Ranexa 375 mg prolonged-release tablets

Ranexa is a medicine used in combination with other medicines to treat angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity.

Do not take Ranexa

• if you are allergic (hypersensitive) to ranolazine or any of the other ingredients of Ranexa 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 medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Take special care with Ranexa

Speak 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.

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

Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.

Using other medicines

Do not use the following medicines if you take Ranexa:

• certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone), or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Tell your doctor or pharmacist before you take Ranexa if you use:

• certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil. These medicines may cause an increase in the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of Ranexa (see section 4). Your doctor may decide to give you a lower dose.
• medicines to treat epilepsy or another neurologic disorder (e.g. phenytoin, carbamazepine, or phenobarbital); are taking rifampicin for an infection (e.g. tuberculosis); or are taking the herbal remedy St. John's Wort, as these medicines may cause Ranexa to be less effective.
• heart medicines containing digoxin or metoprolol, as your doctor may want to change the dose of this medicine whilst you are taking Ranexa.
• certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG.
• certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Taking Ranexa with food and drink

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

Pregnancy

You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.

Breast-feeding

You should not take Ranexa if you are breast-feeding. Ask your doctor for advice if you are breast-feeding.

Ask your doctor for advice before using any medicine.

Driving and using machines
No studies on the effects of Ranexa on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.

Ranexa may cause side effects such as dizziness (common) and blurred vision (uncommon) that may affect your ability to drive or use machinery. If you experience these symptoms, do not drive or operate machinery until they have resolved completely.

Important information about some of the ingredients of Ranexa

The 750 mg prolonged-release tablets contain the azo colouring agent E102. This colouring agent- may cause allergic reactions.

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The 750 mg prolonged-release tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Ranexa exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Always swallow the tablets whole with water. Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.

The starting dose for adults is one 375 mg tablet twice a day. After 2?4 weeks, your doctor may increase the dose to get the right effect. The maximum dose of Ranexa is 750 mg twice a day.

It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick. Your doctor may lower your dose or, if this is not sufficient, stop treatment with Ranexa.

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

If you take more Ranexa than you should
If you accidentally take too many Ranexa tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once. If you cannot contact your doctor, go to the nearest accident and emergency department. Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell 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 nearly time to take your next dose. Do not take a double dose to make up for a forgotten dose.

Like all medicines, Ranexa can cause side effects, although not everybody gets them. These are usually mild or moderate.

You should stop taking Ranexa and see your doctor immediately if you experience the following symptoms of angioedema, which is a rare condition but can be severe:

• swollen face, tongue, or throat
• difficulty swallowing
• hives or difficulty breathing

Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting. Your doctor may lower your dose or stop treatment with Ranexa.

Other side effects you may experience include the following:

Common side effects (occur in 1 to 10 users in 100) are:
Constipation
Dizziness
Headache
Feeling sick, vomiting
Feeling weak

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Uncommon side effects (occur in 1 to 10 users in 1,000) are:
Anxiety, difficulty sleeping
Blurred vision, visual disturbance
Changes in sensation (touch or taste), tremor, feeling tired or sluggish, sleepiness or drowsiness, faint or fainting, dizziness upon standing
Dark urine, blood in urine, difficulty urinating
Dehydration
Difficulty breathing, cough, nose bleed
Excessive sweating, itching
Feeling swollen or bloated
Hot flushes, low blood pressure
Increases in a substance called creatinine or increases in urea in your blood, increase in blood platelets or white blood cells, changes in ECG heart tracing
Joint swelling, pain in extremity
Loss of appetite and/or weight loss
Muscle cramp
Ringing in the ears and/or feeling a spinning sensation
Stomach pain or discomfort, indigestion, dry mouth, or wind

Rare side effects (occur in 1 to 10 users in 10,000) are:
Abnormal laboratory values for liver
Change in sense of smell, numbness in mouth or lips, impaired hearing
Cold sweat, rash
Decrease in blood pressure upon standing
Decreased or loss of consciousness
Disorientation
Feeling of coldness in hands and legs
Hives, allergic skin reaction
Impotence
Inflammation of pancreas or intestine
Loss of memory
Throat tightness

In some isolated cases, acute kidney failure has been reported with the use of Ranexa.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Ranexa after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle.

This medicinal product 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 to protect the environment.

What Ranexa contains

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

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

Depending on the tablet strength, the tablet coatings also contain:
375 mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132) 500 mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)

What Ranexa looks like and contents of the pack

Ranexa prolonged-release tablets are oval shaped tablets.
The 375 mg tablets are pale blue and are engraved with CVT375 or 375 on one side. The 500 mg tablets are light orange and are engraved with CVT500 or 500 on one side. The 750 mg tablets are pale green and are engraved with CVT750 or 750 on one side.

Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles. Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer

Brecon Pharmaceuticals Ltd
Pharos House, Wye Valley Business Park
Hay-on-Wye
Hereford HR3 5PG
United Kingdom

or

Fine Foods N.T.M. SpA
Via dell?Artigianato 8/10
24041 Brembate (BG)
Italy

or

Menarini - Von Heyden GmbH
Leipziger Stra?e 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.

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BelgiëBelgiqueBelgien Menarini Benelux NVSA TélTel 32 02 721 4545 LuxembourgLuxemburg Menarini Benelux NVSA TélTel 32 02 721 4545

- . 359 2 96 00 860 Magyarország Berlin-ChemieA. Menarini Kft. Tel. 36 23501301

eská republika Berlin-ChemieA.Menarini Ceska republika s.r.o. Tel 420 272 937 381 Malta Menarini International Operations Luxembourg S.A. Tel 352 264976

Danmark Berlin-ChemieA.Menarini Danmark ApS Tlf 4548 217 110 Nederland Menarini Benelux NVSA Tel 32 02 721 4545

Deutschland Berlin-Chemie AG Tel 49 0 30 67070 Norge Menarini International Operations Luxembourg S.A. Tlf 352 264976

Eesti OÜ Berlin-Chemie Menarini Eesti Tel 372 667 5001 Österreich A. Menarini Pharma GmbH. Tel 43 1 879 95 85-0

MENARINI HELLAS AE 30 210 8316111-13 Polska Berlin-ChemieMenarini Polska Sp. z o.o. Tel. 48 22 566 21 00

España Laboratorios Menarini S.A. Tel 34-93 462 88 00 Portugal A. Menarini Portugal Farmacêutica, S.A. Tel 351 210 935 500

France MENARINI France Tél 33 01 45 60 77 20 România Berlin-Chemie Menarini Group Tel 40 211 232 34 32

Ireland A. Menarini Pharmaceuticals Ltd Tel 353 1 284 6744 Slovenija Berlin-Chemie AG, Podrunica Ljubljana Tel 386 01 300 2160

Ísland Menarini International Operations Luxembourg S.A. Sími 352 264976 Slovenská republika Berlin-Chemie AG - obchodné zastúpenie v SR Tel 421 2 544 30 730

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SuomiFinland Berlin-ChemieA.Menarini Suomi OY PuhTel 358 403 000 760 Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel 39-055 56801

MENARINI HELLAS AE 30 210 8316111-13 Sverige Menarini International Operations Luxembourg S.A. Tel 352 264976

Latvija SIA Berlin-ChemieMenarini Baltic Tel 371 67103210 United Kingdom A. Menarini Pharma U.K. S.R.L. Tel 44 01628 856400

Lietuva

UAB ?BERLIN-CHEMIE MENARINI
BALTIC?
Tel: +370 52 691 947

This leaflet was last approved in (MM/YYYY).

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