Skinoren 20% cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELAIC ACID

Available from:

Jenapharm GmbH & Co. KG

ATC code:

D10AX03

INN (International Name):

AZELAIC ACID

Pharmaceutical form:

CREAM

Composition:

AZELAIC ACID 20 percent weight/weight

Prescription type:

POM

Therapeutic area:

ANTI-ACNE PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-09-24

Patient Information leaflet

PACKAGE LEAFLET, SKINOREN 20% CREAM
PAGE 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. 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.
PACKAGE LEAFLET, SKINOREN 20% CREAM
PAGE 2
Skinoren Cream is a medicine that is intended only for external
application to
the skin. Skinoren Cream must be applied only to affected areas of
skin. Hands
must be washed after every application of Skinoren Cream.
If excessive or persistent skin irritation occurs, please note the
relevant
information in section 3.
It is important to ensure that Skinoren Cream does not come into
contact with
mucous membranes (nasal mucosa, lips) or get into the eyes. If the
product
gets into the eyes or accidentally comes into contact with the mouth
and/ or
mucosa, which leads to considera

Summary of Product characteristics

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 (in the morning and in
the evening) to the affected
skin locations, carefully rubbing it into the skin. About 2.5 cm Cream
are sufficient for the entire
facial area.
CHILDREN AND ADOLESCENTS
An adjustment of the dosage is not necessary for the application of
Skinoren Cream in adolescents
aged 12 to 18 years.
The safety and efficacy of the application of Skinoren Cream in
children under the age of 12 years
have not been sufficiently established.
METHOD OF ADMINISTRATION
Before Skinoren Cream is applied, the skin should be cleaned
thoroughly with clear water and then
dried. A mild skin cleanser can be used.
It is important to apply Skinoren Cream regularly during the entire
treatment period.
The duration of treatment with Skinoren Cream may vary between
individuals and is determined
partly by the severity of the acne. A significant improvement in
symptoms is generally discernible
after around 4 weeks. In order to achieve the best results, Skinoren
Cream should be used
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6
continuously over a period of several months, if necessary. Clinical
experience is available for
continuous treatment periods of up to one year.
If, as a result of severe skin irritation (see section 4.8), a
reduction of the amount of Cream per
application, a reduction in the frequency of use to once a day or a
brief break from treatment for a
few days is necessary, the frequency of use should be increased back
to twice a day and regular
treatment continued once the irritation has subsided.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substanc