Prospecto:Information for the Patient

Ranolazina pensa 375 mg prolonged-release EFG tablets

Ranolazina pensa 500 mg prolonged-release EFG tablets

Ranolazina pensa 750 mg prolonged-release EFG tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor,eveniftheyare not listed in this prospectus. See section 4.

1.What is Ranolazina pensa and what is it used for

2.What you need to knowbeforestarting totake Ranolazina pensa

3.How to take Ranolazina pensa

4.Possible adverse effects

5Storage of Ranolazina pensa

6.Contents of the package and additional information

Ranolazine is a medication used in combination with others for the treatment of angina pectoris, a disease that produces 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.

Consult a doctor if it worsens or does not improve.

Do not take Ranolazina pensa

• If you are allergic to ranolazina or any of the other components of this medication included in section 6 of this leaflet.
• If you have severe kidney problems.
• If you have moderate or severe liver problems.
• If you are using certain medications to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (AIDS) (protease inhibitors), depression (nefazodone) or heart rhythm disturbances (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) abnormality.
• 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 pensa

Do not use any of the following medications while taking Ranolazina 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 disturbances (e.g. quinidine, dofetilide or sotalol).

Inform your doctor or pharmacist before taking Ranolazina pensa 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 (ciclosporin), or if you are taking heart medication such as diltiazem or verapamil. These medications may cause a higher number of adverse effects, such as dizziness, nausea or vomiting, which are possible adverse effects of ranolazina treatment (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 St. John's Wort, inform your doctor because these medications may make ranolazina less effective.
• Heart medications containing digoxin or metoprolol, as if you are taking this medication, your doctor may decide to change your dose while taking ranolazina.
• Certain medications for allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disturbances (e.g. disopyramide, procainamide) and medications for depression (e.g. imipramine, doxepin, amitriptyline), as these medications may alter your electrocardiogram (ECG).
• Certain medications for depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medications for 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 taking ranolazina.
• Certain medications used for the prevention of organ transplant rejection (e.g. tacrolimus, ciclosporin, 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 using, have used recently or may need to use any other medication.

Use of Ranolazina pensa with food and drinks

Ranolazina pensa can be taken with or without food. While you are on treatment with this medication, do not drink grapefruit juice.

Pregnancy

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

Breastfeeding

Do 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 intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

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

Ranolazina may cause adverse 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 pensa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, which 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 whole 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 this medication.

If you take more Ranolazine pensa 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 reach your doctor, go to the nearest emergency department. Bring with you the remaining tablets, along with the blister (aluminum sheet containing the tablets) and the packaging, so that hospital staff can easily identify what you have taken.

If you forgot to take Ranolazine pensa

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 may cause side effects, although not everyone will experience them.

Stop taking this medicine and consult your doctor immediately if you experience the following angioedema symptoms, which is a rare but 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 the dose or instruct you to stop taking ranolazine.

The following are other side effects you may experience:

Frequent side effects (occurring in between 1 and 10 in every 100 users):

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

Rare side effects (occurring in between 1 and 10 in every 1,000 users):

• Altered sensitivity
• Anxiety, difficulty sleeping, confusion, hallucinations
• Blurred vision, vision disturbances
• Alterations in senses (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up
• Dark urine, blood in urine, difficulty urinating
• Dehydration
• Difficulty breathing, cough, nasal bleeding
• Diplopia
• Excessive sweating, pruritus
• 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 head spinning
• Abdominal pain or discomfort, indigestion, dry mouth, gas

Rare side effects (occurring in between 1 and 10 in every 10,000 users):

• Inability to urinate
• Liver function test alterations
• Acute renal failure
• Alterations in sense of smell, numbness of the mouth or lips, hearing loss
• Cold sweat, urticaria
• 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 blood (hyponatremia) that may cause fatigue and confusion, muscle contractions, cramps, and coma.

Side effects with unknown frequency (cannot be estimated from available data):

• Mioclonus

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

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

This medication does not require special storage conditions.

Do not dispose of the medication through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Ranolazina pensa

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

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

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

Appearance of the product Ranolazina pensa and contents of the packaging

Ranolazina pensa 375 mg prolonged-release tablets EFG

Coated tablets, white or off-white, oblong, biconvex, with the text "375" engraved on one face.

Ranolazina pensa 500 mg prolonged-release tablets EFG

Coated tablets, white or off-white, oblong, biconvex, with the text "500" engraved on one face.

Ranolazina pensa 750 mg prolonged-release tablets EFG

Coated tablets, white or off-white, oblong, biconvex, with the text "750" engraved on one face.

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Italy: Ranolazina Pensa

Portugal: Ranolazina toLife

Last review date of thisleaflet:November 2023

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