Skinoren 20% cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELAIC ACID

Available from:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC code:

D10AX03

INN (International Name):

AZELAIC ACID 20 % (W/W)

Pharmaceutical form:

CREAM

Composition:

AZELAIC ACID 20 % (W/W)

Prescription type:

POM

Therapeutic area:

ANTI-ACNE PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-09-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SKINOREN
®
20% CREAM
Azelaic acid
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 Skinoren Cream is and what it is used for
2.
What you need to know before you use Skinoren Cream
3.
How to use Skinoren Cream
4.
Possible side effects
5.
How to store Skinoren Cream
6.
Contents of the pack and other information
1.
WHAT SKINOREN CREAM IS AND WHAT IT IS USED FOR
Skinoren contains the active substance azelaic acid.
Skinoren Cream is a medicine for the treatment of acne (acne vulgaris)
and is intended for application
to the skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SKINOREN CREAM
DO NOT USE SKINOREN CREAM:
-
if you are allergic to azelaic acid or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Skinoren Cream.
Skinoren Cream is a medicine for external skin treatment only.
Skinoren Cream must be applied only
to the affected skin areas. Hands should be washed after each
application of Skinoren Cream.
If excessive or persistent skin irritation occurs, please follow the
relevant instructions in section 3.
It is important to ensure that Skinoren Cream does not get onto mucous
membranes (lining of the nose,
lips) or into the eye. In the event of accidental contact with the
eyes, which will cause considerable
irritation, or with the mouth and/or mucous membranes, these must be
rinsed thoroughly at once with
plenty of water. If eye irritation persists, please consult a doc

Summary of Product characteristics

Page 1 of 7
INFORMATION FOR HEALTHCARE PROFESSIONALS
1.
NAME OF THE MEDICINAL PRODUCT
Skinoren
20% Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Skinoren Cream contains 200 mg (20%) azelaic acid.
Excipients with known effect: benzoic acid, propylene glycol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White, opaque cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Skinoren Cream should be applied twice daily (morning and evening) to
the affected skin areas and
rubbed carefully into the skin. Approximately 2.5 cm of cream is
sufficient for the entire facial
area.
_ _
Method of administration
For cutaneous use
Before Skinoren Cream is used, the skin must be carefully cleaned with
clear water and dried. A
mild skin cleanser can be used.
It is important to apply Skinoren Cream regularly throughout the
entire treatment period.
For Skinoren Cream, the duration of administration can vary
individually and is also determined by
the severity of the acne. A significant improvement in the clinical
picture can generally be noted
after about 4 weeks. To achieve optimum results, Skinoren Cream should
be used continuously
over several months, if required. Clinical experience has been
obtained with a continuous
administration period of up to one year.
Page 2 of 7
Should it be necessary, due to pronounced skin irritation (see section
4.8 Undesirable effects),
to reduce the amount of cream per application, the frequency of
application to once daily or to
discontinue treatment briefly, the frequency of application must again
be increased to twice
daily and the treatment continued regularly once the symptoms of
irritation have resolved.
ADDITIONAL INFORMATION FOR SPECIFIC PATIENT GROUPS
_Paediatric population _
No dose adjustment is required for the use of Skinoren Cream in
adolescents aged 12-18 years.
The safety and efficacy of using Skinoren Cream in children under 12
years have not been
sufficien