• 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 this medicine is and what it is used for
2. What you need to know before you use this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• If you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from rosacea (flushing and inflammation of the facial skin), acne vulgaris or perioral dermatitis (inflammatory rash around the mouth).
• If you have infections of the skin with viruses such as herpes simplex or chickenpox.
• If you suffer from perianal or genital pruritus (itching around the back passage and genitals).
• If you suffer from ulcers in the skin, atrophy (thinning of skin) or fragile skin vessels.
• If you suffer from ichthyosis (skin disorders characterised by dryness and fish skin-like scaling on the skin).
• If you suffer from juvenile dermatosis (any skin diseases characterised by inflammation) or dermatosis in infants under 1 year of age, including dermatitis (inflammation of the skin) and napkin eruptions.
• If you suffer from ulcerated injuries.
• If you suffer from infected skin lesions caused by infection with fungi or bacteria.

Talk to your doctor or pharmacist before using this medicine:

• If you are pregnant, think you may be pregnant or if you are breast-feeding (see section Pregnancy, breast-feeding and fertility).
• If you use this medicine on large areas of the body for prolonged periods of time, especially when treating children, since it may increase the absorption of the product and the risk of toxicity.
• If you use this medicine on your face, since it may cause atrophic changes like thinning skin. It is important that you do not let the cream get in your eyes.
• If you use this medicine on covered parts of the body. Do not use this product under occlusive dressing; the affected zone has to be in contact with the air and not covered by dressing, tight clothes or similar. In infants, a nappy can act as an occlusive dressing. You should wash your skin before changing the dressing.
• If your doctor has prescribed this medicine for psoriasis. You should visit your doctor regularly to review your progress at periodic intervals.
• If you are using other products (including cosmetics) on the affected skin areas, as they can have a negative effect on this medicine’s activity. Check with your doctor if you are not sure.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• 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 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.

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.

Do not use the product in children under 1 year.

Tell your doctor if the symptoms do not improve within one or two weeks of starting treatment.

Once the skin condition has improved (usually within one to two weeks), you should apply the cream less frequently. Using the cream daily for more than 4 weeks is not recommended.

This medicine should only be used in children to relieve inflamed skin, redness and itching caused by atopic dermatitis under supervision of a medical specialist. You should consult a dermatologist before using this medicine in other types of dermatoses in children.

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

This medicine should only be used during pregnancy if the expected benefit to the mother outweighs the possible risk to the unborn child.

Breast-feeding

It is not known whether fluticasone is secreted in breast milk. This medicine should only be used during lactation if the expected benefit to the mother outweighs the possible risk to the child.

Fluticasone is not known to negatively affect the ability to drive or operate machinery.

This medicine contains cetostearyl alcohol, imidurea and propylene glycol.

As this medicine contains cetostearyl alcohol it may cause local skin reactions (e.g. contact dermatitis).

This medicine contains the preservative imidurea.

Imidurea breaks down to release a very small amount of chemical called formaldehyde.

Formaldehyde may cause local skin reactions (e.g. contact dermatitis).

This medicine contains 100mg propylene glycol in 1 gram of cream.

If you used more of this medicine than you should, especially in children, wash the affected areas of skin carefully to remove all the cream and contact your doctor or pharmacist. In case of accidental ingestion, contact your doctor or pharmacist.

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

If you forget to apply your cream, apply the correct dose when you remember or, if it is close to your next application, then wait until this time.

Do not stop using this medicine, even if you feel better, unless advised by your doctor.

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 the 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 substance is fluticasone propionate. Each 100g of cream contains 0.05g of fluticasone propionate.
• The other ingredients are macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate, paraffinum liquidum, purified water, propylene glycol (E-1520), citric acid monohydrate, disodium phosphate anhydrous, imidazolidinyl urea.

This medicine is a white, viscous cream contained in a 30g aluminium tube with a screw cap.

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