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BETTAMOUSSE 1MG/G (0.1%) CUTANEOUS FOAM

Active substance(s): BETAMETHASONE VALERATE

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283920_G01-MP00878_Layout 1 30/06/2015 09:48 Page 1

1mg/g (0.1%) Cutaneous foam

Betamethasone

Package leaflet: Information for the user
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, talk
to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist
before using Bettamousse if:

• You have any kind of skin infection
• You have open wounds on your scalp
• You are taking any other medicine,
including medicines obtained without
a prescription.
Children and adolescents
Do not give this medicine to children
under the age of 6 years.
Other medicines and Bettamousse
Tell your doctor or pharmacist if you are
taking, using, have recently taken or
used or might take or use any other
medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
There are no known effects on driving
or using machines.
Bettamousse contains Cetyl Alcohol and
Stearyl Alcohol which may cause local
skin reactions (e.g. contact dermatitis)
Bettamousse contains propylene glycol
which may cause skin irritation.'

symptoms have not improved see your
doctor again
Do not use in children under 6 years of
age
As symptoms improve
For adults and children: Where there is
some improvement in symptoms,
Bettamousse can be applied just once a
day. If the condition continues to get
better, it may be possible to apply
Bettamousse once every few days, to
keep the symptoms from coming back.
Infections
If you have a skin infection your doctor
will give you another medicine to treat
the infection
Whilst you have an infection, your
doctor may tell you to stop using
Bettamousse.
If you are not sure about how much
mousse to use, ask your doctor or
pharmacist.
Instructions for use:
1. Remove the cap.

3. How to use Bettamousse
Always use this medicine exactly as your
doctor or pharmacist has told you. Your
dose will be shown clearly on the label
that your pharmacist puts on your
medicine. Check with your doctor or
pharmacist if you are not sure.
Remember:
• Use as little Bettamousse as possible
for the shortest possible time
• Avoid contact with your eyes. If
Bettamousse gets into your eyes, rinse
well with cold water. If your eyes
continue to sting, contact your doctor
• Avoid contact with the inside of your
nose and mouth
• Avoid contact with any open wounds.

2. Turn the can upside down and squirt
the required amount of mousse onto a
clean saucer or something similar. The
mousse melts when it touches your skin,
so do not squirt it in to your hand.

The recommended dose is
Adults:
• No more than a golfball sized amount
of mousse
• Massage into the affected areas of the
scalp twice a day (in the morning and
evening)
• If there is no improvement in your
condition after 7 days, stop using
Bettamousse and see your doctor
again.
Use in children over 6 years of age:
• The dose depends on their physical
size
• The usual dose for children is less than
for adults. For example, for a child
half the size of an adult, use no more
than half a golf ball sized amount of
mousse
• Massage into the affected area of the
scalp twice a day (in the morning and
evening)
• Do not use Bettamousse for more
than 5 to 7 days on children. If the

3. Massage the mousse into the affected
areas of your scalp, and not your hair.
Allow your hair to dry naturally.

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4. Wash your hands immediately after
using the mousse.

5. Do not wash your hair straight after
applying the mousse. Let the mousse
work overnight or through the day.

6. You can wash and dry your hair
immediately before applying the mousse.

• Headache
• Stinging
• Itching.
Uncommon: may affect up to 1 in 100
people)
• Infection of the skin
• Thinning of the skin
• Marking of the skin (such as dark
spots or lines)
• Red rash on the face
• Bruising easily.

refrigerate. Protect from sunlight and
any other sources of direct heat as this
product is very flammable.

Rare: may affect up to 1 in 1,000
people)
• Sensitivity reactions such as itching,
redness and stinging
• Lighter or darker patches of skin
• Hair loss
• Infection of the hair follicles
• Red spots on the skin.

6. Contents of the pack and
other information

Not known: frequency cannot be
estimated from the available data
• Worsening of the scalp condition,
causing pus-filled ulcers to form
• Acne
• Purple stained skin
• Rash around the mouth.

