DERMOVATE 0.5 mg/g Cream

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Dermovate cream and what is it used for
3. Important information before using Dermovate cream
   1. When not to use Dermovate cream
   2. Warnings and precautions
   3. Factors increasing the risk of systemic effects
   4. Children
   5. Risk of bacterial infections under occlusive dressings
   6. Psoriasis
   7. Concomitant infections
   8. Ulcers of the lower limbs
   9. Use on the face
   10. Use on the eyelids
   11. Visual disturbances
   12. Dermovate and other medicines
   13. Pregnancy and breastfeeding
   14. Driving and using machines
   15. Dermovate cream contains chlorocresol, cetyl alcohol, propylene glycol, and paraffin.
4. How to use Dermovate cream
   1. Atopic dermatitis
   2. Patients with frequent relapses
   3. Children
   4. Elderly patients
   5. Renal and/or hepatic impairment
   6. Using more than the recommended dose of Dermovate cream
   7. Missing a dose of Dermovate cream
5. Possible side effects
   1. Reporting side effects
6. How to store Dermovate cream
7. Contents of the packaging and other information
   1. What does Dermovate cream contain
   2. What does Dermovate cream look like and what does the packaging contain
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Importer

Leaflet attached to the packaging: information for the user

Dermovate,0.5 mg/g, cream

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

The active substance of Dermovate cream is clobetasol propionate, a corticosteroid with a very strong anti-inflammatory effect. The medicine is intended for topical use on the skin. Dermovate cream is indicated for adults and adolescents from 12 years of age for the local treatment of skin diseases that respond to corticosteroid therapy, such as:

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

2. Important information before using Dermovate cream

When not to use Dermovate cream

If the patient has:

• untreated skin infections,
• rosacea,
• acne vulgaris,
• perioral dermatitis,
• pruritus without inflammation,
• pruritus in the anal and genital areas,
• children under 12 years of age.

Warnings and precautions

Before starting treatment with Dermovate, discuss it with your doctor or pharmacist if:

• when using Dermovate for the first time, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient is using Dermovate 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 Dermovate with these medications may lead to severe infections. Dermovate cream should be used with caution in patients with hypersensitivity to topical corticosteroids or any of the excipients of the medicine.

In some patients, due to increased systemic absorption of topical corticosteroids, symptoms of hypercortisolism (Cushing's syndrome, including moon face, i.e., accumulation of fatty tissue in the face or abdominal obesity) and reversible suppression of the hypothalamic-pituitary-adrenal axis leading to glucocorticoid deficiencies may occur. If these symptoms occur, the doctor will recommend gradual withdrawal of the medicine by reducing the frequency of application or using a corticosteroid with a weaker effect. Abrupt discontinuation of treatment may lead to glucocorticoid deficiencies (see section 4).

Factors increasing the risk of systemic effects

• strength of the corticosteroid and its form,
• exposure time,
• application to large areas of the body,
• application to tightly covered areas of the skin (e.g., in flexural areas or under occlusive dressings),
• increased hydration of the stratum corneum,
• application to areas where the skin is thin - e.g., on the face,
• application to damaged skin or in situations where the skin barrier may be compromised,
• compared to adults, children may absorb proportionally more topical corticosteroids and are therefore more susceptible to systemic side effects. This is due to the fact that children's skin barrier is immature, and the ratio of surface area to body mass is greater than in adults.

Children

Long-term use of topical corticosteroids in children should be avoided due to the possibility of suppressing the hypothalamic-pituitary-adrenal axis. Children are more prone to atrophic changes in the skin during topical corticosteroid therapy. If clobetasol propionate is used in a child, the treatment time should be limited to a few days, and the patient's condition should be evaluated weekly.

Risk of bacterial infections under occlusive dressings

If it is necessary to use the medicine under an occlusive dressing, the skin should be cleaned before applying the dressing, as the heat and moisture associated with occlusive dressings can promote the development of bacterial infections.

Psoriasis

Caution should be exercised when using topical corticosteroids in the treatment of psoriasis, due to the risk of:

developing tolerance to the medicine, worsening of lesions as a result of the so-called "rebound effect" after discontinuation of the medicine, development of generalized pustular psoriasis, occurrence of local or systemic side effects of corticosteroids resulting from excessive absorption of the medicine through damaged skin. If the medicine is used in psoriasis, medical supervision is required.

Concomitant infections

In the case of secondary infection within the inflammatory lesions, appropriate antimicrobial treatment should be used. If the infection spreads, topical corticosteroid therapy should be discontinued, and appropriate antimicrobial treatment should be used.

Ulcers of the lower limbs

Topical corticosteroids are sometimes used to treat inflammation of the skin around chronic ulcers of the lower limbs. Using them in this case may be associated with a higher frequency of local hypersensitivity reactions and an increased risk of local infections.

Use on the face

Using corticosteroids on the face can lead to atrophy of the skin more often than when used on other areas of the body. Use on the face should be limited to a few days.

Use on the eyelids

When using the medicine on the eyelids, care should be taken to avoid getting the medicine into the eye, as repeated exposure may lead to the development of glaucoma and cataracts.

Visual disturbances

If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Dermovate and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Dermovate cream may interact with medicines that inhibit the activity of CYP3A4 (an enzyme important for the functioning of, among others, the liver and adrenal glands), such as:

• ritonavir (a medicine used to treat HIV infection)
• itraconazole (a medicine used to treat fungal infections of the Candida type)

The patient should inform their doctor if they are taking any of these medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. The doctor will assess whether the patient can use Dermovate cream. Using Dermovate cream during pregnancy or breastfeeding should only be considered when the expected benefits to the mother outweigh the risk to the fetus or child. The smallest amount of medicine should be used for the shortest possible time. During breastfeeding, Dermovate cream should not be applied to the breast skin to avoid accidental ingestion by the child.

Driving and using machines

It is unlikely that possible side effects associated with the use of Dermovate cream will affect driving or using machines.

Dermovate cream contains chlorocresol, cetyl alcohol, propylene glycol, and paraffin.

The medicine contains 0.75 mg of chlorocresol in each gram of cream. Due to the presence of chlorocresol, the medicine may cause allergic reactions. The medicine contains 84 mg of cetyl alcohol in each gram of cream. Due to the presence of cetyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis). The medicine contains 475 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation. Dermovate cream contains paraffin. When using Dermovate, the patient should not smoke or approach open flames due to the risk of severe burns. Materials (clothing, bedding, garments, dressings, etc.) that have come into contact with this medicine are more flammable and pose a significant fire hazard. Washing clothing and bedding may reduce the amount of medicine in them, but not completely remove it.

3. How to use Dermovate cream

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist. Dermovate cream is intended for topical use on the skin, particularly on moist and weeping skin lesions. Affected areas should be covered with a thin layer of the medicine 1 or 2 times a day, in the morning and evening. A thin layer of cream should be applied, gently rubbing it in, using the smallest amount necessary to cover the affected areas. After applying the medicine, the patient should wash their hands (if the hands are not being treated). Treatment should be continued until improvement is achieved, but no longer than 4 weeks, and then the frequency of application should be reduced or another medicine with a weaker effect should be used. Before applying an emollient (a moisturizing preparation) after applying the cream, the patient should wait until the medicine has been absorbed into the skin. The doctor may recommend reusing Dermovate cream for a short time in case of disease exacerbations. In resistant cases (e.g., psoriatic lesions on the elbows and knees), the doctor may recommend using an occlusive dressing (e.g., with polyethylene film). Usually, applying an occlusive dressing only at night brings significant improvement, which can be maintained by using the medicine without an occlusive dressing. If there is no improvement or worsening of the patient's condition within 2 to 4 weeks, the doctor will reevaluate the indications for using the medicine. Treatment should not be continued for more than 4 weeks. If longer treatment is required, a medicine with a weaker effect should be used. The dose should not exceed 50 grams of cream per week.

Atopic dermatitis

During the treatment of atopic dermatitis, after achieving improvement, the use of Dermovate should be gradually discontinued, and an emollient should be used as maintenance therapy. Abrupt discontinuation of clobetasol propionate may lead to a relapse of the disease.

