Belogent

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Belogent, (0.5 mg + 1 mg)/g, ointment
Betamethasone + Gentamicin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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.
• This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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 ointment for topical use contains the following 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, which exerts a potent anti-inflammatory, antipruritic, and vasoconstrictive effect.
Gentamicin sulfate is an aminoglycoside antibiotic with antibacterial activity.

Indications
Belogent ointment is indicated for the local treatment of corticosteroid-responsive skin disorders complicated by bacterial infection in patients over 13 years of age.
Belogent ointment 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-hemolytic), Staphylococcus aureus (both 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 areas,

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• in diaper dermatitis,
• in fungal skin infections,
• in skin infections caused by bacteria resistant to gentamicin.

Warnings and precautions
Before starting treatment with Belogent, consult your doctor or pharmacist.
Do not apply Belogent ointment to hairy skin of the scalp.
If a skin allergic reaction (itching, burning, or redness) occurs after applying Belogent ointment, inform your doctor. The doctor will decide whether the medicine should be discontinued immediately.
Do not use occlusive dressings or bandages, 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 eye area.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Use on facial skin is not recommended due to the risk of dermatitis (similar to acneiform eruptions), perioral dermatitis, skin atrophy, and acne.
If the skin becomes infected, the doctor will initiate appropriate treatment with antibacterial or antifungal medicines.
Since corticosteroids and gentamicin may 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 ointment.
Therefore, avoid using the medicine on large areas of the body, damaged skin, in high doses, for prolonged periods, in patients with impaired liver function, and in children.
Apply the ointment to the armpits and groin areas only when absolutely necessary due to increased absorption.
Particular caution is required when using Belogent ointment in patients with psoriasis, as topical use of corticosteroids in psoriasis may be dangerous, including the risk of disease rebound due to development of tolerance, generalized pustular psoriasis, and systemic toxic effects resulting from 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 ointment is indicated for use in adults and children over 13 years of age.
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 any other medicines the patient is currently taking, has recently taken, or might take in the future.
No interactions with other topically applied medicines are known.
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Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of Belogent ointment in pregnant women is permitted only if 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 small body surface areas.
There are no data from clinical studies on the safety of topical 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 to discontinue treatment with Belogent ointment, 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 skin of the breasts before breastfeeding.
It is not known whether topically applied corticosteroids, including betamethasone dipropionate, are absorbed through the skin to an extent that allows passage into breast milk. Systemically administered corticosteroids are known to pass into human milk.
Gentamicin may be absorbed into the body after topical application.
Driving and operating machinery
Belogent ointment has no influence on the ability to drive or operate machinery.

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 ointment is intended for topical use on the skin 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
occlusive dressings (sealed coverings). 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
Prolonged use (exceeding 2 weeks), application over large skin areas or on damaged skin, use of
occlusive dressings, and use in children may lead to increased systemic absorption of the active
substances into the circulatory system, resulting in overdose and general adverse effects of
corticosteroids and gentamicin.
Symptoms of overdose typical for corticosteroids include, among others: suppression of the
hypothalamic–pituitary–adrenal axis function, Cushing's syndrome, mild intracranial hypertension,
inhibition of growth and development in children, increased blood glucose levels (hyperglycemia),
and glycosuria.
Symptoms of gentamicin overdose include, among others: risk of hearing damage, tinnitus, and
kidney damage, particularly when used concomitantly with nephrotoxic drugs, as well as in patients
with pre-existing kidney function disorders.
If a higher than recommended dose has been used, seek immediate medical advice.
The physician will decide whether treatment with the medicine should be discontinued.
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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 use a double dose to make up for a missed dose.
Discontinuation of Belogent treatment
If you have any further doubts regarding the use of this medicine, consult your physician or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Local application of betamethasone dipropionate may cause:
skin atrophy, irreversible striae, dryness of the 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 (miliaria), and
occurrence of secondary infections.
Local application of gentamicin may cause hypersensitivity reactions, such as
rash, itching, redness, swelling.
Systemic absorption of the active substances into the bloodstream may also lead to general adverse
effects of betamethasone and gentamicin (see above - Use of a higher than recommended dose of
Belogent medicine).
General 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, under occlusive dressing, or use in children,
and 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 adverse effects not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting of adverse effects allows gathering further information on the safety of the medicine.

5. How to store Belogent

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
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.
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Medicines must 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 Belogent ointment contains
The active substances are betamethasone and gentamicin.
Each gram of ointment contains 0.5 mg betamethasone as betamethasone dipropionate and 1 mg gentamicin as gentamicin sulphate.
The other ingredients are: liquid paraffin, white soft paraffin.

What Belogent looks like and contents of the pack
Belogent is an ointment.
The medicinal product is available in an aluminium tube 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
81108 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: 46/285/00-C
Parallel Import Authorisation number: 331/17
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