INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FELODIPINE-HEXAL™ 5 (film-coated slow release tablet)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

FELODIPINE-HEXAL™ 5 (film-coated slow release tablet)

COMPOSITION
Each 5 mg tablet contains
felodipine 5 mg in an extended release formulation.

PHARMACOLOGICAL CLASSIFICATION
A 7.1 Vasodilators - Hypotensive medicines

PHARMACOLOGICAL ACTION
Felodipine is a dihydropyridine Class A calcium antagonist which lowers the arterial blood pressure by decreasing vascular resistance.
In-vitro selectivity for smooth muscle in the arterioles is exhibited by felodipine. In therapeutic doses, felodipine has no direct effect on cardiac contractility. Felodipine does not affect venous smooth muscle or adrenergic vasomotor control.
It has been shown by electro-physiological studies that felodipine has no direct effect on conduction in the specialised conducting system of the heart and has no effect on the AV nodal refractoriness.
Felodipine produces an increase in heart rate which is counteracted when concurrent beta-receptor blockers are admini-stered.
During the first few weeks of therapy, felodipine has a mild natriuretic, diuretic and kaliuretic effect. Felodipine is approximately 99% plasma protein bound.

INDICATIONS
FELODIPINE-HEXAL™ tablets are indicated in the management of hypertension.

CONTRA-INDICATIONS
FELODIPINE-HEXAL™ tablets should not be used in women of child-bearing potential, or in persons hypersensitive to felodipine.
Patients with cardiogenic shock.
It is not known whether felodipine is excreted in breast milk or whether it has harmful effects on the new-born.

WARNINGS
FELODIPINE-HEXAL™ tablets may precipitate significant hypotension with tachycardia. In susceptible individuals this may result in myocardial ischaemia.

DOSAGE AND DIRECTIONS FOR USE
Adults including the elderly:
The dose should be adjusted according to the individual requirements of the patient. 5 mg once daily is the recommended starting dose.
5 mg to 20 mg once daily is the maintenance dose.
In general, the dose of felodipine tablets should not exceed 10 mg daily in the elderly and in patients with impaired liver function. In patients with impaired renal function the pharmacokinetics of felodipine are not significantly affected. The tablets should be taken in the morning, swallowed with water and must not be divided, crushed or chewed.
Children:
The safety and efficacy of FELODIPINE-HEXAL™ tablets in children has not been established. FELODIPINE-HEXAL™ tablets may be used in combination with diuretics or beta-blockers. The effects on blood pressure are likely to be additive and combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Dizziness, fatigue, flushing, headache, hypotension and peripheral oedema may occur. Gastro-intestinal disturbances, as well as eye pain, increased micturition frequency, lethargy, and mental depression have also been reported.
At the start of treatment a paradoxical increase in ischaemic chest pain may occur. In a few patients an excessive fall in blood pressure has led to cerebral or myocardial ischaemia or transient blindness.
There have been reports of abnormalities in liver function, fever and rashes due to hypersensitivity reactions. Gingival hyperplasia has been reported but is often reversible on drug withdrawal. Sexual dysfunction/impotence occurs rarely.

USE IN PREGNANCY AND LACTATION
(See "Contra-Indications")

INTERACTIONS
The elimination of felodipine is increased by powerful enzyme inducing agents such as some anticonvulsants (e.g. phenytoin, carbamazepine and phenobarbitone). In patients taking such medicines higher than normal doses of FELODIPINE-HEXAL™ tablets may be required. Conversely, the elimination of felodipine is impaired by enzyme inhibitors such as cimetidine, erthromycin and certain flavonoids present in grapefruit juice. When such medicines are given concomitantly the dosage of FELODIPINE-HEXAL™ tablets may need to be reduced. No dosage adjustment is required when FELODIPINE-HEXAL™ tablets are given concomitantly with digoxin. Felodipine does not appear to affect the unbound fraction of other extensively bound medicines, such as warfarin, due to its high degree of plasma protein binding.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Excessive peripheral vasodilation with marked hypotension, which may be accompanied by bradycardia, may be caused by overdosage. Severe hypotension should be treated symptomatically with the patient placed supine and legs elevated. Bradycardia, if present, should be treated with atropine 0,5 mg to 1 mg intravenously. If this is not sufficient, plasma volume should be increased by infusion with e.g. glucose, normal saline or dextran solutions. Sympathomimetic drugs with a predominant effect on the alpha
1-adrenoceptor may be given, e.g. metaraminol or phenylephrine.

IDENTIFICATION
FELODIPINE-HEXAL™ 5 mg tablets: Round, biconvex film coated tablets; pale red to grey-red, embossment F5 on one side of the tablet.
Diameter: 7.0 ±0.3 mm
Height: 2.3-3.1 mm

PRESENTATION
FELODIPINE-HEXAL™ 5 mg tablets:        White, opaque PVC/aluminium blisters with 30 tablets

STORAGE INSTRUCTIONS
Store below 25°C in well-closed containers.
Protect from light.
Do not remove the blisters from the outer carton until required for use.
Keep out of reach of children.

REGISTRATION NUMBER
36/7.1/0302

NAME AND BUSINESS ADDRESS OF THE APPLICANT
HEXAL Pharma (SA) (Pty) Ltd
46 Mahogany Road
Mahogany Ridge
Pinetown
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT
06 June 2003

        FELBP1

New addition to this site: January 2005
Source: Community Pharmacy

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