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
Documents
Package Inserts
Plendil PI.pdf
Approved: August 15, 2022