BELOGENT

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Belogent
(0.5 mg + 1 mg)/g, cream
Betamethasone + Gentamicin
Please read this 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 questions, please 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Belogent is and what it is used for
2. Important information before using Belogent
3. How to use Belogent
4. Possible side effects
5. How to store Belogent
6. Contents of the pack and other information

1. What Belogent is and what it is used for

Belogent cream for topical use contains the active substances: betamethasone in the form of
betamethasone dipropionate and gentamicin in the form of gentamicin sulfate.
Betamethasone dipropionate is a synthetic fluorinated corticosteroid for topical use in dermatology,
exerting potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin sulfate is an aminoglycoside antibiotic with antibacterial activity.

Indications
Belogent cream is indicated for the local treatment of corticosteroid-responsive skin disorders complicated by bacterial infection, in patients over 13 years of age.
Belogent cream is used when there is suspicion or bacteriological confirmation of skin infection caused by bacteria sensitive to gentamicin, such as sensitive strains of streptococci (Group A streptococci: alpha- and beta-haemolytic), Staphylococcus aureus (coagulase-positive and coagulase-negative strains, including some penicillinase-producing strains), and Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae.

2. Important information before using Belogent

When not to use Belogent

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• in cutaneous tuberculosis,
• in viral skin infections,
• in acne, perioral dermatitis, rosacea,
• in the anal and genital area,
• in diaper dermatitis,
• in fungal skin infections,
• in skin infections caused by bacteria resistant to gentamicin.

Warnings and precautions
Before starting to use Belogent cream, discuss this with your doctor or pharmacist.
Do not apply Belogent cream to hairy scalp skin.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Belogent cream, inform your doctor. The doctor will decide whether the medicine should be discontinued immediately.
Do not use occlusive dressings or bandages (sealed coverings), as they may enhance absorption of the medicine through the skin.
Avoid contact of the medicine with eyes and mucous membranes. Do not apply the medicine to the eyes or around the eyes.
If blurred vision or other visual disturbances occur, contact your doctor.
Use on facial skin is not recommended due to the risk of skin inflammation (similar to acneiform eruptions), perioral dermatitis, skin atrophy, and acne.
If skin infection occurs, the doctor will initiate appropriate treatment with antibacterial or antifungal medicines.
Since corticosteroids and gentamicin can be absorbed through the skin, there is a risk of systemic adverse effects from corticosteroids (including suppression of adrenal cortex function) and from gentamicin (hearing and kidney damage, especially in patients with impaired renal function) during treatment with Belogent cream.
Therefore, avoid using the medicine over large body surface areas, on damaged skin, in high doses, for prolonged periods, in patients with liver function disorders, and in children.
Apply the cream to the armpits and groin areas only when absolutely necessary due to increased absorption.
Particular caution is required when using Belogent cream in patients with psoriasis, as topical use of corticosteroids in psoriasis may be hazardous, including disease relapse due to development of tolerance, risk of generalized pustular psoriasis, and systemic toxic effects caused by impaired skin barrier function.
Prolonged topical use of gentamicin sulfate may lead to overgrowth of resistant microorganisms and may result in emergence of bacteria resistant to aminoglycoside antibiotics.

Children and adolescents
Belogent cream is indicated for use in adults and children aged 13 years and older.
Use in children under 12 years of age is not recommended due to frequent reports of adverse effects such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and increased intracranial pressure following topical application of potent corticosteroids.

Belogent and other medicines
Tell 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 child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of Belogent cream in pregnant women is permitted only when the doctor considers that the benefit to the pregnant woman outweighs the risk to the fetus. However, such use should be short-term and limited to a small body surface area.
There are no study results available on the safety of topical use of corticosteroids and gentamicin in pregnant women. However, it is known that these substances may be absorbed through the skin.

Breastfeeding
During breastfeeding, the doctor will consider whether to discontinue breastfeeding or discontinue treatment with Belogent cream, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Do not apply the medicine to the breast skin 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. Systemic corticosteroids are known to pass into human milk.
Gentamicin applied to the skin may be absorbed into the body.

Driving and operating machinery
Belogent cream has no effect on the ability to drive or operate machinery.

Belogent contains 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, allergic reactions may occur.

3. How to use Belogent

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Belogent cream is intended for topical use only.
Adults and children over 13 years of age
Apply a thin layer of the medicine to the affected skin areas once or twice daily. Do not use an occlusive (sealed) dressing. In certain cases, the physician may recommend less frequent application.
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 a physician.
Use of a higher than recommended dose of Belogent
When used for prolonged periods (more than 2 weeks), over large skin surface areas, on damaged skin, when occlusive dressings are applied, or in children, enhanced systemic absorption of the active substances may occur, potentially leading to overdose and general adverse effects of corticosteroids and gentamicin.
Symptoms of corticosteroid overdose include, among others: suppression of the hypothalamic–pituitary–adrenal axis, Cushing's syndrome, benign intracranial hypertension, growth and developmental retardation in children, increased blood glucose levels (hyperglycemia), and glycosuria.
Symptoms of gentamicin overdose include, among others: risk of ototoxicity, tinnitus, and nephrotoxicity, particularly when concomitant use of nephrotoxic drugs occurs or in the presence of renal function disorders.
In case of using 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, and general weakness occur, the physician may consider administering a systemic corticosteroid.
Missed dose of Belogent
Do not apply a double dose to make up for a missed dose.
Discontinuation of Belogent
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody 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, swelling, and inflammatory blisters on the skin), perioral dermatitis,
itching, skin discoloration, suppression of sweat gland function (miliaria), and
secondary infections.
Local application of gentamicin may cause hypersensitivity reactions, such as
rash, itching, redness, swelling.
In addition, allergic reactions may occur.
Systemic adverse reactions of betamethasone and gentamicin may also occur due to absorption of the active substances into the bloodstream (see above - Use of a higher than recommended dose of Belogent).
Systemic adverse effects are rare (occurring in no more than 1 in 1,000 people), primarily in cases of prolonged use, application over a large skin surface area, use under occlusive dressing, or use in children, and usually resolve after discontinuation of the medicine.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Frequency not known (cannot be estimated from 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 or pharmacist. 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 the medicine.

5. How to store Belogent

Keep the 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 must 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 package and other information

What Belogent cream contains
The active substances in Belogent are betamethasone and gentamicin.
1 g of cream contains 0.5 mg betamethasone in the form of betamethasone dipropionate and 1 mg gentamicin
in the form of gentamicin sulphate.
Other ingredients are: chlorocresol, monosodium dihydrogen phosphate monohydrate, diluted phosphoric acid, white soft paraffin, liquid paraffin, cetostearyl polyglycol ether, cetostearyl alcohol, sodium hydroxide solution, purified water.

What Belogent looks like and contents of the pack
Belogent is a cream.
The available pack is an aluminium tube containing 30 g of cream, placed in a cardboard box.
For further 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:
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: 46/284/00-C
Parallel Import Authorisation number: 142/19