Package leaflet: Information for the user

Warning! Keep this 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 brand names for the same medicine.
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Dermovate solution for the skin is and what it is used for
Important information before using Dermovate solution for the skin
How to use Dermovate solution for the skin
Possible side effects
How to store Dermovate solution for the skin
Contents of the pack and other information

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

The active substance in Dermovate solution for the skin is clobetasol propionate,
a corticosteroid with very potent anti-inflammatory activity. The medicine is intended for topical application to hairy skin of the scalp.
Dermovate solution for the skin is indicated for the local treatment of inflammatory skin conditions of the hairy scalp, such as:

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

2. Important information before using Dermovate, solution for the skin

When not to use Dermovate, solution for the skin

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 scalp,
in children under one year of age who have skin disorders, including inflammatory skin diseases.

Warnings and precautions
Before starting treatment with Dermovate, discuss this with your doctor or pharmacist if:

during treatment with Dermovate for the first time, the patient experiences bone pain or worsening of pre-existing bone-related symptoms, especially if the patient is using Dermovate for a prolonged period or repeatedly.
the patient is taking orally or applying topically other medicines containing corticosteroids or medicines used 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, solution for the skin should be used with caution in patients with hypersensitivity to topical
corticosteroids or any of the excipients of the medicine.
In some patients, increased systemic absorption of topically applied corticosteroids may lead to symptoms of hypercortisolism (Cushing's syndrome, characterized, among others, by 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 deficiency. If the above symptoms occur, the doctor will recommend gradually discontinuing the medicine by reducing the frequency of application or switching to a corticosteroid with lower potency. Abrupt discontinuation of treatment may
lead to glucocorticoid deficiency (see section 4).
Factors increasing the risk of systemic side effects
potency and formulation of the topical steroids used,
duration of exposure,
application over large body surface areas,
application to tightly covered skin areas (e.g. in intertriginous areas or under occlusive dressings),
increased hydration of the stratum corneum,
application to areas where the skin is thin – e.g. facial skin,
application to damaged skin or in other situations where the skin barrier may be impaired,
compared to adults, children may absorb proportionally larger amounts of topically applied corticosteroids and thus may be more susceptible to systemic adverse effects. This is due to the fact that in children the skin barrier is immature and the surface area to body weight ratio is greater than in adults.

Children
Prolonged use of topical corticosteroids in children should be avoided due to the risk of suppression of the hypothalamic-pituitary-adrenal axis.
Children are more susceptible to skin atrophy during topical corticosteroid treatment. If clobetasol propionate must be used in a child, treatment duration 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 application, as warmth 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 observed risks: development of tolerance to the medicine, exacerbation of lesions due to the so-called "rebound effect" after discontinuation of treatment, development of generalized pustular psoriasis, and occurrence of local or systemic corticosteroid adverse effects resulting from excessive absorption of the medicine through damaged skin. If the medicine is used for psoriasis, medical supervision is required.
Concomitant infections
In case of secondary infection within inflammatory lesions, appropriate antimicrobial treatment should be initiated. If the infection spreads, topical corticosteroid treatment should be discontinued and appropriate antimicrobial therapy should be instituted.
Leg ulcers
Topically applied corticosteroids are sometimes used to treat skin inflammation around chronic leg ulcers. In such cases, use may be associated with a higher frequency of local hypersensitivity reactions and increased risk of local infections.
Vision disturbances
If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
The medicine is highly flammable. Do not go near open flames, sources of ignition, or smoke near, during, or after application of the medicine.
Dermovate and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Dermovate, solution for the skin may interact with medicines that inhibit the activity of CYP3A4 (an enzyme important for the function of, among others, the liver and adrenal cortex), such as:

ritonavir (a medicine used in the treatment of HIV infection),
itraconazole (a medicine used in the treatment of infections caused by fungi of the genus Candida).

Inform your doctor if you are taking any of the above medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The doctor will assess whether the patient may use Dermovate, solution for the skin. The use of Dermovate, solution for the skin during pregnancy or breastfeeding should only be considered if the expected benefit to the mother outweighs the risk to the fetus or child. The smallest possible amount of the medicine should be used for the shortest possible duration.
During breastfeeding, Dermovate should not be applied to the breast skin to avoid accidental ingestion by the infant.
Driving and operating machinery
It is unlikely that possible adverse effects associated with the use of Dermovate, solution for the skin, will affect the ability to drive or operate machinery.

