Ranexa 375 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ranexa 375 mg prolonged-release tablets

Ranexa 500 mg prolonged-release tablets

Ranexa 750 mg prolonged-release tablets

ranolazine

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms, as it may be harmful to them.
• If you experience any side effects, talk to your doctor, even if it is a side effect not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What RANEXA is and what it is used for

Ranexa 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 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 taking RANEXA

Do not take Ranexa

• 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 (AIDS) (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Warnings and precautions

Talk to 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 elderly.

• If you are of low body weight (60 kg or less).

• If you have heart failure.

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

Taking Ranexa with other medicines

Do not use any of the following medicines if you are taking Ranexa:

• 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 Ranexa 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 if you are taking heart tablets such as diltiazem or verapamil. These medicines may increase the likelihood of side effects such as dizziness, nausea, or vomiting, which are possible side effects of treatment with Ranexa (see section 4). If you are taking these medicines, your doctor may decide to prescribe a lower dose of Ranexa.
• 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), you must inform your doctor, as these medicines may make Ranexa less effective.
• Heart medicines containing digoxin or metoprolol, as your doctor may need to adjust the dose of these medicines while you are taking Ranexa.
• Certain medicines used to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), or depression (e.g. imipramine, doxepine, amitriptiline), 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 Ranexa.
• 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 Ranexa.

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

Taking Ranexa with food and drink

Ranexa may be taken with or without food. While being treated with Ranexa, you should not drink grapefruit juice.

Pregnancy

You should not take Ranexa during pregnancy unless your doctor has told you that you may do so.

Breast-feeding

You should not take Ranexa 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 Ranexa on the ability to drive and use machines have been conducted. Ask your doctor whether you can drive or use machines.

Ranexa 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 operate machinery until they have resolved.

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

Ranexa 750 mg prolonged-release tablets contain lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take RANEXA

Follow exactly the instructions for using 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 or crush the tablets, and do not 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 Ranexa 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 Ranexa.

Use in children and adolescents

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

If you take more Ranexa than you should

If you accidentally take more Ranexa tablets than prescribed or take tablets of a higher dose than recommended by your doctor, it is important that you inform your doctor immediately. If you are unable to contact your doctor, go to the nearest emergency department. Take any leftover tablets with you, together with the blister pack (aluminum sheet containing the tablets) and the outer carton, so that hospital staff can easily identify what you have taken.

If you forget to take Ranexa

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 experiences them.

You must stop taking Ranexa and contact your doctor immediately if you experience the following symptoms of angioedema, which is a rare disorder but 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 Ranexa.

The following is a list of other adverse effects you may experience:

Frequent adverse effects (occur in 1 to 10 out of 100 users):

Constipation
Dizziness
Headache
Nausea, vomiting
Weakness (asthenia)

Uncommon adverse effects (occur in 1 to 10 out of 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, nosebleed
Double vision
Excessive sweating, itching
Feeling of swelling or puffiness
Hot flushes, low blood pressure

Increased levels of a substance called creatinine, blood urea, platelet or white blood cell counts in blood, 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 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 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 spasms, 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of RANEXA

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on each tablet blister strip and on the outer packaging and bottle after EXP.

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 and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ranexa

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

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

Depending on the tablet strength, the coating additionally contains:

Tablet 375 mg: macrogol, polysorbate 80, indigo carmine blue no. 2/aluminium lake (E132)

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

Tablet 750 mg: glyceryl triacetate, lactose monohydrate, brilliant blue FCF blue no. 1/aluminium lake (E133), and tartrazine yellow no. 5/aluminium lake (E102)

Appearance of Ranexa and contents of the pack

Ranexa prolonged-release tablets are oval-shaped.

The 375 mg tablets are pale blue and marked with "375" on one side.

The 500 mg tablets are light orange and marked with "500" on one side.

The 750 mg tablets are pale green and marked with "750" on one side.

Ranexa is supplied in boxes containing 30, 60, or 100 tablets in blisters, or 60 tablets in plastic bottles. Some pack sizes may not be marketed.

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.

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

Manufacturer

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 medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.