Clobex

Leaflet attached to the packaging: patient information

Clobex

500 micrograms/g, medicinal shampoo

Clobetasol propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, 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 pack and other information

1. What is Clobex and what is it used for

Clobex contains the active substance clobetasol propionate. This substance belongs to
topically applied corticosteroids (or steroids).
Clobex should only be used on the skin. Topically applied steroids reduce
redness, itching, and inflammation associated with skin changes.
Scalp psoriasis is caused by the rapid production of skin cells on the scalp. Clobex is used
to treat scalp psoriasis of moderate severity in adults.
Corticosteroids for skin use (e.g., shampoo, creams, and ointments) come in four different
strengths. It is classified as 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 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 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 case of weeping wounds on the scalp (oozing lesions).
• In children under 2 years of age.
• You should avoid contact of Clobex with your 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 starting treatment with Clobex, you should discuss it with your doctor or
pharmacist if:

• you are using other medicines that contain 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 serious infections.

Be careful 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., do not use a shower cap, as this may cause the active substance to penetrate the skin and affect other parts of the body.
• When using Clobex, avoid contact of the medicine with the skin of the face, eyelids, armpits, cracked skin, and the genital area. If the medicine accidentally spills outside the scalp, wash it off with water immediately.
• If Clobex gets into your eye, rinse it thoroughly with plenty of water. If irritation persists, consult a doctor.
• If there is no improvement during treatment, consult a doctor.
• If you experience blurred vision or other vision disturbances, contact your doctor.
• You should discuss with your doctor or pharmacist if, during the first use of Clobex, 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

Tell your doctor about all medicines you are taking now or recently, and about medicines you plan to take.

Pregnancy and breastfeeding

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

Driving and using machines:

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

Clobex contains 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

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual daily dose of the medicine is about half a tablespoon (about 7.5 ml) of the medicine,
enough to cover the scalp thoroughly.
If your doctor has not told you otherwise, 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. Avoid using too much Clobex; use enough medicine to cover the dry scalp.
After applying the medicine, wash your hands thoroughly.
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 your regular shampoo if you need more shampoo.
Do not increase the dose of Clobex.
Your doctor will tell you 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, consult your doctor. You should also inform your doctor if there is no improvement at the end of treatment. The treatment requires close monitoring - you should inform your doctor about the progress of the treatment at regular intervals.
Do not use Clobex for longer than prescribed by your doctor.
Your 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, follow
the doctor's instructions carefully. The patient must report to the doctor every week for control before continuing treatment.

Using more Clobex than prescribed

Consult your doctor. This medicine is intended for use only on the scalp. Do not swallow this medicine. In case of accidental ingestion, small amounts of shampoo are not harmful.
If in doubt, consult your doctor immediately.

Missing a dose of Clobex

Do not use a double dose to make up for a missed dose.
Use the medicine as you did before. If you have missed several doses, consult your doctor.

Stopping treatment with Clobex

Consult your doctor.
There is a risk of worsening the disease when stopping treatment with Clobex, especially if the medicine has been used for a long time.
If you have any further questions about using this medicine, ask your 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: may affect up to 1 in 10 people

• Burning sensation of the skin
• Folliculitis

Uncommon: may affect up to 1 in 100 people

• 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 stinging or burning
• Eye irritation
• Feeling of pressure in the eye
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin swelling
• Teleangiectasia (visibility of blood vessels in the skin)
• Worsening of psoriasis
• Hair loss
• Dry skin
• Hives
• Skin thinning (skin atrophy)
• Skin irritation
• Skin tension
• Allergic contact dermatitis
• Redness
• Rash

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

• Blurred vision

Symptoms of skin irritation, itching, hives, visibility of blood vessels, and skin thinning at the treated site are usually mild or moderate.

• If local signs of intolerance, such as a burning sensation or redness, occur at the treated site, you should stop using Clobex until these symptoms subside.
• If the condition of the treated areas worsens during treatment (this is more likely if Clobex shampoo is used for longer than recommended), you should stop using the medicine and consult your doctor. If you experience swelling of the eyelids, face, or lips, you should stop using the medicine, as this may be a sign of hypersensitivity (allergy) 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 of the face 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, you should never use this medicine on the face or on areas other than the scalp.
• To avoid interactions with hair coloring products, Clobex shampoo should be rinsed thoroughly.
• If you experience any unusual, unexplained discomfort, you should consult your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 bottle and carton (EXP).
The expiry date refers to the last day of that month.
Store in the original package to protect from light.
Shelf life after first opening: 6 months.
Discard the bottle after 6 months of first opening.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack 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 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 pack

Clobex is a thick, translucent, colorless to light yellow liquid shampoo with an alcoholic odor.
Clobex is available on prescription only.
The medicine is available in high-density polyethylene (HDPE) bottles with polypropylene snap-on caps, containing 60 ml and 125 ml of shampoo, placed in a cardboard box. The bottles contain 60 ml or 125 ml of shampoo.

Marketing authorization holder and manufacturer

Marketing authorization holder

Galderma Polska Sp. z o.o.
Puławska 145
02-715 Warsaw
Poland
tel.: +48 22 331 21 80

Manufacturer

Laboratoires Galderma
Z.I., Montdésir
74540 Alby-sur-Chéran
France
Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Düsseldorf
Germany

This medicine is authorized in the Member States of the European Economic Area under the following 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.
Date of last revision of the leaflet 18.11.2024.