Clobex

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Clobex
500 micrograms/g, medicated shampoo
Clobetasol propionate
Please read the following information 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 give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 class of medicines called topical corticosteroids (or steroids).
Topical corticosteroids are further classified into groups according to their potency. Clobetasol propionate is a very potent corticosteroid. It is intended for topical use on the skin only. Topical steroids 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.

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 cases of bacterial, viral, fungal or parasitic infections of the scalp skin, such as herpes simplex, chickenpox, shingles, pityriasis (a type of facial rash), fungal skin infections, athlete's foot, fungal infections caused by molds, cutaneous tuberculosis or syphilitic skin disease;
• in the case of ulcerated lesions of the hairy scalp (oozing changes);
• in children under 2 years of age;
• avoid contact of Clobex with 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 the immune system (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Clobex with these medicines may lead to severe infections.

Exercise special caution when using Clobex:

• Clobex should be applied only to the hairy scalp. Do not use the medicine as a regular shampoo. Do not apply the medicine to other parts of the body or use it 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 wear 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 with facial skin, eyelids, armpits, cracked or broken 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 during treatment, contact a doctor.
• Talk to a doctor or pharmacist if, during use of Clobex, the patient experiences bone pain for the first time or worsening of pre-existing bone 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 for a weekly check-up 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 become pregnant, 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.

This medicine contains alcohol (ethanol)
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 as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The usual daily dose of this medicine is approximately half a tablespoon (about 7.5 ml),
sufficient to thoroughly cover the hairy scalp.
Unless otherwise instructed by your doctor, wash your hands and apply Clobex directly to the dry
hairy scalp once daily, taking care to adequately cover and gently massage the medicine into the affected
areas. Avoid using excessive amounts of Clobex; use only enough medicine 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.
Your doctor will inform you how long you should continue treatment with Clobex shampoo for
scalp psoriasis. Treatment should not last longer than 4 weeks. However, if significant improvement of psoriasis occurs toward the end of treatment, consult your doctor. You should also inform your doctor if no improvement is observed by the end of treatment. Treatment requires careful monitoring – you should regularly report treatment progress to your doctor.
Do not use Clobex for a longer period than recommended 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 for weekly 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. If accidentally ingested, small amounts of shampoo are not harmful.
In case of 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 use of Clobex
Consult your doctor.
There is a risk of worsening of the disease if treatment with Clobex is stopped, particularly 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 reactions

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

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

• Sensation of skin burning
• Inflammation of hair follicles

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

• Hormonal disorders (such as suppression of adrenal cortex function, Cushing's syndrome) – 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
• Telangiectasias (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 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 when using Clobex shampoo for longer than recommended), discontinue use and consult a doctor. If swelling of the eyelids, face, or lips occurs, stop using the medicine, 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 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, 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), application of Clobex to the face may exacerbate 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 thinning. 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 shampoo should be thoroughly rinsed off.
• If any unusual or unexplained discomfort occurs, consult a doctor as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 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 must 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 does Clobex contain?

• The active substance in Clobex is clobetasol propionate. One gram (millilitre) of Clobex contains 500 micrograms of the active substance – clobetasol propionate.
• The other ingredients 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 only on prescription.
The medicine is supplied in a high-density polyethylene (HDPE) bottle with a polypropylene snap-cap closure (PP), containing 125 ml of shampoo, 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, SA
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation Number in Spain, country of export: 658226.8
Parallel Import Authorisation Number: 195/23
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.