Package leaflet: Information for the patient

Clobetaxon, 0.5 mg/g, ointment
Clobetasol propionate
Read the entire leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Clobetaxon is and what it is used for

The active substance in Clobetaxon is clobetasol propionate, a corticosteroid with very potent anti-inflammatory action. The medicine is intended for topical application to the skin.
Clobetaxon is indicated in adults, adolescents, and children aged 1 year and older, for short-term local treatment of skin diseases that respond to corticosteroid therapy, such as:

psoriasis (excluding generalized forms),
lichen planus,
discoid lupus erythematosus (DLE),
recurrent eczema,
difficult-to-treat skin diseases that have not responded adequately to treatment with weaker corticosteroids.

2. Information before using Clobetaxon

When not to use Clobetaxon
Do not use Clobetaxon if the patient:

is allergic to clobetasone propionate or any of the other ingredients of this medicine (listed in section 6),
has untreated skin infections,
has rosacea,
has acne vulgaris,
has perioral dermatitis,
has itching without inflammatory condition,
has itching in the anogenital area.
Do not use in children under 1 year of age. Do not apply to skin under diapers, as diapers may act similarly to an occlusive dressing.

Warnings and precautions
Before starting to use Clobetaxon, consult a doctor, pharmacist, or nurse if:

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

Clobetaxon should be used with caution in patients with hypersensitivity to topically applied corticosteroids.
Prolonged use of Clobetaxon should be avoided, as it may lead to systemic adverse effects typical of corticosteroids, suppression of adrenal function, and symptoms of Cushing's syndrome (see section 4).

Factors increasing the risk of systemic effects:

potency and pharmaceutical form of the topical steroids used,
duration of exposure,
application over large body surface areas,
application to tightly covered skin areas (e.g. in skin folds or under occlusive dressings),
increased hydration of the stratum corneum,
application to areas where the skin is thin (e.g. facial skin),
application to damaged skin or in other situations where the skin barrier may be impaired,
in children, as compared to adults, there may be proportionally greater absorption of topically applied corticosteroids, making them more susceptible to systemic adverse effects.

The use of corticosteroids on facial skin may lead to skin atrophy more frequently than when applied to other areas of the body. Therefore, caution should be exercised when using the medicinal product on facial skin, especially in the treatment of psoriasis, lupus, and severe eczema, and treatment should be limited to a few days.

Protect the eyes and mucous membranes from contact with the medicinal product. Avoid using the medicinal product on the eyelids,
as repeated entry of the product into the conjunctival sac may lead to the development of glaucoma or cataracts.

In case of contact with the eyes, rinse thoroughly with plenty of water.

If signs of secondary infection appear at the site of inflammatory lesions being treated with Clobetaxon, the physician may decide to immediately discontinue treatment and administer systemic antimicrobial agents to the patient.

If Clobetaxon is used in the treatment of skin inflammation around chronic leg ulcers, allergic reactions may occur during treatment
or local skin infection may develop.

If it is necessary to use the medicinal product under an occlusive dressing, the skin should be thoroughly cleaned before applying the dressing, as heat and moisture favor the development of bacterial infections.

Patients suffering from psoriasis should be treated under strict medical supervision. Local application of corticosteroids in psoriasis
may be unfavorable due to the risk of rebound phenomena or pustular psoriasis.

tolerance to the drug, exacerbation of pathological changes, development of generalized pustular psoriasis,
or toxic effects resulting from excessive absorption of the drug through damaged skin.
If signs of irritation or hypersensitivity reactions occur, treatment with Clobetaxon should be discontinued.

Children and adolescents
Do not use in children under 1 year of age.
In children and adolescents, prolonged use of the drug should be avoided due to the risk of suppression of the hypothalamic-pituitary-adrenal axis and development of Cushing's syndrome symptoms.

Clobetaxon and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
Clobetaxon may interact with drugs that inhibit the activity of the CYP3A4 isoenzyme (an enzyme important for the function of, among others, the liver), such as:

ritonavir (a drug used in the treatment of HIV infection),
itraconazole (a drug used in the treatment of fungal infections).

Inform your doctor if you are taking any of the above-mentioned drugs.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Clobetaxon may be used during pregnancy or breastfeeding only if decided by a doctor. The use of this medicine during pregnancy or breastfeeding should be considered only when the expected benefit to the mother outweighs the potential risk to the fetus or child. Clobetaxon should be used with minimal frequency and for the shortest possible duration. During breastfeeding, Clobetaxon should not be applied to the breasts to prevent accidental ingestion by the newborn.
There are no data regarding the effect of the drug on fertility in humans.

