Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ranexa

Document Subject

Generated Narrative: MedicinalProductDefinition mp2128cb95d4d26d25d7fa2c3944c0ae92

identifier: http://ema.europa.eu/identifier/EU/1/08/462/001 60 tablets in blister pack

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ranexa 375 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-2128cb95d4d26d25d7fa2c3944c0ae92

identifier: http://ema.europa.eu/identifier/EU/1/08/462/001 60 tablets in blister pack

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ranexa

Attesters

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

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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially sodium-free .

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.

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, muscle weakness 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.

Not known side effects (frequency cannot be estimated from the available data) are: Myoclonus

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.

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.

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

Menarini - Von Heyden GmbH Leipziger Stra e 7-01097 Dresden
Germany

or

Berlin-Chemie AG Glienicker Weg 12489 Berlin Germany

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

Belgi /Belgique/Belgien Menarini Benelux NV/SA T l/Tel: + 32 (0)2 721 4Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: +370 52 691

• / .

.: +359 2 454 0Luxembourg/Luxemburg Menarini Benelux NV/SA T l/Tel: + 32 (0)2 721 4 esk republika Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: +36 17997Danmark Menarini International Operations Luxembourg S.A. Tel: +352 264Malta Menarini International Operations Luxembourg S.A. Tel: +352 264Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4Eesti O Berlin-Chemie Menarini Eesti Tel: +372 667 5Norge Menarini International Operations Luxembourg S.A. Tlf: +352 264
MENARINI HELLAS AE : +30 210 8316111- sterreich A. Menarini Pharma GmbH. Tel: +43 1 879 95 85-0

Espa a Laboratorios Menarini S.A. Tel: +34-93 462 88 Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 France MENARINI France T l: +33 (0)1 45 60 77 Portugal A. Menarini Portugal Farmac utica, S.A. Tel: +351 210 935 Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 Rom nia Berlin-Chemie A. Menarini S.R.L. Tel: +40 211 232 34 Ireland A. Menarini Pharmaceuticals Ltd Tel: +353 1 284 6Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2 sland Menarini International Operations Luxembourg S.A. S mi: +352 264Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o Tel: +421 2 544 30 Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000
MENARINI HELLAS AE : +30 210 8316111-Sverige Menarini International Operations Luxembourg S.A. Tel: +352 264Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856This leaflet was last revised in

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