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BETAMETHASONE VALERATE 0.025% W/W OINTMENT

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

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Package leaflet: Information for the user
Betamethasone Valerate 0.025% w/w Cream &
Betamethasone Valerate 0.025% w/w Ointment
Read all of this leaflet carefully 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. 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 become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet
1.
What is Betamethasone Valerate Cream/Ointment and what is it used for?
2.
Before you use Betamethasone Valerate Cream/Ointment
3.
How to use Betamethasone Valerate Cream/Ointment
4.
Possible side effects
5.
Storing Betamethasone Valerate Cream/Ointment
6.
Further information
1. What is Betamethasone Valerate Cream/Ointment and what is it used for?
Betamethasone Valerate Cream/Ointment contains a medicine called betamethasone valerate. It
belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.
Betamethasone Valerate Cream/Ointment is used to help reduce the redness and itchiness of certain
skin problems. These skin problems include eczema, psoriasis and dermatitis.
Betamethasone Valerate 0.025% w/w preparations contains less active ingredient than
Betamethasone Valerate 0.1% preparations. It is used:
• For milder skin problems, or
• To keep your skin problem under control after Betamethasone Valerate 0.1% has improved it.

2. Before you use Betamethasone Valerate Cream/Ointment
Do not use Betamethasone Valerate Cream/Ointment:
• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of
Betamethasone Valerate Cream/Ointment (listed in Section 6)
• on a child under 1 years old
• to treat any of the following skin problems, it could make them worse:
• acne
• severe flushing of skin on and around your nose (rosacea)
• spotty red rash around your mouth (perioral dermatitis)
• circular to oval red plaques found over the body and the scalp (plaque psoriasis)
• itching around your back passage or private parts – unless your doctor has told you to do so
• itchy skin which is not inflamed
• viral infections, such as cold sores, herpes or chicken pox
• fungal infections, such as ringworm, athletes foot or thrush
• skin blisters or sores that are caused by bacterial infections, such as impetigo.

Do not use this medicine if any of the above apply to you, If you are not sure, talk to your doctor or
pharmacist before using Betamethasone Valerate Cream/Ointment.
Take special care with Betamethasone Valerate Cream/Ointment:
Check with your doctor or pharmacist before using Betamethasone Valerate Cream/Ointment if;
• you have previously had an allergic reaction with another steroid
• you are applying the cream or ointment under an airtight dressing, including a child’s nappy.
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.
• using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.
• you are applying to a large surface area
• you are applying the cream or ointment on broken skin or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the cream or
ointment repeatedly enters the eye.
• you are applying to thin skin such as the face or on children as their skin is thinner than adults and
as a result may absorb larger amounts.
Contact your doctor if you experience blurred vision or other visual disturbances.
Dressing or bandages should not be used on children or on the face where the cream or ointment is
applied.
Use on children or on the face 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 taking
this medicine.
Other medicines and Betamethasone Valerate Cream/Ointment
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine, especially if you are taking ritoavir and itraconazole medications.
If this product comes into contact with dressings, clothing and bedding the fabric can be easily ignited
with a naked flame. You should keep away from fire when using this product.
Pregnancy and breast-feeding:
Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become
pregnant or are breast-feeding.
Important information about some of the ingredients of Betamethasone Valerate
Cream/Ointment:
Betamethasone Valerate Cream contains cetostearyl alcohol which can cause local skin reactions
(e.g.contact dermatitis) and chlorocresol which may cause allergic reactions.
3 How to use Betamethasone Valerate Cream/Ointment
Always use Betamethasone Valerate Cream/Ointment exactly as your doctor or pharmacist has told
you. You should check with your doctor or pharmacist if you are not sure.
Using this medicine

• You usually apply Betamethasone Valerate Cream/Ointment 1 to 3 times a day. This may be

reduced as your skin begins to get better, or stopped when it is better.
• This cream or ointment is for use on your skin only.
• Do not use more than the amount prescribed for you.
• Do not use on large areas of the body for a long time (such as every day for many weeks or

months), unless your doctor tells you to.

• The germs that cause infections like warm and moist conditions under bandages or dressings, so

always clean the skin before a fresh dressing is put on.
• If you are applying the cream or ointment on someone else make sure you wash your hands after

use or wear disposable plastic gloves.
• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.
Guidance on how to apply the cream or ointment
1. Wash your hands.
2. Gently rub the correct amount of cream or ointment into the skin until it has all disappeared.
You can measure how much Betamethasone Valerate Cream/Ointment to use with your fingertip.

