Ranolazine Oral tablet, extended-release

What is this medicine?

RANOLAZINE (ra NOE la zeen) is a heart medicine. It is used to treat chronic chest pain (angina). This medicine must be taken regularly. It will not relieve an acute episode of chest pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• irregular heartbeat

• kidney disease

• liver disease

• low levels of potassium or magnesium in the blood

• an unusual or allergic reaction to ranolazine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take with or without food. Do not take this medication with grapefruit juice. Take your doses at regular intervals. Do not take your medicine more often then directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• antivirals for HIV or AIDS

• cerivastatin

• certain antibiotics like chloramphenicol, clarithromycin, dalfopristin; quinupristin, isoniazid, rifabutin, rifampin, rifapentine

• certain medicines used for cancer like imatinib, nilotinib

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for irregular heart beat like dofetilide, dronedarone

• certain medicines for seizures like carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin

• cisapride

• conivaptan

• cyclosporine

• grapefruit or grapefruit juice

• lumacaftor; ivacaftor

• nefazodone

• pimozide

• quinacrine

• St John's wort

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alfuzosin

• certain medicines for depression, anxiety, or psychotic disturbances like bupropion, citalopram, fluoxetine, fluphenazine, paroxetine, perphenazine, risperidone, sertraline, trifluoperazine

• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin

• certain medicines for stomach problems like octreotide, palonosetron, prochlorperazine

• eplerenone

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• metformin

• nicardipine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• sirolimus

• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. This medicine will not relieve an acute attack of angina or chest pain.

This medicine can change your heart rhythm. Your health care provider may check your heart rhythm by ordering an electrocardiogram (ECG) while you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you are scheduled for any medical or dental procedure, tell your healthcare provider that you are taking this medicine. This medicine can interact with other medicines used during surgery.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• fast, irregular or pounding heartbeat

• feeling faint or lightheaded, falls

• low or high blood pressure

• numbness or tingling feelings

• ringing in the ears

• tremor or shakiness

• slow heartbeat (fewer than 50 beats per minute)

• swelling of the legs or feet

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• constipation

• drowsy

• dry mouth

• headache

• nausea or vomiting

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.