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CLOBETASONE BUTYRATE 0.05% W/W OINTMENT

Active substance(s): CLOBETASONE BUTYRATE / CLOBETASONE BUTYRATE / CLOBETASONE BUTYRATE

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PACKAGE LEAFLET

Package leaflet: Information for the user
Clobetasone Butyrate 0.05% w/w Ointment
Clobetasone Butyrate
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 is Clobetasone Butyrate Ointment and what is it used for
2.
What you need to know before you use Clobetasone Butyrate Ointment
3.
How to use Clobetasone Butyrate Ointment
4.
Possible side effects
5.
How to store Clobetasone Butyrate Ointment
6.
Contents of the pack and other information

1.

What is Clobetasone Butyrate Ointment and what is it used for

Clobetasone Butyrate Ointment contains the active ingredient clobetasone butyrate. This belongs to
a group of medicines called steroids. It helps to reduce swelling and irritation.

Clobetasone Butyrate Ointment is used to help reduce the redness and itchiness of certain skin
problems. It is used for mild skin problems or to keep your skin problems under control. These skin
problems include eczema, dermatitis or insect bites. It is also used to help reduce inflammation of the
outer ear.

2.

What you need to know before you use Clobetasone Butyrate Ointment

Do not use Clobetasone Butyrate Ointment:
if you are allergic (hypersensitive) to clobetasone butyrate or any of the other ingredients of this
medicine (listed in Section 6)
to treat any of the following skin problems, it could make them worse:
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 an infection
itchy skin which is not inflamed
if a dressing is applied to a child under one year of age
if you suffer from skin conditions such as acne, rosacea (redness of the face) and perioral
dermatitis (tiny red bumps around the mouth)
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 Clobetasone Butyrate Ointment.
Warnings and precautions
Talk to your doctor or pharmacist before using Clobetasone Butyrate Ointment
if you have previously had an allergic reaction with another steroid
if using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or

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infection
if you are applying the 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 ointment
if you have psoriasis, your doctor will want to see you more often
if you are applying the ointment on broken skin or within the skin folds
if you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the ointment
repeatedly enters the eye
if 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
if dressing or bandages should not be used on children or on the face where the ointment is
applied
if you are applying to the face over a long period of time as it may cause skin thinning
if use on children should be limited to 7 days
if you accidently swallow. Rinse the mouth out with plenty of water and contact a doctor or
pharmacist for advice immediately

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this
medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.
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.
Other medicines and Clobetasone Butyrate Ointment
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking or have recently taken any of the following
medicines:
Antivirals such as ritonavir which can be used to treat HIV infection
Antifungals such as itraconazole which can be used to treat fungal infections
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Pregnancy and breast feeding
If you are pregnant or 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.
Driving and using machines
This medicine will not affect your ability to drive or use heavy machinery.

3.

How to use Clobetasone Butyrate Ointment

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Using this medicine
You usually apply Clobetasone Butyrate Ointment up to 2 times a day. This may be reduced as
your skin begins to get better.
This ointment is for use on your skin only.
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.
If you are using an emollient (moisturising) preparation allow time for Clobetasone Butyrate

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Ointment to be absorbed after each application before applying the emollient.
If you are applying the ointment on someone else make sure you wash your hands after use or
wear disposable plastic gloves.
If your skin problem does not improve, talk to your doctor.

Guidance on how to apply the ointment
1.
Wash your hands.
2.
Gently rub the correct amount of ointment into the skin until it has all disappeared. You can
measure how much Clobetasone Butyrate Ointment to use with your fingertip. This picture
shows one fingertip unit.

This picture shows one fingertip unit.
3.

Unless you are meant to apply the ointment to your hands as a part of the treatment, wash them
again after using the ointment.

For an adult:
You should find that:
two and a half fingertips of ointment will cover face and neck
two fingertips of ointment will cover both hands or one foot
three fingertips of ointment will cover one arm (not including the hand)
one fingertip for both sides of the hand
six fingertips of ointment will cover one leg (not including the foot)
fourteen fingertips of 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:
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 7 days - unless your doctor
has told you to use it for longer.
If you apply Clobetasone Butyrate Ointment to your face
You should only apply the ointment to your face if your doctor tells you to. The ointment should not be
used for too long as the skin on your face thins easily. Do not let the ointment get into your eyes. If it
does, wash it out with plenty of water.
If you use more Clobetasone Butyrate 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 Clobetasone Butyrate Ointment
If you forget to apply your ointment, apply it as soon as you remember. If it is close to the time you are
next meant to apply it, wait until this time.
If you stop using Clobetasone Butyrate Ointment
If you use Clobetasone Butyrate Ointment 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 Clobetasone Butyrate Ointment and tell your doctor as soon as possible if
You find that your skin problem gets worse or your skin becomes swollen during treatment. You
may be allergic to the ointment, have an infection or need other treatment.
You have psoriasis you may get raised bumps with pus under the skin. This can happen during or
after the treatment and is known as pustular psoriasis.
Other side effects you may notice when using Clobetasone Butyrate Ointment include
Very rare (may affect up to 1 in 10,000 people):
An increased risk of skin infection
An allergic skin reaction where the cream is applied
A feeling of burning, irritation or itching where the ointment is applied
Rash, itchy bumpy skin or redness of the skin
Other very rare side effects if you use Clobetasone Butyrate 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:
Increased hair growth, increased appetite and changes in skin colour
Thinning of your skin that may also damage more easily
Weight gain, rounding of the face and high blood pressure. These are more likely to happen in
infants and children
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
Changes in the normal menstrual cycle for women
Not known (frequency cannot be estimated from the available data):
Blurred vision
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 (Website:
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 Clobetasone Butyrate Ointment

Keep this medicines out of the sight and reach of children.
Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the tube or carton after EXP. The expiry
date refers to the last day of that month.
This medicine should be disposed of 3 months after first opening.
Do not throw away any 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.

6.

Contents of the pack and other Information

What Clobetasone Butyrate Ointment e contains
The active substance is clobetasone butyrate.
Each 1 g contains 0.5 mg of Clobetasone butyrate (0.05% w/w).
The other ingredients are liquid paraffin and white soft paraffin.
What Clobetasone Butyrate Ointment looks like and contents of the pack
Clobetasone Butyrate Ointment is an opaque ointment.
Within each carton is a tube with a plastic screw cap, which contains either 30 or 100 g of ointment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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

This leaflet was last revised in May 2017.

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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