EFUDIX Cream (2019)
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Περιεχόμενα
Name of the medicinal product
Efudix 5% cream.
Qualitative and quantitative composition
Efudix cream contains 5% w/w fluorouracil. For the full list of excipients, see section 6.1.
Pharmaceutical form
White, opaque cream.
Therapeutic indications
Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms; keratoacanthoma; Bowens disease; superficial basal-cell ...
Posology and method of administration
Posology Adults Efudix cream is for topical application. Pre-malignant conditions The cream should be applied thinly to the affected area once or twice daily; an occlusive dressing is not essential. Malignant ...
Contraindications
Efudix is contraindicated in patients with known hypersensitivity to fluorouracil or any of the excipients listed in section 6.1. Coadministration of Efudix with antiviral nucleoside drugs (e.g. brivudine ...
Special warnings and precautions for use
<u>The normal pattern of response includes:</u> early and severe inflammatory phases (typically characterised by erythema, which may become intense and blotchy), a necrotic phase (characterised by skin ...
Interaction with other medicinal products and other forms of interaction
Although no significant drug interactions with Efudix have been reported, potential drug interactions are possible as indicated below. Brivudine, sorivudine and analogues are potent inhibitors of DPD, ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of topical fluorouracil in pregnant women. Studies in animals have shown that fluorouracil is teratogenic (see section 5.3). The potential risk for humans ...
Effects on ability to drive and use machines
It is unlikely that treatment will have any effect on the ability to drive and use machines when used according to the dosage instructions.
Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (>1/10), ...
Overdose
If Efudix is accidentally ingested, signs of fluorouracil overdosage may include nausea, vomiting and diarrhoea. Stomatitis and blood dyscrasias may occur in severe cases. Appropriate measures should be ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Pyrimidine analogues <b>ATC code:</b> L01BC02 Efudix is a topical cytostatic preparation which exerts a beneficial therapeutic effect on neoplastic and pre-neoplastic ...
Pharmacokinetic properties
Fluorouracil is minimally systemically absorbed when applied topically to intact skin. When applied to the skin, the skins barrier function is pathologically altered (e.g., as in ulceration), and the absorption ...
Preclinical safety data
There is evidence from animal work that fluorouracil is teratogenic.
List of excipients
Stearyl alcohol White soft paraffin Polysorbate 60 Propylene glycol Methyl parahydroxybenzoate Propyl parahydroxybenzoate Purified water
Incompatibilities
None known.
Shelf life
The recommended shelf life of Efudix cream is 60 months. Shelf life after first opening the immediate packaging: 90 days for the 20g and 40g tubes.
Special precautions for storage
<u>Storage:</u> The recommended maximum storage temperature for Efudix cream is 30°C. <u>Dilution:</u> Efudix cream should not be diluted.
Nature and contents of container
Efudix cream is supplied in a 20g and a 40g aluminium tube with a plastic screw cap. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0128
Date of first authorization / renewal of the authorization
22/07/2008
Date of revision of the text
April 2019
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