• 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 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

• 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 medicine at the same time)
  • itchy skin 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.

Check with your doctor or pharmacist before using your Betnovate RD if:

• you have previously had an allergic reaction with another steroid
• 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.
• 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 cream on broken skin or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the cream repeatedly enters the eye.
• you have an infection of the skin as this will need to be treated
• 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 cream is applied.

Use on children or on the face should be limited to 5 days.

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

Do not smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressing 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.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

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.

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.

Betnovate RD Cream contains chlorocresol which may cause allergic reactions and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

• You usually apply Betnovate RD once or twice 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 in 2 to 4 weeks, talk to your doctor.

1 Wash your hands.
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 cream but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.

[The picture in the printed leaflet 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.

[Pictogram of an adult with fingertip units to be used as per text below with arrows pointing to relevant body part]

Face and neck:

2 ½ 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.

Your leaflet has a graph in this location, showing the number of fingertip units needed in relation to age and body area:

Number of fingertip units needed:

Child’s age – 1-2 years

Face and neck – 1 ½

Arm and hand – 1 ½

Leg and foot - 2

Front – 2

Back including buttocks – 3

Child’s age – 3-5 years

Face and neck – 1 ½

Arm and hand – 2

Leg and foot - 3

Front – 3

Back including buttocks - 3 ½

Child’s age – 6-10 years

Face and neck – 2

Arm and hand – 2 ½

Leg and foot – 4 ½

Front – 3 ½

Back including buttocks - 5

• 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 of treatment for a child should not normally last more than 5 days - unless your doctor has told you to use it for longer.

If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the cream under an airtight dressing. It will only be at night 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. It should not be for more than 5 days, as the skin on your face thins easily. Do not let the cream get into your eyes.

If you apply too much or if accidentally swallowed, it could make you ill. Talk to your doctor or go to the hospital as soon as possible.

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 use Betnovate RD regularly make sure you talk to your doctor before you stop using it as your condition may get worse if stopped suddenly.

• 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 other treatment.
• 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.

Common (may affect up to 1 in 10 people)

• a feeling of burning, pain, irritation or itching where the cream 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
• thinning and dryness of your skin and it may also damage or wrinkle more easily
• stretch marks may develop
• blood vessels under the surface of your skin may become 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)
• a decrease in the level of the hormone cortisol in your blood
• increased blood sugar levels or sugar in the urine
• high blood pressure

Not Known (frequency cannot be estimated from the available data)

• blurred vision
• 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 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 Yellow Card Scheme Website: 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 ingredient is betamethasone valerate. Each 1 g contains 0.25 mg of betamethasone (0.025% w/w) as valerate.
• The other ingredients are cetostearyl alcohol, cetomacrogol 1000, white soft paraffin, liquid paraffin, chlorocresol, disodium hydrogen phosphate, citric acid monohydrate and purified water.

Within each carton is a tube with a plastic screw cap, which contains 100 g of cream.

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