Clobetaxon

Package Leaflet: Information for the Patient

Clobetaxon, 0.5 mg/g, Ointment

Clobetasol Propionate

Read the Leaflet Carefully Before Using the Medication, 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, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It 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, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Clobetaxon and what is it used for
• 2. Important information before using Clobetaxon
• 3. How to use Clobetaxon
• 4. Possible side effects
• 5. How to store Clobetaxon
• 6. Contents of the pack and other information

1. What is Clobetaxon and what is it used for

The active substance of Clobetaxon is clobetasol propionate, a corticosteroid with very strong anti-inflammatory effects. The medication is intended for topical use on the skin. Clobetaxon is indicated for adults, adolescents, and children over 1 year of age, for short-term local treatment of skin diseases that respond to corticosteroid therapy, such as:

• psoriasis (excluding generalized lesions),
• lichen planus,
• discoid lupus erythematosus (DLE),
• recurrent eczema,
• difficult-to-treat skin diseases, whose previous treatment with weaker corticosteroids has been ineffective.

2. Important information before using Clobetaxon

When not to use Clobetaxon

If the patient has:

• hypersensitivity to clobetasol propionate or any other component of this medication (listed in section 6),
• untreated skin infections,
• rosacea,
• acne vulgaris,
• perioral dermatitis,
• pruritus without inflammation,
• pruritus in the anal and genital areas. Do not use in children under 1 year of age. Do not use on skin under a diaper, as the diaper may act like an occlusive dressing.

Warnings and precautions

Before starting treatment with Clobetaxon, discuss with your doctor, pharmacist, or nurse if:

• during the first use of Clobetaxon, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient is using Clobetaxon for a long time or repeatedly,
• the patient is taking other corticosteroid medications orally or topically, or medications intended to regulate the immune system (e.g., in autoimmune diseases or after organ transplantation). Concomitant use of Clobetaxon with these medications may lead to severe infections.

Clobetaxon should be used with caution in patients with hypersensitivity to topical corticosteroids. Long-term use of the medication should be avoided, as it may lead to systemic side effects characteristic of corticosteroids, adrenal suppression, and Cushing's syndrome (see section 4). Factors that increase the risk of systemic effects:

• potency and pharmaceutical form of topical steroids,
• exposure time,
• use on large areas of the body,
• use on tightly covered areas of the skin (e.g., in areas prone to maceration or under an occlusive dressing),
• increased hydration of the stratum corneum,
• use on thin skin areas (e.g., facial skin),
• use on damaged skin or in situations where the skin barrier may be compromised,
• in children, as they may absorb proportionally more topical corticosteroids than adults and may be more susceptible to systemic side effects.

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, the medication should be used with caution and for the shortest duration possible, due to the risk of adrenal suppression and Cushing's syndrome.

Clobetaxon and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Clobetaxon may interact with medications that inhibit the activity of the CYP3A4 isoenzyme (an enzyme important for liver function), such as:

• ritonavir (a medication used to treat HIV infection),
• itraconazole (a medication used to treat fungal infections). Inform your doctor if you are taking any of these medications.

Pregnancy, breastfeeding, and fertility

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 medication. Clobetaxon should only be used during pregnancy or breastfeeding if your doctor decides it is necessary. The use of this medication during pregnancy or breastfeeding should only be considered if the expected benefits to the mother outweigh the risks to the fetus or child. Clobetaxon should be used with the minimum frequency and for the shortest duration necessary. During breastfeeding, Clobetaxon should not be applied to the breast to prevent accidental ingestion by the infant. There is no data on the effect of the medication on human fertility.

Driving and using machines

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

Clobetaxon contains propylene glycol

The medication contains 50 mg of propylene glycol per 1 gram of ointment.

3. How to use Clobetaxon

This medication should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Clobetaxon is intended for topical use on the skin. Gently rub a small amount of the medication into the affected areas of the skin once or twice a day, in the morning and evening. Ensure that the smallest possible amount of ointment is used. After applying the medication, wash your hands (if they are not being treated). In resistant cases (e.g., psoriatic lesions on the elbows and knees), your doctor may recommend using an occlusive dressing (e.g., with polyethylene film) only at night. This usually results in significant improvement, which can be maintained by using the medication without an occlusive dressing. Duration of treatment Typically, treatment with Clobetaxon lasts for a few days. The amount of medication used within a week should not exceed 50 grams. If there is no improvement after 2 to 4 weeks of treatment, consult your doctor to determine further treatment. When using the medication on the facial skin, treatment should be limited to 5 days and an occlusive dressing should not be used. After achieving improvement, your doctor will gradually discontinue Clobetaxon. The medication should be discontinued gradually. Do not stop treatment abruptly, as this may lead to a relapse of the disease. Your doctor may recommend reusing Clobetaxon in case of disease exacerbation. If your doctor decides that further corticosteroid treatment is necessary, they will prescribe other corticosteroids with weaker effects.

Elderly patients, patients with renal or hepatic impairment

In elderly patients or those with renal or hepatic impairment, the smallest recommended dose of ointment should be used for the shortest duration possible to achieve the therapeutic effect.

Use in children and adolescents

Do not use in children under 1 year of age. In children and adolescents, the smallest possible dose of the medication should be used for the shortest duration possible to achieve the therapeutic effect, due to the increased risk of local and systemic side effects (see sections 2 and 4).

Overdose of Clobetaxon

The occurrence of symptoms of acute overdose is unlikely. In case of prolonged or improper use of the medication, consult your doctor.

Missed dose of Clobetaxon

Do not use a double dose to make up for a missed dose. Use the medication as soon as possible, following the recommended dosing schedule.

4. Possible side effects

Like all medications, Clobetaxon can cause side effects, although not everybody gets them. Clobetaxon should be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist. To minimize the risk of side effects, your doctor should ensure that you use the smallest dose that provides a therapeutic effect. The following side effects have been observed in patients using Clobetaxon. Common(occurring in up to 1 in 10 people):

• Itching, local burning, and/or skin pain.

Uncommon(occurring in up to 1 in 100 people):

• Local atrophic changes in the skin, striae.
• Expansion of superficial blood vessels (telangiectasias). Prolonged treatment and use of high doses may lead to expansion of superficial blood vessels, especially when used in skin folds or under an occlusive dressing.

Rare(occurring in less than 1 in 1,000 people):

• Opportunistic infections.
• Hypersensitivity.
• Adrenal suppression, Cushing's syndrome (e.g., moon face, central obesity), decreased endogenous cortisol levels,

weight gain and/or obesity, hyperglycemia (elevated blood glucose levels) and/or glycosuria (glucose in the urine).

• Glaucoma, cataracts.
• Hypertension.
• Thinning of the skin, skin wrinkles, dry skin, discoloration, excessive hair growth, worsening of primary disease symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria, hair loss, hair fragility.
• Growth retardation in children, osteoporosis,
• Skin irritation or pain at the application site.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. 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 medication.

5. How to store Clobetaxon

Store at a temperature below 25°C. Keep the medication out of sight and reach of children. Do not use after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Shelf life after first opening the tube: 2 years. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 petrolatum.

What Clobetaxon looks like and contents of the pack

The medication is a white to yellowish ointment with a characteristic odor. Packaging: aluminum tube with a polyethylene cap and a piercer, containing 25 grams of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

“HASCO-LEK” S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E

Medication information

tel. 22 742 00 22, e-mail: [email protected]

Date of last revision of the leaflet: