Efudix 5% cream

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Fluorouracil

Dostupno od:

Viatris UK Healthcare Ltd

ATC koda:

L01BC02

INN (International ime):

Fluorouracil

Doziranje:

50mg/1gram

Farmaceutski oblik:

Cutaneous cream

Administracija rute:

Cutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 13080100; GTIN: 5000471001983 5060022632011

Uputa o lijeku

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING 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 is used to treat skin conditions
such as growths of the skin (keratoses) and
some simple skin cancers. The active ingredient
fluorouracil belongs to a group of anti-cancer
medicines.
IMPORTANT INFORMATION ABOUT HOW EFUDIX
WORKS
Efudix destroys cancerous and pre-cancerous
cells, while having little effect on normal cells.
When you use Efudix it is likely that the area of
the skin that you are treating will become red.
This will probably be followed by inflammation/
swelling, possibly some discomfort, skin erosion
and eventually, healing. This is the expected
normal response to treatment and shows that
Efudix is working.
Sometimes the response is more severe (see
section 4 “Possible Side Effects”). If your skin
becomes much worse, you experience pain or if
you are worried, talk to your doctor. Your doctor
may prescribe you another cream to relieve any
discomfort.
After stopping treatment, you may find that your
skin takes one to two months to heal completely.
Efudix will also treat abnormalities of the skin
that were previously not visible to the naked eye,
and these abnormalities may become red and
inflamed.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
EFUDIX CREAM
DO

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efudix 5% cream.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Efudix cream contains 5% w/w fluorouracil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
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 arsenical 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 _
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 conditions _
The cream should be applied once or twice daily under an occlusive
dressing where
this is practicable.
The cream should not harm healthy skin. Treatment should be continued
until there
is marked inflammatory response from the treated area, preferably with
some erosion
in the case of pre-malignant conditions. Severe discomfort may be
alleviated by the
use of topical steroid cream. The usual duration of treatment for an
initial course of
therapy is three to four weeks, but this may be prolonged. 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.
_Special population _
_Elderly _
Many of the conditions for which Efudix is indicated are common in the
elderly. No
special precautions are necessary.
_Paediatric population _
In view of the lack of clinical data available, Efudix is not
recommended for use in
children.
Method of application