Clobex

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Clobex, 500 micrograms/g, medicinal shampoo

Clobetasol propionate

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Clobex and what is it 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 packaging and other information

1. What is Clobex and what is it used for

Clobex contains the active substance clobetasol propionate. This substance belongs to topical corticosteroids (or steroids). Topical corticosteroids are further divided into groups depending on their potency. Clobetasol propionate is a very potent corticosteroid. It should only be used on the skin. Topical steroids reduce redness, itching, and inflammation associated with skin lesions. Psoriasis of the scalp is caused by the rapid production of scalp skin cells. Clobex is used to treat psoriasis of the scalp, of moderate severity, in adults.

2. Important information before using Clobex

When not to use Clobex:

• if the patient is allergic (hypersensitive) to clobetasol propionate or 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 the case of bacterial, viral, fungal, or parasitic infections of the scalp, such as herpes, chickenpox, shingles, impetigo (a type of rash on the face), ringworm, athlete's foot, thrush, tuberculosis of the skin, or syphilitic skin disease;
• in the case of ulcerative lesions of the scalp (oozing lesions);
• in children under 2 years of age;
• contact with the eyes or eyelids should be avoided (risk of glaucoma, i.e., high pressure in the eye, and risk of cataract causing clouding of the eye lens).

Warnings and precautions

Before using Clobex, the patient should talk to their doctor or pharmacist if:

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

Using Clobex with other medicines may increase the risk of severe infections.

Special caution should be exercised when using Clobex:

• Clobex should only be used on the scalp. It should not be used as a regular shampoo. It should also not be used on other areas of the body or as a gel under the shower for the body or as a bath liquid.
• During treatment of the scalp, the treated area should not be covered, e.g., a shower cap should not be used, as this may cause the active substance to penetrate the skin and affect other parts of the body.
• When using Clobex, contact with the face, eyelids, armpits, skin with scratches (cracked skin), and the genital area should be avoided. If the medicine gets on the skin outside the scalp, it should be rinsed off with water immediately.
• If Clobex gets into the eye, it should be rinsed thoroughly with a large amount of water. If irritation persists, the patient should consult a doctor.
• If there is no improvement during treatment, the patient should consult a doctor.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• The patient should talk to their doctor or pharmacist if, during the use of Clobex for the first time, they experience bone pain or worsening of existing bone symptoms, especially if they are using Clobex for a long time or repeatedly.

Children and adolescents

If the medicine has been prescribed for use in a child or adolescent under 18 years of age, the patient must visit their doctor weekly for control before continuing treatment.

Clobex and other medicines

The patient should tell their doctor about all medicines they have taken recently, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Clobex has no influence or negligible influence on the ability to drive and use machines.

Important information about some ingredients of Clobex

This medicine contains 100 mg of alcohol (ethanol) per gram, which is equivalent to 10% w/w. It may cause a burning sensation on damaged skin.

3. How to use Clobex

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The usual daily dose of Clobex is about half a tablespoon (about 7.5 ml) of the medicine, sufficient to cover the scalp. If the doctor has not instructed otherwise, the patient should wash their hands and apply Clobex directly to the dry scalp once a day, making sure to cover and massage the medicine into the affected areas. The patient should avoid using too much Clobex and use the amount sufficient to cover the dry scalp. After applying the medicine, the patient should wash their hands thoroughly. The medicine should be left on the skin for about 15 minutes without covering the head, and then rinsed off and the hair dried as usual. A regular shampoo can be used if more shampoo is needed. The patient should not increase the dose of Clobex. The doctor will inform the patient how long to use Clobex for the treatment of scalp psoriasis. Treatment should not last longer than 4 weeks. However, if there is significant improvement in psoriasis at the end of treatment, the patient should consult their doctor. The patient should also inform their doctor if there is no improvement at the end of treatment. Treatment requires close monitoring - the patient should inform their doctor about the progress of treatment at regular intervals.

Clobex should not be used for a longer period than prescribed by the doctor.

The doctor may prescribe Clobex again in the future, after a period of time when it was not used.

Use in children and adolescents

If the medicine has been prescribed for use in a child between 2 and 18 years of age, the patient should follow the doctor's instructions carefully. The patient must visit their doctor weekly for control before continuing treatment.

Using more Clobex than prescribed

The patient should consult their doctor. This medicine is intended for use only on the scalp. It should not be ingested. In case of accidental ingestion, small amounts of shampoo are not harmful. In case of doubts, the patient should consult their doctor immediately.

Missing a dose of Clobex

The patient should not use a double dose to make up for a missed dose. The patient should use the medicine according to the previous schedule. If several doses have been missed, the patient should consult their doctor.

Stopping Clobex treatment

The patient should consult their doctor. There is a risk of worsening the disease in case of stopping treatment with Clobex, especially if the medicine has been used for a long time. In case of doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Clobex can cause side effects, although not everybody gets them. Clobex may cause the following side effects. Common side effects(less than 1 in 10 patients)

• Burning sensation of the skin
• Folliculitis

Uncommon side effects(less than 1 in 100 patients)

• Hormonal disorders (such as adrenal suppression, Cushing's syndrome) - have been observed during the use of potent topical steroid medicines, especially when used on large areas of the body or for a long time.
• Eye irritation
• Eye discomfort
• Feeling of pressure in the eye
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Swelling of the skin
• Teleangiectasia (visibility of blood vessels in the skin)
• Worsening of psoriasis
• Hair loss
• Dryness of the skin
• Hives
• Skin thinning (skin atrophy)
• Skin irritation
• Skin tension
• Allergic contact dermatitis
• Redness
• Rash

Frequency not known(cannot be estimated from the available data):

• Blurred vision

Skin irritation symptoms, itching, hives, visibility of blood vessels, and skin thinning around the treated area are usually mild or moderate.

• If local intolerance symptoms, such as a burning sensation or redness, occur in the treated areas, the use of Clobex should be stopped until these symptoms resolve.
• If the condition of the affected areas worsens during treatment (the likelihood is higher when using Clobex for a longer period than recommended), the use of Clobex should be stopped and the doctor consulted. If swelling of the eyelids, face, or lips occurs, the use of Clobex should be stopped, as this may indicate an allergy (hypersensitivity) to the medicine or a skin infection.
• Using large amounts of the medicine or leaving it on the scalp for more than 15 minutes may:
• cause skin thinning, making it more susceptible to damage;
• allow the active substance to penetrate the skin: which may cause it to affect other parts of the body, especially in children and during pregnancy.
• Repeated cycles of topical steroid treatment over a long period may cause acne, rash, hair growth disorders, and skin discoloration. Stretch marks and purpura (bruises) may be visible.
• Using Clobex on the face may exacerbate rosacea (redness of the face with sudden flushing and possible pimples).
• Using Clobex on the face may cause perioral dermatitis (patchy, red rash around the mouth).
• Using Clobex on the skin may cause skin thinning. Therefore, this medicine should never be used on the face or on areas other than the scalp.
• To avoid interactions with hair coloring products, Clobex shampoo should be rinsed thoroughly.
• If the patient experiences any unusual, unexplained discomfort, they should consult their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Clobex

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The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
The medicine should be stored in the original packaging to protect it 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Clobex contains

• The active substance of Clobex is clobetasol propionate. 1 g of medicinal shampoo contains 500 micrograms of clobetasol propionate.
• The other ingredients of the medicine are: ethanol, coco-alkyldimethylbetaine, sodium lauryl ether sulfate, polyquaternium-10, sodium citrate, citric acid monohydrate, purified water.

What Clobex looks like and contents of the packaging

Clobex is a thick, translucent, colorless to light yellow liquid shampoo with an alcoholic odor.
Clobex is available on prescription.
The medicine is available in an HDPE bottle with a PP snap-on cap, containing 125 ml of shampoo, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish marketing authorization number, country of export: 658226.8

Parallel import authorization number: 298/23

This medicinal product is authorized in the 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.

Date of leaflet approval: 21.12.2023

[Information about the trademark]
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