CLARELUX 500 mcg/g Foam

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clarelux, 500 micrograms/g, cutaneous foam
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet
3. What is Clarelux and what is it used for
4. Important information before using Clarelux
   1. When not to use Clarelux:
   2. Warnings and precautions
   3. Tell your doctor if:
   4. Children and adolescents
   5. Clarelux with other medicines
   6. Clarelux with food, drinks and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Important information about some of the ingredients of Clarelux
5. How to use Clarelux
   1. WARNINGS:
   2. The container contains a flammable liquid under pressure.
   3. Do not use or store near an open flame, ignition source, heat-generating materials or electrical appliances in use.
   4. Do not smoke while using or holding the container.
   5. Duration of treatment
   6. Using a higher dose of Clarelux than recommended
   7. Missing a dose of Clarelux
   8. Stopping the use of Clarelux
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people, but more frequently than 1 in 100 people):
   2. Rare side effects (may affect up to 1 in 1,000 people):
   3. Very rare side effects (may affect up to 1 in 10,000 people):
   4. Additional side effects with unknown frequency (frequency cannot be estimated from available data):
   5. Side effects due to long-term use with unknown frequency (frequency cannot be estimated from available data):
   6. Reporting side effects
7. How to store Clarelux
8. Contents of the pack and other information
   1. What Clarelux contains
   2. What Clarelux looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet: May 2025

Package Leaflet: Information for the User

Clarelux, 500 micrograms/g, cutaneous foam

Clobetasol propionate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

• 1. What is Clarelux and what is it used for
• 2. Important information before using 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 is Clarelux and what is it used for

Clarelux contains the active substance clobetasol propionate, which belongs to a group of medicines called topical corticosteroids. Clobetasol propionate is a very potent corticosteroid.
Clarelux is available as a cutaneous foam.
Clarelux is used in adults and adolescents from 12 years of age for short-term treatment of scalp disorders that are responsive to topical corticosteroids, such as scalp psoriasis, which do not respond satisfactorily to less potent corticosteroids.

2. Important information before using Clarelux

When not to use Clarelux:

• if you are allergic (hypersensitive) to clobetasol propionate or other corticosteroids or any of the other ingredients of this medicine (listed in section 6);
• if you have skin infections: viral (e.g. herpes, chickenpox, shingles), bacterial (e.g. impetigo), fungal (caused by microscopic fungi) or parasitic;
• if you have burns, ulcers or other skin diseases, such as rosacea, acne, or perioral dermatitis;
• if you have itching in the anal or genital area;
• on any part of the body or face (including eyelids), except the scalp;
• on the eyelids (risk of nerve damage [glaucoma] and lens clouding [cataract])
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Clarelux, discuss it with your doctor or pharmacist.
Tell your doctor if you have ever had an allergy to corticosteroids or any other ingredient of this medicine.
Stop using the medicine and discuss it with your doctor if during treatment the disease worsens, as this may indicate the development of an allergic reaction (whose symptoms include skin rash, itching or painless swelling), infection or the need for other therapy.
Avoid long-term treatment.
If the disease recurs within 2 weeks after the end of treatment, do not use Clarelux again without consulting your doctor, unless your doctor has previously recommended it. If the patient's disease has resolved, but after a relapse, skin redness exceeds the previously treated area and the patient experiences skin burning, consult your doctor before resuming treatment. It may be suspected that a rebound effect has occurred (see section 4).

• 4)

Due to skin barrier disruption, there is a risk of sudden onset of painful, fluid-filled blisters, which may be accompanied by fever (generalized pustular psoriasis) or local or systemic toxicity.
Avoid contact of the medicine with eyes or mucous membranes (nose, mouth).
Do not use Clarelux on the eyelids or on the skin of the face due to the risk of lens clouding in the eyes (cataract) and increased pressure in the eyeball (glaucoma), leading to irreversible eye damage. If the patient experiences blurred vision or other vision disturbances, consult a doctor.
Wash your hands thoroughly after each use of the medicine. Do not touch your eyes before washing your hands.
In case of accidental contact of the medicine with the skin of the face or eyes, rinse these areas thoroughly with plenty of water.
If not supervised by a doctor, avoid using Clarelux on a large skin surface or under a bandage and occlusive dressing due to the risk of penetration of part of the active substance into the blood. Bacterial infection may occur, which is favored by the heat and moisture of the skin under the occlusive dressing. Do not use an occlusive dressing unless advised by a doctor.
In such a case, before each dressing change, clean the skin.
Report any irritation or infection to your doctor, as appropriate treatment may be necessary. If the infection spreads, discontinue Clarelux and treat the infection.
As with all topical corticosteroids, Clarelux may be absorbed through the skin, posing a risk of penetration of the active substance into the blood and causing such side effects as decreased production of adrenal hormones (suppression of the hypothalamic-pituitary-adrenal axis) and Cushing's syndrome - all possible side effects are listed in section 4. The risk of corticosteroid penetration into the blood is increased in the following situations:

• long-term treatment;
• application to a large skin surface;
• bandaging or covering the treated areas, e.g. with an occlusive dressing;
• use on broken, damaged skin, such as wounds or open ulcers;
• use on thin skin, e.g. on the face;
• increased skin moisture.

Tell your doctor if:

• while using Clarelux for the first time, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if Clarelux is used for a long time or repeatedly;
• the patient is taking other medicines containing corticosteroids or medicines intended to regulate the immune system (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Clarelux with these medicines may lead to severe infections.
• after 2 weeks of treatment, the patient's condition does not improve;
• an infection occurs, as discontinuation of Clarelux and administration of appropriate anti-infective treatment may be necessary.

Children and adolescents

Clarelux is not recommended for use in children under 12 years of age.

Clarelux with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Clarelux with food, drinks and alcohol

Not applicable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Clarelux should not be used during pregnancy unless advised by a doctor.
Breastfeeding
Clarelux should not be used during breastfeeding unless advised by a doctor.

Driving and using machines

Clarelux is not expected to affect your ability to drive or use machines.

Important information about some of the ingredients of Clarelux

Clarelux contains:

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

3. How to use Clarelux

WARNINGS:

The container contains a flammable liquid under pressure.

Do not use or store near an open flame, ignition source, heat-generating materials or electrical appliances in use.

Do not smoke while using or holding the container.

Clarelux should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Use Clarelux as intended, i.e. only on the scalp. Do not swallow.
It is not recommended to squeeze the medicine directly onto your hand, as the foam will immediately start to melt when in contact with warm skin.
Apply Clarelux to the affected areas of the scalp, twice a day, once in the morning, once in the evening, according to the following instructions:
Note: To dose the foam correctly, hold the container upside down!

• 1. Shake the container vigorously.

• 2. Turn the container upside downand squeeze a small amount (the size of a walnut) directly onto the scalp or into the cap of the container, onto the bottom or other cool surface, and then onto the scalp. Apply a thin layer of Clarelux, as small as possible, to the affected area. The exact amount needed depends on the size of the affected area. It is not recommended to squeeze the medicine directly onto your hand, as the foam will immediately start to melt when in contact with warm skin.

• 3. Gently move the hair away from the foam and massage the foam into the scalp until it disappears and is absorbed. If necessary, repeat to apply the medicine to the entire affected area.

After each application of Clarelux, wash your hands thoroughly and remove any unused foam.
Do not use Clarelux on the face or eyelids. If the medicine accidentally gets into your eyes, nose or mouth, rinse immediately with cold water. The medicine may cause a burning sensation. If the pain persists, consult a doctor.
Do not bandage or cover the treated areas unless advised by a doctor.
Do not wash or rinse the treated skin areas immediately after applying Clarelux.

Duration of treatment

Do not use more than 50 g of Clarelux per week.
Treatment should not last longer than 2 weeks. After this period, Clarelux may be used sporadically, as needed. Alternatively, your doctor may prescribe a weaker steroid to control your condition.

Using a higher dose of Clarelux than recommended

Immediately inform your doctor if you have used Clarelux:

• in a dose higher than prescribed or
• for a longer period than recommended. There is a risk that the active substance of the medicine may penetrate into the blood, causing side effects such as symptoms of adrenal gland overactivity (weight gain, fat deposition on the face, high blood pressure). Clarelux should be discontinued gradually, under medical supervision, by reducing the frequency of applications or replacing the medicine with a weaker corticosteroid.

Missing a dose of Clarelux

The patient should apply the missed dose as soon as they remember, and then continue treatment as before. If the patient remembers to apply the medicine only at the time of the next dose, they should apply that dose as a single dose for that day, and then continue treatment as before (do not apply a double dose to make up for the missed dose). If several doses are missed, consult a doctor.

Stopping the use of Clarelux

Do not stop treatment abruptly, as this may be harmful. Your doctor may gradually stop treatment. Regular checks may be necessary.
If you have any further questions about the use of this medicine, 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 you experience an allergic reaction (hypersensitivity), such as local irritation.
Side effects include:

Common side effects (may affect up to 1 in 10 people, but more frequently than 1 in 100 people):

• Burning sensation of the skin at the application site of Clarelux
• Other skin reactions at the application site of Clarelux

Rare side effects (may affect up to 1 in 1,000 people):

• Pustular psoriasis (chronic skin inflammation with blistering)

Very rare side effects (may affect up to 1 in 10,000 people):

• Decreased production of adrenal hormones (suppression of the hypothalamic-pituitary-adrenal axis)
• Feeling of numbness, tingling or prickling (paresthesia)
• Eye irritation
• Vascular swelling (vasodilation)
• Skin irritation, pain (tenderness) of the skin, skin tension
• Itchy rash (contact dermatitis), skin inflammation
• Worsening of psoriasis
• Redness (erythema) at the application site
• Itching at the application site
• Pain
• Presence of blood, protein and nitrogen in the urine, which may be detected by your doctor
• Changes in blood tests indicating the presence of more than average red blood cells (increased mean erythrocyte volume)

Additional side effects with unknown frequency (frequency cannot be estimated from available data):

• Possible occurrence of secondary infection, especially when using the medicine under an occlusive dressing or in skin folds (elbow, groin, and genital areas). Symptoms of infection include skin redness, which may be accompanied by pain or itching.
• Excessive hair growth (hypertrichosis)
• Changes in skin color
• Folliculitis
• Rash around the mouth (perioral dermatitis)
• Redness and rash on the face (skin inflammation resembling rosacea)
• Prolonged wound healing
• Clouding of the lens (cataract), high pressure in the eyeball (glaucoma)
• Blurred vision

Side effects due to long-term use with unknown frequency (frequency cannot be estimated from available data):

• Similarly to other topical corticosteroids, Clarelux used in large quantities and for a long time may cause the occurrence of Cushing's disease with symptoms such as weight gain, fat deposition on the face, and bruising due to excessive amounts of steroid hormones.
• Topical steroid withdrawal reaction (rebound effect). If the medicine is used for a long time, in some patients, during treatment or within a few days to weeks after its completion, a withdrawal reaction may occur, which may differ from the previous condition, with some or all of the following symptoms: skin redness, which may cover a larger area than initially treated, burning or prickling sensation, intense itching, skin peeling, oozing open sores.
• Local changes in the skin, such as thinning of the skin (atrophy) and its fragility, colored bruises (ecchymoses), presence of small, visible blood vessels (telangiectasias), especially on the face, stretch marks, especially on the limbs.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clarelux

• The container contains a flammable liquid under pressure.
• Do not store near an open flame, ignition source, heat-generating materials or electrical appliances in use.
• Do not expose to temperatures above 50°C or direct sunlight.
• Do not pierce or burn the container, even if it is empty.
• After completing treatment, dispose of the container in a safe way.

Keep out of sight and reach of children.
Do not use Clarelux after the expiry date stated on the container and carton after: EXP. The expiry date refers to the last day of the month.
Do not store above 25°C. Do not store in the refrigerator. Store in an upright position.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clarelux contains

The active substance of Clarelux is clobetasol propionate.
1 gram of cutaneous foam contains 500 micrograms of clobetasol propionate.
The other ingredients are: anhydrous ethanol, purified water, propylene glycol (E 1520), cetyl alcohol, stearyl alcohol, polysorbate 60 (E 435), anhydrous citric acid, potassium citrate and a mixture of propane, n-butane and isobutane gases.

What Clarelux looks like and contents of the pack

Clarelux is a white cutaneous foam in a pressurized container.
The container contains 50 or 100 grams of cutaneous foam.
Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer/Importer

Recipharm Uppsala AB
Björkgatan 30
751 82 Uppsala
Sweden
Farmol Health Care S.r.L.
Via del Maglio, 6
23868 Valmadrera (LC)
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

CLARELUX 500 micrograms/g cutaneous foam - Austria, Belgium, Czech Republic, France, Germany, Greece, Luxembourg, Netherlands, Poland, Portugal, Slovakia, United Kingdom and Spain.
OLUX 500 micrograms/g cutaneous foam - Italy.
To obtain more detailed information, please contact your local representative of the marketing authorization holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel. 22 559 63 60

Date of last revision of the package leaflet: May 2025