Dermovate

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Dermovate
0.5 mg/g, ointment
Clobetasol propionate
Please read this leaflet carefully before using the 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, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 topical treatment of skin disorders responsive 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
Do not use if the patient has:

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

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

• the patient experiences bone pain or worsening of pre-existing bone symptoms during treatment with Dermovate ointment for the first time, especially if the patient is using Dermovate ointment for a prolonged or repeated period.
• the patient is taking orally or applying topically other medicines containing corticosteroids or medicines used to regulate immune system function (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Dermovate ointment 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, 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 axis, leading to glucocorticoid deficiency. If such symptoms occur, the doctor will recommend gradual discontinuation of 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 topical corticosteroid,
• duration of exposure,
• application over large body surface areas,
• application to tightly covered skin areas (e.g. skin folds or under occlusive dressings),
• increased hydration of the stratum corneum,
• application to areas with thin skin, such as the face,
• application to damaged skin or in other situations where the skin barrier may be impaired,
• in children, compared to adults, there may be proportionally greater absorption of topical corticosteroids, making them 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 axis.
Children are more prone to developing skin atrophy during topical corticosteroid treatment. If use of clobetasol propionate in a child is necessary, treatment duration should be limited to a few days, and the patient's condition should be assessed weekly.

Risk of bacterial infection under occlusive dressing
If Dermovate ointment must be used under an occlusive dressing, the skin should be cleaned before application, as warmth and moisture associated with occlusive dressings promote bacterial infections.

Psoriasis
Caution is required when using topical corticosteroids for the treatment of psoriasis due to the risk of: developing tolerance to the medicine, rebound exacerbation of lesions after discontinuation, generalized pustular psoriasis, and local or systemic corticosteroid adverse effects resulting from excessive absorption 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 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.

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

Use on eyelids
When applying to the eyelids, care must be taken to avoid getting the medicine into the eye, as repeated exposure may lead to glaucoma and cataract.

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

Dermovate ointment and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Dermovate ointment may interact with medicines that inhibit CYP3A4 enzyme activity (an enzyme important for the function of, among others, the liver and adrenal glands), such as:

• ritonavir (a medicine used in the treatment of HIV infection)
• itraconazole (a medicine used in the treatment of infections caused by Candida species)

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. Use of Dermovate ointment 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 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 child.

Driving and operating machinery
It is unlikely that potential 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. Smoking or exposure to open flames should be avoided during treatment 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 serious fire hazard. Laundering clothes and bedding 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 according to the instructions given by your doctor or pharmacist. If in doubt,
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 rubbing it in, using the smallest amount sufficient to cover the affected areas. After applying the ointment, wash your hands (unless the hands are the treated area).
Treatment should continue until improvement is observed, 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 recommend re-initiating treatment with Dermovate ointment for a short period during disease flare-ups.
In 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 at night leads to noticeable improvement, which can then be maintained by continuing treatment without an occlusive dressing.
If the patient's condition worsens or no improvement is observed 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, a less potent medicine should be used.
Do not use more than 50 grams of ointment per week.

Atopic dermatitis
During treatment of atopic dermatitis, after improvement has been achieved, gradually discontinue Dermovate ointment and use an emollient as maintenance therapy. Abrupt discontinuation of clobetasol propionate may lead to disease relapse.

Patients with frequent relapses
After resolution of an acute disease episode treated with continuous topical corticosteroid therapy, consider intermittent treatment (twice weekly, once daily, without occlusive dressing). 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 be used daily. The patient's condition and the benefits and risks of continued treatment should be regularly assessed.

Children
The use of Dermovate ointment in children under 12 years of age is contraindicated.
In children, there is a higher risk of local and systemic adverse effects from topical corticosteroids. In addition, treatment duration is usually shorter and less potent corticosteroids are typically required compared to adults.
Extreme caution should be exercised when using Dermovate ointment in children, and it should be used in the smallest possible amount needed to achieve therapeutic benefit.

Elderly patients
Clinical studies have not shown significant differences in treatment response between elderly patients and younger individuals. However, the higher prevalence of impaired liver or kidney function in elderly patients may result in slower elimination of the drug in case of systemic absorption. Therefore, Dermovate ointment 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 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 ointment 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
With prolonged, excessive dosing or improper use of the medicine, symptoms of hypercortisolism may occur. 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Dermovate ointment should be used as directed by a physician. In case of doubt, consult a
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 ointment.

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

• Itching, local burning/skin pain.

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

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

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

• Local hypersensitivity.
• Suppression of hypothalamic-pituitary-adrenal (HPA) axis function, Cushing's syndrome symptoms: (e.g. moon face, central obesity), delayed weight gain/delayed skeletal growth in children, osteoporosis, hyperglycaemia (high blood sugar levels)/glucosuria (sugar in urine), arterial hypertension, weight gain/obesity, decreased concentration of endogenous cortisol, alopecia, hair fragility.
• Opportunistic infections.
• Skin thinning, skin wrinkles, skin dryness, pigmentation changes, 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 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the 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 in use. This will help protect the environment.

6. Contents of the packaging 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 further information, please contact the responsible party 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 SA
Grunwaldzka 189, 60-322 Poznań, Poland
Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation number in Romania, country of export: 2230/2009/01
Parallel import licence number: 377/22