BETAMETHASONE VALERATE 0.1%W/W OINTMENT

Active substance: BETAMETHASONE VALERATE

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Betamethasone Valerate
0.1%w/w Ointment
betamethasone valerate

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.
If any of the side effects get serious, or if you notice
any side effect not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What Betamethasone ointment is and what it is used
for
2. Before you use Betamethasone ointment
3. How to use Betamethasone ointment
4. Possible side effects
5. How to store Betamethasone ointment
6. Further information

1. What Betamethasone ointment is and
what it is used for
Betamethasone Valerate 0.1%w/w Ointment
(hereinafter referred to as Betamethasone ointment)
contains a topical steroid. 'Topical' means that it is put
on the skin. Topical steroids are used on certain types
of inflamed skin, to reduce the redness and itchiness.
Betamethasone ointment is used to treat inflamed skin
conditions, such as eczema, in patients unresponsive
to less potent creams or ointments.
These steroids should not be confused with "anabolic"
steroids misused by some body builders and athletes
and taken as tablets or injections.

2. Before you use Betamethasone ointment
Do not use Betamethasone ointment:
if you are allergic (hypersensitive) to
betamethasone valerate or any of the other
ingredients of Betamethasone ointment (see
section 6 for other ingredients).
in infants under one year of age
on areas of skin which have the following
conditions:
acne
rosacea (redness and spots or blisters in the
centre of the face around the nose)
peri-oral dermatitis (spotty red rash around the
mouth)
skin infections caused by viruses, bacteria or
fungi, such as cold sores, herpes, chickenpox,
impetigo, ringworm, athlete's foot, thrush
on areas of skin other than those that you
showed to your doctor

around the anus (back passage) or on the
genitals (private parts) unless your doctor has
told you to do so.
This ointment contains propylene glycol, which may
cause skin irritation.
It also contains stearyl alcohol, which may cause local
skin reactions (e.g. contact dermatitis).
Take special care with Betamethasone ointment:
If you have had an allergic reaction, such as
redness or itching, after applying any creams or
ointments. Please tell your doctor or pharmacist if
you have experienced allergies to creams or
ointments in the past.
You should not normally use this ointment on your
face where the skin thins easily unless your doctor
has told you to do so. If possible, any course of
treatment involving the face should not last more
than 5 days.
Do not get the ointment in your eyes. If you
accidentally get some ointment in your eyes wash it
out and contact your doctor immediately.
If your doctor has prescribed the ointment for
psoriasis, you should let your doctor review your
progress at regular intervals, as such treatment
needs careful supervision.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
There are no known interactions with other
medications.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medication. It is advisable to avoid the extensive
use of betamethasone in pregnancy. If you are
pregnant or think you may be pregnant please tell your
doctor or pharmacist before using this medication.
Driving and using machines
There are no known effects of this medicine on your
ability to drive or use machinery.

3. How to use Betamethasone ointment
Always use Betamethasone ointment exactly as your
doctor has told you. You should check with your doctor
or pharmacist if you are not sure. The usual dose is:
Adults and children (over 1 year of age)
Wash your hands each time before you use the
ointment. Apply the ointment in a thin layer to the area
to be treated, and rub in gently. Wash your hands
again when you have finished, unless you are treating
the hands.
Most patients use the ointment two or three times a day
when they start treatment, but can use it less often as
the condition improves.
(continued overleaf)

Body copy set in 9pt Swiss 721 Roman
Sub Heads in 10pt Swiss 721 Bold

If anyone else helps to apply the ointment, they should
wear disposable plastic gloves or wash their hands
thoroughly before and after using the ointment.
You should not use the ointment on large areas of the
body for many weeks or months. This is particularly
important when the ointment is used to treat children.
When used to treat children, the ointment should not
be used for a period longer than five days.
You should not normally use the ointment on the face
where the skin thins easily.
If using on children do not cover the area treated with
a nappy or dressing which does not let the skin
breathe (occlusive dressing) unless your doctor has
told you to do so. Covering the ointment with an
airtight dressing can make it easier for the active
ingredient to pass through the skin.
Do not use Betamethasone ointment on infants
under one year of age
If the skin problem does not improve in two weeks, tell
your doctor.
If you use more Betamethasone ointment than you
should
If you use more than you should, by mistake, on a few
occasions, do not worry. If you apply a lot or a lot is
accidentally swallowed, it could make you ill. Talk to
your doctor or go to the hospital as soon as possible.
If you forget to use Betamethasone ointment
If you forget to apply the ointment at the usual time,
apply it when you remember, unless it is close to the
time for the next application. Do not apply a double
amount to make up for a forgotten application.
If you stop using Betamethasone ointment
It is important that you do not stop using your ointment
unless advised to do so by your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Some people may have side effects when taking this
medicine. If you have any unwanted side effects you
should seek advice from your doctor, pharmacist or
other healthcare professional. Also you can help to
collect more information on the safety of this medicine
by reporting any unwanted side effects via the internet
at www.mhra.gov.uk/yellowcard; alternatively you can
call Freephone 0808 100 3352 (available between
10am-2pm Monday - Friday) or fill in a paper form
available from your local pharmacy.
If you notice any of the following reactions stop using
the ointment and speak to your doctor immediately:
Very rare (occurs in less than 1 in 10,000 people)
skin rash, itching, shortness of breath, wheezing
and/or swollen face (symptoms of an allergic
hypersensitivity reaction).
If you use large amounts of the ointment, use it for a
long time, or use it under an airtight dressing or baby's
nappy you may notice the following side effects:
your face shape seems to be changing ('moon'
face) and/or you gain extra body weight
unexpectedly (features of Cushing's syndrome)

