Plendil® 2.5 mg, 5 mg and 10 mg Tablets – Felodipine

Felodipine (Plendil) is a vasoselective calcium antagonist for the treatment of hyper-tension and stable angina pectoris. The active substance in Plendil, felodipine, is a dihydropyridine derivate. Felodipine exerts its effect by reducing peripheral vascular resistance, particularly in arterial resistance vessels.

Plendil is indicated for the treatment of high blood pressure and can be used as monotherapy to control blood pressure in the majority of patients. Plendil is usually prescribed to patients in whom treatment with other blood pressure medications (eg, diuretics or beta-blockers) has been shown to be ineffective or associated with unacceptable adverse effects.

Plendil is compatible with other blood pressure medicines. Plendil has been shown to have an additive blood pressure lowering effect when prescribed with other blood pressure medicines. Therefore, your doctor may prescribe Plendil with other blood pressure medications (such as diuretics, beta-blockers or ACE inhibitors).

Felodipine (Plendil) is used alone or with other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidneys problems.

Felodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing and widening the blood vessels, which helps blood flow more easily, which contributes to lowering blood pressure.

Felodipine is also used to prevent angina attacks, allowing angina patients to increase their exercise capacity and reduce the frequency of angina attacks. Plendil should not be used to treat angina attack when it occurs. If chest pain occurs as a result of angina, use another class of medication (such as sublingual nitroglycerin) or as directed by your doctor.

How should I take Plendil?

  • Take Plendil once a day, with or without food. It is recommended that you take your dose at the same time each day, such as after breakfast or dinner, or at bedtime.
  • If you miss a dose, take it as soon as you remember. But do not take Plendil if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
  • Other medicines: You can use nitroglycerin and Plendil together. If you are taking nitroglycerin to treat angina, do not stop taking it while you are taking Plendil.
  • While you are taking Plendil, do not stop taking your other prescribed medications, including any other blood pressure medications, without first talking to your doctor.

Plendil – Frequently Asked Questions

What foods interact with Plendil?

Alcohol can further lower your blood pressure and can increase some of the side effects of Felodipine. Grapefruit and grapefruit juice may also interact with Felodipine and lead to potentially serious side effects. Avoid the use of grapefruit products while taking Felodipine.

When do I stop using Plendil?

If you have been using this medication regularly for several weeks, do not suddenly stop using it. Stopping suddenly may cause angina or high blood pressure. Consult your doctor for the best way to reduce the amount you are taking gradually before stopping completely.

How long does it take Plendil to lower blood pressure?

It takes 8 hours for Felodipine (Plendil) to reach its highest concentration in the blood, and about a week to reach the full effect of complete blood pressure control.

Is Plendil taken every day?

Take Felodipine exactly as your doctor has told you, and follow the directions in the package leaflet provided with the medicine. If you are not sure of your dose, check with your doctor or pharmacist. It is usual to take Plendil once daily. You can take your dose at any time of the day, but try to make sure it is around the same time each day.

What time of day should you take Plendil?

Take Plendil once a day, with or without food. It is preferable to take your dose at the same time each day, such as after breakfast or dinner, or at bedtime. Do not take more than one dose of Plendil at a time and if you miss a dose, take it as soon as you remember it.

Does Plendil cause weight gain?

Weight gain is a rare side effect of Plendil (Felodipine) that occurs in less than 1 percent of people who take the medication. A low-salt & low-fat diet may help prevent weight gain.

Does Plendil cause a cough?

Cough is listed as a side effect of Felodipine in the patient information leaflet but this is rare, occurring in less than 0.01% of patients. Coughing is more common when Felodipine is combined with other blood pressure medications (eg, ACE inhibitors).

Does Plendil cause swelling in the feet or ankles?

Swelling of the feet and/or ankles can be a side effect of some blood pressure medications, especially calcium channel blockers (such as Plendil). These medicines (including Plendil) widen/relax the small blood vessels, and in some people, this can cause more fluid to leak from the blood vessels into the tissues, causing swelling in the ankle or foot.

Does Plendil affect erection in men?

Yes, Plendil can cause a decrease in sex drive, a decrease in the hardness of an erection and in some cases impotence, gynecomastia in men.

Plendil rarely causes erectile dysfunction, but most patients with uncontrolled blood pressure (especially those who also have diabetes) are more likely to develop erectile dysfunction as part of a complication of high blood pressure or diabetes.

According to the manufacturers of drugs that contain Felodipine, and based on reports of patients’ experiences after using Plendil , it is clear that in rare cases, Plendil may cause impotence and breast enlargement in men (gynecomastia).

Is there an interaction between Plendil and Viagra (sildenafil)?

There are no known drug interactions between Plendil and sildenafil. And when they are taken together, each of the two drugs does not affect the other in any way.

Composition

  • Felodipine 2.5 mg, 5 mg and 10 mg
  • Pharmaceutical form: film coated extended release tablets

Therapeutic Indications

  • Hypertension
  • Prophylaxis of angina pectoris

Posology and method of administration

The extended-release tablet should be given once daily, preferably in the morning. The duration of effect is 24 hours. The tablet should be swallowed with water but must not be chewed or crushed.

The extended-release tablet may be taken on an empty stomach or together with a light meal that is low in fat and carbohydrates.

Hypertension

The dose should be adjusted individually. Treatment should be initiated with 5 mg once daily. The normal dosage is 5 mg once daily. If necessary, the dose may be further increased or another antihypertensive agent added to Plendil.

For some patients, for example, elderly patients and patients with impaired liver function, 2.5 mg once daily may be sufficient.

Doses higher than 10 mg once daily are usually not needed.

Angina pectoris

The dose should be adjusted individually. Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily.

Plendil may be combined with B-blockers.

Impaired renal function

Impaired renal function does not affect plasma concentrations of felodipine.

No dose adjustment is required. Plendil should be used with caution in patients with severely impaired renal function .

Children

Experience from treatment of children with felodipine is limited.

Undesirable effects

The most common adverse reaction to Plendil is mild to moderate ankle swelling, which is dose-related and caused by precapillary vasodilatation. Experience from clinical trials has shown that 2% of patients interrupted treatment due to ankle swelling.

Flushing, headache, palpitations, dizziness and fatigue may occur at the start of treatment or after a dose increase. These reactions are normally transient.

Occasional cases of confusion and sleep disturbances have been reported, but a connection with felodipine has not been established with certainty.

Cases of gingival enlargement have been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful dental hygiene.

Hyperglycaemia is a class-related undesirable effect, but has only been reported in individual cases for felodipine.

Pregnant and nursing mothers

Felodipine should not be used during pregnancy unless the potential benefit outweighs the potential risk to the mother and fetus.

Felodipine should not be prescribed to nursing mothers.

Patient Information leaflet

Plendil tablets
Plendil tablets

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Product reference code: C08CA02.