CLOBEDERM 0.5 mg/g Cream

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. CLOBEDERM, 0.5 mg/g, cream
   1. Read the package 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 cream and what is it used for
   1. Indications for Use
4. Important Information Before Using Clobederm Cream
   1. When Not to Use Clobederm Cream:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Clobederm Cream and Other Medicines
   5. Pregnancy, Breast-feeding, and Fertility
   6. Driving and Using Machines
   7. What Clobederm Cream Contains
5. How to Use Clobederm Cream
   1. Use in Children and Adolescents
   2. Using More Than the Recommended Dose of Clobederm Cream
   3. Missing a Dose of Clobederm Cream
   4. Stopping Use of Clobederm Cream
6. Possible Side Effects
   1. Additional Side Effects in Children and Adolescents
   2. Reporting Side Effects
7. How to Store Clobederm Cream
8. Contents of the Pack and Other Information
   1. What Clobederm Cream Contains
   2. What Clobederm Cream Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Manufacturer

Package Leaflet: Information for the Patient

CLOBEDERM, 0.5 mg/g, cream

Clobetasol propionate

Read the package 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 you only. 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 any not listed in this leaflet, please tell your doctor or pharmacist or nurse. See section 4.

Table of Contents of the Leaflet:

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

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

Clobederm cream is a medicine for 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 very potent anti-inflammatory, anti-itching, anti-allergic, and vasoconstrictive effects.

Indications for Use

Clobederm cream is used locally for the short-term treatment of acute and severe, non-infected, weeping 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: seborrheic dermatitis, contact dermatitis, atopic dermatitis, chronic psoriasis, discoid lupus erythematosus, polymorphic light eruption, and prurigo nodularis.

2. Important Information Before Using Clobederm Cream

When Not to Use Clobederm Cream:

• -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 vaccinations;
• -in hypersensitivity to clobetasol propionate, other glucocorticosteroids, or hypersensitivity to any excipient of the medicine;
• -in anal and genital itching;
• -in children under 12 years of age;
• -under occlusive dressing (tight bandage);
• -for prolonged periods.

Warnings and Precautions

Before starting to use Clobederm cream, discuss with your doctor or pharmacist or nurse if:

• -during the first use of Clobederm cream, you experience bone pain or worsening of pre-existing bone symptoms, especially if you use Clobederm cream for a long time or repeatedly.
• -you are taking other medicines containing corticosteroids or medicines used to regulate the immune system (e.g., in autoimmune diseases or after organ transplantation). Concomitant use of Clobederm cream with these medicines may lead to severe infections.

If you experience irritation or skin allergic reaction after using Clobederm cream, inform your doctor immediately. The doctor will decide whether to discontinue the use of the medicine. If you experience blurred vision or other vision disturbances, contact your doctor. Do not use the medicine continuously for more than 2 weeks. Due to the fact that corticosteroids are absorbed through the skin, during prolonged use of the medicine or use on a large skin surface, the frequency of general side effects characteristic of corticosteroids increases, such as edema, hypertension, increased blood sugar levels, and decreased immunity. Therefore, you should avoid using the medicine on a large body surface. 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 resolve, contact your doctor. The doctor will decide whether to discontinue the use of the medicine until the infection is cured. Avoid contact of the medicine with 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 narrow or wide angle of filtration and in people with cataracts, due to the risk of exacerbating the disease symptoms. Patients with psoriasis should use the medicine with special caution, as local use of corticosteroids in psoriasis can be dangerous for several reasons, including the risk of disease relapse due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin barrier disruption. On the face and in the axillary and groin areas, use only in cases where it is absolutely necessary, 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 atrophic conditions of subcutaneous tissue, especially in the elderly. Do not use the medicine for longer than prescribed 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 the higher ratio of body surface area to body mass compared to adults, there is a higher risk of systemic side effects of corticosteroids, such as disruption of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome (a syndrome of disease symptoms associated with increased steroid levels in the blood, most commonly caused by prolonged administration of glucocorticosteroids). Chronic treatment with corticosteroids may disrupt growth and development in children.

Clobederm Cream and Other Medicines

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

Pregnancy, Breast-feeding, and Fertility

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

Driving and Using Machines

Clobederm cream has no influence on the ability to drive and use machines.

What Clobederm Cream Contains

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

3. How to Use Clobederm Cream

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 use on the skin only. Gently rub a small amount of cream into the affected areas of skin, usually once or twice a day. Do not use the medicine under occlusive dressing (tight bandage), 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 lower potency, ensuring control of disease symptoms.

Use in Children and Adolescents

Do not use in children under 12 years of age.

Using More Than the Recommended Dose of Clobederm Cream

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

Missing a Dose of Clobederm Cream

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

Stopping Use of Clobederm Cream

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. The following side effects have a frequency not known (frequency cannot be estimated from the available data): Changes similar to acne, perioral dermatitis, skin atrophy, burning sensation, itching, irritation, rash, subcutaneous tissue atrophy, skin dryness, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, secondary infections, generalized pustular psoriasis. Sometimes, urticaria or papular-pustular rash may occur, or worsening of existing disease symptoms, as well as blurred vision. When used locally on the eyelids, glaucoma or cataracts may occur. Due to the absorption of the active substance into the blood, systemic side effects of clobetasol propionate may also occur. These occur mainly in the case of prolonged 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, Cushing's syndrome, growth and development inhibition in children, increased blood sugar levels, glycosuria, edema, hypertension, and decreased immunity.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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 medicine.

5. How to Store Clobederm Cream

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not freeze. 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 Pack and Other Information

What Clobederm Cream Contains

• The active substance is clobetasol propionate. 1g of cream contains 0.5mg of clobetasol propionate.
• The other ingredients are: propylene glycol, disodium edetate, chlorocresol, liquid paraffin, white petrolatum, glycerol monostearate 40-55, cetostearyl alcohol, polysorbate 40, triglycerides of saturated fatty acids of medium chain length, anhydrous colloidal silica, 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 odor. The pack contains a 25g aluminum tube, 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: