranolazine Pensa

• If you are allergic to ranolazine or any of the other components of this medication, including those 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 medications for 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 ranolazine:

• 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 Ranolazine Pensa

Do not use any of the following medications if you are taking Ranolazine Pensa:

• 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).

Tell your doctor or pharmacist before taking Ranolazine Pensa if you are using:

• Certain medications for treating bacterial infections (erythromycin) or fungal infections (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 ranolazine (see section 4). If you are taking these medications, your doctor may decide to give you a lower dose of ranolazine.
• 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 St. John's Wort, you should inform your doctor because these medications may make ranolazine less effective.
• Heart medications that contain digoxin or metoprolol, as your doctor may decide to change the dose while you are taking ranolazine.
• Certain medications for treating 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 treating depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
• Certain medications for treating high cholesterol levels in the blood (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 you are taking ranolazine.
• 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 you are taking ranolazine.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Use of Ranolazine Pensa with food and beverages

Ranolazine Pensa can be taken with or without food. While you are being treated with this medication, you should not drink grapefruit juice.

Pregnancy

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

Breastfeeding

You should not take this medication 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 ranolazine on the ability to drive and use machines. Ask your doctor if you can drive or use machines.

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

Ranolazine Pensa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, i.e., it is essentially "sodium-free".

3. How to take Ranolazine Pensa

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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 how the medication is released in your body.

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

It is essential that you 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.

Use in children and adolescents

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

If you take more Ranolazine Pensa than you should

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

If you forget to take Ranolazine 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). 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 will experience them.

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

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

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

The following are other side effects you may experience:

Frequent side effects (occurring in 1 to 10 out of 100 users):

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

Infrequent side effects (occurring in 1 to 10 out of 1,000 users):

• 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, altered electrocardiogram (ECG)
• Joint swelling, pain in the limbs
• Loss of appetite and/or weight loss
• Muscle cramps, muscle weakness
• Ringing in the ears and/or feeling of spinning
• Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare side effects (occurring in 1 to 10 out of 10,000 users):

• Urination problems
• 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
• Throat tightness
• 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 available data):

• Myoclonus

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ranolazine Pensa

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on each blister pack of tablets and on the outer packaging and bottle after CAD.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. 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 Ranolazine Pensa

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

The other ingredients 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 Ranolazine Pensa and package contents

Ranolazine Pensa 375 mg prolonged-release tablets EFG

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

Ranolazine Pensa 500 mg prolonged-release tablets EFG

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

Ranolazine Pensa 750 mg prolonged-release tablets EFG

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

Ranolazine Pensa 375 mg, 500 mg, and 750 mg are supplied in boxes with 30 or 60 tablets in blisters.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

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

Spain: Ranolazine Pensa 375 mg, 500 mg, 750 mg prolonged-release tablets EFG

Italy: Ranolazina Pensa

Portugal: Ranolazina toLife

Date of the last revision of thisleaflet:November 2023

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/).