Skinoren cream for external use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

azelaic acid

Available from:

Bayer Healthcare Manufacturing S.r.l.

ATC code:

D10AX03

INN (International Name):

azelaic acid

Dosage:

200mg/g

Pharmaceutical form:

cream for external use

Units in package:

30g aluminium tube

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-10-23

Summary of Product characteristics

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Summary of Product Characteristics
Skinoren cream
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Skinoren
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Skinoren cream contains 200 mg (20%) azelaic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acne (acne vulgaris) in its various expressions,
characterised by the
presence of comedones, papules, pustules and small nodules.
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.
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.
_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 sufficiently stu