Betamethasone Valerate/Clioquinol 1 Mg/30 Mg/G Cream
Read all of this leaflet carefully before you start using this medicine.
• 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you use Betamethasone/Clioquinol Cream
3. How to use Betamethasone/Clioquinol Cream
4. Possible side effects
5. How to store Betamethasone/Clioquinol Cream
6. Further information
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.
Always use the cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Betamethasone/Clioquinol Cream contains two different medicines called betamethasone valerate and clioquinol.
• Betamethasone valerate belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.
• Clioquinol is a type of anti-infective medicine.
It fights bacterial and fungal infections of the skin.
This medicine is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis, dermatitis or insect bites, where an infection may be a problem.
Guidance on how to apply the cream
1 Wash your hands.
2 Gently rub the correct amount of cream into the skin until it has all disappeared.
You can measure how much cream to use with your fingertip. This picture shows one fingertip unit.
Do not use Betamethasone/Clioquinol Cream:
• if you are allergic (hypersensitive) to betamethasone valerate, clioquinol or any of the other ingredients (listed in Section 6)
• if you are allergic (hypersensitive) to iodine
• on a child under 1 year
• to treat any of the following skin problems, it could make them worse:
- severe flushing of skin on and around your nose (rosacea)
- spotty red rash around your mouth (perioral dermatitis)
- viral infections, such as cold sores, herpes or chicken pox
- blisters or sores on your face and hands (impetigo), or other bacterial infections
- fungal infections, such as ringworm, athletes foot, or thrush
- itching around your back passage (anus) or private parts (genitals) - unless your doctor has told you to do so.
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.
Take special care with Betamethasone/ Clioquinol Cream
Check with your doctor or pharmacist before using your medicine if:
• you are applying the cream 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.
3 Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream.
For an adult
You should find that:
• two fingertips of cream will cover both hands or one foot
• three fingertips of cream will cover one arm
• six fingertips of cream will cover one leg
• fourteen fingertips of cream 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 year 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.
Please turn over the page
• You usually apply the cream 2 or 3 times a day. This may be reduced as your skin begins to get better.
• This cream 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 cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.
• If your skin problem does not improve after 7 days talk to your doctor.
• Do not mix with any other creams or ointments.
If you apply Betamethasone/Clioquinol Cream to your face
You should only apply the cream 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 get into your eyes.
If you use more Betamethasone/Clioquinol Cream 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 the hospital as soon as possible.
If you forget to use Betamethasone/Clioquinol Cream
If you forget to apply your cream, 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 Betamethasone/Clioquinol Cream
If you use this medicine 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.
• weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.
Staining of your hair, skin and clothes can occur. You can protect clothes by covering the treated area with a cotton bandage or piece of clean cloth.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
• Keep out of the reach and sight of children.
• Do not use this product after the expiry date on the tube end or carton (Exp). The expiry date refers to the last day of that month.
• Do not store above 30°C.
• 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 protect the environment.
Like all medicines, Betamethasone/Clioquinol Cream can cause side effects, although not everybody gets them.
STOP using this medicine and tell your doctor as soon as possible if:
• you find your condition gets worse or becomes swollen during treatment. You may be allergic to the cream or need other treatment.
Other side effects you may notice when using Betamethasone/Clioquinol Cream include:
• a feeling of burning, irritation or itching where the cream is applied
• if 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.
Side effects if you use Betamethasone/Clioquinol Cream 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:
• stretch marks may develop
• veins under the surface of your skin may become more noticeable
• increased hair growth and changes in skin colour
• thinning of your skin and it damages more easily
• The active ingredients are betamethasone valerate and clioquinol. Each 1 g contains 1 mg of betamethasone (0.1% w/w) as valerate and 30 mg of clioquinol (3% w/w).
• The other ingredients are:
chlorocresol, cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, liquid paraffin, sodium acid phosphate, phosphoric acid, sodium hydroxide and purified water.
What Betamethasone/Clioquinol Cream looks like and contents of the pack
Within each carton is a tube with a plastic screw cap, which contains 15 g or 30 g of cream.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom.
Purna Pharmaceuticals NV, Rijksweg 17,
2870 Puurs, Belgium.
96B/L/m/4 ESSENTIAL GENERICS