Dermovate

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Dermovate (Dermovat)
0.5 mg/g (0.05%), ointment
Clobetasol propionate
Dermovate and Dermovat are the same brand names of the same medicine written in Polish and Bulgarian.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Dermovate ointment is and what it is used for
2. What you should know 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,
• recurring eczema,
• difficult-to-treat skin diseases in which previous treatment with weaker corticosteroids has been ineffective.

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.

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

• the patient experiences bone pain or worsening of pre-existing bone symptoms for the first time during treatment with Dermovate, especially if the patient has been using Dermovate for a prolonged or repeated period.
• 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 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, manifested, 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 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 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. 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 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 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 evaluated weekly.
Risk of bacterial infections under occlusive dressing
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 observed risks: development of tolerance to the drug, rebound phenomenon leading to worsening of lesions after discontinuation of treatment, development of generalized pustular psoriasis, occurrence of local or systemic corticosteroid adverse effects due to excessive absorption of the drug through damaged skin. If the medicine is used in psoriasis, medical supervision is required.
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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
Topical corticosteroids are sometimes used to treat dermatitis around chronic leg ulcers. In such cases, there may be an increased frequency of local hypersensitivity reactions and a higher risk of local infections.
Use on facial skin
Application of corticosteroids to facial skin may more frequently lead to skin atrophy than when applied to other body areas.
Use on facial skin should be limited to a few days.
Use on 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 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 ointment. Use of Dermovate ointment 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 ointment 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 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.
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Dermovate ointment contains paraffin. Smoking or approaching open flames should be avoided during use of Dermovate 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 constitute a serious fire hazard. Washing clothing 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 as directed by a doctor or pharmacist. If in doubt,
consult a 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 medicine, wash your hands
(unless the hands are being treated).
Treatment should continue until improvement is observed, but not longer than 4 weeks; then
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.
The doctor may re-prescribe Dermovate ointment for short-term use during disease flare-ups.
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), the doctor may recommend
the use of 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 using the ointment
without an occlusive dressing.
If the patient's condition worsens or no improvement is seen within 2 to 4 weeks, the doctor
will reassess the need for continued use of the medicine.
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 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 using continuous topical corticosteroid therapy,
intermittent treatment (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 be used daily. The patient's condition, as well as the benefits and risks of continued treatment, should be regularly assessed.

Children
Use of Dermovate in children under 12 years of age is contraindicated.
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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 required compared to adults.
Extreme caution should be exercised when using Dermovate, applying the smallest
possible amount needed to achieve therapeutic benefit.

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 drug 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 case of systemic absorption (when the medicine is applied over a large surface area for a prolonged period), 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 a 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Dermovate ointment should be used as directed by the physician. In case of doubts, one should
contact a doctor or pharmacist. To prevent the occurrence of adverse symptoms,
the physician should ensure that the patient uses the lowest effective dose required for therapeutic effect.
Below are the adverse effects observed in patients using
Dermovate ointment.
Common adverse effects (occurring in 1 to 10 out of 100 patients using the medicine):

• Itching, local burning/pain of the skin.

Uncommon adverse effects (occurring 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 effects (occurring in less than 1 out of 10,000 patients using
the medicine):

• Local hypersensitivity.
• Suppression of 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 levels of endogenous cortisol, alopecia, brittle hair.
• Opportunistic infections.

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• Skin thinning, skin wrinkling, skin dryness, 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.
• Clouding of the eye lens (cataract).
• Increased intraocular pressure (glaucoma).

Adverse effects 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 effects
If any adverse effects occur, including those not listed
in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects 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 effects allows the collection of additional information on the safety of the medicine.

5. How to store Dermovate ointment

Store below 30°C.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 entity or the parallel importer.
Responsible entity in Bulgaria, country of export:
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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Manufacturer:
Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Bulgaria (country of export) marketing authorisation number: 20030369
Parallel import authorisation number: 110/26
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