Efudix 5% w/w Cream

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

FLUOROURACIL

Disponible depuis:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Code ATC:

L01BC02

DCI (Dénomination commune internationale):

FLUOROURACIL 5 % (W/W)

forme pharmaceutique:

CREAM

Composition:

FLUOROURACIL 5 % (W/W)

Type d'ordonnance:

POM

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-11-08

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
EFUDIX 5% W/W CREAM
Fluorouracil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1. What Efudix Cream is and what it is used for
2. What you need to know before you use Efudix Cream
3. How to use Efudix Cream
4. Possible side effects
5. How to store Efudix Cream
6. Contents of the pack and other information
1.
WHAT EFUDIX CREAM IS AND WHAT IT IS USED FOR
Efudix Cream belongs to a group of anti-cancer medicines.
Efudix Cream is used to treat certain skin conditions caused by
abnormal cell growth including different
types of keratosis (a horny growth of the skin), keratocanthoma (a
firm nodule on the skin), Bowen’s
disease, and some simple skin cancers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EFUDIX CREAM
Do not use Efudix Cream:
-
If you are pregnant, think you may be pregnant, or are breast feeding.
-
If you are allergic to fluorouracil or any of the other ingredients of
this medicine (listed in section
6).
-
If you are taking antiviral nucleoside drugs (e.g. brivudine)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Efudix Cream.
-
The cream should be kept away from your eyes and mucosal surfaces
(such as mouth, nose, genital
or anus). (see section 3, ‘How to use Efudix Cream’)
-
If you have broken, inflamed or ulcerated skin as this can lead to too
much cream being absorbed
into the blood, which very rarely can cause side effects.
-
if you know that you have reduced or no activity of the enzyme
dihydropyrimidine dehydrogenase
(DP

Résumé des caractéristiques du produit

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1.
NAME OF THE MEDICINAL PRODUCT
Efudix 5% w/w Cream.
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)
0.015% propyl parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Smooth, white, opaque cream.
4.
CLINICAL PARTICULARS
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.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults, including elderly_
:
Efudix cream is for topical application.
_Pre-malignant conditions _
The cream should be applied thinly once or twice daily to the lesion;
an occlusive dressing is not
essential
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_Malignant conditions _
The cream should be applied once or twice daily under an occlusive
dressing where this is
applicable.. Treatment should be continued until there is marked
inflammatory response from the
treated area, preferably some erosion in the case of pre-malignant
conditions. Severe discomfort
may be alleviated by the use of topical steroid cream. The usual
treatment for an initial course is 3
to 4 weeks, but this may be prolonged if required. Lesions on the face
usually respond more quickly
than those on the trunk or lower limbs whilst lesions on the hands and
forearms respond more
slowly. Healing may not be complete until one or two months after
therapy is stopped.
_Children_
:
In view of the lack of clinical data available, Efudix is not
recommended for use in children.
Special population
_Elderly _
Many of the conditions for wh