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BETAMETHASONE 0.1% SCALP APPLICATION

Active substance(s): BETAMETHASONE / BETAMETHASONE VALERATE / BETAMETHASONE / BETAMETHASONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

BETNOVATE® SCALP APPLICATION /
BETAMETHASONE 0.1% SCALP APPLICATION
(betamethasone valerate)
This product is available as any of the above names but will be referred to as
Betnovate throughout the remainder of this 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. This includes any
possible side effects not listed in this leaflet. See section 4.
What is 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 use Betnovate
4. Possible side effects
5. How to store Betnovate
6. Contents of the pack and other information
1. WHAT BETNOVATE IS AND WHAT IT IS USED FOR
Betnovate 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 help 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 USE BETNOVATE
Always use this medicine exactly as your doctor has told you. 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.
• Do not dry your hair with a hairdryer.
• This product is flammable. Keep the liquid away from open fires and flames
and all sources of ignition including smoking during application and
immediately after use.
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.
4. POSSIBLE SIDE EFFECTS
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 this medicine after the expiry date which is stated on the bottle label
or carton after (Exp). The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Keep the container tightly closed when not in use. Contents are flammable. Keep
Betnovate away from all sources of fire, flame and heat.
• Do not leave Betnovate in direct sunlight.
• Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.
• If your medicine become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in your scalp application
The slightly gelled liquid contains:
The active ingredient – betamethasone 0.1% w/v (as betamethasone valerate) in a
base containing carbomer, isopropyl alcohol, sodium hydroxide and purified water.
The scalp application is a clear liquid in a white plastic container with a nozzle and
cap.
The scalp application is packed in 50ml bottles.
PL No: 17805/0044

Betnovate Scalp Application / Betamethasone 0.1% Scalp
Application
POM

Manufactured by Aspen Bad Oldesloe GmbH, Germany and procured from within
the EU by the Product Licence Holder Delta Pharma (Europe) Limited, 1 Colonial
Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by OPD
Laboratories Ltd, Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.08.2015.
More Information
If you have any questions or are not sure about anything, ask your doctor or
pharmacist who will advise you.
You may be able to find out more information from books in public libraries.
Betnovate is a registered trademark of the GlaxoSmithKline group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER

BETNOVATE® SCALP APPLICATION /
BETAMETHASONE 0.1% SCALP APPLICATION
(betamethasone valerate)
This product is available as any of the above names but will be referred to as
Betnovate throughout the remainder of this 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. This includes any
possible side effects not listed in this leaflet. See section 4.
What is 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 use Betnovate
4. Possible side effects
5. How to store Betnovate
6. Contents of the pack and other information
1. WHAT BETNOVATE IS AND WHAT IT IS USED FOR
Betnovate 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 help 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 USE BETNOVATE
Always use this medicine exactly as your doctor has told you. 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.
• Do not dry your hair with a hairdryer.
• This product is flammable. Keep the liquid away from open fires and flames
and all sources of ignition including smoking during application and
immediately after use.
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.
4. POSSIBLE SIDE EFFECTS
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 this medicine after the expiry date which is stated on the bottle label
or carton after (Exp). The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Keep the container tightly closed when not in use. Contents are flammable. Keep
Betnovate away from all sources of fire, flame and heat.
• Do not leave Betnovate in direct sunlight.
• Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.
• If your medicine become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in your scalp application
The slightly gelled liquid contains:
The active ingredient – betamethasone 0.1% w/v (as betamethasone valerate) in a
base containing carbomer, isopropyl alcohol, sodium hydroxide and purified water.
The scalp application is a clear liquid in a white plastic container with a nozzle and
cap.
The scalp application is packed in 50ml bottles.
PL No: 17805/0044

Betnovate Scalp Application / Betamethasone 0.1% Scalp
Application
POM

Manufactured by Glaxo Wellcome GmbH & Co., Germany and procured from within
the EU by the Product Licence Holder Delta Pharma (Europe) Limited, 1 Colonial
Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by OPD
Laboratories Ltd, Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.08.2015.
More Information
If you have any questions or are not sure about anything, ask your doctor or
pharmacist who will advise you.
You may be able to find out more information from books in public libraries.
Betnovate is a registered trademark of the GlaxoSmithKline group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Expand Transcript

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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