Plendil

• Felodipine is used to treat high blood pressure to prevent heart attacks and strokes. It may be used alone or in combination with other drugs.
• It also is used to treat patients with angina although it is not FDA approved for this use.

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Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Your pharmacist can provide more information about felodipine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation.

The most common clinical adverse events reported with PLENDIL administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients. Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving PLENDIL, principally for peripheral edema, headache, or flushing.

Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (PLENDIL, N = 861; Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of PLENDIL or titrated from an initial dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been evaluated in some clinical studies. Although the antihypertensive effect of PLENDIL is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see DOSAGE AND ADMINISTRATION).

Percent of Patients with Adverse Events in Controlled Trials* of PLENDIL (N=861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)

Adverse events that occurred in 0.5 up to 1.5% of patients who received PLENDIL in all controlled clinical trials at the recommended dosage range of 2.5 mg to 10 mg once a day, and serious adverse events that occurred at a lower rate, or events reported during marketing experience (those lower rate events are in italics) are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of PLENDIL is uncertain: Body as a Whole: Chest pain, facial edema, flu-like illness; Cardiovascular: Myocardial infarction, hypotension, syncope, angina pectoris, arrhythmia, tachycardia, premature beats; Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation; Endocrine: Gynecomastia; Hematologic: Anemia; Metabolic: ALT (SGPT) increased; Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain; Nervous/Psychiatric: Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido; Respiratory: Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection; Skin: Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis; Special Senses: Visual disturbances; Urogenital: Impotence, urinary frequency, urinary urgency, dysuria, polyuria.

Gingival hyperplasia, usually mild, occurred in < 0.5% of patients in controlled studies. This condition may be avoided or may regress with improved dental hygiene. (See PATIENT INFORMATION.)

Clinical Laboratory Test Findings

No significant effects on serum electrolytes were observed during short- and long-term therapy (see CLINICAL PHARMACOLOGY, Renal/Endocrine Effects).

No significant effects on fasting serum glucose were observed in patients treated with PLENDIL in the U.S. controlled study.

1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.

Read the entire FDA prescribing information for Plendil (Felodipine)

Serious side effects have been reported with Plendil including:

• hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure, too. Lie down if you feel faint or dizzy. Call your doctor right away.
• congestive heart failure (CHF). Tell your healthcare provider right away if you experience any of the following symptoms of CHF:
  • sudden weight gain
  • worsening shortness of breath
  • increased swelling of your feet, legs, or abdomen
  • needing more pillows or sleeping in a recliner
  • waking from sleep to catch your breath
  • a cough that does not go away
  • new or increasing irregularities in your heart rate
• gingival hyperplasia (overgrowth of the gums). Plendil has been reported to cause gingival hyperplasia. Practicing good dental hygiene may decrease this occurrence or the severity.

Plendil can cause dizziness. Do not drive or operate heavy machinery until you know how Plendil affects you.

Do not take Plendil if you are allergic to Plendil or to any of this medication’s ingredients.

Felodipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Felodipine is used to treat hypertension (high blood pressure).

Felodipine may also be used for other purposes not listed in this medication guide.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• feeling short of breath, swelling in your hands or feet;

• fast or pounding heartbeats;

• numbness or tingly feeling; or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

• headache, dizziness, drowsiness, weakness;

• feeling restless or nervous;

• nausea, upset stomach, constipation, diarrhea, stomach pain;

• sleep problems (insomnia);

• joint pain or muscle cramps;

• warmth, redness, or tingly feeling under your skin;

• mild rash;

• urinating more than usual; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Inhibits the transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations.c

• Hypotensive effect is principally a consequence of a dose-related reduction in peripheral vascular resistance, with a modest reflex increase in heart rate.1

• Negative inotropic effects observed in vitro but not in intact animals.1

• Has no substantial effect on cardiac conduction (PR, PQ, and HV intervals).1

Plendil (felodipine) is in a class of drugs called calcium channel blockers. Felodipine relaxes (widens) your blood vessels (veins and arteries), which makes it easier for the heart to pump and reduces its workload.

Plendil is used to treat hypertension (high blood pressure).

Plendil may also be used for other purposes not listed in this medication guide.

Get emergency medical help if you have any of these signs of an allergic reaction to Plendil: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• feeling short of breath, swelling in your hands or feet;

• fast or pounding heartbeats;

• numbness or tingly feeling; or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious Plendil side effects may include:

• headache, dizziness, drowsiness, weakness;

• feeling restless or nervous;

• nausea, upset stomach, constipation, diarrhea, stomach pain;

• sleep problems (insomnia);

• joint pain or muscle cramps;

• warmth, redness, or tingly feeling under your skin;

• mild rash;

• urinating more than usual; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of Plendil side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• cimetidine (Tagamet);

• conivaptan (Vaprisol);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• tacrolimus (Prograf);

• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

• antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

• an antidepressant such as nefazodone;

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others;

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);

• other heart or blood pressure medications such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

• seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), or phenytoin (Dilantin).

This list is not complete and other drugs may interact with Plendil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.