Skinoren 15% Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azelaic acid

Available from:

Bayer Limited

ATC code:

D10AX; D10AX03

INN (International Name):

Azelaic acid

Dosage:

15 percent

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other anti-acne preparations for topical use; azelaic acid

Authorization status:

Marketed

Authorization date:

2003-06-30

Patient Information leaflet

IE_PIL Skinoren gel_BCH19026
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _
SKINOREN 15 % GEL
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 GEL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SKINOREN GEL
3.
HOW TO USE SKINOREN GEL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SKINOREN GEL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SKINOREN GEL IS AND WHAT IT IS USED FOR
Skinoren Gel contains the active substance azelaic acid and belongs to
the group of anti-acne
preparation for external (cutaneous) use. Skinoren Gel is for the
relief of mild to moderate
papulopustular acne of the face and the treatment of papulopustular
rosacea. Papulopustular acne and
rosacea are associated with inflamed papules and pustules.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SKINOREN GEL
DO NOT USE SKINOREN GEL
-
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 Gel. Skinoren
Gel is for external (cutaneous)
use only. Take care to avoid contact with the eyes, mouth and other
mucous membranes. In the event
of an accidental contact, wash the eyes, mouth and/or affected mucous
membranes with large amounts
of water. You should consult a doctor or pharmacist if an eye
irritation persists.
Please wash your hands after each application of Skinoren Gel.
It is advisable to avoid alcoholic cleansers, tinctures and
astringents, abrasives and peeling

Summary of Product characteristics

Health Products Regulatory Authority
20 August 2019
CRN0098NH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Skinoren 15% Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g Skinoren Gel contains 150 mg (15%) azelaic acid.
Excipients with known effect:
1 mg Benzoic acid /g Gel
0.12 g Propylene glycol /g Gel
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
White to yellowish-white opaque gel
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o For the relief of mild to moderate papular-pustular acne of the
facial area.
o For the topical treatment of papulopustular rosacea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Skinoren 15 % Gel is intended for cutaneous use only.
Posology
Skinoren Gel should be applied to the affected skin areas twice a day
(in the morning and in the evening) and rubbed in gently.
Approximately 0.5 g = 2.5 cm (1 inch) of gel is sufficient for the
entire facial area.
_Pediatric population_
Use in adolescents (12‑18 years of age) for the treatment of acne
vulgaris. Dose adjustment is not required when Skinoren Gel
is administered to adolescents aged 12‑18 years.
The safety and efficacy of Skinoren Gel for the treatment of acne
vulgaris in children below the age of 12 years have not been
established.
The safety and efficacy of Skinoren Gel for the treatment of
papulopustular rosacea in children below the age of 18 years have
not been established.
_Geriatric patients_
No targeted studies have been performed in patients aged 65 and over.
_Patients with hepatic impairment_
No targeted studies have been performed in patients with hepatic
impairment.
_Patients with renal impairment_
No targeted studies have been performed in patients with renal
impairment.
Method of administration
Health Products Regulatory Authority
20 August 2019
CRN0098NH
Page 2 of 7
Before Skinoren Gel is applied, the skin should be thoroughly cleaned
with plain water and dried. A mild skin-cleansing agent
may be used.
Occlusive dressing or wrappings should not be used,