Ranolazine Tillomed 375 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 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).
• 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 (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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

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.

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

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.

Pregnancy

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

Breast-feeding

You should not take ranolazine if you are breast-feeding. Ask your doctor for advice if you are breastfeeding.

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), 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 medicine.

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.

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.

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

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

Uncommon side effects (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
• Cough, nosebleed
• Double vision
• Excessive sweating, itching
• Feeling 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 side effects (may affect up to 1 in 1000 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
• Co-ordination problems
• Decrease in blood pressure upon standing
• Decreased or loss of consciousness
• Disorientation
• Feeling of coldness in hands and legs
• 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):

• Sudden, brief involuntary twitching or jerking of a muscle or group of muscles (myoclonus)

Reporting of side effects

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 ingredient is ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg ranolazine.

The other ingredients are microcrystalline cellulose, lactose monohydrate, methycrylic acid-ethyl acrylate copolymer, sodium hydroxide pellets, hydroxypropyl methylcellulose and magnesium stearate.

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

375 mg tablet: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol (E1521), triacetin, FD&C Blue #2/Indigo Carmine AL 3%-5% (E132), FD&C Blue #2/Indigo Carmine Aluminum Lake 11%-14% (E132).

500 mg tablet: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol (E1521), triacetin, iron oxide yellow (E172).

750 mg tablet: hypromellose (E464), titanium oxide (E171), latose monohyrate, macrogol (E1521), triacetin, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake 3%-5% (E133).

Ranolazine Tillomed 375 mg Prolonged-release Tablets are pale blue, oblong-shaped tablets, ‘RAN375’ debossed on one side and plain on other side.

Ranolazine Tillomed 500 mg Prolonged-release Tablets are yellow, oblong-shaped tablets, ‘RAN500’ debossed on one side and plain on other side.

Ranolazine Tillomed 750 mg Prolonged-release Tablets are light blue, oblong-shaped tablets, ‘RAN750’ debossed on one side and plain on other side.

The tablets are available in pack sizes containing 28, 30, 56, 60 and 100 tablets in PVC/ PE /PVDC - Alu blister packs.

Not all pack sizes may be marketed.