Clarelux

Caution! The package leaflet must be retained. Information on the immediate packaging is in a foreign language.
Clarelux, 500 micrograms/g, foam for skin
Clobetasol propionate
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Clarelux is and what it is 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 Clarelux is and what it is 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 foam for topical application to the skin.
Clarelux is used for short-term treatment of steroid-responsive dermatoses of the scalp, such as scalp psoriasis, which have not responded adequately to treatment with less potent corticosteroids.

2. Important information before using Clarelux

When not to use Clarelux:

• if the patient is allergic (hypersensitive) to clobetasol propionate, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has skin infections: viral (e.g. herpes simplex, shingles, chickenpox), bacterial (e.g. impetigo), fungal (caused by microscopic fungi), or parasitic;
• if the patient has burns, ulcers, or other skin disorders such as rosacea, acne, perioral dermatitis, perianal or genital pruritus;
• on any part of the body or face (including eyelids), except the scalp;
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Clarelux, discuss it with your doctor or pharmacist.
You should immediately stop using Clarelux and consult your doctor if the condition worsens during treatment, as this may indicate the development of an allergic reaction (symptoms of which include skin rash, itching, or painless swelling of tissues - oedema), infection, or the need for alternative therapy.
If the condition recurs within a short time (within 2 weeks) after stopping treatment, do not reapply Clarelux without first consulting your doctor, unless your doctor has previously advised you to do so. If the patient's condition has resolved, but upon recurrence the redness extends beyond the previously treated area and the patient experiences a burning sensation, consult a doctor before resuming treatment. A rebound effect may be suspected.
As with all topical corticosteroids, Clarelux may be absorbed through the skin and cause adverse effects, such as suppression of adrenal cortex function – all possible adverse effects are listed in section 4. Therefore:

• avoid prolonged treatment with Clarelux;
• do not apply Clarelux over a large surface area;
• do not bandage or cover treated areas unless advised by a doctor;
• do not use Clarelux on wounds or ulcers;
• contact your doctor if the patient experiences blurred vision or other visual disturbances.

Inform your doctor if:

• during treatment with Clarelux, the patient experiences bone pain for the first time or worsening of pre-existing bone symptoms, especially if Clarelux has been used for a prolonged period or repeatedly;
• the patient is taking orally or topically other medicines containing corticosteroids or medicines intended to regulate immune system function (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Clarelux with these medicines may lead to severe infections;
• the patient's condition does not improve after 2 weeks of treatment;
• an infection occurs, as discontinuation of Clarelux may be necessary;
• the patient begins to experience visual disturbances, as such medicines may cause cataracts and glaucoma.

Hands should be thoroughly washed after each use of the medicine.
In case of accidental contact with the face or eyes, rinse thoroughly with plenty of water.
Children and adolescents
Use of Clarelux is not recommended in children under 12 years of age.
Clarelux and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Clarelux should not be used during pregnancy or breastfeeding unless the doctor considers it clearly necessary.
Driving and operating machinery
Clarelux is not expected to affect the ability to drive or operate machinery.
Important information about certain ingredients of Clarelux
Clarelux contains:

• 2145 mg of alcohol (ethanol) per application, which may cause a stinging sensation on damaged skin;
• 74 mg of propylene glycol per application;
• cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Clarelux

WARNINGS:
The container contains a flammable liquid under pressure.
Do not use or store near open flame, sources of ignition, materials that generate heat, or electrical devices in use.
Do not smoke while using or holding the container.
Always use Clarelux exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Clarelux should be used only as intended, i.e. exclusively on the hairy scalp. Do not swallow.
It is not recommended to dispense the foam directly onto the hand, as contact with warm skin will cause the foam to melt immediately.
Apply Clarelux to affected areas of the hairy scalp twice daily, once in the morning and once in the evening, as follows:
Note: To dispense the foam correctly, the container must be held upside down!

1. Shake the container well.

2. Turn the container upside down and dispense a small amount (about the size of a walnut) directly onto the hairy scalp or into the cap of the container, onto a saucer, or another cool surface, then apply to the scalp. Apply a thin layer of Clarelux, using the smallest amount necessary to cover the affected area. The exact amount required depends on the size of the affected area. Do not apply to the eyelids or near the eyes, nose, or mouth. It is not recommended to dispense Clarelux foam directly onto the hand, as contact with warm skin will cause the foam to melt immediately.

