Ranolazine Aspire Prolonged-Release Tablets 375 mg Tablet POM

• 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 or pharmacist. 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
• if you have mild liver problems
• if you have ever had an abnormal electrocardiogram (ECG)
• if you are elderly
• if you have low weight (60kg 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 this medicine:

• 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 this medicine 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 this medicine (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 this medicine 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 this medicine.
• 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 this medicine.
• 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 this medicine.

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

This medicine can be taken with or without food. While being treated with this medicine, you should not drink grapefruit juice.

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

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

This medicine 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.

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 (23mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.

Children and adolescents under 18 years old should not take this medicine.

If you accidentally take too much of this medicine 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.

Common (may affect up to 1 in 10 people):

• Constipation
• Dizziness
• Headache
• Feeling sick, vomiting
• Feeling weak.

Uncommon (may affect up to 1 in 100 people):

• 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 (may affect up to 1 in 1,000 people):

• 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 (frequency cannot be estimated from the available data):

• Myoclonus.

If you get any side effects, talk to your doctor or pharmacist. This includes 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 is ranolazine. Each tablet contains 375mg, 500mg and 750mg ranolazine.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, methacrylic acid-ethyl acrylate copolymer, sodium hydroxide, hypromellose, magnesium stearate.

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

375mg tablet: titanium dioxide, macrogol, triacetin, indigo carmine aluminium lake (E132)

500mg tablet: titanium dioxide, macrogol, triacetin, iron oxide yellow (E172)

750mg tablet: titanium dioxide, macrogol, triacetin, brilliant blue FCF aluminium lake (E133).

Ranolazine Aspire prolonged-release tablets are oblong shaped tablets.

The 375mg tablets are pale blue, approximately 15.00mm x 7.20mm, and are debossed with RAN375 on one side.

The 500mg tablets are yellow, approximately 16.50mm x 8.00mm, and are debossed with RAN500 on one side.

The 750mg tablets are light blue, approximately 19.00mm x 9.20mm, and are debossed with RAN750 on one side.

The blisters consist of a PVC/PE/PVDC white opaque base foil and aluminium lidding foil. Ranolazine are supplied in cartons containing 28, 30, 56, 60 or 100 tablets in blister strip. Not all pack-sizes may be marketed.

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