Active ingredient
- clobetasol propionate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00603/0248.
CLARELUX 500 microgram/g cutaneous foam in pressurised container
Package leaflet: Information for the user
CLARELUX 500 microgram/g cutaneous foam in pressurised container
Clobetasol propionate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
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
1. What CLARELUX is and what it is used for
CLARELUX contains the active substance clobetasol propionate which belongs to a group of medicines known as topical corticosteroids. Clobetasol propionate is a highly potent topical corticosteroids.
CLARELUX 500 microgram/g cutaneous foam in pressurised container is a foam to be applied to the skin.
CLARELUX 500 microgram/g cutaneous foam in pressurised container is used as a short-course treatment of steroid response dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids.
2. What you need to know before you use CLARELUX
Do not use CLARELUX:
Warnings and precautions
Talk to your doctor or pharmacist before using CLARELUX.
Stop treatment immediately and talk to your doctor if an allergic reaction occurs, signs of which may include skin rash, itching or painless tissue swelling (oedema).
As with all topical corticosteroids, CLARELUX can be absorbed through the skin and can cause side effects such as adrenocortical suppression - see Section 4 for all possible side effects. Due to this:
Inform your doctor if:
Wash your hands carefully after each application.
In the event of accidental contact with the face or eyes, rinse thoroughly with plenty of water.
Children and adolescents
Treatment is not recommended in children less than 12 years old.
Other medicines and CLARELUX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
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.
CLARELUX should not be used during pregnancy or breast-feeding unless advised by your doctor.
Driving and using machines
CLARELUX should not affect your ability to drive or operate machines.
Important information about some of the ingredients in CLARELUX
This medicine contains:
3. How to use CLARELUX
WARNINGS:
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 apply to the eyelids and take care to avoid contact with eyes, nose, and mouth.
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. 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 50g 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.
If you use more CLARELUX than you should
Inform your doctor immediately if you have applied CLARELUX:
for a longer period than that stated on your prescription
If you forget to use CLARELUX
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.
If you stop using CLARELUX
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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using CLARELUX 500 microgram/g cutaneous foam and contact your doctor immediately if hypersensitivity reactions occur, such as local irritation.
The side effects may include:
Common side effects (may affect up to 1 in 10 people but more than 1 in 100):
Very rare effects (may affect up to 1 in 10,000 people):
Additional side effects may include:
Side effects caused by prolonged use include:
In rare instances, treatment of psoriasis with corticosteroids (or on stopping treatment) may make the condition worse and a pustular form of the disease may occur. On stopping treatment with corticosteroids, sometimes, the scalp condition may return. Also pre-existing infections may worsen if CLARELUX is not used according to the instructions.
Reporting of side effects
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.
5. How to store CLARELUX
Keep out of the sight and reach of children.
Do not use CLARELUX after the expiry date which is stated on the can and the outer carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate. Store upright.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What CLARELUX contains
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, cetyl alcohol, stearyl alcohol, polysorbate 60, citric acid anhydrous, potassium citrate and a propane/n-butane/isobutane propellant mixture.
What CLARELUX looks like and contents of the pack
CLARELUX microgram/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.
Marketing Authorisation Holder
Manufacturer(s)
Or
This medicinal product is authorised in the Member States of the EEA under the following names: CLARELUX 500 micrograms/g cutaneous foam in Austria, Belgium, Czech Republic, France, Germany, Greece, Luxemburg, The Netherlands, Poland, Portugal, Slovakia, United Kingdom and Spain.
OLUX 500 micrograms/g cutaneous foam in Italy.
This leaflet was last approved in 01/2021.
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