Lotriderm 0.05% w/w /1.0% w/w Cream - Patient Information Leaflet (PIL) (2024)

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

• if you are allergic to betamethasone dipropionate, clotrimazole or any of the other ingredients of this medicine (listed in section 6).
• if your skin becomes irritated, or you develop an allergic reaction.
• on any other skin infections as it could make them worse, especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, nappy rash or other skin infections.

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.

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 cream 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.

Do not use this medicine on children under 12 years of age unless advised by your doctor.

If you use more than the correct amount of cream 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
• A moon face 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

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

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.

• cetostearyl alcohol, which may cause localised skin reactions (e.g. contact dermatitis).
• 100mg propylene glycol in each gram, which may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
• 10mg benzyl alcohol in each gram, which may cause allergic reactions or mild local irritation.

• Keep the cream away from your eyes.
• If Lotriderm Cream is used in children, it should not be used on any part of their body for more than 5 days.
• Do not put the cream under a dressing, such as a plaster or bandage, as this makes it easier for the active ingredient of the medicine to pass through the skin and possibly cause some unwanted effects.
• You must not use a large amount of cream on large areas of the body for a long time (for example every day for many weeks or months).
• Do not apply the cream to the face for more than 5 days, in places where the skin folds (e.g. the back of the knee) or on large areas of damaged skin.

Tell your doctor if:

• you (or someone else) accidentally swallows the cream, it should not produce any undesirable effects.
• you use the cream more often than you should, or on large areas of the body, it may cause some side effects.
• you have not followed the dosage instructions, or your doctor’s advice and have used the cream too frequently and/or for a long time

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

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 at: 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 clotrimazole. Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 10 mg clotrimazole.
• The other ingredients are: liquid paraffin; white soft paraffin; cetostearyl alcohol; macrogol cetostearyl ether; benzyl alcohol; sodium dihydrogen phosphate dihydrate; phosphoric acid concentrated; sodium hydroxide; propylene glycol (E 1520); purified water.

Lotriderm Cream is a smooth, white to off white cream. It is available in tubes containing 15g, 30g or 50g.

Not all pack sizes may be marketed.

The holder of the Marketing Authorisation is:

Organon Pharma (UK) Limited
The Hewett Building
14 Hewett Street
London
EC2A 3NP
United Kingdom

The manufacturer is:

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium