Package leaflet: Information for the user

Warning!
Keep this leaflet. The information on the immediate packaging is in a foreign language.
Beloderm
0.5 mg/g, cream
Betamethasone
Please read the entire leaflet 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Beloderm is and what it is used for
Important information before using Beloderm
How to use Beloderm
Possible side effects
How to store Beloderm
Contents of the pack and other information

1. What Beloderm is and what it is used for

Beloderm cream contains the active substance betamethasone in the form of betamethasone dipropionate. Betamethasone is a synthetic fluorinated corticosteroid (adrenal cortex hormone) with strong activity, used topically in dermatology. Betamethasone dipropionate has potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Beloderm cream is indicated for the topical treatment of inflammatory and pruritic skin disorders that respond to corticosteroid therapy.

2. Information before using Beloderm

When not to use Beloderm:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
in cutaneous tuberculosis;
in viral skin infections (e.g. herpes simplex, cowpox, varicella);
in acne, perioral dermatitis, rosacea;
in the anal and genital areas;
in diaper dermatitis;
in fungal or bacterial skin infections, unless the physician has simultaneously initiated appropriate causative treatment.

Warnings and precautions
Before starting treatment with Beloderm, discuss it with your doctor, pharmacist, or nurse.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Beloderm cream, inform your doctor. The doctor will decide whether the medicine should be discontinued immediately.
Do not use occlusive dressings, as they may enhance absorption of the medicine through the skin.
Use on the facial skin is not recommended due to the risk of dermatitis (resembling acneiform eruptions), perioral dermatitis, skin atrophy, and acne.
Avoid contact of the medicine with eyes and mucous membranes. Do not apply to the eyes or around the eyes.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
In case of skin infection, the doctor will initiate appropriate treatment with antibacterial or antifungal medicines.
Beloderm cream should not be used in the treatment of varicose leg ulcers.
Since corticosteroids are absorbed through the skin, there is a risk of systemic adverse effects of corticosteroids, including suppression of adrenal cortex function, during treatment with Beloderm cream. Therefore, avoid use over large body surface areas, on damaged skin, in high doses, during prolonged treatment, and in patients with impaired liver function or in children.
Beloderm cream should be used under the arms and in the groin area only when absolutely necessary, due to increased absorption.
Particular caution is required when using Beloderm cream in patients with psoriasis, as topical corticosteroids may be hazardous in psoriasis, including the risk of disease recurrence due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects resulting from impaired skin barrier function.

Children and adolescents
Use in children under 12 years of age is not recommended due to frequent reports of hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, and increased intracranial pressure following topical application of potent corticosteroids.

Beloderm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other topically applied medicines are known.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of Beloderm cream in pregnant women is permitted only if, in the physician's opinion, the benefit to the pregnant woman outweighs the risk to the fetus. However, treatment should be short-term and limited to a small body surface area.
There are no data on the safety of topical corticosteroids in pregnant women. However, it is known that these substances may be absorbed through the skin.

Breastfeeding
The doctor will consider whether to discontinue breastfeeding or the use of Beloderm cream, taking into account the possibility of adverse effects in the infant and the benefits of treatment for the mother.
Do not apply the medicine to the skin of the breasts before breastfeeding.
It is not known whether topically applied corticosteroids, including betamethasone dipropionate, are absorbed through the skin to such an extent that they can pass into breast milk. Systemically administered corticosteroids (oral or injectable) are known to pass into breast milk.

Driving and operating machinery
There are no data on harmful effects of Beloderm cream on the ability to drive or operate machinery.

Beloderm contains cetostearyl alcohol and chlorocresol
This medicine contains excipients such as cetostearyl alcohol and chlorocresol.
Due to the presence of cetostearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
Due to the presence of chlorocresol, this medicine may cause allergic reactions.

3. How to use Beloderm

This medicine should always be used exactly as directed by the physician. If in doubt, consult your doctor.
Beloderm cream is intended for topical use only.
Adults and children over 12 years of age
A thin layer of the medicine should be gently rubbed into the affected areas of the skin once or twice daily. Do not use an occlusive dressing. Treatment should not last longer than 14 days. Do not use more than 50 g of the medicine per week.
Use in children
Use of this medicine is not recommended in children under 12 years of age.
If the effect of the medicine appears too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Beloderm
Prolonged use (beyond 2 weeks), application over large skin areas or damaged skin, use of occlusive dressings, and use in children may lead to increased systemic absorption of the active substance, resulting in overdose and occurrence of general adverse effects typical of corticosteroids.
Symptoms of corticosteroid overdose may include suppression of the hypothalamic–pituitary–adrenal (HPA) axis, Cushing's syndrome, benign intracranial hypertension, growth and development retardation in children, increased blood glucose levels (hyperglycemia), and glycosuria.
In case of accidental overdose, seek immediate medical advice. The doctor will decide whether treatment should be discontinued.
If symptoms such as fever, muscle pain, joint pain, or general weakness occur, the physician may consider administering a systemic corticosteroid.
Missed dose of Beloderm
Do not use a double dose to make up for a missed dose.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicinal product can cause adverse effects, although not everybody will experience them.
Local application of betamethasone dipropionate may lead to skin atrophy, irreversible striae, dry skin, telangiectasia, folliculitis, hypertrichosis, acne-like changes, allergic contact dermatitis (burning sensation, swelling, inflammatory blisters on the skin), perioral dermatitis, pruritus, skin depigmentation, suppression of sweat gland function (miliaria), and secondary infections.
Additionally, allergic reactions may occur.
As a result of systemic absorption of the active substances into the bloodstream, general adverse effects of betamethasone characteristic of corticosteroids may also occur (see above - Use of a higher than recommended dose).
General adverse effects are rare and occur primarily after prolonged use, application over large areas of skin, use under occlusive dressing, or use in children. These effects usually resolve after discontinuation of the medicine.
Frequency unknown (cannot be estimated from available data): blurred vision.
Reporting of adverse effects
If any adverse effects occur, including any 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 helps to provide more information on the safety of the medicine.

5. How to store Beloderm

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Shelf life after first opening the tube: 3 months when stored below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
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 Beloderm cream contains
The active substance is betamethasone.
1 g of cream contains 0.5 mg of betamethasone in the form of betamethasone dipropionate.
Other ingredients of the medicine are: chlorocresol, sodium dihydrogen phosphate monohydrate, phosphoric acid concentrated, white soft paraffin, liquid paraffin, macrogol cetostearyl ether, cetostearyl alcohol, sodium hydroxide, purified water.

What the medicine looks like and contents of the pack
The medicine is a white cream.
The available pack sizes are aluminium tubes containing 30 g of cream, placed in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Belupo s.r.o.
Cukrová 14, 811 08 Bratislava, Slovakia

Manufacturer:
Belupo lijekovi i kozmetika, d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 46/022/82-S/C
Parallel Import Licence Number: 373/24