Leaflet: information for the user

CLARELUX 500 micrograms/g topical foam in a pressurized container

Clobetasol propionate

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What CLARELUX is and what it is used for

2. What you need to know before using CLARELUX

3. How to use CLARELUX

4. Possible side effects

5. Storage of CLARELUX

6. Contents of the pack and additional information

CLARELUX contains clobetasol propionate as the active ingredient and belongs to a group of medicines known as topical corticosteroids.Clobetasol propionateis a very potent topical corticosteroid.

CLARELUX 500 micrograms/g topical foam in a pressurized container is a foam that is applied to the skin.

CLARELUX 500 micrograms/g topical foam in a pressurized container is used as a short-term treatment for scalp dermatoses that respond to steroids, such as: psoriasis that does not respond satisfactorily to less potent steroids.

No useCLARELUX:

• If you are allergic to clobetasol propionate, or to any of the other components of this medication (listed in section 6).
• If you have infected skin lesions, whether viral (e.g. Herpes simplex, herpes zoster, varicella…), bacterial (e.g. impetigo), fungal (caused by microscopic fungi) or parasitic.
• If you have burns, ulcerative lesions or other skin disorders such as rosacea, acne, dermatitis around the mouth, itching near the anus or genitals.
• In another area of the body or face (including the eyelids) other than the scalp.
• In children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use CLARELUX.

You should consult your doctor and immediately stop treatment if your condition worsens during use, you may be experiencing an allergic reaction, if you present symptoms such as skin rash, itching or swelling of the tissue without pain (edema),ifyou have an infection or if your condition requires a different treatment.

If you experience a recurrence of your condition shortly after (within 2 weeks) stopping treatment, do not restart the use of CLARELUX without consulting your doctor, unless your doctor has previously advised you to do so. If your condition has resolved and, in case of recurrence, the redness extends beyond the initial treatment area and you experience a burning sensation, consult a doctor before restarting treatment, as rebound effect may be suspected.

Like all corticosteroids, CLARELUX can be absorbed through the skin and may cause adverse effects such as adrenal suppression (see section 4). Therefore:

• You should avoid prolonged treatment with CLARELUX.
• CLARELUX should not be used in large areas.
• Treated areas should not be bandaged or covered unless your doctor advises you to do so.
• CLARELUX is not recommended for use in wounds or ulcers.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Inform your doctor if:

• You experience recent bone pain or worsening of previous bone symptoms during treatment with CLARELUX, especially if you have been using CLARELUX for a prolonged period of time or repeatedly.
• You are using another oral or topical medication containing corticosteroids or immunosuppressive medications (e.g. autoimmune disease or after a transplant). The combination of CLARELUX with these medications may result in severe infections.
• Your condition does not improve after 2 weeks of treatment.
• You develop an infection, as treatment with CLARELUX should be discontinued.
• You have any vision problems, as this type of medication may increase the development of cataracts or glaucoma.

Wash your hands carefully after each application.

In case of accidental contact with the face or eyes, wash with plenty of water.

Use in children and adolescents

It is not recommended for use in children under 12 years old.

Use of CLARELUX with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

CLARELUX should not be used during pregnancy or breastfeeding unless your doctor advises you to do so.

Driving and operating machinery

CLARELUX should not affect your ability to drive and operate machinery.

Important information about some of the components of CLARELUX

This medication contains:

• 2145 mg of alcohol (ethanol) in each application, which may cause a burning sensation on damaged skin,
• 74 mg of propylene glycol in each application,

alcohol cetilylate and alcohol stearate,which may cause local skin reactions (such as contact dermatitis).

Follow exactly the administration instructions for CLARELUX as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Use this medication only for the condition for which it was prescribed. CLARELUX should be applied only to the scalp and should not be swallowed.

Do not dispense the foam directly onto the hands, as the foam will start to break down immediately upon contact with warm skin.

Apply CLARELUX to the affected area of the scalptwice a day, once in the morning and once at night, as indicated below:

Attention: To properly dispense the foam, it is essential to keep the containerwith the nozzle facing down!

After applying CLARELUX, wash your hands and dispose of any unused medication.

Do not use CLARELUX on the face. If the foam accidentally gets into the eyes, nose, or mouth, rinse immediately with cold water. You may experience a stinging sensation. Contact your doctor if the pain persists.

Treated areas should not be bandaged or covered unless instructed by your doctor.

Do not wash or shampoo the treated areas of the scalp immediately after applying CLARELUX.

Do not use more than50 gof CLARELUX per week.

The treatment should not continue for more than 2 weeks. After this use, CLARELUX may be used occasionally if necessary. Alternatively, your doctor may prescribe a weaker steroid to control your condition.

