DERMOVATE 0.5 mg/ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Dermovate, 0.5 mg/ml, solution for the skin
   1. Please 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 Dermovate skin solution and what is it used for
4. Important information before using Dermovate skin solution
   1. When not to use Dermovate skin solution
   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. Visual disturbances
   10. Dermovate and other medicines
   11. Pregnancy and breastfeeding
   12. Driving and operating machinery
5. How to use Dermovate skin solution
   1. Method of application
   2. Caution, flammable product
   3. Children
   4. Elderly patients
   5. Renal and/or hepatic impairment
   6. Use of a higher than recommended dose of Dermovate skin solution
   7. Missing a dose of Dermovate skin solution
   8. Discontinuation of Dermovate skin solution
6. Possible side effects
   1. Reporting side effects
7. How to store Dermovate skin solution
8. Contents of the packaging and other information
   1. What does Dermovate skin solution contain
   2. What does Dermovate skin solution look like and what does the packaging contain
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Leaflet accompanying the packaging: information for the user

Dermovate, 0.5 mg/ml, solution for the skin

Clobetasol propionate

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

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 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. Contents of the packaging 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 scalp.
Dermovate skin solution is indicated for the local treatment of inflammatory diseases of the hairy skin of the scalp, 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

Warnings and precautions

Before starting to use Dermovate, the patient should discuss it with their 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 uses Dermovate 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 Dermovate with these medicines may lead to severe infections.

Dermovate skin solution 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 e.g., 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

• potency and form of topical steroids used,
• exposure time,
• use on large areas of the body,
• use on tightly occluded areas of the skin (e.g., in the axillary or under an occlusive dressing),
• increased hydration of the stratum corneum,
• use on areas where the skin is thin - e.g., on the skin of the face,
• use on damaged skin or in situations where the skin barrier may be compromised,
• compared to adults, children may absorb proportionally larger amounts of topical corticosteroids and may be more susceptible to systemic side effects. This is due to the fact that children have an immature skin barrier and a higher surface-to-mass ratio than adults.

Children

Long-term use of topical corticosteroids in children should be avoided due to the possibility of suppression of 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 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: development of tolerance to the medicine, exacerbation 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. In the case of spreading infection, local corticosteroid therapy should be discontinued and appropriate antimicrobial treatment should be used.

Ulcers of the lower limbs

Topical corticosteroids are sometimes used to treat skin inflammation around chronic ulcers of the lower limbs. The use of corticosteroids in such cases 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 while using or after using the medicine.

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 patient should use the smallest amount of medicine 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 operating machinery

It is unlikely that possible side effects associated with the use of Dermovate skin solution will affect driving or operating machinery.

3. How to use Dermovate skin solution

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

Method of application

• 1. Remove the cap from the bottle.
• 2. Direct the nozzle of the bottle between the hair strands over the affected scalp area.
• 3. Gently press the bottle and thoroughly cover the skin with the solution.
• 4. After applying Dermovate skin solution, wash your hands.

Caution, flammable product

• Do not smoke while applying 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.
In children, there is a higher risk of local and systemic side effects of topical corticosteroids. Additionally, a shorter treatment time is usually required and the use of corticosteroids with a lower potency than in adults.
Care should be taken 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 possible time that allows for the expected clinical benefit.

Renal and/or hepatic impairment

In the case of systemic absorption (when the medicine is used on 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 possible time that allows for the expected 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 hypercortisolism 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 patient should use the medicine 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. If there are any 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.

Frequent 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 1000 patients using the medicine):
• Local atrophic changes in the skin, striae.
• 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 levels)/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 symptoms of the underlying disease, allergic contact dermatitis/skin inflammation, pustular psoriasis, erythema, rash, urticaria, acne.
• Irritation of the skin or pain at the application site.
• Clouding of the lens of the eye (cataract).
• Increased intraocular pressure (glaucoma).

Side effects with unknown frequency(frequency cannot be estimated from the 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 Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Dermovate skin solution

Store at a temperature below 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 after: "EXP".
The "Lot" abbreviation means the batch number of the product. The expiry date means the last day of the given 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 used. This will help protect the environment.

6. Contents of the packaging 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 does Dermovate skin solution look like and what does the packaging contain

The medicine is a solution for the skin.
The packaging of the medicine is a bottle with a dosing nozzle and a polyethylene cap, containing 25 ml, 50 ml, or 100 ml of solution, 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

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: (22) 576-90-00
Date of the last update of the leaflet:January 2025