RANOLAZINA 375 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Ranolazina Accord 375 mg prolonged-release tablets
2. ranolazine
   1. What is Ranolazina Accord and what is it used for
   2. What you need to know before you take Ranolazina Accord
3. Ranolazina Accord 500 mg and 750 mg prolonged-release tablets contain lactose
   1. How to take Ranolazina Accord
   2. Possible side effects
   3. How to store Ranolazina Accord
   4. Package contents and other information

Ranolazina Accord 375 mg prolonged-release tablets

Ranolazina Accord 500 mg prolonged-release tablets
Ranolazina Accord 750 mg prolonged-release tablets

ranolazine

Read this leaflet carefully before 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 their symptoms are the same as yours, as it could 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 Ranolazina Accord is and what it is used for
• 2. What you need to know before you take Ranolazina Accord
• 3. How to take Ranolazina Accord
• 4. Possible side effects
• 5. How to store Ranolazina Accord
• 6. Contents of the pack and other information

1. What is Ranolazina Accord and what is it used for

Ranolazina Accord 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 know before you take Ranolazina Accord

Do not take Ranolazina Accord

• 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
Talk to your doctor before taking Ranolazina Accord:

• 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 suffer from heart failure.

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

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

• 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 Ranolazina Accord if you are taking:

• 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 number of undesirable effects, such as dizziness, nausea or vomiting, which are possible undesirable effects of Ranolazina Accord (see section 4). Your doctor may decide to prescribe you a lower 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 Ranolazina Accord.
• 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 Ranolazina Accord.
• 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 muscle pain and muscle damage. Your doctor may decide to change the dose of these medicines while you are taking Ranolazina Accord. certain medicines used to prevent rejection from organ transplantation (e.g. tacrolimus, cyclosporine, sirolimus, everolimus), because the doctor may decide to change the dose of these medicines while you are taking Ranolazina Accord.

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

Ranolazina Accord with food and drink
Ranolazina Accord can be taken with or without food. During treatment with Ranolazina Accord
you should not drink grapefruit juice.

Pregnancy
Do not take Ranolazina Accord during pregnancy unless your doctor advises you to.

Breastfeeding
Do not take Ranolazina Accord 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
Studies have not been performed on the effects of Ranolazina Accord on the ability to drive vehicles and
use machines. Ask your doctor about driving vehicles and using machines.
Ranolazina Accord may cause undesirable effects such as dizziness (common), blurred vision (not
common), confusion (not common), hallucinations (not common), double vision (not common),
coordination problems (rare), which may affect your ability to drive or use
machinery.
If you experience these symptoms, do not drive or use machinery until they have completely resolved.

Ranolazina Accord 750 mg prolonged-release tablets contains the azo dye
E102. It may cause allergic reactions.

Ranolazina Accord 500 mg and 750 mg prolonged-release tablets contain lactose

monohydrate. If your doctor has diagnosed you with intolerance to some sugars, contact them before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e.
it is essentially ‘sodium-free’.

3. How to take Ranolazina Accord

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult
your doctor.
The tablets should 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 dose 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 dose of Ranolazina
Accord is 750 mg twice daily.
It is important that you inform your doctor if you experience undesirable effects such as dizziness or
feeling unwell. Your doctor may reduce the dose or, if this is not sufficient, discontinue
treatment with Ranolazina Accord

Use in children and adolescents
Children and adolescents under 18 years of age should not take Ranolazina Accord.

If you take more Ranolazina Accord than you should
If you accidentally take too many Ranolazina Accord tablets or take a higher dose than
recommended by your doctor, it is important that you inform them 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 hospital staff can easily understand what you are
taking.

If you forget to take Ranolazina Accord
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
forgetting the dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Ranolazina Accord and see your doctor immediately if you experience the following
symptoms of angioedema, which is a rare, but sometimes 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. The
doctor may reduce the dose or stop treatment with Ranolazina Accord .
Other side effects that you may experience include:
Common side effects (may affect up to 1 in 10 people):
Constipation
Dizziness
Headache
Nausea, vomiting
Feeling of weakness.
Uncommon side effects (may affect up to 1 in 100 people):
Altered sensitivity
Anxiety, difficulty sleeping, confused state, 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, nosebleed
Double vision
Excessive sweating, itching
Feeling of bloating or fullness
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
of 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 (may affect up to 1 in 10,000 people):
Difficulty urinating normally
Abnormal liver function tests
Acute renal failure
Alteration of the sense of smell, numbness of the mouth or lips, impaired
hearing
Cold sweats, rash
Coordination problems
Decreased 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 imbalance
Inflammation of the pancreas or intestine
Memory loss
Sensation 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 from available data):
Myoclonus

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Ranolazina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after the
wording “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 Ranolazina Accord contains
The active ingredient of Ranolazina Accord is ranolazine. Each tablet contains 375 mg, 500 mg
or 750 mg of ranolazine.
The excipients are: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1),
hypromellose E5, sodium hydroxide, magnesium stearate.
Depending on the tablet strength, the tablet coatings also contain:
375 mg tablet: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), Carmine
indigo lake aluminum FD&C Blue #2 (E132), polysorbate 80.
500 mg tablet: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), macrogol
(E1521), triacetin, yellow iron oxide (E172), red iron oxide (E172).
750 mg tablet: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171),
triacetin, FD&C blue No.1/brilliant blue FCF aluminum lake (E133) and FD&C yellow No.5/tartrazine aluminum
lake (E102)

Description of the appearance of Ranolazina Accord and contents of the pack
The extended-release tablets of Ranolazina Accord are oval tablets.
The 375 mg tablets are light blue in color, oval in shape, approximately 15.0 × 7.5 mm, film-coated
with the inscription “HI3” on one side and smooth on the other.
The 500 mg tablets are light orange in color, oval in shape, approximately 16.5 × 8.1 mm,
film-coated with the inscription “HI1” on one side and smooth on the other.
The 750 mg tablets are light green in color, oval in shape, approximately 19.1 × 9.3 mm, film-coated
with the inscription “HI4” on one side and smooth on the other.
Ranolazina Accord is packaged in PVC/PVDC/Aluminum blisters containing 30, 60 or 100
tablets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z.o.o.
Ul. Lutomierska 50, 95-200,
Pabianice,
Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta