Package leaflet: Information for the patient

CLOBEDERM, 0.5 mg/g, cream
Clobetasol propionate
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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, pharmacist, or nurse. See section 4.

Leaflet contents:

What Clobederm cream is and what it is used for
Important information before using Clobederm cream
How to use Clobederm cream
Possible side effects
How to store Clobederm cream
Contents of the pack and other information

1. What Clobederm cream is and what it is used for

Clobederm cream is a topical medicine containing the active substance clobetasol propionate. Clobetasol propionate is a very potent synthetic glucocorticosteroid (a type of hormone) intended for topical application to the skin. The medicine has a very strong anti-inflammatory, antipruritic (anti-itch), antiallergic, and vasoconstrictive effect.

Indications
Clobederm cream is indicated for short-term topical treatment of acute and severe non-infectious, exudative inflammatory skin conditions that respond to glucocorticosteroids and are accompanied by persistent itching or excessive keratosis, when treatment with weaker glucocorticosteroid preparations has failed.
Clobederm is indicated in: seborrheic dermatitis, contact dermatitis, atopic dermatitis, chronic plaque psoriasis, lichen planus, erythema multiforme, discoid lupus erythematosus, pruritic lichen planus, and lichenified eczema.

2. Important information before using Clobederm cream

When not to use Clobederm cream:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
in bacterial, viral, or fungal skin infections;
in acne vulgaris;
in rosacea;
in perioral dermatitis;
after vaccination;
in hypersensitivity to clobetasone propionate, other glucocorticosteroids, or to any of the excipients of the medicine;
in anal or genital itching;
in children under 12 years of age;
under occlusive dressings (airtight coverings);
long-term use.

Warnings and precautions
Before starting treatment with Clobederm cream, consult a doctor, pharmacist, or nurse if:

during the first use of Clobederm cream, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient has been using Clobederm cream for a prolonged period or repeatedly.
the patient is taking orally or topically other medicines containing corticosteroids or medicines intended to regulate immune system function (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Clobederm cream with these medicines may lead to severe infections.

If irritation or allergic skin reactions occur after applying Clobederm cream, inform a doctor immediately. The doctor will decide whether treatment should be discontinued.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Do not use the medicine continuously for longer than 2 weeks.
Since corticosteroids are absorbed through the skin, prolonged use or application over large areas of skin increases the risk of systemic adverse effects typical of corticosteroids, such as edema, hypertension, increased blood glucose levels, and reduced immunity.
Therefore, avoid applying the medicine over large areas of the body.
If an infection develops at the site of application, the doctor will initiate appropriate antibacterial or antifungal treatment. If signs of infection persist, contact a doctor. The doctor will decide whether to discontinue treatment until the infection resolves.
Avoid contact of the medicine with eyes, mucous membranes, or open wounds.
Avoid applying the medicine around the eyes due to the risk of glaucoma or cataract.
Avoid using the medicine on eyelids or skin around the eyelids, especially in patients with narrow- or wide-angle glaucoma or cataracts, due to the risk of worsening symptoms.
Patients with psoriasis should use the medicine with particular caution, as topical corticosteroids in psoriasis may be dangerous for several reasons, including disease rebound due to developing tolerance, risk of generalized pustular psoriasis, and systemic toxic effects resulting from impaired skin integrity.
Apply to facial skin, armpits, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through thin skin and a higher risk of adverse effects such as telangiectasia or perioral dermatitis, even after short-term use.
Use with caution in pre-existing atrophic conditions of subcutaneous tissue, especially in elderly patients.
Do not use the medicine longer than prescribed by a doctor.

Children and adolescents
Do not use in children under 12 years of age.
Use with caution in children over 12 years of age.
In children, due to a higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic corticosteroid effects on the hypothalamic-pituitary-adrenal axis and Cushing's syndrome (a cluster of symptoms associated with elevated steroid levels in blood serum, most commonly caused by long-term glucocorticosteroid administration). Chronic corticosteroid treatment may impair growth and development in children.

