RANOLAZINE ALTER 750 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Ranolazine Alter

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 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 taking 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 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 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 if you are using:

• Certain medicines for treating a bacterial infection (erythromycin) or a fungal infection (fluconazole), a medicine used to prevent organ transplant rejection (cyclosporine), or if you are taking heart pills such as diltiazem or verapamil. These medicines may cause more 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 medicines, your doctor may decide to give you a lower dose of ranolazine.
• Medicines 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 medicine called St. John's Wort, you should inform your doctor because these medicines may make ranolazine less effective.
• Heart medicines that contain digoxin or metoprolol, as if you are taking this medicine, your doctor may decide to change the dose while taking ranolazine.
• Certain medicines for treating allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and medicines for the treatment of depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may alter your electrocardiogram (ECG).
• Certain medicines for treating depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medicines for treating high blood cholesterol levels (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and damage. Your doctor may decide to change the dose of this medicine while taking ranolazine.
• Certain medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), so your doctor may decide to change the dose of this medicine while taking ranolazine.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Taking Ranolazine Alter with food and drinks

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

Pregnancy

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

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 have a baby, ask your doctor for advice before taking 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 if you can drive or use machines.

Ranolazine may cause side effects such as dizziness (frequent), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), coordination problems (rare) that 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”.

3. How to take Ranolazine Alter

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with water. Do not chew, suck or crush the tablets or divide them in half, as this may affect the way the medicine is released into your body.

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

It is important 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 enough, tell you to stop taking the treatment with ranolazine.

Use in children and adolescents

Children and adolescents under 18 years should not take ranolazine.

If you take more Ranolazine Alter than you should

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

If you forget to take Ranolazine 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Swelling of 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 tell you to stop taking ranolazine.

The following are other side effects that you may experience:

Common side effects (may affect up to 1 in 10 people):

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (asthenia)

Uncommon side effects (may affect up to 1 in 100 people):

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, nosebleed

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)

Swelling of the joints, pain in the limbs

Lack 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 side effects (may affect up to 1 in 1,000 people):

Urination problems

Abnormal liver laboratory values

Acute kidney failure

Disturbances 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

Cold sensation 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 frequency not known (cannot be estimated from the available data):

Myoclonus

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ranolazine Alter

The active substance of Ranolazine Alter 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 and coating [hypromellose, hydroxypropylcellulose, macrogol 8000 and titanium dioxide (E-171)].

Appearance of the product and contents of the pack

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

The 375 mg tablets are 15 x 7.2 mm in size and have “375” engraved on one side.

The 500 mg tablets are 16.5 x 8.0 mm in size and have “500” engraved on one side.

The 750 mg tablets are 19 x 9.2 mm in size and have “750” engraved on one side.

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

Marketing authorisation 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 last revision of this leaflet: December 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).