Ranolazine 500 mg Prolonged-release Tablet

• Keep this leaflet. You may need to read it again.
• 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 illness 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.

1. What Ranolazine USV is and what it is used for
2. What you need to know before you take Ranolazine USV
3. How to take Ranolazine USV
4. Possible side effects
5. How to store Ranolazine USV
6. Contents of the pack and other information

• 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).

Talk to your doctor before taking Ranolazine USV:

• 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.

Do not use the following medicines if you take Ranolazine USV:

• 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 Ranolazine USV 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 Ranolazine USV (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 Ranolazine USV 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 Ranolazine USV .
• 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 Ranolazine USV .
• 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 Ranolazine USV.

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

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

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

You should not take Ranolazine USV 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.

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

Ranolazine USV 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.

Ranolazine USV 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’.

Children and adolescents under 18 years old should not take Ranolazine USV.

If you accidentally take too many Ranolazine USV 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 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.

If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance in Ranolazine USV prolonged-release tablets is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.

The other ingredients are:

Tablet core: Microcrystalline Cellulose (E460), Methacrylic Acid Ethyl Acrylate Copolymer (1:1) (E1207),Hypromellose (E464),Sodium Carbonate Anhydrous (E500),Silica Colloidal Anhydrous (E551),Magnesium Stearate (E572)

Depending on the tablet strength, the tablet coatings also contain:

375 mg tablet: Hypromellose (E464), Lactose monohydrate, Glycerol triacetate (Triacetin) (E1518),Titanium dioxide (E171), Fd&C Blue #2/Indigo Carmine Aluminum Lake JP (E132)

500 mg tablet: Hypromellose (E464), Lactose monohydrate, Titanium dioxide (E171), Glycerol triacetate (Triacetin) (E1518), Iron oxide yellow (E172), Iron oxide red (E172)

750 mg tablet: Hypromellose (E464), Lactose monohydrate, Titanium dioxide (E171), Glycerol triacetate (Triacetin) (E1518), Iron oxide yellow (E172), Fd&C Blue #1/Brilliant Blue Fcf Aluminum Lake (E133)

Ranolazine USV prolonged-release tablets are oval shaped tablets.

The 375 mg tablets are pale blue, engraved with “L 38” one side and other side plain.

The 500 mg tablets are light orange, engraved with “L 39” one side and other side plain.

The 750 mg tablets are pale green, engraved with “L 40” one side and other side plain.

Ranolazine USV is supplied in cartons containing 10, 14, 20, 28, 30, 40, 56, 60, 84, 98, 100 tablets in blisters strips.

Not all pack-sizes may be marketed.