Felodipine ER 10mg 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.

FELODIPINE EXTENDED-RELEASE - ORAL

(fell-OH-dih-peen)

COMMON BRAND NAME(S): Plendil

USES: Felodipine is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Felodipine is known as a calcium channel blocker. By blocking calcium, this medication relaxes and widens 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 medication may also be used to prevent chest pain (angina).

HOW TO USE: Take this medication by mouth usually once a day on an empty stomach, or as directed by your doctor. If stomach upset occurs, felodipine may be taken with a light meal. Dosage is based on your medical condition and response to therapy. Do not crush or chew extended-release tablets. 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. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day as directed. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. This drug is not effective if you use it only when chest pain occurs. It is very important to take this medication regularly as prescribed to help prevent chest pain. 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 this medication in your bloodstream. Consult your doctor or pharmacist for more details. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

SIDE EFFECTS: Dizziness, lightheadedness, headache, flushing, or stomach upset may occur as your body adjusts to the medication. 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 right away if any of these serious side effects occur: swelling of the hands/ankles/feet (edema). Tell your doctor right away if any of these unlikely but serious side effects occur: fast/irregular heartbeat. Although unlikely, felodipine may cause mild swelling of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly. Tell your doctor right away if this rare but very serious side effect occurs: fainting. Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). 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 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.

PRECAUTIONS: Before taking felodipine, 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: heart disease (e.g., congestive heart failure), liver disease, swelling of the arms and legs (edema). 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. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially dizziness. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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 them first. See also How to Use section. Before using this medication, it is important to tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other medications for high blood pressure, intravenous (IV) calcium. Also tell your doctor or pharmacist if you take drugs affecting the removal of felodipine from your system (CYP 3A4 substrates, inhibitors and inducers) such as: azole antifungals (e.g., itraconazole, ketoconazole), certain anti-seizure medications (e.g., carbamazepine, phenobarbital, phenytoin), cimetidine, macrolide antibiotics (e.g., erythromycin). Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure. Ask your pharmacist for more details. 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 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, slow heartbeat, severe weakness.

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. Have your blood pressure checked regularly while taking this medication. It may be best to learn how to monitor your own blood pressure. Discuss with your doctor and inform him/her of your blood pressure readings.

MISSED DOSE: If you miss a dose, use 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 the US product at room temperature below 86 degrees F (30 degrees C) away from light and moisture. Do not store in the bathroom. Store the Canadian product at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. 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 information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised December 2016. Copyright(c) 2016 First Databank, Inc.