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BETTAMOUSSE 0.1 W/W CUTENEOUS FOAM

Active substance(s): BETAMETHASONE

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S1155 LEAFLET Bettamousse 20151119

PACKAGE LEAFLET: INFORMATION FOR THE USER

BETTAMOUSSE® 0.1% w/w CUTANEOUS FOAM
(betamethasone valerate)

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:

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.





Use as little Bettamousse as possible for the shortest
possible time

Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor or
pharmacist.

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



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.



Avoid contact with the inside of your nose and mouth



Avoid contact with any open wounds.



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 0.1% w/w cutaneous foam will be
called Bettamousse.

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.

What is in this leaflet:
1. What Bettamousse is and what it is used for

Use in children over 6 years of age:

2. What you need to know before you use Bettamousse



The dose depends on their physical size

3. How to use Bettamousse



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

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



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.

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.

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.

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.’

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

Effects of using a high dose of Bettamousse for a long time:
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.



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 or 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 on the MHRA website: 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.

5. How to store Bettamousse

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
can.

Medical check-ups



Do not store above 25°C. Do not refrigerate.

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.



Pressurised container - protect from sunlight and do not expose
to temperatures above 50°C. Do not pierce or burn container
even when empty. Do not spray near a naked flame or any
heat-generating material, and keep this can away from sources
of ignition. Do not smoke when near this can.



When you have finished your treatment, dispose of the can
safely. Never throw the can in a fire even if empty.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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.

6. Contents of the pack and other information

Your condition may return after you stop using Bettamousse. If this
happens, talk to your doctor as soon as possible.

What Bettamousse contains

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



Bettamousse contains 0.1% w/w of the active ingredient,
betamethasone as valerate, in a white foam.



Bettamousse also contain the following inactive ingredients:
cetyl alcohol, stearyl alcohol, polysorbate 60, ethanol, purified
water, propylene glycol, citric acid anhydrous, potassium citrate,
and butane/propane mixture.

4. Possible side effects
Like all medicines Bettamousse can cause side effects, although
not everybody gets them.

What Bettamousse looks like and contents of the pack

Stop using Bettamousse and seek immediate medical advice if
you have any of the following symptoms:



Pressurised container containing a white foam mousse.



It is available in cans of 100g of mousse.



Headache

Product Licence holder



Stinging



Itching.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Uncommon: may affect up to 1 in 100 people

Manufacturer



Infection of the skin

This product is manufactured by



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.

Aerosol Service Italiana S.r.l, Via Del Maglio No. 6
23868 Valmedrera (Lecco), Italy.



Pharmasol Limited., North Way, Walworth Industrial Estate,
Andover, Hampshire, SP10 5AZ, United Kingdom.



Recipharm Ltd., Ashton-under-Lyne, Lancashire, OL7 9RR,
United Kingdom.

POM PL 19488/1155
Leaflet revision date: 19 November 2015
Bettamousse is a registered trade mark of CCL Pharmaceuticals
Limited, UK.
S1155 LEAFLET Bettamousse 20151119

S1155 LEAFLET Betamethasone 20151119

PACKAGE LEAFLET: INFORMATION FOR THE USER

BETAMETHASONE VALERATE 0.1% w/w CUTANEOUS
FOAM
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

3. How to use Betamethasone
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:



Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor or
pharmacist.

Use as little Betamethasone as possible for the shortest
possible time





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.

Avoid contact with your eyes. If Betamethasone 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.





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, Betamethasone valerate 0.1% w/w cutaneous
foam will be called Betamethasone.

What is in this leaflet:

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 Betamethasone and see your doctor again.

1. What Betamethasone is and what it is used for
2. What you need to know before you use Betamethasone

Use in children over 6 years of age:

3. How to use Betamethasone



The dose depends on their physical size

4. Possible side effects



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 Betamethasone for more than 5 to 7 days on
children. If the symptoms have not improved see your
doctor again

5. How to store Betamethasone
6. Contents of the pack and other information.
1. What Betamethasone is and what it is used for
Betamethasone contains the active substance Betamethasone as
valerate.
Betamethasone belongs to a group of medicines called
corticosteroids (‘steroids’ for short).