Clobederm cream and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No interactions are known during topical use of corticosteroids with other medicines.
Do not get vaccinated against smallpox while using this medicine. Other vaccinations should also be avoided, especially during long-term treatment or when applied over large skin areas.
The medicine may enhance the effects of drugs affecting the immune system.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnant or breastfeeding women should not use this medicine unless absolutely necessary in the opinion of a doctor, as the medicine contains a glucocorticosteroid with very strong activity.

Driving and operating machinery
Clobederm cream has no effect on the ability to drive or operate machinery.

Clobederm cream contains:

propylene glycol – due to its content, the medicine may cause skin irritation;
chlorocresol – due to its content, the medicine may cause allergic reactions;
cetostearyl alcohol – due to its content, the medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Clobederm cream

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. Do not extend the duration of treatment beyond
that recommended by the doctor.
This medicine is intended for topical application to the skin.
Gently rub a small amount of cream into the affected areas of skin, usually once or twice
daily.
Do not use the medicine under occlusive dressings (sealed coverings), diapers, or plasters.
After applying the medicine, hands should be washed.
Treatment should not be continued continuously for longer than 2 weeks.
Once improvement is achieved, treatment should be discontinued.
If further corticosteroid treatment is required, the doctor will prescribe corticosteroid-containing
medicines with lower potency that maintain control of disease symptoms.
Use in children and adolescents
Do not use in children under 12 years of age.
Use of a higher than recommended dose of Clobederm cream
With prolonged use or application over large areas of skin, symptoms of overdose may occur,
such as oedema, hypertension, increased blood glucose levels, reduced immunity, or Cushing's syndrome.
If symptoms of overdose occur, consult a doctor.
Missed dose of Clobederm cream
Do not use a double dose to make up for a missed dose.
Stopping Clobederm cream
If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions occur with unknown frequency (frequency cannot be estimated from
the available data):
Acneiform changes, steroid-induced purpura, epidermal atrophy, burning, itching, irritation, rash,
subcutaneous tissue atrophy, dry skin, hypertrichosis or alopecia, skin discoloration or pigmentation changes,
skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, secondary infections, generalized
exanthematous pustulosis. Occasionally urticaria or maculopapular rash may occur, or exacerbation of
pre-existing skin lesions, as well as blurred vision.
When applied locally to the eyelid skin, glaucoma or cataract may occur.
Systemic adverse reactions of clobetasone propionate may also occur due to absorption of the active
substance into the bloodstream.
These are primarily observed with prolonged use of the medicine, application over a large skin surface,
under occlusive dressing, or when used in children.
Additional adverse reactions in children and adolescents
Systemic adverse reactions of clobetasone propionate may occur in children.
Systemic adverse effects of clobetasone propionate typical of corticosteroids include, among others,
suppression of the hypothalamic–pituitary–adrenal (HPA) axis function, Cushing's syndrome, growth
and developmental retardation in children, hyperglycemia, glycosuria, edema, hypertension, and decreased immunity.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor,
pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store Clobederm cream

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Period of use after first opening the tube: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Clobederm cream contains

The active substance is clobetasol propionate. 1 g of cream contains 0.5 mg of clobetasol propionate.
Other ingredients are: propylene glycol, disodium edetate, chlorocresol, liquid paraffin, white vaseline, glyceryl monostearate 40-55, cetostearyl alcohol, polysorbate 40, medium-chain triglycerides, anhydrous colloidal silicon dioxide, sodium citrate, citric acid monohydrate, purified water.

What Clobederm cream looks like and contents of the pack
Clobederm cream is a white, homogeneous cream with a characteristic odour. The pack consists of an aluminium tube containing 25 g of cream, placed in a cardboard box.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21, 58-500 Jelenia Góra
tel. (075) 643 31 02
fax. (075) 752 44 55
e-mail: [email protected]