DERMOVATE SCALP APPLICATION 0.05 %w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOBETASOL PROPIONATE

Available from:

LTT Pharma Limited

ATC code:

D07AD01

INN (International Name):

CLOBETASOL PROPIONATE

Dosage:

0.05 %w/v

Pharmaceutical form:

Cutaneous Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, very potent (group IV)

Authorization status:

Authorised

Authorization date:

2012-12-07

Patient Information leaflet

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 Scalp Application 0.05% w/v Cutaneous
Solution
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 scalp. (These should not be
confused
with “anabolic steroids” misused by some body builders and taken
as tablets
or injections).
Dermovate is used to help reduce the redness and itchiness of certain
scalp
problems in adults, the elderly and children over the age of 1 year.
These include frequently relapsing dermatoses and psoriasis (thickened
patches of inflamed, red skin, often covered by silvery scales) that
have not
responded to milder steroid creams, ointments, lotions or scalp
applications.
WHAT YOU NEED TO KNOW BEFORE YOU USE DERMOVATE
DO NOT USE DERMOVATE:
*
if you are allergic (hypersensitive) to clobetasol propionate or any
of the
other ingredients of Dermovate (listed in Section 6).
*
if you have a skin infection on your scalp
*
on a child under the age of 1 year.
Do not use if any of the above apply to you. If you are not sure, talk
to your
doctor or pharmacist before using Dermovate.
WARNINGS AND PRECAUTIONS
Talk to your docto

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dermovate Scalp Application 0.05% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasol propionate 0.05% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
_Product imported from Portugal_
A colourless, clear to slightly hazy, slightly viscous solution.
4 CLINICAL PARTICULARS
As per PA1077/005/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/005/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Isopropyl Alcohol
Carbomer 980 NF
Sodium Hydroxide
Purified Water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC.
Contents are flammable. Keep away from fire, flame or heat. Do not
leave clobetasol propionate scalp application in
direct sunlight.
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6.5 NATURE AND CONTENTS OF CONTAINER
A plastic bottle with an elongate nozzle containing a colourless,
clear to slightly hazy, slightly viscous liquid.
Pack size: 100 ml
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF TH