Patients with frequent relapses

After healing an acute episode of the disease with continuous topical corticosteroid therapy, it is possible to consider using the medicine with intervals (twice a week, once a day, without an occlusive dressing). It has been shown that this approach can reduce the frequency of relapses. The medicine should be applied to all previously affected areas or areas where relapse is expected. At the same time, emollients should be used daily. The patient's condition and the benefits and risks of continuing treatment should be regularly assessed.

Children

Using Dermovate in children under 12 years of age is contraindicated. In children, there is a greater risk of local and systemic side effects of topical corticosteroids. Moreover, a shorter treatment time is usually required, and corticosteroids with a weaker effect than in adults should be used. Caution should be exercised when treating with Dermovate, and it should be used in the smallest possible amount that provides therapeutic benefits.

Elderly patients

Clinical trials have not shown significant differences in response to treatment in elderly patients compared to younger patients. A higher frequency of liver or kidney function disorders in elderly patients may lead to slower elimination of the medicine in case of systemic absorption. Therefore, Dermovate should be used in the smallest possible amount and for the shortest time necessary to achieve the expected clinical benefit.

Renal and/or hepatic impairment

In the case of systemic absorption (when the medicine is applied to a large area for a long time), metabolism and elimination may be slowed down, and the risk of systemic toxicity may increase. Therefore, Dermovate should be used in the smallest possible amount and for the shortest time necessary to achieve the expected clinical benefit.

Using more than the recommended dose of Dermovate cream

In the case of prolonged, excessive dosing or improper use of the medicine, symptoms of hypercortisolism may occur. In such a case, the patient should contact their doctor.

Missing a dose of Dermovate cream

The patient should not use a double dose to make up for a missed dose. The medicine should be used as soon as possible, according to the recommended dosing schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Dermovate cream should be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. To prevent side effects, the doctor should ensure that the patient uses the smallest dose that provides a therapeutic effect. The following side effects have been observed in patients using Dermovate cream.

Common side effects(in 1 to 10 out of 100 patients using the medicine):

• Itching, local burning/pain of the skin.

Uncommon side effects(in 1 to 10 out of 1,000 patients using the medicine):

• Local atrophic changes in the skin, stretch marks.
• Expansion of superficial blood vessels (telangiectasias).

Rare side effects(in less than 1 out of 10,000 patients using the medicine):

• Local hypersensitivity.
• Suppression of the hypothalamic-pituitary-adrenal axis, symptoms of Cushing's syndrome: (e.g., moon face, abdominal obesity), delayed weight gain/delayed bone growth in children, osteoporosis, hyperglycemia (excessive blood sugar)/glycosuria (sugar in the urine), hypertension, weight gain/obesity, decreased endogenous cortisol levels, hair loss, brittle hair.
• Opportunistic infections.
• Thinning of the skin, wrinkles on the skin, dryness of the skin, discoloration, excessive hair growth, worsening of the primary disease, allergic contact dermatitis/skin inflammation, pustular psoriasis, erythema, rash, urticaria, acne.
• Skin irritation or pain at the injection site.
• Clouding of the lens of the eye (cataract).
• Increased intraocular pressure (glaucoma).

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• Visual disturbances caused by detachment of the retina (central serous chorioretinopathy, CSCR).
• Blurred vision.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be collected on the safety of the medicine.

5. How to store Dermovate cream

Store at a temperature below 30°C. The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The abbreviation "Lot" means the product batch number. The expiry date indicates the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What does Dermovate cream contain

• -The active substance of the medicine is clobetasol propionate (0.5 mg/g);
• -The other ingredients are: glycerol monostearate, arlacel 165, beeswax substitute, cetyl alcohol, propylene glycol, chlorocresol, sodium citrate, citric acid monohydrate, purified water.

What does Dermovate cream look like and what does the packaging contain

An aluminum tube containing 25 grams of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Manufacturer

Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland

Importer

Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland. For more detailed information, please contact the local representative of the marketing authorization holder: GSK Services Sp. z o.o., ul. Rzymowskiego 53, 02-697 Warsaw, tel. (22) 576-90-00. Date of last update of the leaflet: January 2025