Ranexa 375mg. 60 tablets

What RANEXA is and what it is used for
Ranexa is a preparation that is used in combination with other angina pectoris medications in which the complaints are pain from the sternum or an unpleasant feeling that you can feel throughout your upper body between your neck and upper abdomen, often caused by physical activity or too much activity.
If you do not feel better or your condition gets worse, you should seek medical attention.

2. What you need to know before you take RANEXA
Do not take Ranexa:

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 use some medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone), or heart rhythm disorders (eg quinidine, dofetilide or sotalol).
Warnings and precautions
Talk to your doctor before taking Ranexa:

if you have mild to moderate kidney problems;
if you have mild liver problems;
if you have an electrocardiogram (ECG) beyond the normal range;
if you are elderly;
if you are low in weight (60 kg or less);
if you have heart failure.
Your doctor may decide to reduce your dose or take other precautions if any of the above applies to you.

Using other medicines and Ranexa
Do not use the following medicines if you are taking Ranexa:

some medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (eg quinidine, dofetilide or sotalol ).
Before you start taking Ranexa, tell your doctor or pharmacist if you are using:

some medicines to treat bacterial infections (erythromycin) or fungal infections (fluconazole), a medicine to prevent organ rejection (ciclosporin), or if you take some heart tablets like diltiazem or verapamil. These medicines can cause an increase in the number of side effects such as dizziness, nausea or vomiting that possible side effects of Ranexa (see section 4). Your doctor may decide to reduce your dose;
medicines to treat epilepsy or other neurological disorder (eg phenytoin, carbamazepine or phenobarbital); rifampicin in connection with an infection (eg tuberculosis) or the St. John's wort, as these medicines may reduce the effectiveness of Ranexa;
medicines for the cardiovascular system containing digoxin or metoprolol as your doctor may decide to change the dose of this medicine while taking Ranexa;
some medicines to treat allergies (eg terfenadine, astemizole, mizolastine), heart rhythm disorders (eg disopyramide, procainamide) and depression (eg imipramine, doxepin, amitriptyline), as these medicines may affect your ECG ;
certain drugs to treat depression (bupropion), psychosis, HIV infection (efavirenz) or cancer (cyclophosphamide);
certain medicines to treat high levels of cholesterol in the blood (eg simvastatin, lovastatin, atorvastatin). These medicines can cause muscle pain and muscle damage. Your doctor may decide to change the dose of this medicine while taking Ranexa;
certain medicines used to prevent transplant rejection (eg tacrolimus, ciclosporin, sirolimus, everolimus) as your doctor may decide to change the dose of this medicine while taking Ranexa.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ranexa with food and drink
Ranexa can be taken with or without food. You should not drink grapefruit juice during treatment with Ranexa.

Pregnancy
If you are pregnant, you should not take Ranexa unless your doctor advised you to do so.

Breastfeeding
If you are breast-feeding, you should not take Ranexa. Ask your doctor for advice.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.

Driving and using machines
No studies on the effects of Ranexa on the ability to drive and use machines have been performed. Ask your doctor about driving and using machines.
Rarexa may cause side effects such as dizziness (blurred vision), blurred vision (uncommon), confusion (uncommon), hallucinations (uncommon), double vision (uncommon), coordination issues (rarely) that may affect your ability to drive or operate machinery. If you experience these symptoms, do not drive or operate machinery near them
If you take more Ranexa than you should
If you accidentally take too many Ranexa tablets or take a higher dose than your doctor recommends, it is important that you inform him / her immediately. If you can not get in touch with your doctor, go to the nearest emergency department. Take with you all the other tablets, including the pack and the box, so that the hospital staff can easily navigate what you have taken.

If you forget to take Ranexa
If you have forgotten to take a dose, take it as soon as you remember, unless the time (less than 6 hours) is near the next dose. Do not take a double dose to make up for the missed dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

You should immediately stop taking Ranexa and seek your doctor if you experience the following symptoms of angioedema, which is a rare condition but can be severe:

swelling of the face, tongue or throat;
difficult swallowing;
urticaria or difficulty in breathing.
Tell your doctor if you experience frequent side effects such as dizziness or nausea or vomiting. Your doctor may reduce the dose or stop treatment with Ranexa.

Other side effects you may get are as follows:
Common side effects (affects 1 to 10 users in 100) are:

Constipation;
Dizziness;
Headache;
Malaise, vomiting;
Feeling weak.
Uncommon side effects (occurring in 1 to 10 users in 1,000) are:

Changed sensitivity;
Anxiety, difficulty falling asleep, confusion, hallucinations;
Blurred vision, vision disturbance;
Sensory changes (touch or taste), shaking, feeling tired or slow, drowsiness, feeling dizzy or faint, vertigo in straightening;
Dark urine, blood in the urine, difficulty urinating;
Dehydration;
Difficult breathing, coughing, nasal bleeding;
Double vision;
Sweating, itching;
Feeling swollen or swollen;
Hot waves, low blood pressure;
Increase in the amount of the substance called creatinine or increased urea in your blood, increased platelet count or white blood cell count, changes in ECG cardiac output;
Rare edema, pain in limbs;
Loss of appetite and / or weight loss;
Muscle cramps;
Ringing in the ears and / or feeling of rotating motion;
Stomach pain or discomfort, indigestion, mouth dryness or gas.
Rare side effects (affects 1 to 10 users in 10,000) are:

Unable to urinate;
Abnormal laboratory tests of the liver;
Acute renal failure;
Changed sense of smell, numbness of the mouth or lips, disturbed hearing;
Cold sweat, rash;
Coordination issues;
Dropping blood pressure when standing up;
Blurring or loss of consciousness;
Disorientation;
Feeling cold in the hands and feet;
Urticaria, allergic skin reaction;
Impotence;
Inability to walk due to imbalance;
Inflammation of the pancreas or intestines;
Memory loss
Tightening in the throat;
Low level of sodium in the blood (hyponatraemia), which can cause fatigue and confusion, muscle twitching, perception and coma.
Also reported:

Muscle weakness.
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
 How to store RANEXA
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on each blister strip with tablets and on the outside of the pack and the bottle after EXP.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Ranexa contains
The active ingredient in Ranexa is: ranolazine. Each tablet contains 375 mg, 500 mg or 750 mg ranolazine.
The other ingredients are hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.

Depending on the amount of active ingredient in the tablet, the shells also contain:

375 mg tablet: macrogol, polysorbate 80, Blue No. 2 / indigo carmine aluminum lacquer (E132);
500 mg tablet: macrogol, talc, polyvinyl alcohol - hydrolyzed, iron oxide, yellow (E172), iron oxide, red (E172);
750 mg tablet: glycerol triacetate, lactose monohydrate, Blue No. 1 / brilliant blue FCF aluminum lacquer (E133) and yellow No. 5 / tartrazine aluminum lacquer
What Ranexa looks like and contents of the pack
Ranexa prolonged-release tablets are oval-shaped tablets.

The 375 mg tablets are pale blue with the inscription 375 on one side.
The 500 mg tablets are light orange with the inscription 500 on one side.
The 750 mg tablets are pale green with the inscription 750 on one side.
Ranexa is supplied in a pack containing 30, 60 or 100 tablets in blister strips or 60 tablets in a plastic bottle.
Not all pack sizes may be marketed.

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