3. Part the hair and gently massage the foam into the scalp until it disappears and is fully absorbed. If necessary, repeat to ensure the entire affected area is covered.

After each application of Clarelux, wash your hands thoroughly and remove any unused foam residue.
Do not apply Clarelux to the face. If the product accidentally gets into the eyes, nose, or mouth, rinse immediately with cold water. The medicine may cause a stinging sensation. If pain persists, contact your doctor.
Do not bandage or cover treated areas unless directed by your doctor.
Do not wash or rinse the treated areas of the scalp immediately after applying Clarelux.
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 occasionally as needed. Alternatively, your doctor may prescribe a weaker steroid to control your condition.

Use of a higher than recommended dose of Clarelux
Contact your doctor immediately if Clarelux is used:

• in a dose higher than prescribed;
• for a longer period than recommended.

Missed dose of Clarelux
If a dose is missed, apply it as soon as remembered, then continue treatment as before. If the missed dose is remembered at the time of the next scheduled dose, apply only one dose that day and continue treatment as previously directed. Do not apply a double dose to make up for a missed dose. If several doses are missed, contact your doctor.

Stopping Clarelux treatment
Do not stop treatment suddenly, as this may be harmful. Your doctor may discontinue treatment gradually. Regular check-ups may be necessary.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop using Clarelux and contact your doctor immediately if
hypersensitivity reactions occur, such as local irritation.
Adverse reactions include:
Common adverse reactions (may occur in not more than 1 in 10 patients, but more frequently than
in 1 in 100 patients):

• Burning sensation
• Other skin reactions at the application site

Very rare adverse reactions (may occur in not more than 1 in 10,000 patients):

• Tingling or pricking sensation
• Eye irritation
• Vein inflammation (phlebitis)
• Skin irritation and tenderness
• Skin tightness
• Itchy rash (contact dermatitis)
• Worsening of psoriatic rash
• Redness at the application site
• Itching and sometimes pain at the application site
• Presence of blood, protein, and nitrogen in urine may be detected by a physician

Additional adverse reactions occurring with unknown frequency (frequency cannot be estimated from
available data):

• Changes in hair growth (abnormal hair growth away from the application site and on atypical body parts)
• Skin color changes
• Hair follicle irritation, e.g. pain, sensation of heat, and redness
• Rash around the mouth
• Facial redness and eruptions
• Prolonged wound healing
• Effects on eyes (cataract, increased intraocular pressure)
• Vision disturbances

Adverse reactions due to long-term use occurring with unknown frequency (frequency cannot be estimated from
available data):

• White spots on the skin (striae) and dilatation of cutaneous blood vessels
• As with other corticosteroids, prolonged and high-dose use of Clarelux may lead to Cushing's syndrome, characterized by a red, round face (so-called "moon face"), high blood pressure, weight gain, and changes in blood and urine sugar levels
• Long-term steroid treatment may cause skin thinning
• Topical steroid withdrawal reaction ("rebound effect"). If the medicine is used continuously for a long time, abrupt discontinuation may trigger a withdrawal reaction with some or all of the following symptoms: skin redness, which may spread beyond the originally treated area, burning or pricking sensation, intense itching, skin scaling, and oozing open lesions.

In rare cases, treatment of psoriasis with corticosteroids (or discontinuation of treatment) may
lead to exacerbation of lesions and development of pustular psoriasis. After discontinuation of
corticosteroid treatment, lesions on the scalp may sometimes recur. Also, pre-existing infections may worsen if Clarelux is used inappropriately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to 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 open flames, sources of ignition, materials generating heat, 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 treatment is completed, the container should be disposed of safely.

Keep out of sight and reach of children.
Do not use Clarelux after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
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 no longer in use. This will help protect the environment.

6. Contents of the package and other information

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

What Clarelux looks like and contents of the pack
Clarelux is a white cutaneous foam in a pressurized container.
The container holds 100 grams of cutaneous foam.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Greece, country of export:
Pierre Fabre Farmaka A.E., A. Mesogeion 350, 153 41 Agia Paraskevi, Greece

Manufacturer:
Farmol Health Care S.r.L., Via del Maglio, 6, 23868 Valmadrera (LC), Italy

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation number in Greece, country of export: 132338/20/04-08-2021
Parallel Import Licence number: 88/24

This medicinal product is authorised in the European Economic Area (EEA) Member States 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.