Plendil

DRUG DESCRIPTION

PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ethyl methyl 4-(2,3-dichlorophenyl)-1,4- dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its empirical formula is C18H19Cl2NO4 and its structural formula is:

PLENDIL (felodipine) structural formula illustration

Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.

Tablets PLENDIL provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or

10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: Tablets PLENDIL (felodipine) 2.5 mg - hydroxypropyl cellulose, lactose, FD&C Blue 2, sodium stearyl fumarate, titanium dioxide, yellow iron oxide, and other ingredients. Tablets PLENDIL (felodipine) 5 mg and 10 mg - cellulose, red and yellow oxide, lactose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide, and other ingredients.

What are the possible side effects of felodipine (Plendil)?

If you experience any of the following serious side effects, stop taking felodipine and contact your doctor immediately or seek emergency medical treatment:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • unusually fast or slow heartbeat;
  • chest pain;
  • severe dizziness or fainting;
  • abnormal behavior or psychosis;
  • jaundice (yellowing of the skin or eyes), or
  • swelling of the legs, ankles, or...

Read All Potential Side Effects and See Pictures of Plendil

What are the precautions when taking felodipine (Plendil)?

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...

Read All Potential Precautions of Plendil


Plendil Consumer (continued)

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 immediately if any of these serious side effects occur: swelling of the hands/ankles/feet (edema).

Tell your doctor immediately 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 immediately if this rare but very serious side effect occurs: fainting.

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 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.


Plendil Patient Information Including Side Effects

Brand Names: Plendil

Generic Name: felodipine (Pronunciation: fe LOE di peen)

  • What is felodipine (Plendil)?
  • What are the possible side effects of felodipine (Plendil)?
  • What is the most important information I should know about felodipine (Plendil)?
  • What should I discuss with my healthcare provider before taking felodipine (Plendil)?
  • How should I take felodipine (Plendil)?
  • What happens if I miss a dose (Plendil)?
  • What happens if I overdose (Plendil)?
  • What should I avoid while taking felodipine (Plendil)?
  • What other drugs will affect felodipine (Plendil)?
  • Where can I get more information?

What is felodipine (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.

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

Felodipine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of felodipine (Plendil)?

If you experience any of the following serious side effects, stop taking felodipine and contact your doctor immediately or seek emergency medical treatment:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • unusually fast or slow heartbeat;
  • chest pain;
  • severe dizziness or fainting;
  • abnormal behavior or psychosis;
  • jaundice (yellowing of the skin or eyes), or
  • swelling of the legs, ankles, or face.

Other, less serious side effects may be more likely to occur. Continue to take felodipine and talk to your doctor if you experience

  • fatigue or tiredness;
  • headache;
  • insomnia or difficulty sleeping;
  • swelling of your gums;
  • nausea or diarrhea;
  • increased or difficult urination;
  • muscle or joint discomfort; or
  • flushing (redness).

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about felodipine (Plendil)?

Do not stop taking felodipine without first talking to your doctor, even if you begin to feel better. If you stop taking the medication, your condition could become worse.

Brush and floss your teeth regularly as directed by your dentist. Rarely, swelling of the gums may be a side effect from treatment with felodipine. Proper oral hygiene may alleviate these symptoms.

Do not crush, chew, or break the tablets. Swallow them whole.

Grapefruit and grapefruit juice may interact with felodipine. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

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