Clobex

Package leaflet: Information for the patient

Caution! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Clobex, 500 micrograms/g, medicated shampoo
Clobetasol propionate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents:

1. What Clobex is and what it is used for
2. Important information before using Clobex
3. How to use Clobex
4. Possible side effects
5. How to store Clobex
6. Contents of the pack and other information

1. What Clobex is and what it is used for

Clobex contains the active substance clobetasol propionate. This substance belongs to a group of medicines called topical corticosteroids (or steroids).
Clobex is for topical use only (on the skin). Topical corticosteroids reduce redness, itching, and inflammation associated with skin disorders.
Scalp psoriasis is caused by excessive production of skin cells on the scalp. Clobex is used in the treatment of moderate scalp psoriasis in adults.
Topical corticosteroids (e.g. shampoo, creams, ointments) are classified into four different potency levels: mild, moderately potent, potent, and very potent.
Clobetasol is classified as a very potent corticosteroid.

2. Important information before using Clobex

When not to use Clobex:

• if the patient is allergic (hypersensitive) to clobetasol propionate or to any of the other ingredients of this medicine (listed in section 6). If the patient is allergic (hypersensitive) to any of the components of the medicine, they should inform their doctor before starting treatment.
• in bacterial, viral, fungal or parasitic infections of the scalp skin, such as herpes simplex, chickenpox, shingles, tinea (a type of rash on the face), fungal skin infections, athlete's foot, candidiasis, cutaneous tuberculosis or syphilitic skin disease;
• in ulcerated lesions of the hairy scalp (oozing changes);
• in children under 2 years of age;
• avoid contact of Clobex with the eyes or eyelids (risk of glaucoma, i.e. increased intraocular pressure, and risk of cataract causing clouding of the eye lens).

Warnings and precautions
Before starting to use Clobex, discuss this with your doctor or pharmacist if:

• the patient is taking orally or topically other medicines containing corticosteroids or medicines intended to regulate the immune system (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Clobex with these medicines may lead to severe infections.

Special caution is required when using Clobex:

• Clobex should be applied only to the hairy scalp. Do not use the medicine as a regular shampoo. It should also not be applied to other areas of the body or used as a body shower gel or bath liquid.
• During treatment of the hairy scalp, the treated area must not be covered, e.g. do not use a shower cap, as this may cause the active substance to penetrate through the skin and act on other parts of the body.
• When using Clobex, avoid contact of the medicine with facial skin, eyelids, armpits, cracked or fissured skin, and genital areas. If the medicine runs off the hairy scalp, rinse immediately with water.
• If Clobex gets into the eye, thoroughly rinse with plenty of water. If irritation persists, consult a doctor.
• If there is no improvement during treatment, consult a doctor.
• If the patient experiences blurred vision or other visual disturbances during treatment, contact a doctor.
• Talk to your doctor or pharmacist if, during treatment with Clobex, the patient experiences bone pain for the first time or worsening of pre-existing bone-related symptoms, especially if the patient has been using Clobex for a prolonged period or repeatedly.

Children and adolescents
If Clobex has been prescribed for a child or adolescent under 18 years of age, the patient must visit the doctor weekly for check-ups before continuing treatment.

Clobex and other medicines
Tell your doctor 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 a doctor or pharmacist before using this medicine.

Driving and operating machinery
Clobex has no effect or a negligible effect on the ability to drive and operate machinery.

Clobex contains ethanol
This medicine contains 100 mg of alcohol (ethanol) per gram, equivalent to 10% w/w. It may cause stinging of damaged skin.

3. How to use Clobex

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
The usual daily dose is approximately half a tablespoon (about 7.5 ml) of the medicine,
sufficient to completely cover the hairy scalp.
Unless otherwise instructed by the doctor, wash your hands and apply Clobex directly to dry
hairy scalp once daily, taking care to thoroughly cover and massage the medicine into the affected
areas. Avoid using excessive amounts of Clobex; use only the amount sufficient to cover the dry
hairy scalp.
After application, wash your hands thoroughly.
Leave the medicine on the scalp for approximately 15 minutes without covering the head,
then rinse thoroughly and dry the hair as usual. Regular shampoo may be used
if additional cleansing is needed.
Do not increase the dose of Clobex.
Your doctor will inform you how long you should use Clobex for the treatment of psoriasis of the
hairy scalp. Treatment should not last longer than 4 weeks. However, if significant improvement
of psoriasis is observed at the end of treatment, consult your doctor. You should also
inform your doctor if no improvement is seen at the end of treatment. Treatment requires
careful monitoring – you should regularly inform your doctor about progress in treatment.
Do not use Clobex for longer than prescribed by your doctor.
Your doctor may recommend re-treatment with Clobex after a period during which the medicine
was not used.

