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.
NIFEDIPINE SUSTAINED-RELEASE – ORAL
COMMON BRAND NAME(S): Procardia XL
USES: Nifedipine is used alone or in combination with other drugs to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is also used for certain types of chest pain (angina). It may help increase your ability to exercise and decrease the frequency of chest pain attacks. It should not be used to treat chest pain when it occurs. Use other medications (e.g., sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor. Consult your doctor or pharmacist for more details. This medication is known as a calcium channel blocker. It works by relaxing and widening blood vessels so blood can flow more easily.
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 drug may also be used to treat certain blood circulation disorders (Raynaud’s syndrome).
HOW TO USE: Take this medication by mouth, with or without food, usually once daily or as directed by your doctor. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Your doctor may gradually increase your dose. Follow your doctor’s instructions carefully. Dosage is based on your medical condition and response to treatment. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. 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. Tell your doctor if your condition worsens (e.g., increase in your routine blood pressure readings).
SIDE EFFECTS: Headache, dizziness, nausea, flushing, constipation, leg/muscle cramps, or sexual problems may occur. To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. An empty tablet shell may appear in your stool. This is harmless since your body has already absorbed the medication. 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: swelling of the ankles/feet, shortness of breath, unusual weakness/tiredness. Tell your doctor immediately if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, fainting, mental/mood changes, swollen/tender gums, vision changes, severe constipation, severe stomach/abdominal pain, black stools. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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. 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 this medication, tell your doctor or pharmacist if you are allergic to it; or to other calcium channel blockers (e.g., amlodipine, felodipine); 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: heart diseases (e.g., congestive heart failure, aortic stenosis), liver problems, esophagus/stomach/intestine problems (e.g., narrowing/stricture, motility disorders, obstruction), kidney problems, a certain metabolic disorder (porphyria). Before having surgery, tell your doctor or dentist that you are taking this medication. 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. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Nifedipine passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: alpha blockers (e.g., doxazosin), beta blockers (e.g., propranolol, metoprolol), calcium or magnesium sulfate received through a vein, digoxin, fentanyl, melatonin, quinidine, certain drugs that may weaken the immune system (e.g., sirolimus, tacrolimus), drugs affecting liver enzymes that remove nifedipine from your body (e.g., cimetidine, nefazodone, quinupristin/dalfopristin, St. John’s wort, azole antifungals such as itraconazole, macrolide antibiotics such as erythromycin, rifamycins such as rifampin, anti-seizure medicines such as carbamazepine/phenytoin). Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or heart rate (e.g., pseudoephedrine, phenylephrine, chlorpheniramine, diphenhydramine, clemastine, ibuprofen, naproxen). Ask your pharmacist about using these products safely. 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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, fast/slow/irregular heartbeat.
NOTES: Do not share this medication with others. Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Laboratory and/or medical tests (e.g., liver or kidney function tests, EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.
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 away from light and moisture. Do not store in the bathroom. Keep all medications 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.