thinning of skin so that it damages more easily
unusual purple stretch marks anywhere on your
body
surface veins may become more noticeable.
Other possible side effects:
Common (occurs in less than 1 in 10 people)
burning and/or itching where the ointment is
applied.
Rare (occurs in less than 1 in every 1,000 people)
glaucoma (high pressure in your eye) when used
around your eyes
if being treated for psoriasis (or when treatment is
stopped), the condition gets worse.
(Frequency unknown)
inflammation of the skin, including the mouth
acne
abnormal changes in hair growth or skin colour.
In children, absorption of the active ingredient through
the skin can affect the rate at which they grow.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5. How to store Betamethasone ointment
Keep the ointment in a safe place, out of the reach and
sight of children.
Do not store above 25ºC. Store in the original tube with
the top screwed on.
Do not use the ointment after the expiry date, which is
printed on the tube.
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.

6. Further information
What Betamethasone ointment contains
This medicine contains the active ingredient
betamethasone (as valerate) 0.1%w/w. It also contains
cholesterol, stearyl alcohol, white beeswax, white soft
paraffin and propylene glycol.
What Betamethasone ointment looks like and
contents of the pack
The ointment is available in tubes of 30g and 100g.
Marketing Authorisation Holder
Manx Healthcare Ltd., Taylor Group House, Warwick,
CV34 5YA, United Kingdom.
Manufacturer
Beltapharm SpA, Via Stelvio 66, 20095 Cusano, Milan,
Italy.
Other Formats
To request a copy of this leaflet in Braille, large print or
audio please call 01926 482511.
This leaflet was revised in February 2012

URN: GB41B-PIL-07-230212

Body copy set in 9pt Swiss 721 Roman
Sub Heads in 10pt Swiss 721 Bold

PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Betamethasone Valerate
0.1%w/w Ointment
betamethasone valerate

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.
If any of the side effects get serious, or if you notice
any side effect not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What Betamethasone ointment is and what it is
used for
2. Before you use Betamethasone ointment
3. How to use Betamethasone ointment
4. Possible side effects
5. How to store Betamethasone ointment
6. Further information

1. What Betamethasone ointment is and what
it is used for
Betamethasone Valerate 0.1%w/w Ointment (hereinafter
referred to as Betamethasone ointment) contains a topical
steroid. 'Topical' means that it is put on the skin. Topical
steroids are used on certain types of inflamed skin, to
reduce the redness and itchiness. Betamethasone
ointment is used to treat inflamed skin conditions, such as
eczema, in patients unresponsive to less potent creams or
ointments.
These steroids should not be confused with "anabolic"
steroids misused by some body builders and athletes and
taken as tablets or injections.

2. Before you use Betamethasone ointment
Do not use Betamethasone ointment:
if you are allergic (hypersensitive) to betamethasone
valerate or any of the other ingredients of
Betamethasone ointment (see section 6 for other
ingredients).
in infants under one year of age
on areas of skin which have the following conditions:
acne
rosacea (redness and spots or blisters in the centre
of the face around the nose)
peri-oral dermatitis (spotty red rash around the
mouth)
skin infections caused by viruses, bacteria or fungi,
such as cold sores, herpes, chickenpox, impetigo,
ringworm, athlete's foot, thrush.

on areas of skin other than those that you showed to
your doctor
around the anus (back passage) or on the genitals
(private parts) unless your doctor has told you to do
so.
This ointment contains propylene glycol, which may
cause skin irritation.
It also contains stearyl alcohol, which may cause local
skin reactions (e.g. contact dermatitis).
Take special care with Betamethasone ointment:
If you have had an allergic reaction, such as redness
or itching, after applying any creams or ointments.
Please tell your doctor or pharmacist if you have
experienced allergies to creams or ointments in the
past.
You should not normally use this ointment on your
face where the skin thins easily unless your doctor has
told you to do so. If possible, any course of treatment
involving the face should not last more than 5 days.
Do not get the ointment in your eyes. If you
accidentally get some ointment in your eyes wash it
out and contact your doctor immediately.
If your doctor has prescribed the ointment for
psoriasis, you should let your doctor review your
progress at regular intervals, as such treatment needs
careful supervision.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
There are no known interactions with other medications.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medication. It is advisable to avoid the extensive use of
betamethasone in pregnancy. If you are pregnant or think
you may be pregnant please tell your doctor or pharmacist
before using this medication.
Driving and using machines
There are no known effects of this medicine on your ability
to drive or use machinery.

3. How to use Betamethasone ointment
Always use Betamethasone ointment exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is:
Adults and children (over 1 year of age)
Wash your hands each time before you use the ointment.
Apply the ointment in a thin layer to the area to be treated,
(continued overleaf)

and rub in gently. Wash your hands again when you have
finished, unless you are treating the hands.
Most patients use the ointment two or three times a day
when they start treatment, but can use it less often as the
condition improves.
If anyone else helps to apply the ointment, they should
wear disposable plastic gloves or wash their hands
thoroughly before and after using the ointment.
You should not use the ointment on large areas of the
body for many weeks or months. This is particularly
important when the ointment is used to treat children.
When used to treat children, the ointment should not be
used for a period longer than five days.
You should not normally use the ointment on the face
where the skin thins easily.
If using on children do not cover the area treated with a
nappy or dressing which does not let the skin breathe
(occlusive dressing) unless your doctor has told you to do
so. Covering the ointment with an airtight dressing can
make it easier for the active ingredient to pass through the
skin.
Do not use Betamethasone ointment on infants under
one year of age
If the skin problem does not improve in two weeks, tell
your doctor.
If you use more Betamethasone ointment than you
should
If you use more than you should, by mistake, on a few
occasions, do not worry. If you apply a lot or a lot is
accidentally swallowed, it could make you ill. Talk to
your doctor or go to the hospital as soon as possible.
If you forget to use Betamethasone ointment
If you forget to apply the ointment at the usual time, apply
it when you remember, unless it is close to the time for the
next application. Do not apply a double amount to make
up for a forgotten application.
If you stop using Betamethasone ointment
It is important that you do not stop using your ointment
unless advised to do so by your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Betamethasone ointment can cause
side effects, although not everybody gets them.
If you notice any of the following reactions stop using the
ointment and speak to your doctor immediately:
Very rare (occurs in less than 1 in 10,000 people)
skin rash, itching, shortness of breath, wheezing and/
or swollen face (symptoms of an allergic
hypersensitivity reaction).
If you use large amounts of the ointment, use it for a long
time, or use it under an airtight dressing or baby's nappy
you may notice the following side effects:
your face shape seems to be changing ('moon' face)

and/or you gain extra body weight unexpectedly
(features of Cushing's syndrome)
thinning of skin so that it damages more easily
unusual purple stretch marks anywhere on your body
surface veins may become more noticeable.
Other possible side effects:
Common (occurs in less than 1 in 10 people)
burning and/or itching where the ointment is applied.
Rare (occurs in less than 1 in every 1,000 people)
glaucoma (high pressure in your eye) when used
around your eyes
if being treated for psoriasis (or when treatment is
stopped), the condition gets worse.
(Frequency unknown)
inflammation of the skin, including the mouth
acne
abnormal changes in hair growth or skin colour.
In children, absorption of the active ingredient through the
skin can affect the rate at which they grow.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5. How to store Betamethasone ointment
Keep the ointment in a safe place, out of the reach and
sight of children.
Do not store above 25ºC. Store in the original tube with the
top screwed on.
Do not use the ointment after the expiry date, which is
printed on the tube.
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.

6. Further information
What Betamethasone ointment contains
This medicine contains the active ingredient
betamethasone (as valerate) 0.1%w/w. It also contains
cholesterol, stearyl alcohol, white beeswax, white soft
paraffin and propylene glycol.
What Betamethasone ointment looks like and contents
of the pack
The ointment is available in tubes of 30g and 100g.
Marketing Authorisation Holder
Manx Healthcare Ltd., Taylor Group House, Warwick,
CV34 5YA, United Kingdom.
Manufacturer
Pharmaserve Ltd., Clifton Technology Park, Wynne
Avenue, Swinton, Greater Manchester, M27 8FF,
United Kingdom.
This leaflet was revised in
June 2011
WIP URN: 220611-GB41-PIL-11

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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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