Betnovate Rd Ointment
v3
GlaxoSmithKline
10000000110355
Package Leaflet: Information for the User
Betnovate® RD Ointment
your hands as a part of the treatment, wash them again after using the ointment.
For an adult
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, askyour 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, talktoyour 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 RD is and what it is used for
2 What you need to know before you use Betnovate RD
3 How to use Betnovate RD
4 Possible side effects
5 How to store Betnovate RD
6 Contents of the pack and other information
1 What Betnovate RD is and what it is used for
Betnovate RD contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids that reduce swelling and irritation.
Betnovate RD is used to help reduce the redness and itchiness of certain skin problems, such as eczema, psoriasis and dermatitis.
RD stands for 'Ready Diluted', it contains less active ingredient than Betnovate. It is used:
• for milder skin problems, or
• to keep your skin problem under control after Betnovate has improved it.
2 What you need to know before you use Betnovate RD
Do not use Betnovate RD:
• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betnovate RD (listed in Section 6)
• on a child under 1 year
• 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)
- itching around your back passage or private parts
- infected skin (unless the infection is being treated with an anti-infective medicineatthesametime)
- itchyskin which is not inflamed
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Betnovate RD.
Warnings and precautions
Talk to your doctor or pharmacist before using Betnovate if:
• you have previously had an allergic reaction with another steroid
• 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.
• 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 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 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.
_Dressing or bandages should not be used on children
or on the face where the 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 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 RD
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 apply Betnovate RD once or twice 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 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, moist conditions under bandages or dressings so always clean the skin before a fresh dressing is put on.
• 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 in2to4 weeks, talktoyour doctor.
Guidance on how to apply the ointment
1 Washyourhands.
2 Apply a thin layer to the affected area(s) and gently rub into the skin until it has all disappeared. You can measure how much Betnovate to use with your fingertip. For children you will need to use less ointment but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.
Face and neck:
2 'h fingertip units. Back: 7 fingertip units. Front: 7 fingertip units. One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including the foot):
6 fingertip units.
One foot:
2 fingertip units.
Do not worry if you find you need a little more or less than this. It is only a rough guide.
For a child aged 1 - 10
|
Number of fingertip units needed | |||||
|
Child's age |
Face and neck |
Arm and hand |
Leg and foot |
Front |
Back including buttocks |
|
1-2 years |
1 'h |
1 'h |
2 |
2 |
3 |
|
3-5 years |
1 'h |
2 |
3 |
3 |
3% |
|
6-10 years |
2 |
2'h |
4% |
3% |
5 |
• thinning and dryness of your skin and it mayalso damage or wrinkle more easily
• stretch marks may develop
• veins under the surface of your skin maybecome 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 directlyvia the Yellow Card Schemeat: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
• Do not use it on children under 1 year of age.
• It is especially important in children not to exceed the prescribed amount.
• A course oftreatmentfor 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 ointment under an airtight dressing. It will only be at night to help the ointment to start working. After a short period of time you will then apply the ointment as normal.
If you apply Betnovate RD to your face
You should only apply the 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 ointment get into your eyes.
If you use more Betnovate RD than you should
If you apply too much or if accidentally swallowed, it could makeyou ill. Talk to your doctor orgo to the hospital as soon as possible.
If you forget to use Betnovate RD 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 Betnovate RD If you use Betnovate RD regularly make sureyou 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.
• Keep out of the sight and reach of children.
• Do not use Betnovate RD after the expiry date on the tube or carton after (Exp). The expiry date refers to the last day of that month.
• Do not store above 30°C.
• 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Betnovate RD 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 RD, have an infection or need othertreatment.
• 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 RD include:
Common (may affect up to 1 in 10 people)
• a feeling of burning, pain, irritation or itching where the ointment is applied.
Very rare (may affect up to 1 in 10,000 people)
• an increased risk of infection
• an allergic skin reaction where the cream is applied
• rash, itchy bumpy skin or redness of the skin
What Betnovate RD ointment contains
• The active ingredient is betamethasone valerate. Each 1 g contains 0.25 mg of betamethasone (0.025% w/w) as valerate.
• The other ingredients are liquid paraffin and white soft paraffin.
What Betnovate RD looks like and contents of the pack
Within each carton is a tube with a plastic screw cap, which contains 100gof ointment.
Marketing Authorisation Holder and Manufacturer
Product Licence held by Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufactured by Glaxo Wellcome Operations, Barnard Castle, Durham DL12 8DT 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.
Other formats:
To listen to or reguest a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
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Product name:
Betnovate RD Ointment
Reference number 10949/0022
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in:
July 2013
Betnovate is a registered trademark of the GlaxoSmithKline group of companies.
© 2013 GlaxoSmithKline group of companies.
All rights reserved.
GlaxoSmithKline
10000000110355