Dermovate

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Dermovate

0.5 mg/g, ointment

Clobetasol propionate

Read the leaflet carefully 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, the doctor, pharmacist, or nurse should be consulted.
• 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Dermovate ointment and what is it 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 packaging and other information

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

The active substance of Dermovate ointment is clobetasol propionate, a corticosteroid with a very strong anti-inflammatory effect. The medicine is intended for topical use on the skin. Dermovate ointment is indicated for adults and adolescents from 12 years of age for the treatment of skin diseases that respond to corticosteroid therapy, such as:

• psoriasis (excluding generalized lesions),
• lichen planus,
• discoid lupus erythematosus,
• recurrent eczema,
• difficult-to-treat skin diseases, whose previous treatment with weaker corticosteroids has been ineffective.

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 inflammation,
• itching in the anal and genital areas,
• children under 12 years of age.

Warnings and precautions

Before starting treatment with 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 is using Dermovate for a long time or repeatedly.
• the patient is taking other corticosteroid medicines orally or topically, 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 ointment 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 hypercorticism (Cushing's syndrome, including moon face, i.e., accumulation of fat in the 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.

Factors increasing the risk of systemic effects

• potency and form of topical corticosteroids,
• duration of exposure,
• application to large areas of the body,
• application to tightly covered areas of the skin (e.g., in flexural 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 situations where the skin barrier may be compromised,
• compared to adults, children may absorb proportionally more topical corticosteroids and may be more susceptible to systemic side effects. This is due to the fact that children's skin barrier is immature, and the ratio of surface area to body mass is greater than in adults.

Children

Long-term use of topical corticosteroids in children should be avoided due to the possibility of suppressing 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 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 occlusive dressings can 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, worsening of lesions as a result of the so-called "rebound effect" after stopping 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. If the infection spreads, topical corticosteroid treatment should be discontinued, and appropriate antimicrobial treatment should be used.

Ulcers of the lower limbs

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

Use on facial skin

Using corticosteroids on facial skin can lead to atrophy of the skin more frequently than when used on other areas of the body. Use on facial skin should be limited to a few days.

Use on eyelids

When using the medicine on the eyelids, care should be taken to avoid getting the medicine into the eye, as repeated exposure can lead to glaucoma and cataracts.

Visual disturbances

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

Dermovate and other medicines

The patient should inform 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 ointment 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 Candida type)

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 ointment. Using Dermovate ointment 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 ointment 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 ointment will affect driving or using machines.

Dermovate ointment contains propylene glycol and paraffin.

The medicine contains 50 mg of propylene glycol per gram of ointment. Propylene glycol may cause skin irritation. Dermovate ointment contains paraffin. When using the medicine, the patient should not smoke or approach open flames due to the risk of severe burns. Materials (clothing, bedding, garments, dressings, etc.) that have come into contact with this medicine are more flammable and pose a significant fire hazard. Washing clothing and bedding may reduce the amount of medicine in them, but not completely remove it.

3. How to use Dermovate ointment

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. Dermovate ointment is intended for topical use on the skin, particularly on dry, lichenified, or scaly skin lesions. The affected areas should be covered with a thin layer of the medicine 1 or 2 times a day, in the morning and evening. A thin layer of ointment should be applied, gently rubbing it in, using the smallest amount necessary to cover the affected areas. After applying the medicine, the hands should be washed (if the hands are not being treated). Treatment should be continued until improvement is achieved, but no longer than 4 weeks, and then the frequency of application should be reduced or another medicine with a weaker effect should be used. Before applying an emollient (a moisturizing preparation) after applying the ointment, the patient should wait until the medicine is absorbed into the skin. The doctor may recommend reusing Dermovate ointment for a short period in case of disease exacerbations.

Atopic eczema

During the treatment of atopic eczema, after improvement is achieved, the use of Dermovate should be gradually stopped, and an emollient should be used as maintenance therapy. Abrupt discontinuation of clobetasol propionate may lead to a relapse of the disease.

Patients with frequent relapses

After healing an acute episode of the disease with continuous topical corticosteroid therapy, intermittent use of the medicine (twice a week, once a day, without occlusive dressing) may be considered. It has been shown that this approach can reduce the frequency of relapses. The medicine should be applied to all previously affected areas or areas where relapse is expected. At the same time, emollients should be used daily. The patient's condition and the benefits and risks of continuing treatment should be regularly evaluated.

Children

Using Dermovate in children under 12 years of age is contraindicated. Children are at a higher risk of local and systemic side effects of topical corticosteroids. 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 the medicine 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 lead to slower elimination of the medicine in case of systemic absorption. Therefore, Dermovate should be used in the smallest possible amount and for the shortest time necessary to achieve the expected clinical benefit.

Renal and/or hepatic impairment

In case of systemic absorption (when the medicine is used on a large surface 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 time necessary to achieve the expected clinical benefit.

Using more than the recommended dose of Dermovate ointment

In 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 ointment

A double dose should not be used to make up for a missed dose. The medicine should be used as soon as possible, according to the recommended dosing schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Dermovate ointment should be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. 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 ointment.

Common 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 1,000 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, hair fragility.
• Opportunistic infections.
• Thinning of the skin, wrinkles on the skin, dryness of the skin, discoloration, excessive hair growth, worsening of the primary disease, contact allergic dermatitis/skin inflammation, pustular psoriasis, erythema, rash, urticaria, acne.
• Skin irritation 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 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 doctor, pharmacist, or nurse should be informed. 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: 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 can help gather more information on the safety of the medicine.

5. How to store Dermovate ointment

Store in a temperature below 30°C in the original packaging. 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 specified month. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 ointment contain

• The active substance of the medicine is clobetasol propionate (0.5 mg/g);
• The other ingredients are propylene glycol, sorbitan sesquioleate, white petrolatum.

What does Dermovate ointment look like and what does the packaging contain

An aluminum tube containing 25 g of ointment, placed in a cardboard box. For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznań, Poland

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorization number in Romania, the country of export: 2230/2009/01

Parallel import authorization number: 273/24

Date of leaflet approval: 04.07.2024

[Information about the trademark]