Ranexa 375 mg Tablets

RANEXA is used in combination with other medicines to treat angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity. You must talk to a doctor if you do not feel better or if you feel worse.

Do not take RANEXA:

• if you are hypersensitive (allergic) to ranolazine or any of the other ingredients of RANEXA 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).
• if you are pregnant or breastfeeding.

Warnings and precautions

Take special care with RANEXA:

• 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 share medicines prescribed for you with any other person. Always take RANEXA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with RANEXA will last. If you have the impression that the effect of RANEXA is too strong or too weak, tell your doctor or pharmacist.

Always swallow the tablets whole with water. Do not crush, suck or chew the tablets or break them in half, as this might affect the way RANEXA is released from the tablets into your body. The starting dose for adults is one 375 mg tablet twice a day. After 2 – 4 weeks, your doctor may increase the dose to get the right effect. The maximum dose of RANEXA is 750 mg twice a day. It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick. Your doctor may lower your dose or, if this is not sufficient, stop treatment with RANEXA.

Use in children and adolescents

Children and adolescents under 18 years old should not take RANEXA.

RANEXA can have side effects. Not all side effects reported for RANEXA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RANEXA, please consult your health care provider for advice.

If any of the following happens, stop taking RANEXA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to RANEXA. You may need urgent medical attention or hospitalisation.

Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting. Your doctor may lower your dose or stop treatment with RANEXA.

Other side effects you may experience include the following:

Frequent side effects:

• constipation
• dizziness
• headache
• feeling sick, vomiting
• feeling weak

Less frequent side effects:

• feeling anxious, sleeping problems, feeling confused, hallucinations (seeing or hearing things that do not exist)
• blurred vision, visual disturbances, double vision
• 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, loss of appetite and/or weight loss
• difficulty breathing, cough, nose bleed
• excessive sweating, itching
• stomach pain/discomfort, dry mouth, heartburn, 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, muscle cramps/weakness
• ringing in the ears and/or feeling a spinning sensation

Side effects with a frequency unknown:

• acute kidney failure, a lack of ability to urinate
• abnormal laboratory values for liver
• change in sense of smell, numbness in mouth or lips
• cold sweat, rash
• coordination problems
• decrease in blood pressure upon standing
• decreased or loss of consciousness
• disorientation
• impaired hearing
• feeling of coldness in hands and legs
• impotence
• 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.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SHAPRA website. By reporting side effects, you can help provide more information on the safety of RANEXA.

• Store at or below 30 °C. Protect from light.

• Keep blister strips in outer carton.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).