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Meda Health Sales

Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co. Meath, Dublin, Ireland
Telephone: 00 353 18026624
Fax: 00 353 18026629
Medical Information Direct Line: 00 353 1 802 6627
Medical Information e-mail: medinfo@meda.ie
Medical Information Facsimile: 00 353 1 802 6629


Summary of Product Characteristics last updated on medicines.ie: 25/08/2011
SPC Efudix 5% Cream



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1. NAME OF THE MEDICINAL PRODUCT

Efudix 5% w/w Cream.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Efudix cream contains:

Active substance:

5% w/w

Fluorouracil

Excipients:

15%

stearyl alcohol

11.5%

propylene glycol (E1520)

0.025%

methyl parahydroxybenzoate (E218)

.015%

propyl parahydroxybenzoate (E216)

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Cream.

Smooth, white, opaque cream.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenic forms; keratoacanthoma, Bowen's disease, superficial basal-cell carcinoma. Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to Efudix therapy. It should be used only as a palliative therapy in such cases where no other form of treatment is possible.


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4.2 Posology and method of administration

Adults, including the elderly:

The cream should be applied thinly once or twice daily to the lesion. An occlusive dressing should preferably be used with malignant lesions. The usual treatment course is 3 to 4 weeks, but this may be prolonged if required.

Children: not recommended.


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4.3 Contraindications

• Pregnancy or lactation

• Known hypersensitivity to Efudix or parabens.


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4.4 Special warnings and precautions for use

• Care should be taken to avoid contact with the eyes or mucous membranes and hands should be washed thoroughly after applying the cream.

• An area in excess of 500 cm2 should not be treated at one time.

• If the product is used excessively or the area of application is extensive and ulceration is present, absorption may occur.

• The pattern of normal therapeutic response to Efudix follows a sequence of erythema, vesiculation, erosion, ulceration and necrosis followed by epithelialisation, without damaging normal skin. Therefore, the appearance of the lesions may initially be worse prior to resolution.

• This product should be used under specialist medical direction.

• Patients should not treat further lesions similar to those for which the product was originally recommended without seeking further medical advice.

• The excipients stearyl alcohol and propylene glycol may cause local skin irritations (e.g. contact dermatitis); the excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).


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4.5 Interaction with other medicinal products and other forms of interaction

No significant drug interactions with Efudix have been reported.


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4.6 Pregnancy and lactation

Use during pregnancy or in lactation in women breast feeding infants is not recommended. Animal studies indicate that there is a teratogenic effect and there is no evidence of safety in human pregnancy.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

Efudix is well tolerated. Transient erythema may occur in healthy skin surrounding the area being treated. Pre-existing subclinical lesions may become apparent. Exposure to sunlight may increase the intensity of the reaction. Dermatitis, allergic skin reactions and, rarely, erythema multiforma has been reported (see 4.4 Special Warnings and Precautions for Use).

Percutaneous absorption of fluorouracil should not lead to clinically significant systemic toxicity when Efudix is administered as directed. However, this possibility should be borne in mind if the product is used excessively, especially on ulcerated or broken skin.


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4.9 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 taken for the prevention of systemic infection and daily white cell counts should be performed.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Efudix is a topical cytostatic preparation which exerts a beneficial therapeutic effect on neoplastic and pre-neoplastic skin lesions without damaging normal skin. The pattern of response follows this sequence, erythema, vesiculation, erosion, ulceration, necrosis and epithelisation. The active ingredient fluorouacil is a fluorinated analogue or uracil, a component of RNA. Fluorouracil interferes with DNA and RNA synthesis at the nucleotide level.


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5.2 Pharmacokinetic properties

Animal studies have shown that after topical application of fluorouracil, less than 10% is systemically absorbed. This may be metabolised by catabolic or anabolic routes which are similar to that of endogenous uracil.


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5.3 Preclinical safety data

No new data are presented


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Stearyl alcohol

White soft paraffin

Polysorbate 60

Propylene glycol (E1520)

Methyl parahydroxybenzoate (E218)

Propyl paradroxybenzoate (E216)

Purified water


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

5 years.

Shelf life after first opening the immediate packaging: 28 days for the 5g tube, 90 days for the 20g and 40g tubes


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6.4 Special precautions for storage

Do not store above 30°C.


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6.5 Nature and contents of container

Efudix cream is packed in 40g, 20g and 5g aluminium membrane-sealed tubes, coated inside with an epoxy phenolic resin derivative lacquer. The tube is closed with a polypropylene PP membrane piercing cap.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Efudix is for topical use only and care should be taken to avoid contact with mucous membranes or the eyes. The hands should be washed carefully after applying the cream.


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7. MARKETING AUTHORISATION HOLDER

Meda Health Sales Ireland Limited,

Unit 34/35, Block A,

Dunboyne Business Park,

Dunboyne, Co. Meath,

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1332/32/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1st April 1979

Date of last renewal: 01st April 2009


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10. DATE OF REVISION OF THE TEXT

August 2011



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Active Ingredients

 
   Fluorouracil