MedPath
HSA Approval

PLENDIL TABLET 2.5 mg

SIN07738P

PLENDIL TABLET 2.5 mg

PLENDIL TABLET 2.5 mg

June 15, 1994

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA SINGAPORE PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET, EXTENDED RELEASE

**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.

ORAL

Medical Information

**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.

C08CA02

felodipine

Manufacturer Information

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA AB

ASTRAZENECA PTY LTD

AstraZeneca Pharmaceutical Co. Ltd

Active Ingredients

FELODIPINE

2.5 mg

Felodipine

Documents

Package Inserts

Plendil PI.pdf

Approved: August 15, 2022

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