This picture shows one fingertip unit.

3. Unless you are meant to apply the cream or ointment to your hands as a part of the treatment, wash
them again after using the cream or ointment.
For an adult:
You should find that:
• two fingertips of cream or ointment will cover both hands or one foot
• three fingertips of cream or ointment will cover one arm
• six fingertips of cream or ointment will cover one leg
• fourteen fingertips of cream or ointment will cover the front and back
of the body.
Do not worry if you find you need a little more or a little less than this. It is only a rough guide.
For a child:
• Do not use it on children under 1 years of age.
• The smaller the child the less you will need to use.
• A child of 4 years needs about a third of the adult amount.
• A course of treatment for a child should not normally last more than 5 days – unless your doctor
has told you to use it for longer.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the
cream or ointment under an airtight dressing. It will only be at night to help the cream or ointment to
start working. After a short period of time you will then apply the cream or ointment as normal.
If you apply Betamethasone Valerate Cream/Ointment to your face
You should only apply the cream or ointment to your face if your doctor tells you to. It should not be
used for more than 5 days, as the skin on your face thins easily. Do not let the cream or ointment
get into your eyes. If it does, wash it out with plenty of water.
If you use more Betamethasone Valerate Cream/Ointment than you should
If , by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if
a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as
possible.
If you forget to use Betamethasone Valerate Cream/Ointment
If you forget to apply your cream or ointment, apply it as soon as you remember. If it close to the time
you are next meant to apply it, wait until this time.
If you stop using Betamethasone Valerate Cream/Ointment

If you use Betamethasone Valerate Cream/Ointment regularly make sure you talk to your doctor
before you stop using it.
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 Valerate Cream/Ointment can cause side effects, although not
everybody gets them.
Stop using Betamethasone Valerate Cream/Ointment and tell your doctor as soon as possible if:
• you develop a generalized rash on your skin
• you find that your skin problem gets worse or becomes swollen during treatment. You may be

allergic to the cream or ointment, have an infection or need other treatment.
• you have psoriasis you may 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 Betamethasone Valerate Cream/Ointment
include:
Common (affects less than 1 in 10 people)
• A feeling of burning, pain, irritation or itching where the cream or ointment is applied.
Side effects if you use Betamethasone Valerate Cream/Ointment for a long time, or you use a lot
each time you apply it, or you apply it under an airtight dressing or a nappy.
Very Rare (affects less than 1 in 10,000 people)
• An increased risk of infection
• An allergic skin reaction where the cream or ointment 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
• Increased hair growth or reduction in hair growth or hair loss and changes in skin colour.
• Weight gain, rounding of the face and high blood pressure. These are more likely to happen in
infants and 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
• Slow growth in children
• Decreased endogenous cortisol levels.
Not known (cannot be estimated from the available data)
• Blurred vision
If any of the above side effects are troublesome or last more than a few days or if you notice any side
effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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. Storing Betamethasone Valerate Cream/Ointment
Keep all medicines out of the reach and sight of children.
Do not store above 30 °C.
Once opened, do not use this medicine for more than 3 months.
Do not use Betamethasone Valerate Cream/Ointment after the expiry date which is shown on the
tube or carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines that are no longer required. This will help to protect the environment.
6.

Further information

What Betamethasone Valerate Cream/Ointment contains:
The active ingredient is betamethasone valerate.
Each 1g contains 0.25 mg of betamethasone (0.025% w/w) as betamethasone valerate.
The other ingredients are:
Cream: Macrogol cetostearyl ether 20, cetostearyl alcohol, chlorocresol, disodium hydrogen
phosphate dodecahydrate, citric acid monohydrate, liquid paraffin, white soft paraffin and purified
water.
Ointment: liquid paraffin and white soft paraffin.
What Betamethasone Valerate Cream/Ointment looks like and contents of the pack:
Betamethasone Valerate Cream is a white or almost white cream.
Betamethasone Valerate Ointment is an opaque ointment.
Within each carton is a tube with a plastic screw cap, which contains 100 g of cream or ointment.
Marketing authorisation holder
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4
7TL, UK.
Manufacturer
Tiofarma B.V., Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, The Netherlands.
More information
If you have any questions or are not sure about anything, ask your doctor or pharmacist who will
advise you.
Other sources of information are:
• National Eczema Society, Hill House, Highgate Hill, London N19 5NA
• The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF
• You may also be able to find out more from books in public libraries.

This leaflet was last revised in May 2017

For information in large print, on tape, on CD or in Braille,

phone +44 (0) 1895 627 420.

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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