BELODERM 0.5 mg/g Ointment

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning!
3. Please keep this leaflet. Information on the direct packaging in a foreign language.
4. Beloderm
   1. Please read carefully the contents of this leaflet before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
5. What is Beloderm and what is it used for
6. Important information before using Beloderm
   1. When not to use Beloderm:
   2. Warnings and precautions
   3. Children and adolescents
   4. Beloderm and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
7. How to use Beloderm
   1. Adults and children over 12 years
   2. Use in children
   3. Using a higher dose of Beloderm than recommended
   4. Missing a dose of Beloderm
8. Possible side effects
   1. Reporting side effects
9. How to store Beloderm
10. Contents of the pack and other information
    1. What Beloderm ointment contains
    2. What Beloderm looks like and contents of the pack
    3. Marketing authorization holder in the Czech Republic, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 374/24
    8. Date of approval of the leaflet: 24.10.2024

Package Leaflet: Information for the User

Warning!

Please keep this leaflet. Information on the direct packaging in a foreign language.

Beloderm

0.5 mg/g, ointment
Betamethasone

Please read carefully the contents of this leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Beloderm and what is it 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 is Beloderm and what is it 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 action, used locally in dermatology. Betamethasone dipropionate has strong anti-inflammatory, antipruritic, and vasoconstrictive effects on blood vessels.
Indications
Beloderm ointment is indicated for the local treatment of inflammatory and pruritic skin diseases 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 any of the other ingredients of this medicine (listed in section 6);
• in tuberculosis of the skin;
• in viral skin infections (e.g., common herpes, cowpox, chickenpox);
• in acne, perioral dermatitis, rosacea;
• in the anal and genital areas;
• in diaper rash;
• in fungal or bacterial skin infections, unless the doctor also prescribes appropriate causal treatment.

Warnings and precautions

Before starting to use Beloderm, you should discuss it with your doctor, pharmacist, or nurse.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Beloderm ointment, you should inform your doctor. The doctor will decide whether to discontinue the medicine immediately.
Do not use occlusive dressings, as they may increase the absorption of the medicine through the skin.
It is not recommended to use the medicine on the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy, and rosacea.
Avoid contact of the medicine with the eyes and mucous membranes. Do not use in the eyes or around the eyes.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
In the case of skin infection, the doctor will prescribe appropriate antibacterial or antifungal treatment.
Beloderm ointment should not be used to treat venous leg ulcers.
Since corticosteroids are absorbed through the skin, there is a risk of systemic side effects of corticosteroids when using Beloderm ointment, including adrenal suppression. Therefore, you should avoid using it on a large surface area of the body, on damaged skin, using large amounts, prolonged treatment, and using it in patients with liver function disorders and in children.
The medicine should be used on the axillary and groin areas only in cases where it is absolutely necessary, due to increased absorption.
Particular caution is required when using Beloderm ointment in patients with psoriasis, as local use of corticosteroids in psoriasis can be hazardous, including the risk of relapse due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin function disorders.

Children and adolescents

It is not recommended to use the medicine in children under 12 years of age, due to frequent reports of adrenal suppression, Cushing's syndrome, and increased intracranial pressure after local use of potent corticosteroids.

Beloderm and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No interactions with other locally used medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of Beloderm ointment in pregnant women is allowed only in cases where the benefit to the pregnant woman outweighs the risk to the fetus. However, it should be short-term and limited to a small surface area of the body.
There are no results of studies on the safety of local use of corticosteroids in pregnant women. However, it is known that these substances can be absorbed through the skin.
Breastfeeding
The doctor will consider whether to stop breastfeeding or using Beloderm ointment, taking into account the possibility of side effects in children and the benefits of treatment for the mother.
Do not use the medicine on the breast before breastfeeding.
It is not known whether locally used corticosteroids, including betamethasone dipropionate, are absorbed through the skin to an extent that they can pass into breast milk. Systemically administered corticosteroids (orally or by injection) pass into breast milk.

Driving and using machines

There are no data on the harmful effects of Beloderm ointment on the ability to drive and use machines.

3. How to use Beloderm

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor.
Beloderm ointment is for use on the skin only.

Adults and children over 12 years

A thin layer of the medicine should be gently rubbed into the affected areas of the skin once or twice a day. 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

The medicine is not recommended for use in children under 12 years of age.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Using a higher dose of Beloderm than recommended

When using the medicine for a longer period (more than 2 weeks), using it on large areas of the skin, or on damaged skin, using occlusive dressings, and in children, due to increased absorption of the active substances into the bloodstream, they may be overdosed and systemic side effects of corticosteroids may occur.
Overdose symptoms characteristic of corticosteroids include adrenal suppression, Cushing's syndrome, mild intracranial hypertension, growth and development retardation in children, increased blood sugar levels (hyperglycemia), and glycosuria.
If you use a higher dose of the medicine than recommended, you should immediately consult your doctor.
The doctor will decide whether to discontinue the medicine.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the doctor will consider the use of a systemic corticosteroid.

Missing a dose of Beloderm

Do not use a double dose to make up for a missed dose.
If you have any doubts about using the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local use of betamethasone dipropionate may cause atrophic changes in the skin, irreversible striae, dryness of the skin, widening of small blood vessels, folliculitis, hypertrichosis, acne-like changes, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), perioral dermatitis, itching, skin discoloration, inhibition of sweat gland function (hypohidrosis), and secondary infections.
Due to the absorption of the active substances into the blood, systemic side effects of betamethasone, characteristic of corticosteroids (see above - Using a higher dose of Beloderm than recommended), may also occur.
Systemic side effects are rare and occur mainly in the case of prolonged use of the medicine, use on a large surface area of the skin, under an occlusive dressing, and in children, and usually disappear after discontinuation of the medicine.
Frequency not known (cannot be estimated from the available data): blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Beloderm

The medicine should be kept out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Shelf life after first opening of the tube: 3 months when stored at a temperature 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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Beloderm ointment contains

The active substance of the medicine is betamethasone.
1 g of ointment contains 0.5 mg of betamethasone in the form of betamethasone dipropionate.
The other ingredients of the medicine are: liquid paraffin, white petrolatum.

What Beloderm looks like and contents of the pack

The medicine is a white ointment.
The medicine is available in aluminum tubes containing 30 g of ointment, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in the Czech Republic, the country of export: 46/021/82-S/C

Parallel import authorization number: 374/24

Date of approval of the leaflet: 24.10.2024

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