Ranolazine Extended-Release Tablets

What is this medication?

RANOLAZINE (ra NOE la zeen) is a heart medication. It is used to treat chronic chest pain (angina). 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.

COMMON BRAND NAME(S): Ranexa

What should I tell my care team before I take this medication?

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

• Heart disease
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low levels of potassium or magnesium in the blood
• An unusual or allergic reaction to ranolazine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the tablets whole.

You may take it with or without food. If it upsets your stomach, take it with food.

Do not take this medication with grapefruit juice.

Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication 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 medication?

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

• Cerivastatin
• Certain antibiotics like clarithromycin, rifabutin, rifampin, rifapentine
• Certain antivirals for hepatitis or HIV
• Certain medicines used for cancer treatment
• Certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medicines for irregular heart beat like dronedarone
• Certain medicines for seizures like carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin
• Cisapride
• Conivaptan
• Nefazodone
• Pimozide
• St. John's wort
• Thioridazine

This medicine may also interact with the following medications:

• Certain medicines for depression, anxiety, or psychotic disturbances
• Certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin
• Cyclosporine
• Digoxin
• Diltiazem
• Dofetilide
• Eplerenone
• Ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• Erythromycin
• Fluconazole
• Grapefruit or grapefruit juice
• Metformin
• Other medicines that prolong the QT interval (which can cause an abnormal heart rhythm)
• Sirolimus
• Tacrolimus
• Verapamil

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication will not relieve an acute attack of angina or chest pain.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up 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 effects of this medication. Avoid alcoholic drinks.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning or tingling sensation in hands or feet
• Change in vision
• Heart rhythm changes— fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Ringing in ears
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Swelling of the ankles, hands, or feet
• Tremors or shaking

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

• Constipation
• Dizziness
• Headache
• Nausea
• Upset Stomach

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 medication?

Keep out of the reach of children and pets.

Store at room temperature at 25 degrees C (77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.