Prospect: Information for the User

Ranexa 375 mg prolonged-release tablets

Ranexa 500 mg prolonged-release tablets

Ranexa 750 mg prolonged-release tablets

ranolazine

Read 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor even if they do not appear in this leaflet. See section 4.

RANEXA is a medication used in combination with others for the treatment of angina pectoris, a disease that causes chest pain or discomfort felt anywhere in 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 Ranexa

• If you are allergic to ranolazine or any of the other components of this medication listed 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 (acquired immunodeficiency syndrome) (protease inhibitors), depression (nefazodone) or heart rhythm disturbances (e.g. quinidine, dofetilide or sotalol).

Warnings and precautions

Consult your doctor before taking Ranexa:

• 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 medication or take other precautions.

Use of Ranexa with other medications

Do not use any of the following medications while taking Ranexa:

• Certain medications for the treatment of bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (acquired immunodeficiency syndrome) (protease inhibitors), depression (nefazodone) or heart rhythm disturbances (e.g. quinidine, dofetilide or sotalol).

Inform your doctor or pharmacist before taking Ranexa if you are using:

• Certain medications to treat bacterial infections (erythromycin) or fungal infections (fluconazole), a medication used to prevent organ transplant rejection (cyclosporine), or if you are taking heart medication such as diltiazem or verapamil. These medications may cause a higher number of side effects, such as dizziness, nausea or vomiting, which are possible side effects of Ranexa treatment (see section 4). If you are taking these medications, your doctor may decide to give you a lower dose of Ranexa.
• 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 Ranexa 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 Ranexa.
• Certain medications for allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disturbances (e.g. disopyramide, procainamide) and medications for the treatment of depression (e.g. imipramine, doxepin, amitriptyline), as these medications may alter your electrocardiogram (ECG).
• Certain medications for the treatment of depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide).
• Certain medications used to lower 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 Ranexa.
• Certain medications used for the prevention of organ transplant rejection (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), as your doctor may decide to change the dose of this medication while taking Ranexa.

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

Use of Ranexa with food and drinks

Ranexa can be taken with or without food. While taking Ranexa, do not drink grapefruit juice.

Pregnancy

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

Breastfeeding

Do not take Ranexa 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 Ranexa on the ability to drive and operate machinery. Ask your doctor if you can drive or operate machinery.

Ranexa 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 operate machinery. If you notice any of these symptoms, do not drive or operate machinery until they have passed.

Ranexa 750 mg prolonged-release tablets contain the azo dye E102 (tartrazine). This dye may cause allergic reactions.

Ranexa 750 mg prolonged-release tablets contain lactose monohydrate. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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. Consult your doctor or pharmacist if you have any doubts.

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 Ranexa 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 Ranexa treatment.

Use in children and adolescents

Children and adolescents under 18 years old should not take Ranexa.

If you take more RANEXA than you should

If you accidentally take more tablets of Ranexa 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 contact your doctor, go to the nearest emergency department. Bring with you the remaining tablets, along with the aluminum foil containing the tablets and the packaging, so that hospital staff can easily identify what you have taken.

If you forgot to take RANEXA

If you forget 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 medications, this medication may cause side effects, although not everyone will experience them.

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

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 Ranexa.

The following are other side effects you may experience:

Frequent side effects (occurring in 1 to 10 of every 100 users):

Constipation

Dizziness

Headache

Nausea, vomiting

Weakness (Astenia)

Rare side effects (occurring in 1 to 10 of every 1000 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, itching

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 1 to 10 of every 10000 users):

Inability to urinate

Abnormal liver function test values

Acute renal failure

Alterations in the sense of smell, numbness of the mouth or lips, hearing loss

Cold sweat, hives

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 the blood (hyponatremia) that may cause fatigue and confusion, muscle contractions, cramps, and coma.

Unknown frequency side effects (cannot be estimated from available data): Myoclonus

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 medication.

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.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Ranexa

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

The other components are: hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.

Depending on the concentration of the tablet, the coating contains in addition:

Tablet of 375 mg: macrogol, polisorbate 80, blue no. 2/aluminum lake carmine (E132)

Tablet of 500 mg:macrogol, talc, poly(vinyl alcohol)-partially hydrolyzed, yellow iron oxide (E172), red iron oxide (E172).

Tablet of 750 mg: triacetin, lactose monohydrate, blue no. 1/aluminum lake brilliant blue FCF (E133) and yellow no. 5/aluminum lake tartrazine (E102)

Appearance of the product Ranexa and contents of the package

The prolonged-release tablets of Ranexa have an oval shape.

The tablets of 375 mg are pale blue and have 375 engraved on one face.

The tablets of 500 mg are light orange and have 500 engraved on one face.

The tablets of 750 mg are pale green and have 750 engraved on one face.

Ranexa is supplied in boxes with 30, 60 or 100 tablets in blisters or 60 tablets in plastic bottles. Only some package sizes may be marketed.

Marketing Authorization Holder

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Responsible for manufacturing

Menarini - Von Heyden GmbH

Leipziger Straße 7-13

01097 Dresden

Germany

or

Berlin Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder

Date of the last review of this leaflet {MM/YYYY}.

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.