Clobex

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Clobex, 500 micrograms/g, medicinal shampoo

Clobetasol propionate

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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 changes. Psoriasis of the scalp is caused by the rapid production of skin cells on the scalp. 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 you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6). If you are allergic (hypersensitive) to any of the ingredients of the medicine, you should inform your 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), fungal infection of the skin, athlete's foot, thrush, tuberculosis of the skin, or syphilitic skin disease;
• in the case of ulcerative lesions of the scalp (oozing changes);
• in children under 2 years of age;
• you should avoid contact of Clobex with the eyes or eyelids (risk of glaucoma, i.e., high pressure in the eye, and risk of cataract causing clouding of the lens of the eye).

Warnings and precautions

Before using Clobex, you should talk to your doctor or pharmacist if:

• you are using 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.

After using Clobex, you should wash your hands thoroughly.

You should exercise special caution when using Clobex:

• Clobex should only be used on the scalp. Do not use the medicine as a regular shampoo. Also, do not use the medicine 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., you should not use a shower cap, as this may cause the active substance to penetrate the skin and act on other parts of the body.
• When using Clobex, you should avoid contact of the medicine with the skin of the face, eyelids, armpits, skin with scratches (cracked) and the genital area. If the medicine spills beyond the scalp, it should be rinsed immediately with water.
• If Clobex gets into the eye, it should be rinsed thoroughly with a large amount of water. If irritation persists, you should consult a doctor.
• If there is no improvement during treatment, you should consult a doctor.
• If you experience blurred vision or other vision disturbances, you should contact a doctor.
• You should talk to your doctor or pharmacist if, during the use of Clobex for the first time, you experience bone pain or worsening of pre-existing bone symptoms, especially if you 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 report to the doctor every week for control before continuing treatment.

Clobex and other medicines

You should tell your doctor about all medicines you have taken recently, including those that are available without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.

Driving and using machines

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

Clobex contains alcohol (ethanol)

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 your doctor. If you are unsure, you should consult a doctor or pharmacist. The usual daily dose of the medicine is about half a tablespoon (about 7.5 ml) of the medicine, sufficient to cover the scalp thoroughly. If the doctor has not recommended otherwise, you should wash your hands and apply Clobex directly to the dry scalp once a day, making sure to cover and massage the medicine into the affected areas. You should avoid using too much Clobex; use the amount of medicine sufficient to cover the dry scalp. After applying the medicine, you should wash your hands thoroughly. You should leave the medicine on the skin for about 15 minutes without covering your head, and then rinse and dry your hair as usual. You can use a regular shampoo for washing your hair if you need more shampoo. You should not increase the dose of Clobex. Your doctor will inform you how long you should use Clobex to treat psoriasis of the scalp. Treatment should not last longer than 4 weeks. However, if there is significant improvement in psoriasis at the end of treatment, you should consult a doctor. You should also inform your doctor if there is no improvement at the end of treatment. Treatment requires close monitoring - you should inform your doctor about the progress of treatment at regular intervals. You should not use Clobex for a longer period than recommended by your doctor.Your doctor may recommend reusing Clobex 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, you should follow the doctor's instructions carefully. The patient must report to the doctor every week for control before continuing treatment.

Using more than the recommended dose of Clobex

You should consult a doctor. This medicine is intended for use only on the scalp. Do not ingest this medicine. In case of accidental ingestion, small amounts of shampoo are not harmful. If you are unsure, you should consult a doctor immediately.

Missing a dose of Clobex

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

Stopping use of Clobex

You should consult a 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. If you are unsure about using the medicine, you should consult a 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.
• Stinging or burning of the eyes
• Irritation of the eyes
• 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
• Thin skin (skin atrophy)
• Skin irritation
• Skin tension
• Allergic contact dermatitis
• Redness
• Rash

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

• Blurred vision

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

• If local symptoms of intolerance, such as a burning sensation or redness, occur in the treated areas, you should stop using Clobex until these symptoms disappear.
• If the condition of the affected areas worsens during treatment (the likelihood is higher when using Clobex for a longer period than recommended), you should stop using the medicine and consult a doctor. If swelling of the eyelids, face, or lips occurs, you should stop using the medicine, 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 head for more than 15 minutes may:
• cause thinning of the skin, making it more susceptible to damage;
• allow the active substance to penetrate the skin: which may cause it to act on 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 thinning of the skin. For this reason, you should never use this medicine on the face or in areas other than the scalp.
• To avoid interactions with hair dye products, Clobex should be rinsed thoroughly.
• If you experience any unusual, unexplained discomfort, you should consult a doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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, you can help provide more information on the safety of the medicine.

5. How to store Clobex

The medicine should be stored 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 month stated. 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. You should ask your pharmacist how to dispose of medicines that are no longer used. 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. One gram (milliliter) of Clobex contains 500 micrograms of the active substance - 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 what the packaging contains

Clobex is a thick, semi-transparent, colorless to light yellow liquid shampoo with an alcoholic odor. Clobex is available on prescription only. 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, you 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:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Spanish marketing authorization number:658226.8

Parallel import authorization number: 166/22

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, medicinal shampoo France, Germany, Belgium, Poland, Spain, Hungary, Netherlands, Sweden, Denmark, Austria, Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia, and Finland: Clobex 500 micrograms/g, medicinal shampoo. Date of leaflet approval: 12.04.2022[Information about the trademark]