CLOBEDERM 0.5 mg/g Ointment

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. CLOBEDERM, 0.5 mg/g, ointment
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Clobederm ointment and what is it used for
   1. Indications for use
4. Important information before using Clobederm ointment
   1. When not to use Clobederm ointment:
   2. Warnings and precautions
   3. Children and adolescents
   4. Clobederm ointment and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Clobederm ointment contains:
5. How to use Clobederm ointment
   1. Use in children and adolescents
   2. Using a higher dose of Clobederm ointment than recommended
   3. Missing a dose of Clobederm ointment
   4. Stopping use of Clobederm ointment
6. Possible side effects
   1. Systemic side effects of unknown frequency (frequency cannot be estimated from the available data):
   2. Additional side effects in children and adolescents
   3. Reporting side effects
7. How to store Clobederm ointment
8. Contents of the packaging and other information
   1. What Clobederm ointment contains
   2. What Clobederm ointment looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

CLOBEDERM, 0.5 mg/g, ointment

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 or nurse.
• -This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• -If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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

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

Clobederm ointment is a medicine for topical use on the skin, containing the active substance clobetasol propionate. Clobetasol propionate is a very potent synthetic glucocorticosteroid (a type of hormone) for local use on the skin. The medicine has a very potent anti-inflammatory, anti-itching, anti-allergic, and vasoconstrictive effect.

Indications for use

Clobederm ointment is used topically for the short-term treatment of acute and severe, non-infected, dry inflammatory skin conditions that respond to glucocorticosteroids and are accompanied by persistent itching or excessive scaling, when treatment with weaker glucocorticosteroid preparations has failed. Clobederm is indicated for: seborrhoeic dermatitis, contact dermatitis, atopic dermatitis, chronic psoriasis, discoid lupus erythematosus, polymorphic erythema, and pruritic lichen.

2. Important information before using Clobederm ointment

When not to use Clobederm ointment:

• -if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• -in bacterial, viral, and fungal skin infections;
• -in common acne;
• -in rosacea;
• -in perioral dermatitis;
• -after protective vaccinations;
• -in hypersensitivity to clobetasol propionate, other glucocorticosteroids, or hypersensitivity to any excipient of the medicine;
• in anal or genital itching;
• under occlusive dressing (tight);
• in children under 12 years of age;
• for a long time.

Warnings and precautions

Before starting to use Clobederm ointment, you should discuss it with your doctor or pharmacist or nurse.

• when using Clobederm ointment for the first time, the patient experienced bone pain or worsening of pre-existing bone symptoms, especially if the patient uses Clobederm ointment for a long time or repeatedly.
• the patient is taking other medicines containing corticosteroids or medicines intended to regulate the immune system (e.g., in autoimmune diseases or after organ transplantation). Concomitant use of Clobederm ointment with these medicines may lead to severe infections. If irritation or allergic skin reaction occurs after using Clobederm ointment, you should immediately inform your doctor. The doctor will decide whether to stop using the medicine.

If you experience blurred vision or other vision disturbances, you should contact your doctor. Do not use the medicine without interruption for more than 2 weeks. Due to the fact that corticosteroids are absorbed through the skin, during long-term use of the medicine or use on a large skin surface, the frequency of general side effects characteristic of corticosteroids, such as edema, hypertension, increased blood sugar levels, and decreased immunity, often increases. Therefore, you should avoid using the medicine on a large body surface area. If an infection occurs at the site of application, the doctor will apply appropriate antibacterial or antifungal treatment. If the symptoms of infection do not disappear, you should contact your doctor. The doctor will decide whether to interrupt the use of the medicine until the infection is cured. You should avoid contact of the medicine with the eyes, mucous membranes, or wounds. Avoid using the medicine around the eyes, due to the risk of glaucoma or cataracts. Avoid using the medicine on the eyelids or on the skin around the eyelids, especially in people with glaucoma with a narrow or wide angle of filtration, as well as in people with cataracts, due to the risk of worsening the symptoms of the disease. Patients with psoriasis should use the medicine with special caution, as local use of corticosteroids in psoriasis can be dangerous for many reasons, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin continuity disorders. On the face and in the armpits and groin, use only in absolutely necessary cases, due to increased absorption of corticosteroids through delicate skin and a higher risk of side effects, such as telangiectasia or perioral dermatitis, even after short-term use. Use with caution in existing subcutaneous tissue atrophy, especially in the elderly. Do not use the medicine for longer than recommended by your 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 ratio of body surface area to body mass than in adults, there is a higher risk of systemic side effects caused by corticosteroids, such as disorders of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome (a disease characterized by symptoms such as obesity, muscle atrophy, skin changes, hypertension, easy fatigue, and others). Chronic treatment with corticosteroids can disrupt growth and development in children.

Clobederm ointment and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. There are no known interactions during topical use of corticosteroids with other medicines. Do not get vaccinated against smallpox while using the medicine. Do not have other vaccinations, especially during long-term use of the medicine or use on a large skin surface. The medicine may enhance the effect of medicines that affect the immune system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. Women who are pregnant or breastfeeding should not use the medicine unless it is absolutely necessary, as it contains a very potent glucocorticosteroid.

Driving and using machines

Clobederm ointment has no effect on the ability to drive and use machines.

Clobederm ointment contains:

• propylene glycol - due to its presence, the medicine may cause skin irritation.

3. How to use Clobederm ointment

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not use the medicine for longer than prescribed by your doctor. The medicine is for topical use on the skin. Gently rub a small amount of ointment into the affected areas of skin, usually once or twice a day. Do not use the medicine under occlusive dressing (sealing), diaper, or bandage. After using the medicine, wash your hands. Treatment should not be continued without interruption for more than 2 weeks. After improvement, treatment should be discontinued. If further treatment with corticosteroids is necessary, the doctor will use medicines containing corticosteroids with a lower potency, ensuring control of the disease symptoms.

Use in children and adolescents

Do not use in children under 12 years of age.

Using a higher dose of Clobederm ointment than recommended

After long-term use or use on large skin surfaces, symptoms of overdose may occur, such as edema, hypertension, high blood sugar levels, decreased immunity, and Cushing's disease. If you experience symptoms of overdose, contact your doctor.

Missing a dose of Clobederm ointment

Do not use a double dose to make up for a missed dose.

Stopping use of Clobederm ointment

If you have any further questions about using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Local side effects of unknown frequency(frequency cannot be estimated from the available data):

• blurred vision,
• glaucoma or cataracts (when used topically on the eyelids),
• acne-like changes,
• post-steroid pustulosis,
• atrophy of the epidermis,
• burning, itching, skin irritation,
• rash,
• subcutaneous tissue atrophy,
• dry skin,
• excessive hair growth or hair loss,
• skin discoloration or hyperpigmentation,
• skin atrophy and striae,
• telangiectasia,
• perioral dermatitis,
• folliculitis,
• secondary skin infections,
• generalized pustular psoriasis,
• urticaria or papular-pustular rash or worsening of existing skin conditions.

Systemic side effects of unknown frequency (frequency cannot be estimated from the available data):

Due to the absorption of the active substance into the blood, systemic side effects of clobetasol propionate may also occur. They occur mainly in the case of long-term use of the medicine, use on a large skin surface, under occlusive dressing, or in children.

Additional side effects in children and adolescents

In children, systemic side effects of clobetasol propionate may occur. Systemic side effects of clobetasol propionate characteristic of corticosteroids include:

• suppression of the hypothalamic-pituitary-adrenal axis (leading to disorders of certain hormone secretion),
• Cushing's syndrome (a disease characterized by symptoms such as obesity, muscle atrophy, skin changes, hypertension, easy fatigue, and others),
• growth and development retardation in children,
• high blood sugar levels, glycosuria,
• edema,
• hypertension,
• decreased immunity.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Clobederm ointment

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Shelf life after first opening the tube: 3 months. 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 packaging and other information

What Clobederm ointment contains

• The active substance of the medicine is clobetasol propionate. 1g of ointment contains 0.5mg of clobetasol propionate.
• The other ingredients are: propylene glycol, sorbitan sesquioleate, white petrolatum.

What Clobederm ointment looks like and contents of the packaging

Clobederm ointment is a white, semi-transparent ointment. The available packaging is an aluminum tube containing 25g of ointment, placed in a cardboard box.

Marketing authorization 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]

Date of last revision of the leaflet: