Beloderm

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Beloderm
0.5 mg/g, ointment
Betamethasone
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Beloderm is and what it is used for
2. Important information before using Beloderm
3. How to use Beloderm
4. Possible side effects
5. How to store Beloderm
6. 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 potent activity, used topically in dermatology. Betamethasone dipropionate has strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Beloderm ointment is indicated for the topical 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 drug should be discontinued immediately.
Do not use occlusive dressings, as they may enhance absorption of the drug through the skin.
The use of Beloderm on the facial skin is not recommended due to the risk of dermatitis (resembling acneiform lesions), perioral dermatitis, skin atrophy, and acne.
Avoid contact of the drug 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 venous 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 in the axillary and groin areas 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 dangerous, including the risk of disease rebound due to tolerance development, 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 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 opinion of the physician, the benefit to the pregnant woman outweighs the potential risk to the fetus.
However, such use should be short-term and limited to small areas of the body.
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 physician will consider whether to discontinue breastfeeding or the use of Beloderm ointment, taking into account the possibility of adverse effects in infants and the benefits of treatment for the mother.
Do not apply the drug 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 as directed by the physician. In case of doubt, consult your
doctor.
Beloderm ointment is intended for topical use on the skin 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 the medicine is not recommended in children under 12 years of age.
If you feel the effect of the medicine is 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 on damaged skin, use under
occlusive dressings, and use in children may lead to increased systemic absorption of the active
substance, resulting in overdose and general adverse effects typical of corticosteroids.
Symptoms of overdose characteristic of corticosteroids include suppression of the hypothalamic–
pituitary–adrenal (HPA) axis, Cushing's syndrome, mild intracranial hypertension, growth and
development retardation in children, increased blood glucose levels (hyperglycaemia), 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 reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
Local application of betamethasone dipropionate may cause atrophic skin changes,
irreversible striae, dry skin, telangiectasia (dilation of small arteries), folliculitis,
hypertrichosis, acneiform eruptions, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), perioral dermatitis, pruritus, skin discoloration, suppression of sweat gland function (anhidrosis), 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 doses higher than recommended of Beloderm).
General adverse effects are rare and occur primarily with prolonged use, application over large skin areas, use under occlusive dressings, and use in children. These effects usually resolve after discontinuation of the medicine.
Frequency unknown (cannot be estimated from the available data): blurred vision.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 this medicine.

5. How to store Beloderm

Keep this medicine out of sight and reach of children.
Store below 25 ºC. Do not freeze.
Shelf life after first opening of the tube: 3 months when stored below 25 ºC.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging 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 ingredients of the medicine are: liquid paraffin, white soft paraffin.

What Beloderm looks like and contents of the pack
The medicine is a white ointment.
The available pack is an aluminium tube containing 30 g of ointment, placed in a cardboard box.

For further 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in the Czech Republic, country of export:
46/021/82-S/C

Parallel import authorisation number: 54/25