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Ranolazine is used for:

Treating chronic chest pain (angina). It may be used alone or in combination


with other medicines.

Ranolazine is an antianginal medicine. Exactly how it works is not known.


Do NOT use ranolazine if:

you are allergic to any ingredient in ranolazine


you have liver cirrhosis
you are taking certain azole antifungals (eg, itraconazole, ketoconazole),
barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin),
certain macrolide antibiotics (eg, clarithromycin), nefazodone, certain
protease inhibitors (eg, indinavir, nelfinavir, ritonavir, saquinavir), a rifamycin
(eg, rifampin), St. John's wort, or telithromycin

Contact your doctor or health care provider right away if any of these apply
to you.
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Before using ranolazine:

Some medical conditions may interact with ranolazine. Tell your doctor or
pharmacist if you have any medical conditions, especially if any of the
following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding


if you are taking any prescription or nonprescription medicine, herbal

preparation, or dietary supplement


if you have allergies to medicines, foods, or other substances
if you have a history of liver problems, kidney problems or if you are on
dialysis, or have diabetes
if you have a personal or family history of irregular heartbeat (eg,
prolonged QTc interval, congenital long QT syndrome), abnormal heart
function tests, or low blood potassium levels
if you take certain antipsychotics (eg, thioridazine, ziprasidone) or
antiarrhythmics (eg, amiodarone, dofetilide, quinidine, sotalol), or any other
medicine that may increase the risk of a certain type of irregular heartbeat
(prolonged QT interval). Check with your doctor or pharmacist if you are
unsure if any of your medicines may increase the risk of this type of irregular
heartbeat

Some MEDICINES MAY INTERACT with ranolazine. Tell your health care
provider if you are taking any other medicines, especially any of the
following:

Aprepitant, azole antifungals (eg, itraconazole, ketoconazole, fluconazole),


cyclosporine, diltiazem, macrolide antibiotics (eg, clarithromycin,
erythromycin), nefazodone, protease inhibitors (eg, boceprevir, ritonavir),
telithromycin, or verapamil because they may increase the risk of
ranolazine's side effects
Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg,
phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may
decrease ranolazine's effectiveness
Digoxin, metformin, lovastatin, simvastatin, sirolimus, tacrolimus, or
tricyclic antidepressants (eg, amitriptyline) because the risk of their side
effects may be increased by ranolazine

This may not be a complete list of all interactions that may occur. Ask your
health care provider if ranolazine may interact with other medicines that you
take. Check with your health care provider before you start, stop, or change
the dose of any medicine.
How to use ranolazine:

Use ranolazine as directed by your doctor. Check the label on the medicine
for exact dosing instructions.

Take ranolazine by mouth with or without food.


Swallow ranolazine whole. Do not break, crush, or chew before swallowing.
Check with your doctor before you eat grapefruit or drink grapefruit juice
while you are taking ranolazine.
If you miss a dose of ranolazine, skip the missed dose and go back to your
regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use
ranolazine.
Important safety information:

Ranolazine may cause dizziness, light-headedness, or blurred vision. These


effects may be worse if you take it with alcohol or certain medicines. Use
ranolazine with caution. Do not drive or perform other possibly unsafe tasks
until you know how you react to it.
Ranolazine may cause dizziness, light-headedness, or fainting; alcohol, hot
weather, exercise, or fever may increase these effects. To prevent them, sit
up or stand slowly, especially in the morning. Sit or lie down at the first sign
of any of these effects.
Do NOT take more than the recommended dose without checking with your
doctor.
Ranolazine is not effective in treating an angina attack. Talk to your doctor
about how to treat an angina attack.
Kidney failure has happened in people taking ranolazine who already had
kidney problems. Discuss any questions or concerns with your doctor.
Lab tests, including heart function and kidney function, may be performed
while you use ranolazine. These tests may be used to monitor your condition
or check for side effects. Be sure to keep all doctor and lab appointments.

Use ranolazine with caution in the ELDERLY; they may be more sensitive to
its effects.
Ranolazine should be used with extreme caution in CHILDREN; safety and
effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you think you may be pregnant,
contact your doctor. You will need to discuss the benefits and risks of using
ranolazine while you are pregnant. It is not known if ranolazine is found in
breast milk. Do not breast-feed while taking ranolazine.

Possible side effects of ranolazine:

All medicines may cause side effects, but many people have no, or minor,
side effects. Check with your doctor if any of these most COMMON side
effects persist or become bothersome:

Constipation; dizziness; headache; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness


in the chest; swelling of the mouth, face, lips, or tongue; unusual
hoarseness); blurred vision; chest pain; confusion; decreased sense of touch;
fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore
throat; numbness, burning, prickling, or tingling of the skin; severe or
persistent dizziness, light-headedness, or weakness; shortness of breath;
swelling of the hands or feet; symptoms of kidney problems (eg, blood in the
urine, change in the amount of urine produced); tremor; unusual bruising or
bleeding.

This is not a complete list of all side effects that may occur. If you have
questions about side effects, contact your health care provider. Call your
doctor for medical advice about side effects. To report side effects to the
appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control


Centers), your local poison control center, or emergency room immediately.
Symptoms may include confusion; double vision; fainting; numbness,
burning, prickling, or tingling of the skin; severe or persistent dizziness,
nausea, or vomiting.
Proper storage of ranolazine:

Store ranolazine at 77 degrees F (25 degrees C). Brief storage at


temperatures between 59 and 86 degrees F (15 and 30 degrees C) is
permitted. Store away from heat, moisture, and light. Do not store in the
bathroom. Keep ranolazine out of the reach of children and away from pets.
General information:

If you have any questions about ranolazine, please talk with your doctor,
pharmacist, or other health care provider.
Ranolazine is to be used only by the patient for whom it is prescribed. Do
not share it with other people.
If your symptoms do not improve or if they become worse, check with your
doctor.
Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take


ranolazine or any other medicine. Only your health care provider has the
knowledge and training to decide which medicines are right for you. This
information does not endorse any medicine as safe, effective, or approved for
treating any patient or health condition. This is only a brief summary of
general information about ranolazine. It does NOT include all information
about the possible uses, directions, warnings, precautions, interactions,
adverse effects, or risks that may apply to ranolazine. This information is not
specific medical advice and does not replace information you receive from
your health care provider. You must talk with your healthcare provider for
complete information about the risks and benefits of using ranolazine.
Issue Date: December 3, 2014

Database Edition 14.4.1.003


Copyright 2014 Wolters Kluwer Health, Inc.

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