Ranolazine Alter 750 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ranolazine Alter 375 mg prolonged-release tablets EFG

Ranolazine Alter 500 mg prolonged-release tablets EFG

Ranolazine Alter 750 mg prolonged-release tablets EFG

Read all of this 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ranolazina is a medication used in combination with other drugs for the treatment of angina pectoris, a condition that causes chest pain or discomfort felt anywhere in the upper half of the body, from the neck to the upper abdomen, often occurring after 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 Alter

Do not take Ranolazina Alter

• 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 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 elderly.
• If you are underweight (60 kg or less).
• If you have heart failure.

If you are in any of these situations, your doctor may decide to prescribe a lower dose of the medicine or take other precautions.

Other medicines and Ranolazina Alter

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).

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 (cyclosporine), or if you are taking heart medications such as diltiazem or verapamil. These medicines may increase the risk 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 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 an herbal remedy called St. John’s wort (Hypericum perforatum), you must inform your doctor, as these medicines may make ranolazine less effective.
• 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), or depression (e.g. imipramine, doxepin, 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 (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.

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

Taking Ranolazina Alter with food and drink

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

Pregnancy

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

Breast-feeding

You must not take ranolazine 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, 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 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 Alter contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially “sodium-free”.

3. How to take Ranolazina Alter

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Always swallow the tablets whole with water. Do not chew, suck, crush the tablets, or split them 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

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

If you take more Ranolazina Alter than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately 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 Ranolazina Alter

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

You must stop taking ranolazine and consult your doctor immediately if you experience the following symptoms of angioedema, a rare but potentially serious disorder:

• 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 possible 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 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

Sensation of swelling or puffiness

Hot flushes, low blood pressure

Increased levels of a substance called creatinine, blood urea, 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 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 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 contractions, cramps, and coma.

Adverse effects with unknown frequency (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 through the national reporting system: 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 Alter

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ranolazina Alter

The active substance in 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, polyethylene glycol 8000 and titanium dioxide (E-171)].

Appearance of the product and contents of the pack

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

The 375 mg tablets measure 15 x 7.2 mm and are marked with "375" on one side.

The 500 mg tablets measure 16.5 x 8.0 mm and are marked with "500" on one side.

The 750 mg tablets measure 19 x 9.2 mm and are marked with "750" on one side.

The tablets are available in PVC/PVDC-Al blister packs in packs of 60 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

Manufacturer

Adamed Pharma S.A.
ul. Marszalka Józefa Pilsudskiego 5
Pabianice, 95-200
Poland

Date of the most recent review of this leaflet: December 2022

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/).