If you use moreCLARELUXthan you should

Consult your doctor immediately if you have applied CLARELUX:

• in amounts greater than prescribed.
• for a longer period than prescribed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to useCLARELUX

It should be used as soon as possible, then continue as before.

If you remember to apply the next dose, use a single dose and continue the treatment as described by your doctor (do not apply a double dose to compensate for the missed doses). If you have forgotten several doses, inform your doctor.

If you interrupt the treatment withCLARELUX

Do not stop treatment suddenly, as this may cause harm. Your doctor should discontinue treatment gradually and perform regular check-ups.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop using CLARELUX 500 micrograms/g topical foam in a pressurized container and contact your doctor immediately if you experience hypersensitivity reactions, such as local irritation.

The side effects include:

Very common (in fewer than 1 in 10, but more than 1 in 100 people):

• Itching sensation.
• Other skin reactions when applied to the skin.

Very rare (in fewer than 1 in 10,000 people):

• Prickling or stinging sensation.
• Eye irritation.
• Swelling of the veins.
• Irritation and pain upon palpation of the skin.
• Tightness of the skin.
• Skin eruption that causes itching (contact dermatitis).
• Worsening of skin scaly eruption (worsening of psoriasis).
• Redness at the application site.
• Itching and sometimes pain at the application site.
• Presence of blood, proteins, and nitrogen in urine.

The following additional side effects may also occur with unknown frequency (cannot be estimated from available data):

• Changes in hair growth (abnormal hair growth outside the application site and in areas where hair normally does not grow).
• Changes in skin color.
• Follicular irritation, for example, pain, itching, and redness.
• Mouth eruption.
• Redness and eruptions on the face.
• Delayed healing of wounds.
• Effects on the eyes (cataracts, increased eye pressure).
• Blurred vision.

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

• White marks on the skin (striae) and dilation of skin blood vessels.
• Like other topical corticosteroids, when CLARELUX is used in large quantities and for a long period of time, this may lead to the so-called Cushing's syndrome, whose symptoms include redness, swelling, and a rounded face (moon face), increased blood pressure, weight gain, and changes in blood sugar and urine levels.
• Prolonged steroid treatments can cause skin thinning.
• Topical corticosteroid withdrawal reaction (rebound effect). If used continuously for prolonged periods, a withdrawal reaction from topical corticosteroids may occur. This occurs when treatment is suddenly stopped, with some or all of the following characteristics: skin redness that may extend beyond the initially treated area, burning or itching sensation, intense itching, skin peeling, open sores.

In rare circumstances, psoriasis treatment with corticosteroids (or upon suspension of treatment) may worsen the condition and lead to a form of pustular psoriasis. Sometimes, scalp condition may reappear after suspension of corticosteroid treatment. Existing infections may also worsen if CLARELUX is not used as instructed by your doctor.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly tothrough the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use CLARELUX after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not refrigerate. Store in an upright position.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofCLARELUX

• The active ingredient is propionate of clobetasol and1 gof cutaneous foam contains 500 micrograms of propionate of clobetasol.
• The other components are:anhydrous ethanol, purified water, propylene glycol, cetyl alcohol, stearic alcohol, polisorbate 60, anhydrous citric acid, potassium citrate, and a propellant mixture of propane/n-butane/isobutane.

Appearance of the product and contents of the package

CLARELUX 500 micrograms/g cutaneous foam is a white cutaneous foam in a pressurized container. Each package contains 50 or100 grams.

All packages may not be commercially available.

Holder of the marketing authorization

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Responsible for manufacturing

Recipharm Uppsala AB

Björkgatan 30

751 82 Uppsala

Sweden

or

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 Areaand in the United Kingdom (Northern Ireland)with the following names:

Germany and Austria:CLARELUX 500 Mikrogramm/g Foam for cutaneous application in a pressurized container

Belgium and Luxembourg:CLARELUX 500 microgrammes/g Mousse for cutaneous application in a pressurized container

Slovak Republic:CLARELUX 500 mikrogramov/g dermal foam, in a pressurized container

Czech Republic:CLARELUX 500 mikrogramu/g cutaneous foam

France:CLARELUX 500 microgrammes/g Mousse for cutaneous application in a pressurized container

Greece:CLARELUX 500μicrograms/gdermal foamin a pressurized container

United Kingdom (Northern Ireland):CLARELUX 500 microgram/g cutaneous foam in pressurised container

Netherlands:CLARELUX 500 microgram/g Foam for cutaneous use in a spray can

Poland:Clarelux 500 mikrogramów/g, foam for skin

Portugal:CLARELUX 500 microgramas/g cutaneous foam in a pressurized container

Italy:OLUX 500 microgrammi/g cutaneous foam

Last review date of this leaflet: December 2022

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/”