3. How to use Dermovate, cutaneous solution

This medicine should always be used exactly as directed by your doctor or pharmacist. In case of doubt,
consult your doctor or pharmacist.
This medicine is intended for topical use on hairy scalp skin.
Affected areas should be covered with a thin layer of the medicine twice daily, in the morning
and evening, until improvement is achieved. Thereafter, for maintenance treatment, the medicine may be used
once daily or less frequently.
If the patient intends to wash their hair, the medicine should be applied only after washing and drying
the hair.
Protect the eyes from contact with the medicine.

Instructions for use

Remove the cap from the bottle tip.
Direct the bottle tip between hair strands onto the affected area of the scalp.
Gently squeeze the bottle and thoroughly cover the skin with the solution.
After applying Dermovate cutaneous solution, wash your hands.

Caution: This medicine is flammable

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 1 year of age is contraindicated.
In children, there is a higher risk of local and systemic adverse effects from topically applied corticosteroids. Additionally, treatment duration is usually shorter and corticosteroids with lower potency are typically required compared to adults.
Caution should be exercised when treating with Dermovate, and the medicine should be used in the smallest possible amount needed to achieve therapeutic benefits.

Elderly patients
Clinical studies have not shown significant differences in treatment response between elderly patients and younger individuals. However, the higher prevalence of liver or kidney impairment in elderly patients may result in slower elimination of the medicine in case of systemic absorption. Therefore, Dermovate should be used in the smallest possible amount and for the shortest duration necessary to achieve the desired clinical benefit.

Renal and/or hepatic impairment
In cases of systemic absorption (when the medicine is applied over a large area for prolonged periods), metabolism and elimination may be slowed, thereby increasing the risk of systemic toxicity. Therefore, Dermovate should be used in the smallest possible amount and for the shortest duration necessary to achieve the desired clinical benefit.

Use of a higher than recommended dose of Dermovate cutaneous solution
Prolonged overuse or improper use of the medicine may lead to symptoms of hypercortisolism. In such cases, consult your doctor.

Missed dose of Dermovate cutaneous solution
Do not use a double dose to make up for a missed dose. Apply the medicine as soon as possible, following the recommended dosing schedule.

Stopping treatment with Dermovate cutaneous solution
If the patient has been using the medicine regularly, consult a doctor before discontinuing treatment.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Dermovate should be used as directed by the physician. In case of doubts, consult a doctor or pharmacist.
To prevent the occurrence of adverse reactions, the doctor should ensure that the patient uses the lowest effective dose necessary to achieve the therapeutic effect.
Below are the adverse reactions observed in patients using Dermovate solution for the skin.

Common adverse reactions (in 1 to 10 out of 100 patients using the medicine):

Itching, local burning/pain of the skin.

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

Local skin atrophy, striae.
Dilation of superficial blood vessels (telangiectasia).

Very rare adverse reactions (in less than 1 out of 10,000 patients using the medicine):

Local hypersensitivity.
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, symptoms of Cushing's syndrome (e.g. moon face, central obesity), delayed weight gain/delayed skeletal growth in children, osteoporosis, hyperglycaemia (high blood sugar levels)/glucosuria (sugar in urine), hypertension, weight gain/obesity, decreased concentration of endogenous cortisol, alopecia, brittle hair.
Opportunistic infections.
Skin thinning, skin wrinkling, dry skin, skin discoloration, excessive hair growth, exacerbation of symptoms of the underlying disease, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.
Skin irritation or pain at the site of application.
Lens opacity of the eye (cataract).
Increased intraocular pressure (glaucoma).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

Visual disturbances caused by retinal detachment (central serous chorioretinopathy, CSCR).
Blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dermovate solution for the skin

Do not store above 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Keep the bottle tightly closed.
This medicine is flammable. Keep away from fire, sources of ignition, and high temperatures.
Do not leave the medicine in direct sunlight.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Dermovate solution for the skin contains

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

What Dermovate solution for the skin looks like and contents of the pack
The medicine is in the form of a solution for the skin.
The medicine pack consists of a bottle with a dosing tip and a polyethylene cap containing 50 ml of solution, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party 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.
Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorisation 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 authorisation number: 204/09