RANEXA ER 1,000 MG TABLET

USES: Ranolazine is used to treat a certain type of chest pain (chronic stable angin...

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 (including 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.

Indications : prevention of anginal pain associated with coronary artery disease, ventricular tachycardia

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used for irregular heartbeat.

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. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: numbness, shaking (tremor), swelling of the ankles/feet, unexpected weight gain, vision changes, signs of kidney problems (such as change in the amount of urine). Get medical help right away if you have any very serious side effects, including: fainting, severe dizziness, slow/fast/irregular/pounding heartbeat. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not take more of this medication than your doctor prescribes. 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 (such as if your chest pain happens more often).

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 rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ranolazine, tell your doctor or pharmacist of all the drugs you take and 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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially dizziness, constipation, and QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. 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: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Many drugs besides ranolazine may affect the heart rhythm (QT prolongation), including amiodarone, pimozide, dofetilide, procainamide, quinidine, sotalol, among others. Other medications can affect the removal of ranolazine from your body, which may affect how ranolazine works. Examples include clarithromycin, cobicistat, nefazodone, azole antifungals (such as itraconazole, ketoconazole), HIV protease inhibitors (such as nelfinavir, ritonavir), rifamycins (such as rifabutin, rifampin), drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), St. John's wort, among others.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/fainting, fast/irregular/very slow heartbeat, mental/mood changes (such as confusion, hallucinations), vomiting, severe tremor, unsteadiness.

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