Dermovate

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dermovate (Butavate)

0.5 mg/ml (0.05% w/v), solution for the skin

Clobetasol propionate
Dermovate and Butavate are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Dermovate skin solution and what is it used for
• 2. Important information before using Dermovate skin solution
• 3. How to use Dermovate skin solution
• 4. Possible side effects
• 5. How to store Dermovate skin solution
• 6. Package contents and other information

1. What is Dermovate skin solution and what is it used for

The active substance of Dermovate skin solution is clobetasol propionate, a corticosteroid with a very strong anti-inflammatory effect. The medicine is intended for local use on the hairy skin of the head.
Dermovate skin solution is indicated for the local treatment of inflammatory diseases of the hairy skin of the head, such as:

• psoriasis,
• difficult-to-treat forms of eczema, in which the previously used treatment with weaker steroid medicines has proven ineffective.

2. Important information before using Dermovate skin solution

When not to use Dermovate skin solution

• if the patient is allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has infections of the hairy skin of the head,
• in children under one year of age, who have skin diseases, including inflammatory skin diseases.

Warnings and precautions

Before starting to use Dermovate, the patient should discuss it with their doctor or pharmacist if:

• during the use of Dermovate for the first time, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient uses Dermovate for a long time or repeatedly.
• the patient is using other corticosteroid medicines orally or locally, or medicines intended to regulate the immune system (e.g., in autoimmune diseases or

after organ transplantation). The concomitant use of Dermovate with these medicines may lead to severe infections.
Dermovate skin solution should be used with caution in people with hypersensitivity to locally applied corticosteroids or any of the excipients of the medicine.
In some patients, due to increased systemic absorption of locally applied corticosteroids, symptoms of hypercorticism (Cushing's syndrome, including, among others, the appearance of a moon 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 lower potency. Abrupt discontinuation of treatment may lead to glucocorticoid deficiencies (see section 4).

Factors increasing the risk of systemic effects

• the potency of the steroids used locally,
• the duration of exposure,
• application to large areas of the body,
• application to tightly covered areas of the skin (e.g., in the axillary or under an occlusive dressing),
• 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 other situations where the skin barrier may be damaged,
• compared to adults, children may absorb a proportionally larger amount of locally applied corticosteroids and may be more susceptible to systemic side effects. This is due to the fact that in children, the skin barrier is immature, and the ratio of surface area to body mass is greater than in adults.

Children

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

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 the use of occlusive dressings promote the development of bacterial infections.

Psoriasis

Caution should be exercised when using local corticosteroids in the treatment of psoriasis, due to the risk of: developing tolerance to the medicine, exacerbation of changes as a result of the so-called "rebound effect" after stopping the use 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 changes, appropriate anti-infective treatment should be used. In the case of spreading infection, local corticosteroid treatment should be discontinued, and appropriate anti-infective treatment should be used.

Ulcers of the lower limbs

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

Visual disturbances

If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
The medicine is flammable. Do not stay near fire, ignition sources, or smoke near the medicine during or after application.

Dermovate and other medicines

The patient should tell 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 skin solution 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 genus Candida).

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 skin solution. The use of Dermovate skin solution 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 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 skin solution will affect driving or using machines.

3. How to use Dermovate skin solution

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for local use on the hairy skin of the head.
The affected areas should be covered with a thin layer of the medicine twice a day, in the morning and evening, until improvement is achieved. Then, in maintenance treatment, the medicine can be used once a day or less frequently.
If the patient intends to wash their hair, they should apply the medicine only after washing and drying their hair.
Protect the eyes from contact with the medicine.

Method of application

• 1. Remove the cap from the bottle tip.

• 2. Direct the bottle tip between the hair strands over the affected skin of the head.
• 3. Gently press the bottle and carefully cover the skin with the solution.
• 4. After applying Dermovate skin solution, the patient should wash their hands.

Warning, flammable medicine

• Do not smoke during application of the medicine.
• Avoid fire, flames, and heating devices, including hair dryers, after applying the medicine.

Children

The use of Dermovate in children under one year of age is contraindicated.
Children are at a higher risk of local and systemic side effects of corticosteroids used locally. Additionally, a shorter treatment time and the use of corticosteroids with a lower potency than in adults are usually required.
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. The higher frequency of liver or kidney function disorders in elderly patients may result in slower elimination of the medicine in the event of systemic absorption. Therefore, Dermovate should be used in the smallest possible amount and for the shortest time that allows for the desired 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 increases. Therefore, Dermovate should be used in the smallest possible amount and for the shortest time that allows for the desired clinical benefit.

Use of a higher than recommended dose of Dermovate skin solution

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

Missing a dose of Dermovate skin solution

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.

Discontinuation of Dermovate skin solution

If the patient is using the medicine regularly, they should consult their doctor before discontinuing its use.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dermovate should be used as directed by the doctor. 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 skin solution:

• Itching, local burning/pain of the skin.

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

• Local atrophic skin changes, 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 (high blood sugar)/glycosuria (sugar in the urine), hypertension, weight gain/obesity, decreased levels of endogenous cortisol, 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 symptoms, contact allergic dermatitis/skin dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.
• Irritation of the skin 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 from 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 any side effects not listed in the leaflet, the patient should tell 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Dermovate skin solution

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store the bottle tightly closed.
The medicine is flammable. Keep away from fire, ignition sources, and high temperatures.
Do not leave the medicine in sunny places.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What does Dermovate skin solution contain

• The active substance of the medicine is clobetasol propionate. 1 ml of skin solution contains 0.5 mg of clobetasol propionate.
• The other ingredients are: carbomer, isopropyl alcohol, sodium hydroxide, purified water.

What Dermovate skin solution looks like and what the package contains

The medicine is a skin solution.
The packaging of the medicine is a bottle with a dosing tip and a polyethylene cap, containing 50 ml of solution, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

GlaxoSmithKline Monoprosopi SA
266 Kifisias avenue
152 32 Chalandri
Greece

Manufacturer:

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:21705/11-09-1996
15321/24-2-2009
18757/19-03-2010
110172/17/18-4-2018
Parallel import authorization number:204/09

Date of leaflet approval: 01.10.2024

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