Ranolazine 500mg prolonged-release tablets

• 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 is and what it is used for
2. What you need to know before you take Ranolazine
3. How to take Ranolazine
4. Possible side effects
5. How to store Ranolazine
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, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).

Talk to your doctor before taking ranolazine if you:

• have mild or moderate kidney problems.
• have mild liver problems.
• have ever had an abnormal electrocardiogram (ECG).
• are elderly.
• have low weight (60 kg or less).
• 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:

• 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 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 (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 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.
• 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.
• 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.

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

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

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

You should not take ranolazine 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 on the ability to drive and use machines have been performed. Ask your doctor for advice about driving or using machines.

Ranolazine may cause side effects such as dizziness (common), blurred vision (uncommon), confusion (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 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.

These medicines 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.

If you accidentally take too many ranolazine 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 the 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 Zentiva is ranolazine. Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
• The other ingredients are: methacrylic Acid – ethyl acrylate copolymer (1:1), microcrystalline cellulose, hypromellose, sodium hydroxide and magnesium stearate.

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

375 mg tablet: hypromellose, titanium dioxide, macrogol 8000, polysorbate 80 and FD&C Blue#2/Indigotine Aluminium Lake (E132)

500 mg tablet: polyvinyl alcohol, titanium dioxide, macrogol 3350, macrogol 8000, talc, yellow iron oxide (E172iii) and red iron oxide (E172ii)

750 mg tablet: hypromellose, lactose monohydrate, titanium dioxide, triacetin, iron oxide yellow (E172), FD&C Blue#1/FCF Fast Blue Aluminium Lake (E133)

Ranolazine Zentiva 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.

Ranolazine Zentiva is supplied in carton boxes containing 60 tablets in blisters.

Not all pack-sizes may be marketed.