Dermovate 0.05 % w/w Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clobetasol propionate

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

D07AD; D07AD01

INN (International Name):

Clobetasol propionate

Dosage:

0.05 percent weight/weight

Pharmaceutical form:

Ointment

Therapeutic area:

Corticosteroids, very potent (group IV); clobetasol

Authorization date:

2017-04-13

Patient Information leaflet

DERMOVATE 0.05% W/W OINTMENT
(clobetasol propionate)
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.
*
In this leaflet, Dermovate 0.05 % w/w Ointment will be called
Dermovate.
WHAT IS IN THIS LEAFLET
What Dermovate is and what it is used for
What you need to know before you use Dermovate
How to use Dermovate
Possible side effects
How to store Dermovate
Contents of the pack and other information
WHAT DERMOVATE IS AND WHAT IT IS USED FOR
Dermovate contains the active substance clobetasol propionate which
belongs to a group of medicines called corticosteroids. It helps to
reduce
redness, swelling and irritation of the skin. (These should not be
confused
with “anabolic” steroids misused by some body builders and
athletes and
taken as tablets or injections).
Dermovate is used to help reduce the redness and itchiness of certain
skin
problems in adults, the elderly and children over the age of 1 year.
These skin problems include:
*
frequently relapsing eczema
*
psoriasis (thickened patches of inflamed, red skin, often covered by
silvery
scales), excluding widespread plaque psoriasis
*
lichen planus (a skin disease that causes itchy, reddish-purple,
flat-topped
bumps on wrists, forearms or lower legs)
*
discoid lupus erythematosus (a disease of the skin most often
affecting the
face, ears and scalp causing scarring and increased sensitivity of the
affected skin to sunlight)
*
conditions that have not responded to milder steroid creams or
ointments.
For children over the age of 1 year, Dermovate is used for dermatitis
that
has not r

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2022
CRN00CT8T
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dermovate 0.05 % w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 0.5 mg of clobetasol propionate
(equivalent to 0.05% w/w).
Excipients with known effect:
Propylene glycol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment
_Product imported from Romania_
A white to off-white, translucent, homogeneous ointment.
4 CLINICAL PARTICULARS
As per PA1077/005/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/005/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Propylene glycol
Sorbitan sesquioleate
White soft paraffin
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the tube and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30
°
C in the original packaging.
Health Products Regulatory Authority
23 February 2022
CRN00CT8T
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Dermovate Ointment is supplied in 4 x 25g collapsible aluminium tubes.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
Patients should be advised to wash their hands after applying
Dermovate, unless it is the hands that are being treated.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/005/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13
th
April 2017
10 DATE OF REVISION OF THE TEXT
February 2022