Ranexa ER 1000mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RANOLAZINE EXTENDED-RELEASE - ORAL

(ra-NOE-la-zeen)

COMMON BRAND NAME(S): Ranexa

USES: Ranolazine is used to treat a certain type of chest pain (chronic stable angina). It decreases the number of times you may get chest pain. Relieving symptoms of angina can increase your ability to exercise and perform strenuous work. Ranolazine works differently than other drugs for angina, so it can be used with your other angina medications (e.g., nitrates, calcium channel blockers such as amlodipine, beta blockers such as metoprolol). It is thought to work by improving how well the heart uses oxygen so that it can do more work with less oxygen.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking ranolazine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth, usually twice daily with or without food or as directed by your doctor. Swallow this medication whole. Do not crush, chew, or split tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. The dosage is based on your medical condition, response to treatment, and other medications you may be taking (see Drug Interactions section). Do not take more of this medication than your doctor prescribes. Do not take more than 1000 milligrams twice a day. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. This medication must be taken regularly to be effective. It should not be used to treat angina when it occurs. Use other medications (e.g., sublingual nitroglycerin) to relieve an angina attack as directed by your doctor. Consult your doctor or pharmacist for details. Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Inform your doctor if your condition does not improve or if it worsens (e.g., your chest pain happens more often).

SIDE EFFECTS: Dizziness, headache, lightheadedness, nausea, tiredness, and constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness, shaking (tremor), swelling of the ankles/feet, unexpected weight gain, vision changes, change in the amount of urine. Seek immediate medical attention if any of these rare but serious side effects occur: fainting, sudden dizziness, slow/fast/irregular/pounding heartbeat. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ranolazine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as cirrhosis), kidney problems. Ranolazine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using ranolazine, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ranolazine safely. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Before having surgery, tell your doctor or dentist that you are using this medication. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and constipation. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious interactions may occur: drugs that strongly affect the removal of ranolazine from your body (including azole antifungals such as itraconazole/ketoconazole, macrolide antibiotics such as clarithromycin, nefazodone, HIV protease inhibitors such as lopinavir/ritonavir, rifamycins such as rifampin, St. John's wort, drugs used to treat seizures such as carbamazepine/phenytoin). If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting ranolazine. Many drugs besides ranolazine may affect the heart rhythm (QT prolongation), including amiodarone, pimozide, dofetilide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using ranolazine, report all medications you are currently using to your doctor or pharmacist. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other drugs that affect the removal of ranolazine from your body (e.g., cyclosporine, diltiazem, erythromycin, fluconazole, verapamil). Ranolazine can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include digoxin, simvastatin, trazodone, tricyclic antidepressants (such as amitriptyline, imipramine), certain antipsychotics (such as clozapine, haloperidol, risperidone), among others. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness/fainting, fast/irregular/very slow heartbeat, confusion.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., blood pressure, electrocardiograms) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.