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BETTAMOUSSE 0.1% CUTANEOUS FOAM

Active substance(s): BETAMETHASONE / BETAMETHASONE VALERATE

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BETTAMOUSSE® 0.1% CUTANEOUS FOAM

(betamethasone valerate)

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.
The name of your medicine is
®
BETTAMOUSSE 0.1% CUTANEOUS
FOAM Tablets but will be referred to as
Bettamousse throughout this leaflet.
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.

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.

2. What you need to know
before you 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

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.

Bettamousse contains propylene glycol
which may cause skin irritation.'

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:







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 into your hand.

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.

The recommended dose is
Adults:





Do not use Bettamousse:



Infections

Bettamousse contains Cetyl Alcohol and
Stearyl Alcohol which may cause local
skin reactions (e.g. contact dermatitis)

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.

it may be possible to apply Bettamousse
once every few days, to keep the symptoms
from coming back.

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.

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

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
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,

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.
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.
Medical check-ups
If you use this medicine for a long period of
time, your doctor may ask you to have
check-ups. These are to make sure that
your medicine is working properly and that
the dose you are taking is right for you.
If you use more Bettamousse than you
should
Wash your scalp straight away and start
again. It is unlikely that you will suffer side
effects from using too much on one
occasion. If you are concerned, contact the
nearest hospital casualty department or
your doctor.
Using more than the recommended dose of
Bettamousse for a long time can lead to a
number of side effects (see section 4).
If you forget to use Bettamousse
Do not use a double dose to make up for a
forgotten dose. Simply take the next dose
as planned.
If you stop using Bettamousse
Do not stop using Bettamousse without first
talking to your doctor.
Your condition may return after you stop
using Bettamousse. If this happens, talk to
your doctor as soon as possible.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

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:





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.
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

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.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.

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)
• Mood changes or sleep problems
• Blurred vision or pain in the eye
• Stomach upsets or discomfort
• Acne
• Headaches.

Leaflet date: 13.08.2015

These effects are more likely to happen in
children, and if dressings are applied to
cover the scalp after Bettamousse has
been applied. The frequency of
these effects on prolonged use is
unknown.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help
provide more information on the safety of
this medicine.

5. How to store Bettamousse
Keep out of the sight and reach of children.
Do not take your Bettamousse after the
expiry date which is stated on the label after
‘Exp’. The expiry date refers to the last day
of that month.
Do not store above 25°C. Do not
refrigerate.
Protect from sunlight, do not expose to
temperatures above 50°C and any other
sources of direct heat as this product is
very flammable.
Do not pierce or burn the can, even when
empty.
Medicines should not be disposed of via
wastewater or household waste. Return any
medicine you no longer need to your
pharmacist.

6. Contents of the pack and
other information
What Bettamousse contains
The active substance is betamethasone
valerate 1mg/g (0.1%).
The other ingredients are cetyl alcohol,
stearyl alcohol, polysorbate 60, ethanol,
purified water, propylene glycol, citric acid
anhydrous, potassium citrate with a
butane/propane mixture as the propellant.
What Bettamousse looks like and
contents of the pack
Bettamousse is a white, foam mousse in a
white/blue pressurised canister fitted with a
valve and a clear, plastic cap.
Each pack consists of a canister containing
100 grams of the mousse.
Manufactured by: Aerosol Service Italiana
S.r.l., Via Del Maglio, 6-23868, Valmadrera,
Italy.

®

BETTAMOUSSE 0.1% CUTANEOUS
FOAM
PL No: 18799/0797
POM
Bettamousse is a registered trademark of
RPH Pharmaceuticals AB.
.

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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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