CLARELUX 500MICROGRAMS/G CUTANEOUS FOAM IN PRESSURISED CONTAINER

Active substance: CLOBETASOL PROPIONATE

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Read all of this leaflet carefully before you
start using this medicine.
- 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 any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What CLARELUX is and what it is used for
2. Before you use CLARELUX
3. How to use CLARELUX
4. Possible side effects
5. How to store CLARELUX
6. Further Information
1. WHAT CLARELUX IS AND WHAT IT IS USED FOR
CLARELUX is a foam to be applied to the skin, containing 500 microgram/g
clobetasol propionate as the active ingredient. Clobetasol propionate belongs to
a group of medicines known as topical corticosteroids.
CLARELUX is one of the stronger corticosteroids and is used as a short-term
treatment for scalp conditions, e.g. psoriasis of the scalp, which do not respond
satisfactorily to weaker corticosteroids.
2. BEFORE YOU USE CLARELUX
Do not use CLARELUX:
• If you are allergic to clobetasol propionate, to other corticosteroids or any of
the other ingredients of CLARELUX
• If you suffer from burns and other skin condition such as rosacea, acne, skin
inflammation around the mouth, itching (pruritus) around the anus or genitals,
or have a skin infection
• On any area of your body or face, apart from your scalp.
Take special care with CLARELUX
As with all topical corticosteroids, CLARELUX can be absorbed through the skin
and can cause side effects- see Section 4 for all possible side effects. Due to this:
• Long-term treatment with CLARELUX should be avoided.
• CLARELUX should not be applied to a large surface area.
• The treated areas should not be bandaged or covered unless directed by your
doctor.
When your skin condition is better or after a maximum duration treatment of
two weeks, your doctor should modify or change your treatment.
Inform your doctor:
• If your condition does not improve after 2 weeks of treatment.
• If an infection occurs, as this may require discontinuation of treatment with
CLARELUX.
• If you have a problem with your liver.
• If you start to experience problems with your vision, as this type of medicine
may increase the development of cataracts.
Children and adolescents: Treatment is not recommended in children
and adolescents.

Driving and using machines: CLARELUX should not affect your ability
to drive or operate machines.
Using other Medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without prescription.
Pregnancy and breast-feeding
Please inform your doctor if you are pregnant, planning to become pregnant,
breast-feeding or planning to breast-feed. CLARELUX should not be used during
pregnancy or breast-feeding unless advised by your doctor.
Important information about some of the ingredients in
CLARELUX
CLARELUX contains propylene glycol, which may cause skin irritation. It also
contains cetyl and stearyl alcohol, which may cause local skin reactions (e.g.
contact dermatitis).
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. You should 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.

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
If you use CLARELUX Foam in a larger quantity or for a long period of time
without your doctor’s knowledge you should tell your doctor immediately.
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, CLARELUX can cause side effects, although not everybody
gets them.
Stop using CLARELUX and contact your doctor immediately if hypersensitivity
reactions occur, such as local irritation. The side effects may include:
Common side effects (occurring in less than 1 in 10 people
but more than 1 in 100):
• Burning sensation
• Other skin reaction when applied to the skin
Very rare effects (occurring in less than 1 in 10,000 people):
• Sensation of tingling or pricking
• Eye irritation
• Swollen veins
• Skin irritation and tenderness
• Skin tightness
• Itchy skin rash (contact dermatitis)
• Aggravated scaly skin rash (psoriasis aggravated)
• Redness at the application site
• Itching and sometimes with pain at the application site
• Presence of blood, protein and nitrogen in your urine may be detected by a
doctor
Additional side effects may include:
• Changes in hair growth (abnormal hair growth away from the application site
and on unusual parts of the body )
• Changes in skin colour
• Irritation of the hair follicules e.g. pain, heat and redness
• Mouth rashes
• Redness and eruptions on the face
• Delay in wound healing
• Effects on the eyes
Side effects caused by prolonged use include:
• White markings on skin (striae) and dilatation of the blood vessels of the skin
• As with other topical corticosteroids, when CLARELUX is used in large amounts
and for a long period of time, this can lead to a disorder called Cushing’s syndrome which symptoms include a red, puffy and rounded face (called a moon
face), high blood pressure, weight gain and changes in sugar levels in the blood
and urine.
• Prolonged treatment with steroids may cause thinning of the skin.

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. If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CLARELUX
• The canister contains a pressurised, flammable liquid.
• Do not store near a naked flame, source of ignition, any heat
generating material or electrical device in use.
• Do not expose to temperatures higher than 50°C or to direct
sunlight.
• Do not pierce or burn the can even when empty.
• When you have finished your treatment, dispose of the can safely.
Keep out of the reach and sight 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.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
WHAT CLARELUX CONTAINS
1 g of cutaneous foam CLARELUX contains 500 microgram of clobetasol
propionate as active substance.
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 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: Pierre Fabre Dermatologie 45, place Abel-Gance - 92100 Boulogne - France.
Manufacturer: Aerosol Service Italiana S.R.L. (ASI) - Via del Maglio,6 - 23868
Valmadrera (LC) - Italy
This medicinal product is authorised in the Member States of the EEA under
the following names: CLARELUX 500 microgram/g cutaneous foam in Austria,
Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Luxemburg,
The Netherlands, Norway, Poland, Portugal, Slovakia, United-Kingdom and Spain.
OLUX 500 microgram/g cutaneous foam in Italy.
Other formats: To listen to or request a copy of this leaflet in Braille, large print
or audio please call:
United Kingdom: 0800 198 5000
Ireland: +44 (0)1733 375370
Please be ready to give the following information: Clarelux foam For United Kingdom: PL20693/0004 - For Ireland: PA1230/1/1.
This is a service provided by the Royal National institute of the Blind.
Clarelux is a trademark of Pierre Fabre Dermatologie.
Sold under Stiefel License - Patent n° GB 9504265
This leaflet was last approved in 12/2012.

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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