Skinoren 20% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azelaic acid

Available from:

LEO Pharma

ATC code:

D10AX03

INN (International Name):

Azelaic acid

Dosage:

200mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5016703001720

Patient Information leaflet

IIT001-01 - Page 1 + 2 - 165 x 300 mm – DRA_90036
IIT001-01 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert, 50 g
165 x 300 mm
IIT001-01
09/08/2018
JUG
28/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90036
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
WHAT IS IN THIS LEAFLET
1. What Skinoren
®
is and what it is used for
2. What you need to know before you use
Skinoren
®
3. How to use Skinoren
®
4. Possible side effects
5. How to store Skinoren
®
6. Contents of the pack and other information
1. WHAT SKINOREN
® IS AND WHAT IT IS USED FOR
• Skinoren is a skin cream used to treat
COMMON ACNE (ACNE VULGARIS).
• Skinoren Cream should only be used to treat
acne. You should not use this medicine for
any other skin condition.
• Skinoren attacks the bacterium called
Propionibacterium acnes, which plays an
essential part in causing acne. Skinoren also
reduces growth of the harder outermost skin
cells that block the pores of the skin to cause
blackheads and whiteheads.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SKINOREN
®
DO NOT USE SKINOREN
• 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.
Skinoren is for external use on the skin only.
You should not allow Skinoren to come into
contact with your eyes, mouth or other mucous
membranes. If it does, wash the eyes, mouth
or other mucous membranes immediately with
large amounts of cool water.
Rarely, it has been reported that in some
patients with asthma who were treated with
azelaic acid worsening of asthma symptoms
had occurred.
Skinoren is not recommended for use in
children below the age of 12 due to a lack of
data on safety and efficacy.
OTHER MEDICINES AND SKINOREN
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
PREGNANCY AND BREAST-FEEDING
There is limited experience with use of the
active substance

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Skinoren 20% Cream.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Skinoren Cream contains 200 mg (20% w/w) azelaic acid.
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
METHOD OF ADMINISTRATION
Cutaneous use
DOSAGE REGIMEN
Skinoren Cream should be applied to the affected areas of skin twice
daily
(mornings and evenings), and rubbed in gently. As a guide 2.5 cm
(approx. 0.5
g) of cream is sufficient for the entire facial area. If other areas
of acne, in
addition to the face require treatment, for example the chest and
back, the
amount of cream should be adjusted accordingly.
Patients with sensitive skin should be advised to use Skinoren only
once a day
(in the evening) for the first week of treatment and then proceed to
twice daily
applications.
Before Skinoren Cream is applied, the skin should be thoroughly
cleaned with
plain water and dried. A mild skin-cleansing agent may be used.
The duration of use of Skinoren Cream can vary from patient to patient
and
also depends on the severity of the acne. In general, a distinct
improvement
becomes apparent after about 4 weeks. To obtain the best results,
Skinoren
Cream should be used continuously over a period of several months (see
Section 5.1 Pharmacodynamic properties).
It is important to continue to use Skinoren Cream regularly over the
entire
period of treatment. However, in the event of intolerable skin
irritation (see
Section 4.8 Undesirable effects), the amount of cream per application
should
be reduced or the frequency of use of Skinoren Cream should be reduced
to
once a day until the irritation ceases. If required, treatment might
have to be
temporarily interrupted for a few days.
ADDITIONAL INFORMATION ON SPECIAL POPULATIONS
PEDIATRIC PATIENTS
Use in adolescents (12 - 18 years of age): dose adjustment is not
requ