Driving and operating machinery
Clobetaxon has no effect or has a negligible effect on the ability to drive and operate machinery.

Clobetaxon contains propylene glycol
The medicine contains 50 mg of propylene glycol in 1 gram of ointment.

3. How to use Clobetaxon

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Clobetaxon is intended for topical application to the skin.
A small amount of the ointment should be gently rubbed into the affected skin areas once or twice
daily, in the morning and evening. Ensure that the smallest effective dose of the ointment is used.
After applying the medicine, hands should be washed (unless the hands themselves are being treated).
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), the doctor may recommend
the use of an occlusive dressing (e.g. polyethylene film) overnight. This usually leads to noticeable
improvement, which can be maintained by continuing treatment without an occlusive dressing.
Duration of treatment
Treatment with Clobetaxon usually lasts several days. The amount applied within one week must not
exceed 50 g. If there is no improvement after 2 to 4 weeks of treatment, contact your doctor to discuss
further management.
When applying the medicine to the facial skin, treatment should be limited to 5 days and occlusive
dressings must not be used.
After improvement is achieved, the doctor will gradually taper off Clobetaxon. The medicine should be
discontinued gradually. Abrupt discontinuation should be avoided, as this may lead to disease recurrence.
The doctor may re-prescribe Clobetaxon during disease flare-ups.
If continued corticosteroid treatment is deemed necessary by the doctor, a corticosteroid with weaker
potency will be used.
Elderly patients, patients with renal or hepatic impairment
In elderly patients or those with renal or hepatic impairment, the smallest effective dose should be used
for the shortest duration necessary to achieve therapeutic benefit.
Use in children and adolescents
Do not use in children under 1 year of age. In children and adolescents, the smallest effective dose should
be used for the shortest duration necessary to achieve therapeutic benefit, due to increased risk of local
and systemic adverse effects (see section 2 and section 4).
Use of more than the recommended dose of Clobetaxon
Acute overdose symptoms are unlikely. In case of prolonged or inappropriate use, consult a doctor.
Missed dose of Clobetaxon
Do not apply a double dose to make up for a missed dose. Apply the medicine as soon as possible,
following the recommended dosing schedule.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Clobetaxon should be used according to the doctor's instructions. If in doubt, contact your
doctor or pharmacist. To minimize the risk of adverse effects, the doctor should ensure that the
patient uses the lowest dose that provides therapeutic effect.
Below are the adverse effects observed in patients using Clobetaxon.
Common (occurring in no more than 1 in 10 people):

Itching, local burning and (or) skin pain.

Uncommon (occurring in no more than 1 in 100 people):

Localized skin atrophy, striae.
Dilation of superficial blood vessels (telangiectasia). Prolonged treatment and use of the medicine in high doses may lead to dilation of superficial blood vessels, particularly when applied in skin folds or under occlusive dressing.

Very rare (occurring in fewer than 1 in 10,000 patients):

Opportunistic infections.
Hypersensitivity.
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis, symptoms of Cushing's syndrome (e.g. moon face, central obesity), decreased concentration of endogenous cortisol,
Increased body weight and (or) obesity, hyperglycaemia (excessively high blood glucose concentration) and (or) glycosuria (glucose in urine).
Glaucoma, cataract.
Hypertension.
Skin thinning, skin wrinkles, dry skin, skin discoloration, hypertrichosis, exacerbation of symptoms of the underlying disease, allergic contact dermatitis, pompholyx, erythema, rash, urticaria, alopecia, brittle hair.
Delayed bone growth in children, osteoporosis,
Skin irritation or pain at the site of application.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Clobetaxon

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the tube: 2 years.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Clobetaxon contains

The active substance is clobetasol propionate. 1 gram of ointment contains 0.5 mg of clobetasol propionate.
The other ingredients (excipients) are: propylene glycol, sorbitan sesquioleate, white soft paraffin.

What Clobetaxon looks like and contents of the pack
This medicinal product is a white to yellowish ointment with a characteristic odour.
Packaging: Membrane aluminium tube with a polyethylene cap with a piercing device, containing 25 g of ointment, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicines Information
tel. 22 742 00 22
e-mail: [email protected]