Package Insert: Information for the Patient

Ranolazine Alter 375 mg Extended-Release Tablets EFG

Ranolazine Alter 500 mg Extended-Release Tablets EFG

Ranolazine Alter 750 mg Extended-Release Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ranolazina is a medication used in combination with others for the treatment of angina pectoris, a disease that causes 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 takeRanolazine Alter

- If you are allergic to ranolazine or 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 (HIV/AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Warnings and precautions

Consult your doctor before taking 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 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 medicine or take other precautions.

Other medicines and Ranolazine Alter

Do not use any of the following medicines while taking ranolazine:

- Certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (HIV/AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Inform 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 (ciclosporin), or if you are taking heart tablets such as diltiazem or verapamil. These medicines may cause a higher number of side 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 give you a lower dose of ranolazine.

- Medicines 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 a herbal medicine called St. John's Wort, inform your doctor because these medicines may make ranolazine less effective.

- Heart medicines containing digoxin or metoprolol, as if you are taking this medicine, your doctor may decide to change your dose while taking ranolazine.

- Certain medicines to treat allergies (e.g. terfenadine, astemizole, or mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and medicines to treat depression (e.g. imipramine, doxepin, or amitriptyline), as these medicines may alter your electrocardiogram (ECG).

- Certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).

- Certain medicines to treat high cholesterol levels in the blood (e.g. simvastatin, lovastatin, or atorvastatin). These medicines may cause muscle pain and damage. Your doctor may decide to change the dose of this medicine while you are taking ranolazine.

- Certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, ciclosporin, sirolimus, or everolimus), so your doctor may decide to change the dose of this medicine while you are taking ranolazine.

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

Taking Ranolazine Alter with food and drinks

Ranolazine can be taken with or without food. While you are taking ranolazine, do not drink grapefruit juice.

Pregnancy

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

Breastfeeding

Do not take ranolazine 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 medicine.

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 Alter contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Swallow the entire 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 adverse 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 ranolazine.

If you take more Ranolazina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ranolazina Alter

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

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

• Swelling in the face, tongue, or throat

• Difficulty swallowing

• Urticaria or difficulty breathing

Inform your doctor if you experience frequent side effects such as dizziness, nausea, or vomiting. Your doctor may reduce your dose or advise 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)

Infrequent 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 sensation (touch or taste), tremors, fatigue or weakness, drowsiness or lethargy, weakness or fainting, dizziness when standing up

Dark urine, blood in the 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 the 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

Abnormal liver function test results

Acute renal failure

Alterations in the 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

Urticaria, skin allergic 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):

Mioclonus

Reporting 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 the national notification system: Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ranolazina Alter

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

The other components are: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1), sodium hydroxide, hypromellose, magnesium stearate, and coating [hypromellose, hydroxypropylcellulose, macrogol 8000, and titanium dioxide (E-171)].

Appearance of the product and content of the container

Ranolazina Alter prolonged-release tablets are film-coated, white, oval, and convex tablets.

The 375 mg tablets measure 15 x 7.2 mm and have “375” engraved on one face.

The 500 mg tablets measure 16.5 x 8.0 mm and have “500” engraved on one face.

The 750 mg tablets measure 19 x 9.2 mm and have “750” engraved on one face.

The tablets are available in containers with PVC/PVDC-Al blisters in containers of 60 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

Pabianice, 95-200

Poland

Last review date of this leaflet: December 2022

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