Beclometasone dipropionate 0.25 mg/g Cream

• 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.

1. What Beclometasone dipropionate 0.25 mg/g Cream is and what it is used for
2. What you need to know before you use Beclometasone dipropionate 0.25 mg/g Cream
3. How to use Beclometasone dipropionate 0.25 mg/g Cream
4. Possible side effects
5. How to store Beclometasone dipropionate 0.25 mg/g Cream
6. Contents of the pack and other information

• if you are allergic to beclometasone dipropionate or any of the other ingredients (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:
• 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 - unless your doctor has told you to do so
• viral infections, such as cold sores, herpes or chicken pox
• fungal infections, such as ringworm, athlete’s 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, speak to your doctor or pharmacist.

Talk to your doctor or pharmacist before using Beclometasone dipropionate 0.25 mg/g Cream

• 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
• if you have psoriasis. Your doctor will want to see you more often.

If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the cream without consulting your prescriber unless your prescriber has previously advised you to so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment.

Contact your doctor if you experience blurred vision or other visual disturbances.

Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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.

Beclometasone dipropionate 0.25 mg/g Cream is unlikely to affect your ability to operate machinery or to drive.

This medicine contains chlorocresol, which may cause allergic reactions. This medicine also contains cetostearyl alcohol including cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Beclometasone dipropionate 0.25 mg/g Cream is classed as a moderate corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.

• 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.

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.

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.

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.

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.

How long

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, 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 the cream, use it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.

Do not use a double dose to make up for a forgotten dose.

If you use Beclometasone dipropionate Cream regularly make sure you talk to your doctor before you stop using it.

• you find that your skin problem gets worse. You may be allergic to the cream or have a skin infection which needs other treatment.

• 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
• blurred vision.

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.

Steroid withdrawal reaction: If used continuously for prolonged periods a withdrawal reaction may occur on stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance 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. (See end of section 2 for further information on chlorocresol and cetostearyl alcohol).

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.