Do not use in children under 6 years of age

Betamethasone 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. Betamethasone 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.

For adults and children: Where there is some improvement in
symptoms, Betamethasone can be applied just once a day. If the
condition continues to get better, it may be possible to apply
Betamethasone once every few days, to keep the symptoms from
coming back.

2. What you need to know before you use Betamethasone

If you have a skin infection your doctor will give you another
medicine to treat the infection

Do not use Betamethasone:





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.

As symptoms improve

Infections

Whilst you have an infection, your doctor may tell you to stop using
Betamethasone.
If you are not sure about how much mousse to use, ask your doctor
or pharmacist.
Instructions for use:
1. Remove the cap.

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 Betamethasone
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 Betamethasone
Tell your doctor or pharmacist if you are taking, using, have recently
taken or used or might take or use any other medicines.

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.

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.
Betamethasone contains Cetyl Alcohol and Stearyl Alcohol
which may cause local skin reactions (e.g. contact dermatitis)
Betamethasone contains propylene glycol which may cause skin
irritation.’

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

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 Betamethasone 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 Betamethasone 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 or 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 on the MHRA website: www.mhra.gov.uk/yellowcard.
6. You can wash and dry your hair immediately before applying
the mousse.

By reporting side effects you can help provide more information on
the safety of this medicine.

This product is flammable. Do not use Betamethasone near a
naked flame or direct source of heat. Do not smoke while using or
holding the can.

5. HOW TO STORE BETAMETHASONE


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Medical check-ups



Do not use after the expiry date printed on the carton label or
can.



Do not store above 25°C. Do not refrigerate.



Pressurised container - protect from sunlight and do not expose
to temperatures above 50°C. Do not pierce or burn container
even when empty. Do not spray near a naked flame or any
heat-generating material, and keep this can away from sources
of ignition. Do not smoke when near this can.



When you have finished your treatment, dispose of the can
safely. Never throw the can in a fire even if empty.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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 Betamethasone 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 Betamethasone for a
long time can lead to a number of side effects (see section 4).
If you forget to use Betamethasone
Do not use a double dose to make up for a forgotten dose. Simply
take the next dose as planned.
If you stop using Betamethasone
Do not stop using Betamethasone without first talking to your
doctor.
Your condition may return after you stop using Betamethasone. If
this happens, talk to your doctor as soon as possible.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



Betamethasone contains 0.1% w/w of the active ingredient,
betamethasone as valerate, in a white foam.



Betamethasone also contain the following inactive ingredients:
cetyl alcohol, stearyl alcohol, polysorbate 60, ethanol, purified
water, propylene glycol, citric acid anhydrous, potassium citrate,
and butane/propane mixture.

What Betamethasone contains

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

What Betamethasone looks like and contents of the pack


Pressurised container containing a white foam mousse.



Headache



It is available in cans of 100g of mousse.



Stinging

Product Licence holder



Itching.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Uncommon: may affect up to 1 in 100 people


Infection of the skin

Manufacturer



Thinning of the skin

This product is manufactured by



Marking of the skin (such as dark spots or lines)





Red rash on the face



Bruising easily.

23868 Valmedrera (Lecco), Italy.


Pharmasol Limited., North Way, Walworth Industrial Estate,
Andover, Hampshire, SP10 5AZ, United Kingdom.



Recipharm Ltd., Ashton-under-Lyne, Lancashire, OL7 9RR,
United Kingdom.

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.

Aerosol Service Italiana S.r.l, Via Del Maglio No. 6

POM PL 19488/1155
Leaflet revision date: 19 November 2015
S1155 LEAFLET Betamethasone 20151119

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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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