Bettamousse 1mg/g (0.1% w/w) Cutaneous Foam

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Betamethasone

Dostupno od:

PCO Manufacturing Ltd.

ATC koda:

D07AC; D07AC01

INN (International ime):

Betamethasone

Doziranje:

1 (0.1%) milligram(s)/gram

Farmaceutski oblik:

Cutaneous foam

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Corticosteroids, potent (group III); betamethasone

Status autorizacije:

Authorised

Datum autorizacije:

2008-02-22

Uputa o lijeku

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETTAMOUSSE
® 1MG/G (0.1%)
CUTANEOUS FOAM
Betamethasone
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
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

In this leaflet, Bettamousse 1mg/g (0.1%) cutaneous foam
will be called Bettamousse.
WHAT IS IN THIS LEAFLET:
1.
What Bettamousse is and what it is used for
2.
What you need to know before you use Bettamousse
3.
How to use Bettamousse
4.
Possible side effects
5.
How to store Bettamousse
6.
Contents of the pack and other information
1.
WHAT BETTAMOUSSE IS AND WHAT IT IS USED FOR
Bettamousse contains the active substance Betamethasone as
valerate. Bettamousse belongs to a group of medicines called
corticosteroids (‘steroids’ for short).
Bettamousse is used to treat skin disorders of the scalp such as
psoriasis (raised red patches of skin covered in silvery scales)
that may feel itchy, tight or sore.
Bettamousse works by reducing inflammation (redness, itching
and soreness). It is important to use this medicine to prevent
damage to the skin and infections from developing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETTAMOUSSE
DO NOT USE BETTAMOUSSE:

If you are allergic to betamethasone valerate or any of the
other ingredients of this medicine (listed in section 6). Some
of these ingredients (stearyl alcohol, cetyl alcohol and
propylene glycol) may cause local skin reactions (e.g.
contact dermatitis).

If you have any kind of infection of the scalp, unless this is
already being treated

On a child under 6 years of age
If any of the above applies to you,

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bettamousse 1mg/g (0.1% w/w) Cutaneous Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone 1mg/g (0.1% w/w) as valerate
Excipients contains:
Cetyl alcohol 1.1% w/w
Stearyl alcohol 0.5% w/w
Propylene glycol 2.0% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous foam
_Product imported from Italy:_
Appearance: White, foam mousse
4 CLINICAL PARTICULARS
As per PA 1638/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 1638/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Ethanol
Purified Water
Propylene glycol
Citric acid anhydrous
Potassium Citrate
Butane/Propane
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not refrigerate.
6.5 NATURE AND CONTENTS OF CONTAINER
Pressurised container
Aluminium can with clear cover cap, with a net weight of 100g.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath