CLARELUX 500 microgram/g cutaneous foam in pressurised container

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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 CLARELUX is and what it is used for
2. What you need to know before you use CLARELUX
3. How to use CLARELUX
4. Possible side effects
5. How to store CLARELUX
6. Contents of the pack and other information

• If you are allergic to clobetasol propionate, to other corticosteroids or any of the other ingredients of this medicine (listed in section 6).
• If you have an infectious skin disease, either viral (e.g. herpes, shingles, chickenpox...), bacterial (e.g. impetigo ...), fungal (caused by microscopic fungi) or parasitic.
• If you suffer from burns, ulcerated lesions or other skin conditions such as rosacea, acne, skin inflammation around the mouth.
• If you have itching (pruritus) around the anus or genitals.
• On any area of your body or face (including the eyelids), apart from your scalp.
• In application to the eyelids (risk of damage to the nerve in the eye (glaucoma) and clouding of the lens (cataract)).
• In infants (children under 2 years old).

Talk to your doctor or pharmacist before using CLARELUX.

Inform your doctor if you previously had an allergy to corticosteroids and/or to any components of this medicine.

Stop treatment immediately and talk to your doctor if there is a worsening of your condition during use – you may be experiencing an allergic reaction, signs of which may include skin rash, itching or painless tissue swelling (oedema), have an infection or your condition requires a different treatment.

Long-term treatment should be avoided.

If you experience a recurrence of your condition shortly (within 2 weeks) after stopping treatment, do not restart using CLARELUX 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, because a rebound phenomenon could be suspected (see section 4).

Due to the deterioration of the skin barrier, there is a risk of sudden onset of painful pustules filled with non-infectious fluid that may be accompanied by fever (generalized pustular psoriasis) or the occurrence of local or systemic toxicity.

Avoid contact with eyes or mucous membranes (nose, mouth).

Do not apply CLARELUX on the eyelids or on the face due to risk of developing cloudy lens in the eyes (cataract) and increased pressure in the eye (glaucoma) which cause irreversible damage to the eyes. Contact your doctor if you experience blurred vision or other visual disturbances.

Wash your hands carefully after each application. Do not touch your eyes until you have washed your hands. In the event of accidental contact with the face or eyes, rinse thoroughly with plenty of water.

Unless supervised by a physician, the application of CLARELUX over a large surface area, or under bandaged and covered areas is to be avoided due to risk of some of the active ingredient passing to the bloodstream. Bacterial infection may occur, facilitated by the heat and moisture in skin under occlusive dressings. Do not use an occlusive dressing, unless directed by your doctor. In this case the skin should be cleaned before each dressing change.

Report any irritation or infection to your doctor as appropriate treatment will need to be used if infection occurs. If the infection spreads, CLARELUX should be discontinued and the infection treated.

As with all topical corticosteroids, CLARELUX can be absorbed through the skin with a risk of the active ingredient passing into the blood stream causing side effects such as the decreased production of adrenal glands hormones (pituitary adrenal system suppression) and Cushing’s syndrome - see Section 4 for all possible side effects. The risk of this corticosteroid passing into the bloodstream is increased in the following situations:

• Long-term treatment;
• Application to a large surface area;
• Application under bandaged or covered areas, such as occlusive dressings;
• Application on broken, damaged skin, such as wounds or open sores (ulcerations);
• Application on thin skin area such as the face;
• Increased skin hydration.

Inform your doctor if:

• You experience newly developed bone pain or worsening of previous bone symptoms during a treatment with CLARELUX, especially if you have been using CLARELUX for a prolonged time or repeatedly.
• You use other oral/topical medication containing corticosteroids or medication intended to control your immune system (e.g. for autoimmune disease or after a transplantation). Combining CLARELUX with these medicines may result in serious infections.
• Your condition does not improve after 2 weeks of treatment.
• An infection occurs, as this may require discontinuation of treatment with CLARELUX and administration of appropriate antimicrobial therapy.

Treatment is not recommended in children less than 12 years old.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Not applicable.

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

Pregnancy

CLARELUX should not be used during pregnancy unless advised by your doctor.

Breast-feeding

CLARELUX should not be used during breast-feeding unless advised by your doctor.

CLARELUX should not affect your ability to drive or operate machines.

This medicine contains:

• 2145 mg of alcohol (ethanol) in each application, which may cause burning sensation on damaged skin,
• 74 mg of propylene glycol (E 1520) in each application,
• cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
• polysorbate 60 (E 435), which can cause allergic reactions.

The canister contains a pressurised, flammable liquid.

Do not use or store near a naked flame, source of ignition, any heat generating material or electrical device in use.

Do not smoke whilst using or holding this can.

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

Use this medication only for the condition for which it was prescribed. CLARELUX must only be applied to the scalp and should not be swallowed.

Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin.

Apply CLARELUX to the affected area of the scalp twice a day, once in the morning and once at night, as follows:

Attention: for proper dispensing of foam, it is important to hold the container upside down!

1. Shake the can well.

2. Turn the can upside down and squirt a small amount (the size of a walnut) either directly onto the scalp, or into the cap of the can, onto a saucer or other cool surface and then onto the scalp.

CLARELUX should always be applied thinly, so use as little as possible when covering the affected areas. The exact amount you need depends on the size of the affected area.

Do not squirt CLARELUX onto your hands, as the foam will begin to melt immediately upon contact with warm skin.

3. Move the hair away from the foam and gently massage into the scalp, until it disappears and is absorbed. Repeat if necessary, to treat the entire affected area.

Wash your hands after applying CLARELUX and discard any unused foam.

Do not use CLARELUX on your face or to your eyelids. If some foam accidentally gets into your eyes, nose or mouth, rinse immediately with cold water. You may feel a stinging sensation. Contact your doctor, if the pain continues.

The treated areas should not be bandaged or covered unless directed by your doctor.

Do not wash or rinse the treated scalp areas immediately after applying CLARELUX.

Do not use more than 50 g of CLARELUX foam per week.

Treatment should not be given for more than 2 weeks. After this period CLARELUX may be used occasionally if needed. Alternatively, your doctor may prescribe a weaker steroid to control your condition.

Inform your doctor immediately if you have applied CLARELUX in quantities larger than the prescribed dose or for a longer period than that stated on your prescription. In these cases, there is a risk of the active ingredient passing into the blood stream causing side effects such as symptoms of hypercorticoidism (weight gain, fat build-up on the face, high blood pressure). The use of CLARELUX should be withdrawn gradually and under medical supervision, by reducing the frequency of application or by substituting to a less potent corticosteroid.

Use it as soon as you remember, then continue as before. If you only remember at the time of your next dose, use a single dose and continue as before (do not apply a double dose to make up for the forgotten dose). If you miss several doses, tell your doctor.

Do not stop using CLARELUX suddenly as this may harm you. Your doctor may need to discontinue the treatment gradually and you may need regular check-ups.

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 clobetasol propionate and 1 g of cutaneous foam contains 500 micrograms of clobetasol propionate.

The other ingredients are: ethanol anhydrous, purified water, propylene glycol (E 1520), cetyl alcohol, stearyl alcohol, polysorbate 60 (E 435), citric acid anhydrous, potassium citrate and a propane/n-butane/isobutane propellant mixture.

CLARELUX 500 micrograms/g cutaneous foam is a cutaneous white foam in pressurised container.

Each can contains 50 or 100 grams.

Not all pack sizes may be marketed.

Or