BETAMETHASONE 0.1%W/W SCALP APPLICATION

Active substance: BETAMETHASONE VALERATE

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Ref: 0996/100114/1/F

Betnovate®Scalp Application
(betamethasone valerate)
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine
because it contains important infromation 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.
Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Betnovate Scalp Application but will be referred to as
Betnovate throughout Leaflet.
In this leaflet:
1

What Betnovate is and what it is used for

2

What you need to know before you use Betnovate

3

How to take Betnovate

4

Possible side effects

5

How to store Betnovate

6

Contents of the pack and other infromation

1

What Betnovate is and what is it used for

Betnovate Scalp Application (called 'Betnovate' in this leaflet) contains a
medicine called betamethasone valerate. It belongs to a group of medicines
called steroids that help to reduce swelling and irritation.
Betnovate is used to reduce the redness and itchiness of certain scalp
problems, such as psoriasis and dermatitis.

2

What you need to know before you use Betnovate

Do not use Betnovate:
• if you are allergic (hypersensitive) to betamethasone valerate or any of the
other ingredients of Betnovate (listed in Section 6)
• if you have a skin infection on your scalp
• on a child under 1 year.
Do not use Betnovate if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before using Betnovate.
Warnings and precautions
Talk to your doctor or pharmacist before you use this medicine if:
• you have previously had an allergic reaction with another steroid.
• you are applying the liquid under an airtight dressing. These dressings
make it easier for the active ingredient to pass through the skin.
It is possible to accidentally end up using too much.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the liquid to broken skin or within the skin folds.
• you are applying to a large surface area.
• you are applying to thin skin or on children as their skin is thinner than
adults and as a result may absorb larger amounts.
• Dressing or bandages should not be used on children where the scalp
application is applied.
• Use on children should be limited to 5 days.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using this medicine.

Other medicines and Betnovate
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, especially if you are taking ritonavir and
itraconazole medications.
Pregnancy and breast-feeding and fertility
If you are pregnant or are 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.

3

How to take Betnovate

Always use Betnovate exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Using this medicine
* You usually put Betnovate on your scalp in the morning and at night. This
may be reduced as your scalp problem begins to get better.
* Do not use Betnovate more often than prescribed.
* Do not use it for a long time (such as every day for many weeks or
months) - unless your doctor tells you to.
* Be very careful not to get the liquid in your eyes. Do not touch your eyes
until you have washed your hands.
* If you wash or shampoo your hair it should be dried before applying the
liquid.
* If you are applying Betnovate on someone else make sure you wash your
hands after use or wear disposable plastic gloves.
* The liquid is flammable, you should keep it away from fire.
* Do not dry your hair with a hairdryer or be near a fire.
* Avoid smoking whilst applying to the scalp.
Guidance on how to apply the liquid
1 Wash your hands.
2 Unscrew the bottle cap and place the nozzle on the scalp that needs
treating.
3 Gently squeeze the bottle to cover the area with a thin and even layer of
liquid.
4 You can rub this liquid in, but you don't have to.
5 Your scalp will feel cool until the liquid has dried.
6 Wash your hands again.
7 It is important not to exceed the prescribed amount.
If you use more Betnovate than you should
If you apply too much or if 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 Betnovate
If you forget to apply Betnovate, apply it as soon as you remember. If it is
close to the time you are next meant to apply it you can wait until this time.
If you stop using Betnovate
If you use Betnovate regularly make sure you talk to your doctor before you
stop using it as your condition may get worse if stopped suddenly.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Ref: 0996/100114/1/B

Betnovate®Scalp Application
(betamethasone valerate)
Patient Information Leaflet (continued)

Possible side effects

4

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop using Betnovate and tell your doctor immediately if:
• you find that your skin condition gets worse, you develop a generalised
rash or your skin becomes swollen during treatment. You may be allergic
to Betnovate, have an infection or need other treatment.
• you have psoriasis and get raised bumps with pus under the skin. This
can happen very rarely during or after treatment and is known as pustular
psoriasis.
Other side effects you may notice when using Betnovate include:
Common
(may affect up to 1 in 10 people)
• a feeling of burning, pain, irritation or itching where the liquid is applied.
Very rare
(may affect up to 1 in 10,000 people)
• an increased risk of infection
• an allergic skin reaction where the liquid is applied
• rash, itchy bumpy skin or redness of the skin
• thinning and dryness of your skin and it may also damage or wrinkle more
easily
• stretch marks may develop
• veins under the surface of your skin may become more noticeable
• an increase or reduction in hair growth or hair loss and changes in skin
colour
• weight gain, rounding of the face
• delayed weight gain or slowing of growth in children
• bones can become thin, weak and break easily
• cloudy lens in the eye (cataract) or increased pressure in eye (glaucoma)
• increased blood sugar levels or sugar in the urine
• high blood pressure
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Betnovate

Keep out of the sight and reach of children.
Do not use Betnovate after the expiry date on the bottle label or carton
(Exp). The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the liquid is
flammable.
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.

Expiry Date
Do not use this scalp application after the expiry date shown on the bottle or
carton label. If your doctor tells you to stop using this application, return any
unused application to your pharmacist (chemist) for safe disposal. Only keep
this application, if your doctor tells you to. If your application shows any
signs of deterioration, consult your pharmacist (chemist) who will tell you
what to do.

6

Contents of the pack and other infromation

What Betnovate contains
Contains 0.1% w/w of betamethasone (as betamethasone valerate) as the
active ingredient. Also contains the following inactive ingredients: carbomer,
isopropyl alcohol, purified water and sodium hydroxide.
What Betnovate looks like and contents of the pack
Available in bottles of 50ml
Marketing Authorisation Holder and Manufacturer
Betnovate is manufactured by Aspen Bad Oldesloe GmbH, Germany and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0996

Betnovate is a registered trademark of the GlaxoSmithKline Group of
Companies.
Revision date: 10/01/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0996/100114/2/F

Betamethasone 0.1% w/w Scalp Application
(betamethasone valerate)
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine
because it contains important infromation 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.
Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Betamethasone Scalp Application but will be referred
to as Betamethasone throughout Leaflet.
In this leaflet:
1

What you need to know before you use Betamethasone

3

How to take Betamethasone

4

Possible side effects

5

How to store Betamethasone

6

Contents of the pack and other infromation

Other medicines and Betamethasone
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, especially if you are taking ritonavir and
itraconazole medications.
Pregnancy and breast-feeding and fertility
If you are pregnant or are 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.

What Betamethasone is and what it is used for

2

• Dressing or bandages should not be used on children where the scalp
application is applied.
• Use on children should be limited to 5 days.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using this medicine.

1

What Betamethasone is and what is it used for

Betamethasone Scalp Application (called 'Betamethasone' in this leaflet)
contains a medicine called betamethasone valerate. It belongs to a group of
medicines called steroids that help to reduce swelling and irritation.
Betamethasone is used to reduce the redness and itchiness of certain scalp
problems, such as psoriasis and dermatitis.

2

What you need to know before you use
Betamethasone

Do not use Betamethasone:
• if you are allergic (hypersensitive) to betamethasone valerate or any of the
other ingredients of Betamethasone (listed in Section 6)
• if you have a skin infection on your scalp
• on a child under 1 year.
Do not use Betamethasone if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before using Betamethasone.
Warnings and precautions
Talk to your doctor or pharmacist before you use this medicine if:
• you have previously had an allergic reaction with another steroid.
• you are applying the liquid under an airtight dressing. These dressings
make it easier for the active ingredient to pass through the skin.
It is possible to accidentally end up using too much.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the liquid to broken skin or within the skin folds.
• you are applying to a large surface area.
• you are applying to thin skin or on children as their skin is thinner than
adults and as a result may absorb larger amounts.

3

How to take Betamethasone

Always use Betamethasone exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Using this medicine
* You usually put Betamethasone on your scalp in the morning and at night.
This
may be reduced as your scalp problem begins to get better.
* Do not use Betamethasone more often than prescribed.
* Do not use it for a long time (such as every day for many weeks or
months) - unless your doctor tells you to.
* Be very careful not to get the liquid in your eyes. Do not touch your eyes
until you have washed your hands.
* If you wash or shampoo your hair it should be dried before applying the
liquid.
* If you are applying Betamethasone on someone else make sure you wash
your
hands after use or wear disposable plastic gloves.
* The liquid is flammable, you should keep it away from fire.
* Do not dry your hair with a hairdryer or be near a fire.
* Avoid smoking whilst applying to the scalp.
Guidance on how to apply the liquid
1 Wash your hands.
2 Unscrew the bottle cap and place the nozzle on the scalp that needs
treating.
3 Gently squeeze the bottle to cover the area with a thin and even layer of
liquid.
4 You can rub this liquid in, but you don't have to.
5 Your scalp will feel cool until the liquid has dried.
6 Wash your hands again.
7 It is important not to exceed the prescribed amount.
If you use more Betamethasone than you should
If you apply too much or if 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
If you forget to apply Betamethasone, apply it as soon as you remember. If it
is close to the time you are next meant to apply it you can wait until this
time.
If you stop using Betamethasone
If you use Betamethasone regularly make sure you talk to your doctor before
you stop using it as your condition may get worse if stopped suddenly.

Ref: 0996/100114//B

Betamethasone 0.1% w/w Scalp Application
(betamethasone valerate)
Patient Information Leaflet (continued)
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4

Expiry Date
Do not use this scalp application after the expiry date shown on the bottle or
carton label. If your doctor tells you to stop using this application, return any
unused application to your pharmacist (chemist) for safe disposal. Only keep
this application, if your doctor tells you to. If your application shows any
signs of deterioration, consult your pharmacist (chemist) who will tell you
what to do.

Possible side effects

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

6

Contents of the pack and other information

Stop using Betamethasone and tell your doctor immediately if:
• you find that your skin condition gets worse, you develop a generalised
rash or your skin becomes swollen during treatment. You may be allergic
to Betamethasone, have an infection or need other treatment.
• you have psoriasis and get raised bumps with pus under the skin. This
can happen very rarely during or after treatment and is known as pustular
psoriasis.

What Betamethasone contains
Contains 0.1% w/w of betamethasone (as betamethasone valerate) as the
active ingredient. Also contains the following inactive ingredients: carbomer,
isopropyl alcohol, purified water and sodium hydroxide.

Other side effects you may notice when using Betamethasone include:
Common
(may affect up to 1 in 10 people)
• a feeling of burning, pain, irritation or itching where the liquid is applied.

Marketing Authorisation Holder and Manufacturer
Betamethasone is manufactured by Aspen Bad Oldesloe GmbH, Germany
and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

Very rare
(may affect up to 1 in 10,000 people)
• an increased risk of infection
• an allergic skin reaction where the liquid is applied
• rash, itchy bumpy skin or redness of the skin
• thinning and dryness of your skin and it may also damage or wrinkle more
easily
• stretch marks may develop
• veins under the surface of your skin may become more noticeable
• an increase or reduction in hair growth or hair loss and changes in skin
colour
• weight gain, rounding of the face
• delayed weight gain or slowing of growth in children
• bones can become thin, weak and break easily
• cloudy lens in the eye (cataract) or increased pressure in eye (glaucoma)
• increased blood sugar levels or sugar in the urine
• high blood pressure
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Betamethasone
Keep out of the sight and reach of children.
Do not use Betamethasone after the expiry date on the bottle label or
carton
(Exp). The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the liquid is
flammable.
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.

What Betamethasone looks like and contents of the pack
Available in bottles of 50ml

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0996

Revision date: 10/01/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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