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CLARELUX 500 MICROGRAMS/G CUTANEOUS FOAM IN PRESSURISED CONTAINER

Active substance(s): CLOBETASOL PROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Clarelux 500 micrograms/g Cutaneous Foam in pressurised container
(clobetasol propionate)
Other medicines and CLARELUX ®

This medicine is known as the above but will be referred to as
CLARELUX® throughout this leaflet.

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

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.

Pregnancy and breast-feeding

• Keep this leaflet. You may need to read it again.

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.

• 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.

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

• 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.

Driving and using machines

What is in this leaflet:

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

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

Important information about some of the ingredients in CLARELUX ®
This medicine 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®

1. What CLARELUX ® is and what it is used for

WARNINGS:

CLARELUX®contains the active substance clobetasol propionate which
belongs to a group of medicines known as topical corticosteroids.
CLARELUX® is a highly potent topical corticosteroids.

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.

CLARELUX® is a foam to be applied to the skin.
CLARELUX® is used as a short-term treatment for scalp conditions, e.g.
psoriasis of the scalp, which do not respond satisfactorily to weaker
corticosteroids.

Do not smoke whilst using or holding this can.

2. What you need to know before you use CLARELUX ®

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.

Always use CLARELUX® exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Do not use CLARELUX®:







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

If you are allergic to clobetasol propionate, to other corticosteroids or
any of the other ingredients of CLARELUX®;
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 condition
such as rosacea, acne, skin inflammation around the mouth, itching
(pruritus) around the anus or genitals.
On any area of your body or face (included the eyelids), apart from
your scalp.

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.

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:

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;

The use of CLARELUX® on wounds or ulcerations is not
recommended.

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.



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 start to experience problems with your vision, as this type of
medicine may increase the development of cataracts and glaucoma.

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.

Wash your hands carefully after each application.

Do not apply to the eyelids and take care to avoid contact with eyes,
nose, and mouth.

In the event of accidental contact with the face or eyes, rinse thoroughly
with plenty of water.

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

Children and adolescents
Treatment is not recommended in children and adolescents.

1

3. Move the hair away from the foam and gently massage into the scalp,
until it disappears and is absorbed.



Effects on the eyes (cataract, high pressure in the eye)

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.



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.

Reporting of side effects

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

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.

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.

5. How to store CLARELUX®

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®

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 50ºC 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 sight and reach of children.

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).

Do not use CLARELUX® after the expiry date which is stated on the can
and the outer carton after EXP.

If you miss several doses, tell your doctor.

The expiry date refers to the last day of that month.

If you stop using CLARELUX ®

Do not store above 25°C. Do not refrigerate. Store upright.

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 your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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.

4. Possible side effects
6. Contents of the pack and other information

Like all medicines, CLARELUX® can cause side effects, although not
everybody gets them.

What CLARELUX ® contains

®

Stop using CLARELUX and contact your doctor immediately if
hypersensitivity reactions occur, such as local irritation.

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.

The side effects may include:
Common side effects (occurring in less than 1 in 10 people but more
than 1 in 100):



What CLARELUX ® looks like and contents of the pack
CLARELUX® is a cutaneous white foam in a pressurised container. Each
filled canister is fitted into a spout actuator with dust cap. Each container
contains 100g of foam. Each pack contains 1 container.

Burning sensation
Other skin reaction when applied to the skin

Very rare effects (occurring in less than 1 in 10,000 people):











Manufacturer
Aerosol Service Italiana S.R.L. (ASI), Via del Maglio, 6 - 23868
Valmadrera (LC) - Italy.

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

Procured from within the EU and repackaged by Product Licence Holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL16378/0565
Revision Date: 12.07.2016
Leaflet Ref: Clar-Fo

Additional side effects may include:







POM

CLARELUX® is a trademark of Pierre Fabre Dermatologie.

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

2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clobetasol Propionate 500 micrograms/g Cutaneous Foam in pressurised container
Wash your hands carefully after each application.

This medicine is known as the above but will be referred to as 'Clobetasol
Propionate Cutaneous Foam' throughout this leaflet.

In the event of accidental contact with the face or eyes, rinse thoroughly
with plenty of water.

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.

Children and adolescents

• Keep this leaflet. You may need to read it again.

Treatment is not recommended in children and adolescents.

• If you have any further questions, ask your doctor or your pharmacist.

Other medicines and Clobetasol Propionate Cutaneous Foam

• 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.

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

• 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.

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.

What is in this leaflet:
1. What Clobetasol Propionate Cutaneous Foam is and what it is used for
2. What you need to know before you use Clobetasol Propionate
Cutaneous Foam
3. How to use Clobetasol Propionate Cutaneous Foam
4. Possible side effects
5. How to store Clobetasol Propionate Cutaneous Foam
6. Contents of the pack and other information

Clobetasol Propionate Cutaneous Foam should not be used during
pregnancy or breast-feeding unless advised by your doctor.
Driving and using machines
Clobetasol Propionate Cutaneous Foam should not affect your ability to
drive or operate machines.
Important information about some of the ingredients in Clobetasol
Propionate Cutaneous Foam

1. What Clobetasol Propionate Cutaneous Foam is and what it is
used for

This medicine 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).

Clobetasol Propionate Cutaneous Foam contains the active substance
clobetasol propionate which belongs to a group of medicines known as
topical corticosteroids. Clobetasol Propionate Cutaneous Foam is a highly
potent topical corticosteroids.

3. How to use Clobetasol Propionate Cutaneous Foam
WARNINGS:

Clobetasol Propionate Cutaneous Foam is a foam to be applied to the
skin.

The canister contains a pressurised, flammable liquid.

Clobetasol Propionate Cutaneous Foam is used as a short-term treatment
for scalp conditions, e.g. psoriasis of the scalp, which do not respond
satisfactorily to weaker corticosteroids.

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.

2. What you need to know before you use Clobetasol Propionate
Cutaneous Foam

Always use Clobetasol Propionate Cutaneous Foam exactly as your
doctor has told you. You should check with your doctor or pharmacist if
you are not sure.

Do not use Clobetasol Propionate Cutaneous Foam:








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

If you are allergic to clobetasol propionate, to other corticosteroids or
any of the other ingredients of Clobetasol Propionate Cutaneous
Foam
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 condition
such as rosacea, acne, skin inflammation around the mouth, itching
(pruritus) around the anus or genitals.
On any area of your body or face (included the eyelids), apart from
your scalp.

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

Warnings and precautions



Talk to your doctor or pharmacist before using Clobetasol Propionate
Cutaneous Foam
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, Clobetasol Propionate Cutaneous Foam
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:

Long-term treatment with Clobetasol Propionate Cutaneous Foam
should be avoided;

Clobetasol Propionate Cutaneous Foam should not be applied to a
large surface area;

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

The use of Clobetasol Propionate Cutaneous Foam on wounds or
ulcerations is not recommended.

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.



Inform your doctor:




Clobetasol Propionate Cutaneous Foam 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.

If your condition does not improve after 2 weeks of treatment.
If an infection occurs, as this may require discontinuation of
treatment with Clobetasol Propionate Cutaneous Foam.
If you start to experience problems with your vision, as this type of
medicine may increase the development of cataracts and glaucoma.

Do not apply to the eyelids and take care to avoid contact with eyes,
nose, and mouth.

1

Do not squirt Clobetasol Propionate Cutaneous Foam 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.

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 (cataract, high pressure in the eye)

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 Clobetasol Propionate
Cutaneous Foam 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 Clobetasol Propionate Cutaneous Foam is not used
according to the instructions.

Wash your hands after applying Clobetasol Propionate Cutaneous Foam
and discard any unused foam.
Do not use Clobetasol Propionate Cutaneous Foam 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
Clobetasol Propionate Cutaneous Foam .2 2

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.

Do not use more than 50g of Clobetasol Propionate Cutaneous Foam per
week.
Treatment should not be given for more than 2 weeks.
After this period Clobetasol Propionate Cutaneous Foam may be used
occasionally if needed. Alternatively your doctor may prescribe a weaker
steroid to control your condition.

5. How to store Clobetasol Propionate Cutaneous Foam

If you use more Clobetasol Propionate Cutaneous Foam than you
should




If you use Clobetasol Propionate Cutaneous 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 Clobetasol Propionate Cutaneous Foam




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).

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 50ºC 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 sight and reach of children.

If you miss several doses, tell your doctor.

Do not use Clobetasol Propionate Cutaneous Foam after the expiry date
which is stated on the can and the outer carton after EXP.

If you stop using Clobetasol Propionate Cutaneous Foam

The expiry date refers to the last day of that month.

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

Do not store above 25°C. Do not refrigerate. Store upright.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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.

4. Possible side effects
Like all medicines, Clobetasol Propionate Cutaneous Foam can cause
side effects, although not everybody gets them.

6. Contents of the pack and other information

Stop using Clobetasol Propionate Cutaneous Foam and contact your
doctor immediately if hypersensitivity reactions occur, such as local
irritation.

What Clobetasol Propionate Cutaneous Foam contains
1 g of cutaneous foam contains 500 micrograms of clobetasol propionate.

The side effects may include:
Common side effects (occurring in less than 1 in 10 people but more
than 1 in 100):

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 Clobetasol Propionate Cutaneous Foam looks like and
contents of the pack

Burning sensation
Other skin reaction when applied to the skin

Clobetasol Propionate Cutaneous Foam is a cutaneous white foam in a
pressurised container. Each filled canister is fitted into a spout actuator
with dust cap. Each container contains 100g of foam. Each pack contains
1 container.

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

Manufacturer
Aerosol Service Italiana S.R.L. (ASI), Via del Maglio, 6 - 23868,
Valmadrera (LC) - ITALY
Procured from within the EU and repackaged by Product Licence Holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL16378/0565

Additional side effects may include:


Revision Date: 12.07.2016
Leaflet Ref: Clar-Fo

Changes in hair growth (abnormal hair growth away from the
application site and on unusual parts of the body)

2

POM

Expand view ⇕

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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