Beclometasone Dipropionate 0.25 Mg/G Cream
204352 LC221 127/L/m/2
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.
Beclometasone dipropionate Cream contains a medicine called beclometasone dipropionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.
This medicine is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis or dermatitis.
• if you are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients of the cream (listed in Section 6)
• on the eyes
• on a child under 1 year old
• 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)
- itching around your back passage or private parts - unless your doctor has told you to do so
- 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
- varicose ulcers (ulcers caused by swollen veins)
- stasis ulcers (ulcers caused by reduced blood or body fluid flow).
If any of the above apply to you, or if you are not sure, speak to your doctor or pharmacist.
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 cream
• you have psoriasis. Your doctor will want to see you more often.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, and herbal products.
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 Beclometasone dipropionate Cream
May cause allergic reactions.
• Cetostearyl alcohol
May cause local skin irritations (e.g. contact dermatitis).
Always use the cream exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
Using this medicine
• You usually apply the cream twice a day. This may be reduced as your skin begins to get better.
• If your skin problem does not improve after 2 to 4 weeks talk to your doctor.
• This cream 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.
• The germs that cause infections like warm and moist conditions under 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.
• Do not mix with any other creams or ointments.
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.
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.
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.
• 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.
Your doctor may suggest applying the cream under an airtight dressing. It will only be to help the cream to start working. After a short period of time you will then apply the cream as normal.
If you apply Beclometasone dipropionate Cream to your face
You should only apply the cream to your face if your doctor tells you to and for not more than 5 days. Do not cover the treated area with a dressing, as the skin on your face thins easily.
Do not let the cream get into your eyes. If it does, wash it out with plenty of water.
You should stop using the cream as soon as the skin problem is better.
Sometimes only a few days treatment is needed. If there is no improvement after 2 to 4 weeks, see your doctor again. If the doctor recommends that you continue to use the cream, you should never use it for more than 4 weeks without seeing your doctor again.
If your doctor has prescribed the cream for psoriasis you should let your doctor review your progress at regular intervals, as such treatment needs careful supervision.
If you use more 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.
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the cream tube with you so that people can see what you have used or taken.
3. Do this even if you feel well.
If you forget to use
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.
Do not use a double dose to make up for a missed dose.
If you stop using
If you use Beclometasone dipropionate Cream 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.
Side effects if you use this medicine 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
• weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.
If you absorb or swallow this medicinal product in large quantities, it can make you ill. This is unlikely when you use the cream normally. 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 after the expiry date which is stated on the tube and on the carton. The expiry date refers to the last day of that month.
• Store below 25°C and protect from light.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
Like all medicines, Beclometasone dipropionate Cream can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP using Beclometasone dipropionate Cream and tell your doctor as soon as possible if:
• you find that your skin problem gets worse. You may be allergic to the cream or have a skin infection which needs other treatment.
Other side effects you may notice when using Beclometasone dipropionate Cream include:
• a feeling of burning, irritation or itching where the cream is applied. These may be similar to the skin condition being treated
• 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.
• The active ingredient is:
beclometasone dipropionate. Each 1 g contains 0.25 mg of beclometasone (0.025% w/w) as dipropionate
• The other ingredients are:
chlorocresol, cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, liquid paraffin, sodium acid phosphate, phosphoric acid, sodium hydroxide and purified water.
Within each carton is an aluminium tube with a plastic screw cap, which contains 15 g, 30 g or 50 g of cream.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Limited, trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Purna Pharmaceuticals NV,
Rijksweg 17, 2870 Puurs, Belgium.