Use in children and adolescents
If Clobex has been prescribed for a child aged between 2 and 18 years, follow the doctor's
instructions precisely. The patient must attend weekly check-ups with the doctor before continuing
treatment.

Use of more than the recommended dose of Clobex
Consult your doctor. This medicine is intended for external use on the hairy scalp only.
Do not ingest this medicine. Accidental ingestion of small amounts of the shampoo is not harmful.
If in doubt, contact your doctor immediately.

Missed dose of Clobex
Do not use a double dose to make up for a missed dose.
Continue using the medicine as previously directed. If several doses have been missed, consult
your doctor.

Stopping Clobex treatment
Consult your doctor.
There is a risk of worsening of the condition if treatment with Clobex is stopped, especially
if the medicine has been used for a prolonged period.

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.
Clobex may cause the following adverse reactions.

Common: may occur in fewer than 1 in 10 patients

• Burning sensation of the skin
• Inflammation of hair follicles

Uncommon: may occur in fewer than 1 in 100 patients

• Hormonal disorders (such as suppression of adrenal cortex function, Cushing's syndrome) – observed during topical use of potent corticosteroid medicines, particularly when used over large areas of the body or for prolonged periods
• Stinging or burning of the eyes
• Eye irritation
• Feeling of pressure in the eye
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin swelling
• Telangiectasia (visible blood vessels in the skin)
• Worsening of psoriasis
• Hair loss
• Dry skin
• Urticaria
• Skin atrophy (thinning of the skin)
• Skin irritation
• Skin tightness
• Allergic contact dermatitis
• Erythema
• Rash

Frequency not known: frequency cannot be estimated from the available data

• Blurred vision

Symptoms of skin irritation, itching, urticaria, visible blood vessels, and skin atrophy around the treated area are usually mild or moderate in severity.

• If local intolerance symptoms such as burning sensation or redness occur at the treated sites, use of Clobex should be discontinued until these symptoms resolve.
• If the condition of the affected areas worsens during treatment (more likely if Clobex is used for longer than recommended), treatment should be stopped and medical advice sought. If swelling of the eyelids, face, or lips occurs, discontinue use of the medicine, as this may indicate sensitization (hypersensitivity) to the medicine or a skin infection.
• Applying large amounts of the medicine or leaving it on the scalp for longer than 15 minutes may:
  • cause thinning of the skin, making it more susceptible to damage;
  • allow the active substance to penetrate through the skin, potentially causing systemic effects, particularly in children and during pregnancy.
• Repeated cycles of long-term topical corticosteroid treatment may lead to acne, rash, abnormal hair growth, and skin discoloration. Stretch marks and bruising (ecchymoses) may also appear.
• In cases of rosacea (facial redness with sudden flushing episodes and possible papules), application of Clobex to the face may worsen the condition.
• Application of Clobex to the face may cause perioral dermatitis (a patchy red rash around the mouth).
• Application of Clobex to the skin may cause skin atrophy. Therefore, this medicine should never be used on the face or in areas other than the hairy scalp.
• To avoid interactions with hair-coloring products, Clobex should be thoroughly rinsed out after use.
• If any unusual or unexplained discomfort occurs, consult a doctor as soon as possible.

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 also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store Clobex

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Shelf life after first opening: 6 months.
The bottle should be discarded 6 months after first opening.
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 Clobex contains

• The active substance in Clobex is clobetasol propionate. 1 g of medicinal shampoo contains 500 micrograms of the active substance – clobetasol propionate.
• Other components of the medicine are: ethanol, cocoyl dimethyl betaine, ethoxylated sodium lauryl sulphate, polyquaternium-10, sodium citrate, citric acid monohydrate, purified water.

What Clobex looks like and contents of the pack
Clobex is a thick, slightly viscous, colourless to pale yellow, translucent liquid shampoo with an alcoholic odour.
Clobex is available on prescription only.
The medicine is supplied in a 125 ml HDPE bottle with a PP snap-cap closure, placed in a cardboard carton.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Galderma International
Tour Europlaza, 20 avenue André Prothin
La Défense 4, 92927 La Défense Cedex
Paris, France

Manufacturer:
Laboratoires Galderma
Z.I.- Montdésir, 74540 Alby-sur-Chéran, France

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

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

Marketing Authorisation Number in the Czech Republic, the country of export: 46/037/07-C
Parallel Import Licence Number: 279/25

This medicine is authorised for sale in the European Economic Area (EEA) Member States under the following trade names:
United Kingdom (Northern Ireland), Italy, Ireland and Portugal: Etrivex 500 micrograms/g, shampoo
France, Belgium, Poland, Spain, Hungary, Netherlands, Malta, Sweden, Denmark, Austria, Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia and Finland: Clobex 500 micrograms/g, shampoo.