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HSA Approval

PLENDIL TABLET 5 mg

SIN08781P

PLENDIL TABLET 5 mg

PLENDIL TABLET 5 mg

July 3, 1996

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

5 mg

Felodipine

Documents

Package Inserts

Plendil PI.pdf

Approved: August 15, 2022

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