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Ranexa (Latixa) (ranolazine) – Package leaflet - C01EB18

Updated on site: 09-Oct-2017

Medication nameRanexa (Latixa)
ATC CodeC01EB18
Substanceranolazine
ManufacturerMenarini International Operations Luxembourg S.A. (MIOL)

Package leaflet: Information for the patient

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.

In addition to this leaflet, you will find a Patient Alert Card within the box, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa.

-Keep this leaflet and the Patient Alert Card. You may need to read it again.

-Always show the Patient Alert Card to any doctor involved in your treatment, including physicians treating conditions other than angina pectoris.

-Please make sure you have a list of all your other medicines with you at any visit to a health care professional.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illnes are the same as yours.

-If you get any side effects talk to your doctor. This includes any possible side effects 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 you take 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 is used for

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.

You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take 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 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).

Warning 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 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 and Ranexa

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).

-certain medicines to treat high levels of cholesterol in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines may cause muscle pain and muscle injury. Your doctor may decide to change the dose of this medicine while you are taking Ranexa.

-certain medicines used to prevent transplanted organ rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus) as your doctor may decide to change the dose of this medicine while you are taking Ranexa.

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

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.

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 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), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems (rare), that may affect your ability to drive or use machines. If you experience these symptoms, do not drive or operate machinery until they have resolved completely.

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

Ranexa 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.

3.How to take RANEXA

Always take this medicine exactly as your doctor has told you to. 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.

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 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 (less than 6 hours) to take your next dose. Do not take a double dose to make up for a forgotten dose.

4.Possible side effects

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

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

Uncommon side effects (occur in 1 to 10 users in 1,000) are: Altered sensation

Anxiety, difficulty sleeping, confusional state, hallucination 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 Double vision

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: A lack of ability to urinate

Abnormal laboratory values for liver Acute kidney failure

Change in sense of smell, numbness in mouth or lips, impaired hearing Cold sweat, rash

Coordination problems

Decrease in blood pressure upon standing Decreased or loss of consciousness Disorientation

Feeling of coldness in hands and legs Hives, allergic skin reaction Impotence

Inability to walk due to imbalance Inflammation of pancreas or intestine Loss of memory

Throat tightness

Low level of sodium in the blood (hyponatremia) which can cause tiredness and confusion, muscle twitching, cramps, and coma.

The following has also been reported:

Muscle weakness.

Reporting of side effects

If you get any any side effects talk to your doctor or pharmacist. This include any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store RANEXA

Keep this medicine out of the sight and reach of children.

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

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What Ranexa contains

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

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 375 on one side.

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

The 750 mg tablets are pale green and are engraved with 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

Fine Foods N.T.M. SpA Via dell’Artigianato 8/10 24041 Brembate (BG)

Italy

or

Menarini - Von Heyden GmbH

Leipziger Straβe 7-13

01097 Dresden

Germany

or

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

or

Fine Foods N.T.M. SpA

Via R. Follereau 25

24027 Nembro (BG)

Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Menarini Benelux NV/SA

UAB “BERLIN-CHEMIE MENARINI

Tél/Tel: + 32 (0)2 721 4545

BALTIC”

 

Tel: +370 52 691 947

България

Luxembourg/Luxemburg

“Берлин-Хеми/А. Менарини България”

Menarini Benelux NV/SA

ЕООД

Tél/Tel: + 32 (0)2 721 4545

тел.: +359 2 96 55 365

 

Česká republika

Magyarország

Berlin-Chemie/A.Menarini Ceska republika

Berlin-Chemie/A. Menarini Kft.

s.r.o.

Tel.: +36 23501301

Tel: +420 267 199 333

 

Danmark

Malta

Berlin-Chemie/A.Menarini Danmark ApS

Menarini International Operations

Tlf: +4548 217 110

Luxembourg S.A.

 

Tel: +352 264976

Deutschland

 

Berlin-Chemie AG

Nederland

Tel: +49 (0) 30 67070

Menarini Benelux NV/SA

 

Tel: +32 (0)2 721 4545

Eesti

Norge

Berlin-Chemie Menarini Eesti

Menarini International Operations

Tel: +372 667 5001

Luxembourg S.A.

 

Tlf: +352 264976

Ελλάδα

 

MENARINI HELLAS AE

Österreich

Τηλ: +30 210 8316111-13

A. Menarini Pharma GmbH.

 

España

Polska

Laboratorios Menarini S.A.

Berlin-Chemie/Menarini Polska Sp. z o.o.

Tel: +34-93 462 88 00

Tel.: +48 22 566 21 00

France

Portugal

MENARINI France

A. Menarini Portugal – Farmacêutica, S.A.

Tél: +33 (0)1 45 60 77 20

Tel: +351 210 935 500

Hrvatska

România

Berlin-Chemie Menarini Hrvatska d.o.o.

Berlin-Chemie A. Menarini S.R.L.

Tel: + 385 1 4821 361

Tel: +40 211 232 34 32

Ireland

Slovenija

A. Menarini Pharmaceuticals Ltd

Berlin-Chemie AG, Podružnica Ljubljana

Tel: +353 1 284 6744

Tel: +386 01 300 2160

Ísland

Slovenská republika

Menarini International Operations

Berlin-Chemie AG - obchodné zastúpenie v

Luxembourg S.A.

SR

Sími: +352 264976

Tel: +421 2 544 30 730

Italia

Suomi/Finland

A. Menarini Industrie Farmaceutiche

Berlin-Chemie/A.Menarini Suomi OY

Riunite s.r.l.

Puh/Tel: +358 403 000 760

Tel: +39-055 56801

 

Κύπρος

Sverige

MENARINI HELLAS AE

Menarini International Operations

Τηλ: +30 210 8316111-13

Luxembourg S.A.

 

Tel: +352 264976

Latvija

United Kingdom

SIA Berlin-Chemie/Menarini Baltic

A. Menarini Farmaceutica Internazionale

Tel: +371 67103210

S.R.L.

 

Tel: +44 (0)1628 856400

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

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