Dermovate

Package leaflet: Information for the user

Dermovate, 0.5 mg/ml, solution for the skin
Clobetasol propionate
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Dermovate solution for the skin is and what it is used for
2. What you need to know before using Dermovate solution for the skin
3. How to use Dermovate solution for the skin
4. Possible side effects
5. How to store Dermovate solution for the skin
6. 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 the hairy 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 milder steroid medicines has been ineffective.

2. Important information before using Dermovate scalp solution

When not to use Dermovate scalp 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 scalp
• in children under 1 year of age who have skin disorders, including inflammatory skin diseases.

Warnings and precautions
Before starting treatment with Dermovate, consult a doctor or pharmacist if:

• during treatment with Dermovate, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient is using Dermovate for a prolonged or repeated period.
• the patient is taking orally or topically other medicines containing corticosteroids or medicines used to regulate the immune system (e.g. in autoimmune diseases or after organ transplantation). Concurrent use of Dermovate with these medicines may lead to severe infections.

Dermovate scalp solution should be used with caution in patients with hypersensitivity to topically applied 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, including moon face – accumulation of fatty tissue in the face – or abdominal obesity) and reversible suppression of the hypothalamic-pituitary-adrenal axis, leading to glucocorticoid deficiency. If these 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 the groin area 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 greater 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 higher 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 developing skin atrophy during topical corticosteroid treatment. If clobetasol propionate treatment is necessary in a child, the duration of treatment 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 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 risk of: 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 started.

Leg ulcers
Topical corticosteroids are sometimes used to treat skin inflammation around chronic leg ulcers. In such cases, there may be an increased risk of local hypersensitivity reactions and local infections.

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

The medicine is flammable. Do not go near open flames, sources of ignition, or smoke while using or immediately after applying the medicine.

Dermovate and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Dermovate scalp solution 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 the doctor if any of the above medicines are being taken.

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 can use Dermovate scalp solution. The use of Dermovate scalp solution during pregnancy or breastfeeding should only be considered if the expected benefit to the mother outweighs the potential 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 skin of the breasts to avoid accidental ingestion by the infant.

Driving and operating machinery
It is unlikely that possible adverse effects associated with the use of Dermovate scalp solution will affect the ability to drive or operate machinery.

3. How to use Dermovate Scalp Solution

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a 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.
Avoid contact with the eyes.

Instructions for use

1. Remove the cap from the bottle tip.
2. Position the bottle tip between hair strands over the affected area of the scalp.
3. Gently squeeze the bottle and thoroughly cover the skin with the solution.
4. After applying Dermovate Scalp Solution, wash your hands.

Warning: Flammable product

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

Children
The use of Dermovate in children under 1 year of age is contraindicated.
In children, there is an increased risk of local and systemic adverse effects associated with topical corticosteroids. Additionally, treatment duration is usually shorter, and corticosteroids with lower potency are generally required compared to adults.
Caution should be exercised when using Dermovate, and it should be applied in the smallest possible amount needed to achieve therapeutic benefits.

Elderly patients
Clinical studies have not shown significant differences in treatment response in elderly patients compared to younger individuals. However, the higher prevalence of impaired liver or kidney function 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.

Impaired kidney and/or liver function
In the case of systemic absorption (when the medicine is applied over a large surface 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 Scalp Solution
Prolonged, excessive dosing or incorrect use of the medicine may lead to symptoms of hypercortisolism. In such cases, consult a doctor immediately.

Missed dose of Dermovate Scalp 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 Scalp Solution
If the patient has been using the medicine regularly, they should 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 according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist. To prevent the occurrence of adverse reactions,
the doctor should ensure that the patient uses the lowest effective dose required to achieve 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/skin pain.

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 wrinkles, 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 application site.
• Lens opacity (cataract).
• Increased intraocular pressure (glaucoma).

Adverse reactions with unknown frequency (frequency cannot be estimated from the 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 be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dermovate solution for the skin

Store below 25°C.
Keep the medicine 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" refers to the product batch number. The expiry date refers to the last day of the stated month.
Keep the bottle tightly closed.
This medicine is highly flammable. Keep away from fire, sources of ignition, and high temperatures.
Do not leave the medicine in sunlight.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dermovate Scalp Application contains

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

What Dermovate Scalp Application looks like and contents of the pack
The medicine is in the form of a solution for application to the scalp.
The medicine is supplied in a bottle with a dosing nozzle and a polyethylene cap, containing 25 ml, 50 ml or 100 ml of solution, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00