BELODERM 0.5 mg/g Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning!
3. The leaflet must be kept. Information on the immediate packaging in a foreign language.
4. Beloderm
   1. Read the leaflet carefully 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. Beloderm contains cetostearyl alcohol and chlorocresol
7. How to use Beloderm
   1. Adults and children over 12 years of age
   2. Use in children
   3. Using more than the recommended dose of Beloderm
   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 cream 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: 373/24
    8. Date of approval of the leaflet: 24.10.2024

Package Leaflet: Information for the User

Warning!

The leaflet must be kept. Information on the immediate packaging in a foreign language.

Beloderm

0.5 mg/g, cream
Betamethasone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your 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 cream contains the active substance betamethasone in the form of betamethasone dipropionate. Betamethasone is a synthetic fluorinated corticosteroid (adrenal cortex hormone) with strong effects, used locally in dermatology. Betamethasone dipropionate has strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Beloderm cream 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 you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in skin tuberculosis;
• in viral skin infections (e.g., herpes simplex, chickenpox, shingles);
• in acne, perioral dermatitis, rosacea;
• in the anal and genital areas;
• in diaper dermatitis;
• in fungal or bacterial skin infections, unless the doctor also prescribes appropriate causal treatment.

Warnings and precautions

Before starting to use Beloderm, discuss it with your doctor, pharmacist, or nurse.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Beloderm cream, 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 with the eyes and mucous membranes. Do not use in or around the eyes.
If you experience blurred vision or other vision disturbances, contact your doctor.
In the case of skin infection, the doctor will use appropriate antibacterial or antifungal treatment.
Beloderm cream should not be used to treat venous leg ulcers.
Since corticosteroids are absorbed through the skin, during the use of Beloderm cream, there is a risk of systemic side effects of corticosteroids, including adrenal suppression. Therefore, it should be avoided to use it on a large surface of the body, on damaged skin, in large doses, for prolonged treatment, and in patients with liver function disorders and in children.
On the skin of the armpits and groin, Beloderm cream can be used only in cases where it is absolutely necessary, due to increased absorption.
Particular caution is required when using Beloderm cream in patients with psoriasis, as local use of corticosteroids in psoriasis can be hazardous, including the risk of relapse caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin function disorders.

Children and adolescents

It is not recommended to use 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Beloderm cream should only be used in pregnant women when the potential benefit to the mother justifies the potential risk to the fetus. However, it should be used for a short period and on a small surface 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 cream, 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 skin before breastfeeding.
It is not known whether locally used corticosteroids, including betamethasone dipropionate, are absorbed through the skin to such 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 cream on the ability to drive and use machines.

Beloderm contains cetostearyl alcohol and chlorocresol

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

3. How to use Beloderm

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor.
Beloderm cream is for 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 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

It is not recommended to use the medicine in children under 12 years of age.
If you feel that the effect of the medicine is too strong or too weak, ask your doctor.

Using more than the recommended dose of Beloderm

When using the medicine for a longer period (more than 2 weeks), on large areas of the skin, or on damaged skin, with 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 inhibition in children, increased blood sugar levels (hyperglycemia), and glycosuria.
If you use more than the recommended dose of the medicine, seek medical attention immediately. 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, ask 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 skin changes, irreversible striae, dry 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.
Additionally, allergic reactions may occur.
Due to the absorption of active substances into the blood, systemic side effects of betamethasone, characteristic of corticosteroids (see above - Using more than the recommended dose), may also occur.
Systemic side effects are rare, mainly occurring in the case of prolonged use of the medicine, use on a large surface 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 get any side effects, talk to your doctor, pharmacist, or nurse. Side effects can also be reported to the Department of Drug Safety Monitoring 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

Keep the medicine 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 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.
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 pack 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.
The other ingredients are: chlorocresol, sodium dihydrogen phosphate monohydrate, phosphoric acid concentrated, white petrolatum, liquid paraffin, macrogol cetostearyl ether, cetostearyl alcohol, sodium hydroxide, purified water.

What Beloderm looks like and contents of the pack

The medicine is a white cream.
Beloderm cream is available in aluminum tubes containing 30 g of cream, placed in a cardboard box.
For more detailed information, 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
Marketing authorization number in the Czech Republic, the country of export: 46/022/82-S/C

Parallel import authorization number: 373/24

Date of approval of the leaflet: 24.10.2024

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