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BETAMETHASONE 0.1% W/W CUTANEOUS FOAM

Active substance(s): BETAMETHASONE

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Bettamousse® 0.1% w/w cutaneous foam/
Betamethasone 0.1% w/w cutaneous foam
(betamethasone valerate)
Your medicine is known by either of the above names, but will be referred to
as Bettamousse throughout this:
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 or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
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.

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.
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
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.

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.'

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.

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

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.

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.

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.
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.

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.

5) How to store Bettamousse
 Keep all medicines out of the reach and sight of children.
 Do not use Bettamousse after the expiry date printed on the can and carton
label. The expiry date refers to the last day of that month.
 Do not store above 25°C. Do not refrigerate.
 Keep away from fire or direct heat as this product is extremely flammable.
Do not spray on a naked flame or any heat-generating material. Do not
smoke whilst using or holding this can, and keep the can away from all
sources of ignition.
 Do not pierce or burn the can, even when empty.
 If the medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 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 to protect the environment.

6. Contents of the pack and other information
What Bettamousse contains
Bettamousse contains as the active ingredient 0.1% w/w betamethasone (as
betamethasone valerate).
It also contains cetyl alcohol, stearyl alcohol, polysorbate 60, ethanol, purified
water, propylene glycol, citric acid anhydrous, potassium citrate with a
propane and butane mixture as the propellant.
What Bettamousse looks and contents of the pack
The container consists of aluminium can with a valve and a clear cap.
The can contains 100g of white foam.
PL 10383/1688

Bettamousse 0.1% w/w cutaneous foam/
Betamethasone 0.1% w/w cutaneous foam

POM

Marketing Authorisation Holder and Manufacturer
Your medicine is manufactured by Aerosol Service Italiana S.r.l. Via del
Maglio, 6-23868 Valmadrera Italy and is procured from within the EU and
repackaged by the Product Licence holder: Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 04.09.2015.
Bettamousse is a registered trademark of RPH Pharmaceuticals AB, Sweden.

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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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