Betamethasone + Salicylic Acid 0.05 %w/w + 3 %w/w Ointment

• 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 take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• if you have an allergy to betamethasone diproprionate, salicylic acid or any of the other ingredients of this medicine (listed in section 6).
• any other skin problem as it could make it worse especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, genital itching, nappy rash, cold sores, chickenpox or other skin conditions.

If you have psoriasis, your doctor may want to review your treatment regularly. Contact your doctor if your psoriasis gets worse or you get raised bumps filled with pus under your skin.

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

This medicine should not be used under bandages or plasters.

Side effects that may happen with inhaled or oral corticosteroids may also occur with corticosteroids use on the skin, especially in infants and children.

In adults, the changes in hormone levels may lead rarely to puffiness or rounding of the face, weakness, tiredness, and dizziness when standing or sitting down.

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 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 ointment 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.

If you use more than the correct amount of ointment and/or use it for longer than is recommended, it can affect your child’s hormones. Rarely this may lead to:

If you use more than the correct amount of ointment and/or use it for longer than is recommended, it can affect your child’s hormones. Rarely this may lead to:

• Delayed growth and development
• Puffiness or rounding of the face
• A build-up of pressure around the brain which can produce:
  • a bulging of the fontanelle (the soft spot in the top of the skull) in infants
  • a constant thumping headache
  • blurred vision or other visual disturbances

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Usually for adults and children, a thin layer of ointment should be gently rubbed into the affceted area of skin twice a day.

You should always follow these instructions when using this medicine:

• Do not use the ointment on your face for more than 5 days
• Do not use a large amount of ointment on large areas of the body for a long time (for example every day for many weeks or months)
• Avoid getting the ointment in your eyes or inside your nose or mouth.

Use as stated above. Do not use this ointment on any part of your child's body for more than 5 days. Do not put the ointment under your child’s nappy, as this makes it easier for the active ingredients of the medicine to pass through the skin and possibly cause some unwanted effects.

If you (or somebody else) accidentally swallow the ointment, it should not cause any problems. However, if you are worried, you should see your doctor. If you use the ointment more often than you should, or on large areas of your body, it can affect some of your hormones. In children this may affect their growth and development. It also may cause you to feel and/or be sick and to hear ringing in your ears. If you have not used the ointment as you were told to do and have used it too often and/or for a long time, you should tell your doctor or pharmacist.

If you forget to use your ointment at the right time, use it as soon as you remember, then carry on as before.

If you have been using the ointment for a long time and your skin problem seems to have got better, you should not suddenly stop using the ointment. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor who will gradually reduce how often you need to use the ointment until you stop treatment altogether.

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 substances are betamethasone dipropionate and salicylic acid. One gram of ointment contains 0.5 mg of betamethasone (as betamethasone dipropionate 0.64 mg) and 30 mg of salicylic acid.
• The other ingredients are: paraffin, liquid; paraffin, white soft

This medicine is white, semi-transparent homogeneous ointment, packed in an aluminium tube with internal protective lacquer (epoxy phenolic lacquer) and protective membrane and a HDPE screw cap with piercing spike, in a carton box.

Pack size: 30 g, 100g. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer