Dermovate

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language
Dermovate
0.5 mg/g, ointment
Clobetasol propionate
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

The active substance in Dermovate ointment is clobetasol propionate, a corticosteroid with very potent anti-inflammatory action. The medicine is intended for topical application to the skin.
Dermovate ointment is indicated in adults and adolescents aged 12 years and older for the local treatment of skin disorders that respond to corticosteroid therapy, such as:

• Psoriasis (excluding generalized forms),
• Lichen planus,
• Discoid lupus erythematosus,
• Recurrent eczema,
• Difficult-to-treat skin conditions that have not responded adequately to treatment with weaker corticosteroids.

2. Important information before using Dermovate ointment

When not to use Dermovate ointment
If the patient has:

• untreated skin infections,
• rosacea,
• acne vulgaris,
• perioral dermatitis,
• itching without inflammatory changes,
• itching of the anal or genital area,
• children under 12 years of age.

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

• for the first time during treatment with Dermovate, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient has been using Dermovate for a prolonged period or repeatedly.
• the patient is taking orally or topically other medicines containing corticosteroids or drugs intended to regulate immune system function (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Dermovate with these drugs may lead to severe infections. Dermovate ointment should be used with caution in patients with hypersensitivity to topically applied corticosteroids or to 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, manifesting, among others, as moon face – i.e. accumulation of fatty tissue in the face – or abdominal obesity) and reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, resulting in 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 adverse effects

• potency and formulation of the topically applied corticosteroid,
• duration of exposure,
• application over large body surface areas,
• application to tightly covered skin areas (e.g. in skin folds or under occlusive dressings),
• increased hydration of the stratum corneum,
• application to areas with thin skin – 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 children have an immature skin barrier and a higher surface area-to-body weight ratio than adults.

Children
Prolonged use of topical corticosteroids in children should be avoided due to the risk of suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
Children are more susceptible to skin atrophy during topical corticosteroid treatment. If treatment with clobetasol propionate 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 apply 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 reported risks of developing tolerance to the drug, 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 adverse effects of corticosteroids resulting from excessive absorption through damaged skin. If the medicine is used in 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
Topically applied corticosteroids are sometimes used to treat dermatitis around chronic leg ulcers. In such cases, there may be an increased risk of local hypersensitivity reactions and local infections.

Application to facial skin
Application of corticosteroids to facial skin may lead to skin atrophy more frequently than when applied to other body areas.
Application to the face should be limited to a few days.

Application to the eyelids
When applying to the eyelids, care should be taken to avoid contact with the eye, as repeated exposure may lead to glaucoma and cataracts.

Visual disturbances
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.

Dermovate and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Dermovate ointment may interact with drugs 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, 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 ointment. The use of Dermovate ointment during pregnancy or breastfeeding should only be considered if the expected benefits to the mother outweigh the risks to the fetus or child. The smallest possible amount of the medicine should be used for the shortest possible duration.
During breastfeeding, Dermovate ointment 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 ointment will affect the ability to drive or operate machinery.

Dermovate ointment contains propylene glycol and paraffin.
The medicine contains 50 mg of propylene glycol in each gram of ointment. Propylene glycol may cause skin irritation.
Dermovate ointment contains paraffin. While using Dermovate, smoking or approaching open flames should be avoided due to the risk of serious burns. Materials (clothing, bed linen, garments, dressings, etc.) that have come into contact with this medicine are more flammable and constitute a serious fire hazard. Washing clothes and bed linen may reduce the amount of medicine present, but will not completely remove it.

