Duofilm

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

LACTIC ACID, SALICYLIC ACID

متاح من:

Beecham Group PLC 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC رمز:

D11AF

INN (الاسم الدولي):

LACTIC ACID 15 % (W/W) SALICYLIC ACID 16.7 % (W/W)

الشكل الصيدلاني:

CUTANEOUS SOLUTION

تركيب:

LACTIC ACID 15 % (W/W) SALICYLIC ACID 16.7 % (W/W)

نوع الوصفة الطبية :

OTC

المجال العلاجي:

OTHER DERMATOLOGICAL PREPARATIONS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2006-05-30

نشرة المعلومات

PHARMA CODE REF. NO. 625
PHARMA CODE REF. NO. 625
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use Duofilm carefully to
get the best results from it.
•
Keep this leaflet. You may need to read it
again.
•
Ask your pharmacist or doctor if you need
more information or advice.
•
You must contact your doctor if your
symptoms worsen or do not improve.
•
If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What Duofilm is and what it is used for
2.
Before you use Duofilm
3.
How to use Duofilm
4.
Possible side effects
5.
How to store Duofilm
6.
Further information
1. What Duofilm is and what it is used for
The name of your medicine is Duofilm. It contains
two medicines called salicylic acid and lactic acid.
It works by softening the skin of a wart, causing it
to peel off.
Duofilm is used to treat warts.
•
A wart is an infection in the top layers of the
skin. It is caused by a virus.
•
Warts can be spread when the virus touches
damaged skin.
•
It is more likely to spread in places which are
warm and moist. This is why one of the most
common places to catch warts is swimming
pools.
•
It can take from a few weeks to several
months for the wart to appear.
2. Before you use Duofilm
Do not use Duofilm if:
•
you are allergic to the salicylic acid, lactic acid
or any of the other ingredients of Duofilm
(listed in Section 6).
•
you have warts on your face, around your
back passage or genitals, moles, birthmarks,
warts with hair growing from them or other
sensitive areas.
•
the area of skin is irritated, reddened or infected.
Do not use on open wounds.
•
the child being treated is under 2 years of age.
Do not use Duofilm if the above applies to you. If
you are not sure, talk to your doctor or
pharmacist before you start using Duofilm.
Take special care with Duofilm
•
Do not inhale the vapour.
•
Do not use with other medicine

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Duofilm
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic acid BP 16.7% w/w
Lactic acid BP 15% w/w
Also contains colophony
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for topical administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duofilm is indicated for the treatment of warts.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children aged 2 years and over.
Apply daily to the affected areas only.
Children:
Children under the age of 12 years should be treated under
supervision.
Treatment of infants under the age of 2 years is not recommended.
Duofilm should be applied to the wart once daily preferably at
bedtime.
Procedure for application:
1. The wart should be soaked in warm water for 5 minutes and dried
thoroughly with a clean towel.
2. The surface of the wart should be rubbed with a nail file, pumice
stone,
emery board or coarse washcloth, with care taken not to cause
bleeding.
3. A thin layer of Duofilm should be applied directly to the wart.
Care should
be taken to avoid the healthy surrounding skin.
4. The solution should be allowed to dry thoroughly. The wart should
be
covered with a plaster (dressing) if it is large or if it is on the
foot to help
penetration of ingredients.
It is recommended that treatment continues until whichever of the
following
occurs first:
•
Warts have been treated for 12 weeks
•
The wart is completely cleared and the normal ridgelines of the skin
have
been restored.
For warts, clinically visible improvement should occur in 1-2 weeks,
but the
maximum effect may be expected after 4-8 weeks.
If warts persist beyond 12 weeks of treatment, the patient should be
advised to
consult their pharmacist or doctor.
Consider alternative treatments if warts cover a large area of the
body (more
than 5 cm
2
) (see _Warnings and Precautions_).
Patients should be advised to consult a pharmacist or doctor if skin
irritation
develops.
Due to the flammable natur