Patient Information Leaflet

Caution! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Clobex, 500 micrograms/g, medicated shampoo
Clobetasol propionate
Please read this 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, pharmacist, or nurse.
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 the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Clobex is and what it is used for
Important information before using Clobex
How to use Clobex
Possible side effects
How to store Clobex
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 class of medicines called topical corticosteroids (or steroids).
Topical corticosteroids are further classified into groups depending on their potency. Clobetasol propionate is a very potent corticosteroid. It is intended for use on the skin only. Topical steroids reduce redness, itching, and inflammation associated with skin conditions.
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.

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 ingredients 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, pityriasis (a type of rash on the face), fungal skin infections, athlete's foot, tinea versicolor, 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 using Clobex, talk to your doctor or pharmacist if:

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 Clobex with these medicines may lead to severe infections.

Exercise particular caution when using Clobex:

Clobex should be applied only to the hairy scalp. Do not use the medicine as a regular shampoo. Do not use it on other parts of the body, nor as a body shower gel or bath liquid.
During treatment of the hairy scalp, the treated area must not be covered; for example, do not use a shower cap, as this may cause the active substance to penetrate through the skin and exert systemic effects.
When using Clobex, avoid contact with the facial skin, eyelids, armpits, cracked or fissured skin, and genital area. 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, contact a doctor.
Talk to a 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 Clobex has been used 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 monitoring before continuing treatment.

Clobex and other medicines
Tell your doctor about all medicines you are currently taking, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

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

Important information about some of the ingredients of the medicine
This medicine contains 100 mg of alcohol (ethanol) per gram, equivalent to 10% w/w. It may cause stinging on 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 thoroughly cover the hairy scalp.
Unless otherwise instructed by your doctor, wash your hands and apply Clobex directly to dry
hairy scalp skin once daily, taking care to adequately 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 skin for approximately 15 minutes without covering the head,
then rinse and dry the hair as usual. Regular shampoo may be used
if additional cleansing is needed.
Do not increase the dose of Clobex.
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Your doctor will inform you how long to use Clobex shampoo in the treatment of scalp
psoriasis. Treatment should not last longer than 4 weeks. However, if significant improvement
in 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 treatment progress.
Do not use Clobex for longer than prescribed by your doctor.
Your doctor may recommend re-treatment with Clobex in the future, after a period of time
during which it was not used.
Use in children and adolescents
If Clobex has been prescribed for a child aged 2 to 18 years, follow your doctor's instructions
carefully. The patient must visit the doctor weekly for check-ups 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.
In case of doubt, contact your doctor immediately.
Missing a 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 use of Clobex
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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Clobex may cause the following adverse effects.

Common adverse effects (less than 1 case in 10 patients)

Sensation of skin burning
Inflammation of hair follicles

Uncommon adverse effects (less than 1 case in 100 patients)

Hormonal disorders (such as suppression of adrenal cortex function, Cushing's syndrome) – have been observed during topical use of potent corticosteroids, particularly when applied over large areas of the body or for prolonged periods.
Stinging or burning sensation in the eyes
Eye irritation
Feeling of eye pressure
Glaucoma
Hypersensitivity
Headache
Skin pain
Sensation of 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 (cannot be estimated from available data):

Blurred vision

Symptoms such as 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 occur at the treated sites, such as burning sensation or redness, use of Clobex should be discontinued until these symptoms resolve.
If the condition of the affected areas worsens during treatment (more likely if Clobex shampoo is used for longer than recommended), discontinue use and consult a physician. If eyelid, facial, or lip swelling occurs, stop using the medicine immediately, as this may indicate hypersensitivity (allergy) to the medicine or a skin infection.
Using large amounts of the medicine or leaving it on the scalp for longer than 15 minutes may:
cause skin thinning, 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, disturbances in hair growth, and skin discoloration. Stretch marks and purpura (bruising) may also appear.
In cases of rosacea (facial redness with sudden flushing episodes and possible papules), applying Clobex to the face may worsen the condition.
Applying 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. For this reason, this medicine should never be used on the face or on areas other than the hairy scalp.
To avoid potential interactions with hair coloring products, Clobex shampoo should be thoroughly rinsed out.
In case of any unusual or unexplained discomfort, consult a physician as soon as possible.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 effects helps to provide more information on the safety of this medicine.

5. How to store Clobex

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Keep this medicine out of 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Clobex contains

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

What Clobex looks like and contents of the pack
Clobex is a thick, slightly viscous, transparent to pale yellow liquid shampoo with an alcoholic odour.
Clobex is available by prescription only.
The medicine is supplied in a 125 ml HDPE bottle with a PP snap-cap closure, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
Laboratorios Galderma, S.A., Serrano Galvache, 56, 28033 Madrid, Spain
Manufacturer:
Laboratoires Galderma, Z.I.- Montdésir, 74540, Alby-sur-Chéran, France
Galderma Laboratorium GmbH, Toulouser Allee 23a, 40211 Düsseldorf, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Spanish (country of export) marketing authorisation number: 658226.8
Parallel import authorisation number: 298/23
This medicinal product is authorised in the following Member States under the following names:
United Kingdom (Northern Ireland), Italy, Ireland and Portugal: Etrivex 500 micrograms/g, shampoo
France, Germany, Belgium, Poland, Spain, Hungary, Netherlands, Sweden, Denmark, Austria, Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia and Finland: Clobex 500 micrograms/g, shampoo.
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