3. How to use Dermovate ointment

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Dermovate ointment is intended for topical application to the skin, particularly for dry, lichenified,
scaling skin lesions.
Affected areas should be covered with a thin layer of the ointment once or twice daily, in the morning
and evening. Apply a thin layer of ointment gently by massaging it in, using the smallest amount
sufficient to cover the affected areas. After applying the medicine, wash your hands (unless the hands
are the area being treated).
Treatment should continue until improvement occurs, but not longer than 4 weeks, after which the
frequency of application should be reduced or a less potent medicine should be used. Before applying
an emollient (a skin-moisturizing preparation), wait until the ointment has been absorbed into the skin.
Your doctor may re-prescribe Dermovate ointment for short-term use during disease flare-ups.
For treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), your doctor may
recommend using an occlusive dressing (e.g. polyethylene film). Usually, applying an occlusive dressing
only overnight leads to noticeable improvement, which can then be maintained by continuing the
medicine without an occlusive dressing.
If there is no improvement or if the condition worsens within 2 to 4 weeks, your doctor will reassess
the need for continued treatment.
Do not continue treatment beyond 4 weeks. If longer treatment is required, use a less potent medicine.
Do not use more than 50 grams of ointment per week.
Atopic dermatitis
During treatment of atopic dermatitis, once improvement is achieved, gradually discontinue Dermovate
and use an emollient as maintenance therapy. Abruptly stopping clobetasol propionate may lead to
disease recurrence.
Patients with frequent relapses
After resolution of an acute episode treated with continuous topical corticosteroid therapy, intermittent
use (twice weekly, once daily, without occlusive dressing) may be considered. This approach has been
shown to reduce the frequency of relapses.
The medicine should be applied to all areas previously affected by disease or to areas where relapse is
expected. Emollients should also be used daily. The patient's condition, as well as the benefits and
risks of continued treatment, should be regularly assessed.
Children
Dermovate ointment is contraindicated in children under 12 years of age.
In children, there is a higher risk of local and systemic adverse effects from topical corticosteroids.
Moreover, treatment duration is usually shorter and less potent corticosteroids are typically required
compared to adults.
Exercise caution when using Dermovate in children, and apply the smallest amount possible that still
provides therapeutic benefit.
Elderly patients
Clinical studies have not shown significant differences in treatment response between elderly and
younger patients. However, the higher prevalence of impaired liver or kidney function in elderly
patients may lead to slower elimination of the drug in the event 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 cases 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 more than the recommended dose of Dermovate ointment
Prolonged, excessive dosing or improper use of the medicine may lead to symptoms of hypercortisolism.
In such cases, consult your doctor.
Missed dose of Dermovate ointment
Do not apply a double dose to make up for a missed dose. Apply the medicine as soon as possible,
following the recommended dosing schedule.

4. Possible adverse reactions

Like any medicinal product, this medicine can cause adverse reactions, although not everyone experiences them.
Dermovate ointment should be used according to the doctor's recommendations. In case of doubts, please consult your doctor or pharmacist. To prevent adverse reactions from occurring, the doctor should ensure that the patient uses the lowest effective dose required to achieve the therapeutic effect.
Below are the adverse reactions observed in patients using Dermovate ointment.

Common adverse reactions (occur in 1 to 10 per 100 patients using the medicine):

• Itching, local burning/pain in the skin.

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

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

Very rare adverse reactions (occur in less than 1 per 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)/glucosuria (sugar in urine), arterial 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 (hypertrichosis), 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 available data):

• Visual disturbances due to retinal detachment (central serous chorioretinopathy, CSCR).
• Blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to improve the safety information available for this medicine.

5. How to store Dermovate ointment

Store below 30°C, in the original packaging.
Keep the medicine out of the 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.
Medicines should 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 package and other information

What Dermovate ointment contains

• The active substance is clobetasol propionate (0.5 mg/g);
• The other ingredients are: propylene glycol, sorbitan sesquioleate, white soft paraffin.

What Dermovate ointment looks like and contents of the pack
An aluminium tube containing 25 g of ointment, placed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
GLAXOSMITHKLINE PHARMACEUTICALS S.A.
Grunwaldzka 189
60-322 Poznan, Poland
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź, Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź, Poland
Marketing Authorisation Number in Romania, country of export: 2230/2009/01
Parallel Import Licence Number: 304/24