Effects of using a high dose of
Bettamousse for a long time:
• Extra hair growth
• Changes in skin colour
• Irregular periods in women,
• Water retention (bloated feeling)
Medical check-ups
• Mood changes or sleep problems
If you use this medicine for a long
• Blurred vision or pain in the eye
period of time, your doctor may ask
you to have check-ups. These are to
• Stomach upsets or discomfort
make sure that your medicine is
• Acne
working properly and that the dose
• Headaches.
you are taking is right for you.
These effects are more likely to happen
If you use more Bettamousse than you in children, and if dressings are applied
should
to cover the scalp after Bettamousse
has been applied. The frequency of
Wash your scalp straight away and
these effects on prolonged use is
start again. It is unlikely that you will
suffer side-effects from using too much unknown.
on one occasion. If you are concerned, Reporting of side effects
contact the nearest hospital casualty
If you get any side effects, talk to your
department or your doctor.
doctor or pharmacist or nurse. This
Using more than the recommended
includes any possible side effects not
dose of Bettamousse for a long time
listed in this leaflet.
can lead to a number of side effects
United Kingdom: You can also report
(see section 4).
side effects directly via Yellow Card
Scheme on the MHRA website
If you forget to use Bettamousse
(www.mhra.gov.uk/yellowcard). By
Do not use a double dose to make up
reporting side effects you can help
for a forgotten dose. Simply take the
provide more information on the safety
next dose as planned.
of this medicine.
Ireland: You can also report side effects
If you stop using Bettamousse
Do not stop using Bettamousse without directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2. Tel:
first talking to your doctor.
+353 1 6764971. Fax: +353 1
Your condition may return after you
6762517.
stop using Bettamousse. If this
happens, talk to your doctor as soon as Website: www.hpra.ie, e-mail:
medsafety@hpra.ie. By reporting side
possible.
effects you can help provide more
If you have any further questions on
information on the safety of this
the use of this medicine, ask your
medicine.
doctor or pharmacist.
This product is flammable. Do not use
Bettamousse near a naked flame or
direct source of heat. Do not smoke
while using or holding the can.

4. Possible side effects
Like all medicines Bettamousse can
cause side effects, although not
everybody gets them.
Stop using Bettamousse and seek
immediate medical advice if you have
any of the following symptoms:

5. How to store Bettamousse
Keep this medicine out of the sight and
reach of children.
Do not use Bettamousse after the
expiry date on the label. The expiry
date refers to the last day of that
month.
Do not store above 25oC. Do not

Do not pierce or burn the can, even
when empty.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

What Bettamousse contains
The active substance is betamethasone
(as valerate) 1 mg/g (0.1 %).
The other ingredients are cetyl alcohol,
stearyl alcohol, polysorbate 60,
ethanol, purified water, propylene
glycol, citric acid anhydrous,
potassium citrate, and butane/propane.
What Bettamousse looks like and
contents of the pack
Bettamousse is a white cutaneous foam
mousse.
Bettamousse comes in an aluminium
can with a valve and a clear cap. It
comes in two sizes, 50 g or 100 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
RPH Pharmaceuticals AB,
Lagervägen 7,
136 50 Jordbro, Sweden
Manufacturers
Pharmasol Limited
North Way
Walworth Industrial Estate
Andover
Hampshire
SP10 5AZ
UK
Aerosol Service Italia S.r.l.
Via del Maglio No. 6
Valmadrera
23868 LECCO
Italy
Recipharm Ltd
Ashton-under-Lyne
Lancashire, OL7 9RR UK
If this leaflet is difficult to see or read
or you would like it in a different
format, please contact:
RPH Pharmaceuticals AB, Lagervägen 7,
136 50 Jordbro,
Sweden
This leaflet was last revised June 2015
MP00878

283920_G01-MP00878_Layout 1 30/06/2015 09:48 Page 3

32-42 Station Road
Heaton Mersey, Stockport
Cheshire. SK4 3QT
Product Description/Component

MP00878 Bettamousse UK PIL

TECHNICAL SUPPORT APPROVAL
SIGNATURE

185mm x 280mm
Size folded

PRINT NAME

185mm x 30mm

POSITION

Scale

DATE

100%
Draft / Date

8. 30/06/15
Colours

REGULATORY APPROVAL*

Black & tints of black
Originator

SIGNATURE

Pulse Creative
Pharma

241

241

Material

White opaque 50gsm

REGULATORY/COMPANY

PRINT NAME
POSITION
DATE

Title to view/code reverse
Supercedes

Min text size

9pt
Pulse code

283920_H01
Other info

*AUTHORISED TO PRINT COMPONENT

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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