Elocon Ointment

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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

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

Do not use Elocon

If you have:

• an allergy (hypersensitivity) to mometasone furoate or any of the other ingredients in this medicine (listed in section 6) or to other similar medicines.
• any other skin problems as it could make them worse especially:
  • rosacea (a skin condition affecting the face)
  • acne
  • skin atrophy (thinning of the skin)
  • dermatitis around the mouth
  • genital itching
  • nappy rash
  • cold sores
  • chickenpox
  • shingles
  • warts
  • ulcerated skin
  • wounds
  • other skin infections

Ask your doctor or pharmacist if you are not sure.

Warning and precautions

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 experience blurred vision or other visual disturbances.

If your skin becomes irritated or sensitive after using Elocon, you should stop using it and tell your doctor.

If you think that you have developed an infection on your skin while using Elocon, you should tell your doctor.

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

If you use more than the correct amount of ointment and/or use it for longer than is recommended, it can affect the levels of certain hormones in the body, particularly 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.

Children

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

• Delayed growth and development
• Puffiness or rounding of the face

Other medicines and Elocon

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

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 taking this medicine.

Elocon Ointment contains propylene glycol stearate

Elocon Ointment contains propylene glycol stearate, which can cause skin irritation.

Use in children

Elocon is not recommended for children under the age of 2.

How much to use

Usually for adults and children aged 2 and above, a thin layer of Elocon Ointment should be gently rubbed into the affected area of skin once a day.

Before using Elocon

You should always follow these instructions when using Elocon:

• Do not use the ointment on your face for more than 5 days
• Do not apply the ointment to children, on any part of their body, for more than 5 days.
• Do not put the ointment under your child’s nappy, as this makes it easier for the active drug to pass through the skin and possibly cause some unwanted effects.
• You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or plaster.
• You should 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).
• Do not use in or around your eyes, including eye-lids

If you use more Elocon than you should

If you (or somebody else) accidentally swallows the ointment, it should not produce 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 the body, it can affect some of your hormones.

In children, this may affect their growth and development.

If you have not used the cream as you were told to do and have used it too often and/or for a long time, you should tell your doctor.

If you forget to use Elocon

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 stop using Elocon

If you have been using Elocon 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.

Reporting of side effects

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

What Elocon contains

• The active substance is mometasone furoate, each gram contains 1 mg of mometasone furoate.
• The other ingredients are hexylene glycol; purified water; phosphoric acid; propylene glycol stearate; white bees wax; white soft paraffin.

What Elocon looks like and contents of the pack

The ointment is available in a tube containing 5, 15, 30, 45 and 100 g. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer