Dermovate

Patient Information Leaflet

Dermovate, 0.5 mg/g, cream
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 only. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 cream is and what it is used for
2. What you need to know before using Dermovate cream
3. How to use Dermovate cream
4. Possible side effects
5. How to store Dermovate cream
6. Contents of the pack and other information

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

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

• psoriasis (excluding generalized forms),
• lichen planus,
• discoid lupus erythematosus,
• recurrent eczema,
• difficult-to-treat skin disorders that have not responded to previous treatment with weaker corticosteroids.

2. Important information before using Dermovate cream

When not to use Dermovate cream
Do not use this medicine 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, consult a doctor or pharmacist if:

• during treatment with Dermovate for the first time, the patient experiences bone pain or worsening of pre-existing bone symptoms, 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 used to regulate immune system function (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of Dermovate with these medicines may lead to severe infections. Dermovate cream 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, 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 any of 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 topical corticosteroid,
• duration of exposure,
• application over large body surface areas,
• application to tightly covered skin areas (e.g. intertriginous areas 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 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 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 Dermovate must be used under 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 is required when using topical corticosteroids in the treatment of psoriasis due to the risk of: developing tolerance to the drug, rebound phenomenon (worsening of lesions after discontinuation of treatment), generalized pustular psoriasis, and local or systemic corticosteroid adverse effects 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 initiated.

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
Topical corticosteroids applied to facial skin may more frequently than on other body areas lead to skin atrophy.
Use on facial skin should be limited to a few days.

Use on eyelids
When applying to eyelids, care should be taken to avoid contact with 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 and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Dermovate cream 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 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 baby, she should consult a doctor before using this medicine.
The doctor will assess whether the patient may use Dermovate cream. The use of Dermovate cream during pregnancy or breastfeeding should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus or infant. The lowest effective amount should be used for the shortest possible duration.
During breastfeeding, Dermovate cream should not be applied to the breast area to avoid accidental ingestion by the infant.

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

Dermovate cream contains chlorocresol, cetostearyl alcohol, propylene glycol, and paraffin.
The medicine contains 0.75 mg of chlorocresol per gram of cream. Due to the presence of chlorocresol, the medicine may cause allergic reactions.
The medicine contains 84 mg of cetostearyl alcohol per gram of cream. Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis).
The medicine contains 475 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.
Dermovate cream contains paraffin. While using Dermovate, do not smoke or go near 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 serious fire hazard. Laundering clothes and bedding may reduce the amount of medicine present, but will not completely eliminate it.

3. How to use Dermovate cream

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
Dermovate cream is intended for topical application to the skin, particularly for moist and weeping
skin lesions.
Affected areas should be covered with a thin layer of the cream 1 or 2 times daily, in the morning
and evening. Apply a thin layer of cream, 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 occurs, but not longer than 4 weeks, after which
the frequency of application should be reduced or a weaker-acting medicine should be used.
Before applying an emollient (a skin-moisturizing preparation), wait until the cream has been
absorbed into the skin.
The doctor may re-prescribe Dermovate cream for short-term use during disease flare-ups.
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), the 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 using
the cream without an occlusive dressing.
If the patient's condition worsens or no improvement is seen within 2 to 4 weeks, the doctor will
re-evaluate the indication for continued use of the medicine.
Do not continue treatment for longer than 4 weeks. If longer treatment is required, a weaker-acting
medicine should be used.
Do not use more than 50 grams of cream per week.
Atopic dermatitis
During treatment of atopic dermatitis, after improvement has been achieved, gradually discontinue
Dermovate and use an emollient as maintenance therapy. Abrupt discontinuation of clobetasol
propionate may lead to relapse of the disease.
Patients with frequent relapses
After resolution of an acute episode treated with 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 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
Use of Dermovate 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.
Additionally, treatment duration is usually shorter, and corticosteroids with lower potency are
typically required compared to adults.
Exercise caution when treating with Dermovate and use 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 liver or kidney dysfunction 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.
Impaired kidney and/or liver function
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 cream
With prolonged, excessive dosing or improper use of the medicine, symptoms of hypercortisolism
may occur. In such cases, consult a doctor.
Missed dose of Dermovate cream
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.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dermovate cream should be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
To prevent the occurrence of adverse effects, the physician should ensure that the patient uses the lowest dose that provides therapeutic efficacy.
Below are the adverse effects observed in patients using Dermovate cream.

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

• Itching, local burning/pain of the skin.

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

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

Rare adverse effects (in fewer 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, abdominal obesity), delayed weight gain/delayed skeletal growth in children, osteoporosis, hyperglycaemia (high blood sugar)/glucosuria (sugar in urine), hypertension, weight gain/obesity, decreased concentration of endogenous cortisol, alopecia, brittle hair.
• Opportunistic infections.
• 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.
• Lens opacities (cataract).
• Increased intraocular pressure (glaucoma).

Adverse effects 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 effects
If any adverse effects occur, including any adverse effects 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, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dermovate cream

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 packaging after "EXP".
"Lot" is the product batch number. 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 cream contains

• The active substance is clobetasol propionate (0.5 mg/g);
• The other ingredients are: glycerol monostearate, arlacel 165, synthetic beeswax, cetostearyl alcohol, propylene glycol, chlorocresol, sodium citrate, citric acid monohydrate, purified water.

What Dermovate cream looks like and contents of the pack
An aluminium tube containing 25 g of cream, placed 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
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
Importer
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
For further information, please contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00