RANEXA 375 mg Extended-Release Tablet

Зміст інструкції

1. Ranexa 375 mg prolonged-release tablets
   1. What is RANEXA and what it is used for
   2. What you need to do before taking RANEXA
2. Ranexa 750 mg prolonged-release tablets contains the azo dye coloring agent
   1. How to take RANEXA
   2. Possible side effects
   3. How to store RANEXA
   4. Package contents and other information

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 as it contains
important information for you.

• Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of 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 is RANEXA and what it is used for

Ranexa is a medicine used in combination with other medicines for the treatment of angina
pectoris, a condition that manifests with pain or discomfort in the chest located anywhere in the upper
part of the trunk between the neck and the upper abdomen, often triggered by exercise or
excessive activity.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to do 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 using certain medicines for the treatment of 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).

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 elderly.
• if you weigh little (60 kg or less).
• if you have heart failure.

In these cases, your doctor may decide to give you a lower dose or take other
precautions.

Other medicines and Ranexa
Do not use the following medicines if you are taking Ranexa:

• certain medicines for the treatment of 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 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 tablets for the heart such as diltiazem or verapamil. These medicines may increase the number of side effects, such as dizziness, nausea or vomiting, which are the possible side effects of Ranexa (see section 4). Your doctor may decide to prescribe you a reduced dose.
• medicines to treat epilepsy or another neurological disorder (e.g. phenytoin, carbamazepine or phenobarbital); if you are taking rifampicin for an infection (e.g. tuberculosis) or the herbal product "St John's wort", as these medicines may reduce the effectiveness of Ranexa.
• medicines for the heart based on digoxin or metoprolol, because your doctor may decide to change the dose of these medicines while you are taking Ranexa.
• certain medicines for the treatment of allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide) and depression (e.g. imipramine, doxepin or amitriptyline), as these medicines may alter the ECG.
• certain medicines for the treatment of depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide). certain medicines for the treatment of high cholesterol levels in the blood (e.g. simvastatin, lovastatin, atorvastatin). These medicines can cause pain and muscle damage. Your doctor may decide to change the dose of these medicines while you are taking Ranexa. certain medicines used to prevent rejection from organ transplantation (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because your doctor may decide to change the dose of these medicines while you are taking Ranexa.

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

Ranexa with food and drink
You can take Ranexa with or without food. During treatment with Ranexa, you should not drink grapefruit juice.

Pregnancy
Do not take Ranexa during pregnancy unless advised by your doctor.

Breastfeeding
Do not take Ranexa if you are breastfeeding. Ask your doctor for advice if you are breastfeeding. If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
for advice before taking this medicine.

Driving and using machines
No studies have been performed on the effects of Ranexa on the ability to drive and operate
machinery. Ask your doctor about driving and using machines. Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon),
confusion (uncommon), hallucinations (uncommon), double vision (uncommon),
abnormal coordination (rare), which may affect your ability to drive or operate
machinery. If you experience these symptoms, do not drive or operate machinery until they have completely resolved.

Ranexa 750 mg prolonged-release tablets contains the azo dye coloring agent

E102. This coloring agent may induce allergic reactions.
Ranexa 750 mg prolonged-release tablets contains lactose monohydrate. If your doctor has
told you that you suffer from an intolerance to any type of sugar, contact them before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet,
meaning essentially ‘sodium-free’.

3. How to take RANEXA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The tablets must always be swallowed whole with water. Do not crush, suck or chew
the tablets or break them in half, as this could affect the way the medicine is
released from the tablet into your body.
The initial dosage in adults is one 375 mg tablet twice daily. After 2–4 weeks
your doctor may increase the dosage to achieve the desired effect. The maximum dosage of Ranexa is
750 mg twice daily.
It is important that you inform your doctor if you experience undesirable effects such as dizziness, nausea or
vomiting. Your doctor may reduce the dosage or, if that is not enough, discontinue treatment with Ranexa.

Use in children and adolescents
Children and adolescents under 18 years of age 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 inform him/her immediately. If you cannot contact your
doctor, go to the nearest emergency room. Bring with you any remaining tablets, including
the container and the box so that the hospital staff can easily understand what you are
taking.

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 to
take the next dose (if less than 6 hours remain). Do not take a double dose to make up for
a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Ranexa and see your doctor immediately if you experience the following symptoms
of angioedema, which is a rare, but potentially serious condition:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria or difficulty breathing.

