Clobex

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Clobex, 500 micrograms/g, medicated shampoo
Clobetasol propionate
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 group 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 topical use 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 case of bacterial, viral, fungal, or parasitic infections of the scalp skin, such as herpes simplex, chickenpox, shingles, tinea (a type of rash on the face), fungal skin infections, athlete's foot, candidiasis, cutaneous tuberculosis, or syphilis of the skin;
• in 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. high 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 use 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 the skin of the face, eyelids, armpits, cracked or fissured skin, and genital area. If the medicine runs off beyond the hairy scalp, immediately rinse it off with water.
• If Clobex gets into the eye, thoroughly rinse it with plenty of water. If irritation persists, consult a doctor.
• If there is no improvement during treatment, consult a doctor.
• If blurred vision or other visual disturbances occur, contact a doctor.
• Talk to a doctor or pharmacist if, during treatment with Clobex for the first time, the patient experiences bone pain 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 weekly for check-ups before continuing treatment.

Clobex with other medicines
Tell your doctor about all medicines you have recently taken, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might 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.

Clobex contains alcohol (ethanol)
This medicine contains 100 mg of alcohol (ethanol) per gram, equivalent to 10% w/w. It may cause stinging of damaged skin.

3. How to use Clobex

This medicine should always be used exactly as your doctor has instructed. 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 completely cover the hairy scalp.
Unless otherwise directed by your doctor, wash your hands and apply Clobex directly to dry hairy scalp once daily, taking care to thoroughly cover and gently massage the medicine into the affected areas. Avoid using excessive amounts of Clobex; use only enough to cover the dry hairy scalp.
After application, wash your hands thoroughly.
Leave the medicine on the scalp 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 treatment with Clobex should continue for scalp psoriasis. Treatment should not last longer than 4 weeks. However, if significant improvement of psoriasis occurs towards 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 close monitoring – you should regularly inform your doctor about treatment progress.
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 during which the medicine was not used.

Use in children and adolescents
If Clobex has been prescribed for use in a child aged 2 to 18 years, follow your doctor's instructions carefully. The patient must attend weekly check-ups with the doctor before continuing treatment.

If you use more Clobex than you should
Consult your doctor. This medicine is intended for external use on the hairy scalp only. Do not swallow this medicine. Accidental ingestion of small amounts of shampoo is not harmful.
In case of doubt, contact your doctor immediately.

If you forget to use Clobex
Do not use a double dose to make up for a missed dose. Continue using the medicine as prescribed. If you have missed several doses, consult your doctor.

Stopping 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 about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Clobex may cause the following adverse effects.

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

• Skin burning sensation
• Folliculitis

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

• Hormonal disorders (such as adrenal cortex suppression, Cushing's syndrome) – observed during topical use of potent corticosteroids, particularly when applied over large body surface areas or for prolonged periods
• Pricking or burning sensation in the eyes
• Eye irritation
• Feeling of eye pressure
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• 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

Skin irritation symptoms, itching, urticaria, visible blood vessels, and skin atrophy around the treated area are usually mild or moderate in severity.

• If local intolerance symptoms such as burning sensation or redness occur at the treated sites, use of Clobex should be discontinued until these symptoms resolve.
• If the condition of the affected areas worsens during treatment (more likely if Clobex is used for longer than recommended), treatment should be stopped and a doctor should be consulted. If eyelid, facial, or lip swelling occurs, discontinue use of the medicine immediately, as this may indicate hypersensitivity (allergy) to the medicine or a skin infection.
• Application of 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, abnormal hair growth, and skin discoloration. Stretch marks and purpura (bruising) may also appear.
• In cases of rosacea (facial redness with sudden flushing episodes and possibly papules), applying Clobex to the face may worsen 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 should be thoroughly rinsed off.
• If any unusual or unexplained discomfort occurs, consult a doctor as soon as possible.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects helps provide more information on the safety of the medicine.

5. How to store Clobex

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 the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Clobex contains

• 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 opalescent, colourless to pale yellow liquid shampoo with an alcoholic odour.
Clobex is available on prescription only.
The medicine is supplied in a 125 ml HDPE bottle with a PP snap-cap closure, placed in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, country of export: 658226.8
Parallel Import Licence Number: 166/22
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, medicated shampoo
France, Germany, Belgium, Poland, Spain, Hungary, the Netherlands, Sweden, Denmark, Austria, Luxembourg, Iceland, the Czech Republic, Norway, Greece, Slovakia and Finland: Clobex 500 micrograms/g, medicated shampoo.