Ranolazine Alter 500 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 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 you should not give it to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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 treatments for the management of chronic angina pectoris, a condition that causes chest pain or discomfort felt anywhere in the upper half of the body between the neck and the upper abdomen, 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 starting to take Ranolazine Alter

Do not take Ranolazine 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 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).

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 have low body weight (60 kg or less).
• If you have heart failure.

If you fall into any of these categories, your doctor may decide to prescribe a lower dose of the medicine or take other precautions.

Other medicines and Ranolazine 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).

Tell 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 rejection of a transplanted organ (cyclosporine), or 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 the herbal remedy St. John’s wort (Hypericum perforatum), 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, doxepine, 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 cholesterol levels in the blood (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), in which case 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 Ranolazine Alter with food and drink

Ranolazine may be taken with or without food. While taking ranolazine, you should not drink grapefruit juice.

Pregnancy

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

Breast-feeding

Do not take ranolazine if you are 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.

Ranolazine Alter contains sodium

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

3. How to take Ranolazina Alter

Follow exactly the instructions for use of this medicine given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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, stating 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). Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

You must stop taking ranolazine and contact your doctor immediately if you experience the following symptoms of angioedema, a rare condition that 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 between 1 and 10 out of every 100 users):

Constipation
Dizziness
Headache
Nausea, vomiting
Weakness (asthenia)

Uncommon adverse effects (occur in between 1 and 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, drowsiness or lethargy, weakness or fainting, dizziness upon standing
Dark urine, blood in urine, difficulty urinating
Dehydration
Breathing difficulty, 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 spinning
Stomach pain or discomfort, indigestion, dry mouth, or gas

Rare adverse effects (occur in between 1 and 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 feet
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 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 refers to 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 in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack 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, methacrylic acid and ethyl acrylate copolymer (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 containing 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).