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, ointment
Betamethasone
Please read the entire leaflet carefully before using the medicine, as 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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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 ointment 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 ointment is indicated for the local treatment of inflammatory and pruritic skin disorders that respond to corticosteroid therapy.

2. Important 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, vaccinia, 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 this with your doctor, pharmacist, or nurse.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Beloderm ointment, 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.
The use of Beloderm ointment on the face is not recommended due to the risk of dermatitis (resembling acneiform lesions), 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 physician will initiate appropriate antibacterial or antifungal treatment.
Beloderm ointment 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 ointment. Therefore, avoid use over large areas of the body, on damaged skin, in high doses, during prolonged treatment, and in patients with hepatic impairment or in children.
Beloderm ointment 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 ointment in patients with psoriasis, as topical corticosteroids in psoriasis may be hazardous, including the risk of disease rebound due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects caused by impaired skin function.

Children and adolescents
Use in children under 12 years of age is not recommended due to frequent reports of hypothalamic-pituitary-adrenal (HPA) 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 any other medicines you are currently taking, have recently taken, or might 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.

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

Breastfeeding
The physician will consider whether to discontinue breastfeeding or the use of Beloderm ointment, 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 ointment on the ability to drive or operate machinery.

3. How to use Beloderm

This medicine should always be used exactly as prescribed by the physician. In case of doubts, consult
your doctor.
Beloderm ointment is intended for topical use only.
Adults and children aged above 12 years
A thin layer of the medicine should be gently rubbed into the affected areas of 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 the medicine is not recommended in children under 12 years of age.
If the effect of the medicine seems too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Beloderm
When used for prolonged periods (more than 2 weeks), over large areas of skin or on damaged skin,
or when occlusive dressings are used, particularly in children, increased systemic absorption of the
active substances may lead to overdose and 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
inhibition in children, increased blood glucose levels (hyperglycemia), and glucosuria.
In case of administration of a higher than recommended dose, seek immediate medical advice.
The physician 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.
In case of any doubts regarding the use of the medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Local application of betamethasone dipropionate may cause skin atrophy, irreversible striae, dry skin, telangiectasia, folliculitis, hypertrichosis, acne-like changes, allergic contact dermatitis (burning sensation, swelling, and inflammatory blisters on the skin), perioral dermatitis, itching, skin discoloration, suppression of sweat gland function (hypohidrosis), and secondary infections.
Due to systemic absorption of the active substance into the bloodstream, general adverse effects of betamethasone characteristic of corticosteroids may also occur (see above - Use of a dose higher than recommended).
General adverse effects are rare and occur primarily after prolonged use, application over large skin areas, under occlusive dressing, or 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, Phone: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows additional information on the safety of the medicine to be collected.

5. How to store Beloderm

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Use within 3 months after first opening the tube, 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 required. This will help protect the environment.

6. Contents of the package and other information

What Beloderm ointment contains
The active substance is betamethasone.
1 g of ointment contains 0.5 mg of betamethasone in the form of betamethasone dipropionate.
Other components of the medicine are: liquid paraffin, white vaseline.

What Beloderm looks like and contents of the pack
The medicine is a white ointment.
Available pack sizes are aluminium tubes containing 30 g of ointment, placed in a cardboard box.
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 in:
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: 46/021/82-S/C
Parallel import authorisation number: 374/24