BETAMETHASONE VALERATE 0.1W/W CUTANEOUS FOAM

Active substance: BETAMETHASONE

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How much to use

S1155 LEAFLET Bettamousse 20121005

Adults:

PACKAGE LEAFLET: INFORMATION FOR THE USER



BETTAMOUSSE 0.1% w/w CUTANEOUS FOAM
(betamethasone valerate)
Your medicine is known as Bettamousse 0.1% w/w Cutaneous
Foam but will be referred to as Bettamousse in the following leaflet.
Read all of this leaflet carefully before you start using this
medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
In this leaflet:

The usual adult dose is 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.

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

1. What Bettamousse is for

Do not use in children under 6 years of age

2. Before you use Bettamousse

As symptoms improve

3. How to use Bettamousse

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

4. Possible side effects
5. How to store Bettamousse
6. Further information.
1. WHAT BETTAMOUSSE IS FOR
Bettamousse belongs to a group of medicines called corticosteroids
(‘steroids’ for short).
Bettamousse works by reducing inflammation (redness, itching and
soreness). 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.
It is important to use this medicine to prevent damage to the skin
and infections from developing.

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.

2. BEFORE YOU USE BETTAMOUSSE
Do not use Bettamousse:


If you are allergic to betamethasone valerate



If you are allergic to any of the other ingredients of
Bettamousse (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.
Check with your doctor before using Bettamousse if:


You have any kind of skin infection



You have open wounds on your scalp



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.

You are taking any other medicine, including medicines
obtained without a prescription.

3.

Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding
ask your doctor or pharmacist for advice before using Bettamousse.
3. HOW TO USE BETTAMOUSSE
Important:
Your doctor will choose the dose that is right for you. Your
dose will be shown clearly on the label that your pharmacist
puts on your medicine. If it does not, or you are not sure, ask
your doctor or pharmacist.
Remember:


Always use Bettamousse exactly as your doctor has told
you



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.

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.

Other side effects:


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:


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



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

Extra hair growth



Headaches.

These effects are more likely to happen in children, and if dressings
are applied to cover the scalp after Bettamousse has been applied.
6. You can wash and dry your hair immediately before applying
the mousse.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your 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.

5. HOW TO STORE BETTAMOUSSE


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 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 missed 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 about the use of this medicine,
ask your doctor or pharmacist.

6. FURTHER INFORMATION
What Bettamousse contains


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


Headache



Stinging



Itching.

Uncommon side effects

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.
What Bettamousse looks like and contents of the pack


Pressurised container containing a white foam mousse.

 It is available in cans of 100g of mousse.
Product Licence holder



Infection of the skin

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



Thinning of the skin

Manufacturer



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



Red rash on the face

This product is manufactured by Aerosol Service Italiana S.r.l, Via
Del Maglio, 6-23868, Valmedrera, Italy.

(affect less than 1 in 100 people):

 Bruising easily.
Rare side effects

POM PL No. 19488/1155

(affect less than 1 in 1000 people):


Sensitivity reactions such as itching, redness and stinging

Leaflet revision date: 05 October 2012



Lighter or darker patches of skin



Hair loss

Bettamousse is a registered trade mark of CCL Pharmaceuticals
Limited, UK.



Infection of the hair follicles



Red spots on the skin.

S1155 LEAFLET Bettamousse 20121005

S1155 LEAFLET Betamethasone 20121005

PACKAGE LEAFLET: INFORMATION FOR THE USER

BETAMETHASONE VALERATE 0.1% w/w CUTANEOUS
FOAM
(betamethasone valerate)
Your medicine is known as Betamethasone Valerate 0.1% w/w
Cutaneous Foam but will be referred to as Betamethasone in the
following leaflet.
Read all of this leaflet carefully before you start using this
medicine.


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



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

Adults:


The usual adult dose is 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.

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

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



How much to use

In this leaflet:
1. What Betamethasone is for

Do not use in children under 6 years of age

2. Before you use Betamethasone

As symptoms improve

3. How to use Betamethasone

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.
Infections

4. Possible side effects
5. How to store Betamethasone
6. Further information.
1. WHAT BETAMETHASONE IS FOR
Betamethasone belongs to a group of medicines called
corticosteroids (‘steroids’ for short).
Betamethasone works by reducing inflammation (redness, itching
and soreness). 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.
It is important to use this medicine to prevent damage to the skin
and infections from developing.

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
Betamethasone.
If you are not sure about how much mousse to use, ask your doctor
or pharmacist.
Instructions for use:
1. Remove the cap.

2. BEFORE YOU USE BETAMETHASONE
Do not use Betamethasone:


If you are allergic to betamethasone valerate



If you are allergic to any of the other ingredients of
Betamethasone (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.
Check with your doctor before using Betamethasone if:
3.
 You have any kind of skin infection


You have open wounds on your scalp



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.

You are taking any other medicine, including medicines
obtained without a prescription.

Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding
ask your doctor or pharmacist for advice before using
Betamethasone.
3. HOW TO USE BETAMETHASONE
Important:
Your doctor will choose the dose that is right for you. Your
dose will be shown clearly on the label that your pharmacist
puts on your medicine. If it does not, or you are not sure, ask
your doctor or pharmacist.
Remember:


Always use Betamethasone exactly as your doctor has
told you



Use as little Betamethasone as possible for the shortest
possible time



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.

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.

Other side effects:


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 Betamethasone for a long time:


Water retention (bloated feeling)
Mood changes or sleep problems
Blurred vision or pain in the eye



Stomach upsets or discomfort



Acne



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.
Medical check-ups

Irregular periods in women,




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

Changes in skin colour




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

Extra hair growth



Headaches.

These effects are more likely to happen in children, and if dressings
are applied to cover the scalp after Betamethasone has been
applied.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE BETAMETHASONE

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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

If you use more Betamethasone than you should



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.

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

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS



Like all medicines Betamethasone can cause side effects, although
not everybody gets them.

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



Betamethasone also contains 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

Stop using Betamethasone and seek immediate medical help if
you have any of the following symptoms:


Headache



Stinging



Itching.

Uncommon side effects

What Betamethasone looks like and contents of the pack


Pressurised container containing a white foam mousse.



It is available in cans of 100g of mousse.

(affect less than 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 side effects

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Aerosol Service Italiana S.r.l, Via
Del Maglio, 6-23868, Valmedrera, Italy.

(affect less than 1 in 1000 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.

POM PL No. 19488/1155
Leaflet revision date: 05 October 2012
S1155 LEAFLET Betamethasone 20121005

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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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