PLENDIL TABLET 2.5 mg

4.1 Therapeutic indications

Hypertension. Stable angina pectoris.

4.3 Contraindications

• Pregnancy, including the early stages. Women who are likely to become pregnant should not be treated with felodipine.
• Known hypersensitivity to felodipine or any other component of the product (see “Description” section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
• Uncompensated heart failure.
• Acute myocardial infarction.
• Unstable angina pectoris.
• Haemodynamically significant cardiac valvular obstruction.
• Dynamic cardiac outflow obstruction.

4.2 Posology and method of administration

Adults

Hypertension

The dose should be adjusted individually.

Treatment should be started with 5 mg once daily. In elderly patients a starting dose of 2.5 mg once daily should be considered.

If necessary, the dose can be increased in 2.5 or 5 mg/day increments. The usual maintenance dose is 5 mg to 10 mg daily. Doses higher than 20 mg daily of Plendil are not recommended.

Stable angina pectoris

Treatment should be started with 5 mg once daily and if needed be increased to 10 mg once daily.

Administration

PLENDIL tablets should be swallowed whole and taken with water and must not be divided, crushed or chewed.

Paediatric patients

Felodipine should, due to limited clinical trial experience, not be used in paediatric patients.

Elderly patients

The dose should be adjusted individually, taking patient age into consideration (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). An initial dose of 2.5 mg once daily should be considered.

Patients with hepatic impairment

The dose of felodipine should be reduced in patients with severely impaired liver function.

Patients with renal impairment

Impaired renal function does not influence felodipine peak plasma concentrations or AUC, and a dosage reduction is not necessary for patients with renal impairment.