Tell your doctor if you experience common side effects such as dizziness, nausea or vomiting. Your doctor may
reduce the dosage or stop treatment with Ranexa.
Other side effects that you may experience include:
Common side effects (occur in 1–10 people out of 100):
constipation
dizziness
headache
nausea, vomiting
feeling weak.
Uncommon side effects (occur in 1–10 people out of 1000):
altered sensation
anxiety, difficulty sleeping, confusion, hallucinations
blurred vision, visual disturbances,
changes in the senses (of touch or taste), tremor, feeling tired or drowsy,
numbness or sleepiness, feeling faint or fainting, dizziness when standing up
dark urine, blood in the urine, difficulty urinating
dehydration
difficulty breathing, cough, nosebleeds
double vision
excessive sweating, itching
feeling of fullness or bloating
hot flushes, low blood pressure
increases in a substance called creatinine or increases in urea in the blood, increased
number of platelets or white blood cells in the blood, changes in the heart tracing
on the ECG
swelling of the joints, pain in the extremities
loss of appetite and/or weight loss
muscle cramps, muscle weakness
feeling of sounds in the ears and/or dizziness
stomach pain or discomfort, indigestion, dry mouth or flatulence.
Rare side effects (occur in 1–10 people out of 10,000):
difficulty urinating normally
abnormal liver function tests
acute kidney failure
altered sense of smell, numbness of the mouth or lips, impaired
hearing
cold sweat, rash
problems with coordination
lowering of blood pressure when standing up
reduced or loss of consciousness
disorientation
feeling of coldness in the hands and feet
urticaria, allergic skin reaction
impotence
difficulty walking due to lack of balance
inflammation of the pancreas or intestine
memory loss
feeling of tightness in the throat
Low levels of sodium in the blood (hyponatremia) which can cause fatigue and confusion,
muscle contractions, cramps and coma.
Side effects with unknown frequency (frequency cannot be estimated based on available data):
Myoclonus
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system indicated in Annex 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 reported on each blister pack of tablets and
on the outer packaging of the box and bottle after the words “Exp.”.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ranexa contains
The active ingredient of Ranexa is ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg of
ranolazine.
The excipients are: hypromellose, magnesium stearate, ethyl acrylate and methacrylic acid
copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Depending on the tablet concentration, the coating also contains:
375 mg tablet: macrogol, polysorbate 80, blue No. 2/E132 indigotine aluminium lake
500 mg tablet: macrogol, talc, partially hydrolysed polyvinyl alcohol, yellow iron oxide
(E172), red iron oxide (E172)
750 mg tablet: triacetin glycerol, lactose monohydrate, blue No. 1/E133 brilliant blue FCF aluminium
lake and yellow No. 5/E102 tartrazine aluminium lake

Description of Ranexa and package contents
Ranexa prolonged-release tablets are oval-shaped tablets.
The 375 mg tablets are light blue with the inscription 375 on one side.
The 500 mg tablets are light orange with the inscription 500 on one side.
The 750 mg tablets are light green with the inscription 750 on one side.
Ranexa is supplied in packs of 30, 60, or 100 tablets contained in blisters or 60 tablets in a
bottle. 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 HeydenGmbH
Leipziger Straβe 7-13
01097 Dresden
Germany
or
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder.

België/Belgique/Belgien
MenariniBenelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Lietuva
UAB “BERLIN-CHEMIE MENARINI
BALTIC”
Tel: +370 52 691 947

България
“Берлин-Хеми/А. Менарини България”
ЕООД
тел.: +359 2 454 0950

Luxembourg/Luxemburg
MenariniBenelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Českárepublika
Berlin-Chemie/A.MenariniCeskarepublikas.r.o.
Tel: +420 267 199 333

Magyarország
Berlin-Chemie/A. MenariniKft.
Tel.: +36 23501301

Danmark
Menarini International OperationsLuxembourg
S.A.
Tel: +352 264976

Malta
Menarini International OperationsLuxembourg
S.A.
Tel: +352 264976

Deutschland
Berlin-Chemie AG
Tel: +49 (0) 30 67070

Nederland
MenariniBenelux NV/SA
Tel: +32 (0)2 721 4545

Eesti
OÜ Berlin-ChemieMenariniEesti
Tel: +372 667 5001

Norge
Menarini International OperationsLuxembourg
S.A.
Tlf: +352 264976

Ελλάδα
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Österreich

• A. Menarini Pharma GmbH. Tel: +43 1 879 95 85-0

España
LaboratoriosMenarini S.A.
Tel: +34-93 462 88 00

Polska
Berlin-Chemie/MenariniPolskaSp. z o.o.
Tel.: +48 22 566 21 00

France
MENARINI France
Tél: +33 (0)1 45 60 77 20

Portugal

• A. MenariniPortugal – Farmacêutica, S.A. Tel: +351 210 935 500

Hrvatska
Berlin-ChemieMenariniHrvatskad.o.o.
Tel: + 385 1 4821 361

România
Berlin-ChemieA. MenariniS.R.L.
Tel: +40 211 232 34 32

Ireland

• A. MenariniPharmaceuticalsLtd Tel: +353 1 284 6744 SlovenijaBerlin-Chemie / A. Menarini Distribution Ljubljanad.o.o. Tel: +386 01 300 2160

Ísland
Menarini International OperationsLuxembourg
S.A.
Sími: +352 264976

Slovenskárepublika
Berlin-Chemie / A. Menarini Distribution
Slovakias.r.o
Tel: +421 2 544 30 730

Italia

• A. MenariniIndustrieFarmaceuticheRiunites.r.l. Tel: +39-055 56801 Suomi/FinlandBerlin-Chemie/A.MenariniSuomi OY Puh/Tel: +358 403 000 760

Κύπρος
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Sverige
Menarini International OperationsLuxembourg
S.A.
Tel: +352 264976

Latvija
SIA Berlin-Chemie/MenariniBaltic
Tel: +371 67103210

United Kingdom

• A. MenariniFarmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

More detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu .