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Extended release formulation.
* Therapeutic Indications:
– Hypertension.
– Angina pectoris.
* Psology 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 5mg
once daily, if needed, increased to 10 mg once daily. Plendil may be combined with beta-blockers.
– Impaired renal function: Impaired renal function does not affect plasm concentrations of felodipine.
No dose adjustment is required. Plendil should be used with caution in patients with severly impaired
renal function.
– Children: Experience from treatment of children with felodipine is limited.
* Contraindications:
– Pregnancy.
– Known hypersensitivity to felodipine or any other component of the product.
– Uncompensated heart failure.
– Acute myocardial infarction.
– Unstable angina pectoris.
* Special warnings and precautions for use:
– Aortic stenosis, liver impairment, severly impaired renal function (GFR<30 mL/min), heart
failure after acute myocardial infarction. Hypotension, which may cause myocardial ischaemia
in sensitive patients.
– Concomitant administration of drugs that induce CYP 3A4 leads to strongly reduced levels
of felodipine and the risk of a lack of effect of Plendil. This combination should be avoided.
– Concomitant administration of drugs that are potent inhibitors of CYP 3A4 leads to markedly
elevated levels of felodipine. This combination should be avoided.
– Concomitant intake of grapefruit juice leads to markedly elevated levels of felodipine.
This combination should be avoided.
* Do not store above 30 degrees C.
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