AUDAVATE 0.1% W/W CREAM - patient leaflet, side effects, dosage

5|How to store Audavate

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Once opened, do not use this medicine for more than 3 months.

Do not use this medicine after the expiry date which is stated on the tube or carton. The expiry date refers to the last day of that month.

Do not throw away any 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.

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0 Contents of the pack and other information

What Audavate contains

The active ingredient is betamethasone valerate.

Each 1g contains 1mg of betamethasone (0.1% w/w) as betamethasone valerate.

The other ingredients are macrogol cetostearyl ether 20, cetostearyl alcohol, chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide, liquid paraffin, white soft paraffin and purified water.

What Audavate looks like and contents of the pack

Audavate Cream is a white or almost white cream.

Within each carton is a tube with a plastic screw cap, which contains 30g or 100g of cream.

Marketing Authorisation Holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturers

Tiofarma B.V., Benjamin Franklinstraat 5–10, 3261 LW Oud-Beijerland, The Netherlands

Tiofarma B.V., Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, The Netherlands

More information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of information are:

• National Eczema Society, 11 Murray Street, London, NW1 9RE.
• The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF.
• You may also be able to find out more from books in public libraries.

This leaflet was last revised in October 2021

If you would like a leaflet with larger text, please contact 01271 385257.

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, 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.
• The full name of this medicine is AudavateTM 0.1% w/w Cream but within the leaflet it will be referred to as Audavate.

What is in this leaflet

i^What Audavate is and what it is used for

^What you need to know before ; use Audavate

jlHow to use Audavate jlPossible side effects _5lHow to store Audavate ^Contents of the pack and other information

i|What Audavate is and what it is used for

Audavate contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids that reduce swelling and irritation.

Audavate is used to help reduce the redness and itchiness of certain skin problems, such as eczema, psoriasis and dermatitis.

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jlWhat you need to know before you use Audavate

Do not use Audavate:

• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of this medicine (listed in section 6)
• on a child under 1 year old
• to treat any of the following skin problems, as 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 Audavate.

Warnings and precautions

Talk to your doctor or pharmacist before using Audavate 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, as your doctor will want to see you more often
• you are using it 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 Continued over page
• 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.

If there is a worsening of your condition during use, consult your doctor – 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 doctor unless your doctor has previously advised you to do 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.

Children and adolescents

Dressings 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.

Other medicines and Audavate

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, breast-feeding and fertility 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 using this medicine.

Audavate contains cetostearyl alcohol and chlorocresol

Audavate cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.

3|How to use Audavate

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using this medicine

• You usually apply Audavate 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.

Guidance on how to apply the cream

• 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 Audavate 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.

• 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
• two and a half fingertips of cream will cover the face and neck.

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 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	1 y2	1 y2	2	2	3
3–5 years	1 y2	2	3	3	3 y2
6–10 years	2	2 y2	4 y2	3 y2	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 psoriasis

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.

If you apply Audavate 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 it does, wash it out with plenty of water.

If you use more Audavate than you should

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

If you forget to use Audavate

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 Audavate

If you use Audavate regularly, make sure you 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.

^Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Audavate 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 Audavate, 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.

Other side effects you may notice when using Audavate include:

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