Finacea 15% gel

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:

150mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 4260085520510

Patient Information leaflet

IIT003-00 - Page 1 of 2 - 148 x 420 mm – DRA_001123/LF0001
IIT002-00 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert
148 x 420 mm
IIT003-00
29/01/2019
JUG
100%
All products
Used for:
Segrate keyline DRA_001123/LF0001
Comments:
Approval:
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Revision info:
WHAT IS IN THIS LEAFLET
1. WHAT FINACEA
® IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE FINACEA
®
3. HOW TO USE FINACEA
®
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FINACEA
®
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT FINACEA
® IS AND WHAT IT IS
USED FOR
Finacea 15 % Gel (Finacea) contains the
active substance azelaic acid and belongs
to the group of anti-acne preparations for
external use (on the skin). Finacea 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 FINACEA
®
DO NOT USE FINACEA
•
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 Finacea.
Finacea is for external use on the skin
only.
Take care to avoid contact with the eyes,
mouth and other mucous membranes
(the thin skin around body openings).
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 Finacea.
It is advisable to avoid alcoholic
cleansers, tinctures and astringents,
abrasives and peeling agents when using
Finacea for treatment of rosacea.
Rarely, it has been reported that in some
patients with asthma who were treated
with azelaic acid worsening of asthma
symptoms had occurred.
CHILDREN AND ADOLESCENTS
Safety and efficacy in the treatment of
acne have been studied in 12-18 years
old adolescen

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finacea 15% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Finacea 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
For the relief of mild to moderate papular-pustular acne of the facial
area. For the topical treatment of papulopustular rosacea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Finacea 15 % Gel is intended for cutaneous use only.
Posology
Finacea 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 Finacea Gel is administered to
adolescents aged 12-18 years.
The safety and efficacy of Finacea Gel for the treatment of acne
vulgaris in
children below the age of 12 years have not been established.
The safety and efficacy of Finacea 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
Before Finacea 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, and hands should
be
washed after applying the gel.
In the event of skin irritation (see section 4.8 Undesirable effects),
the amount
of gel per application