PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Keep this leaflet, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it 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.

Table of contents

What Belogent is and what it is used for
Important information before using Belogent
How to use Belogent
Possible side effects
How to store Belogent
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 diseases 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 (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 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,
in diaper dermatitis,
in fungal skin infections,
in bacterial skin infections caused by organisms resistant to gentamicin.

Warnings and precautions
Before starting treatment with Belogent, discuss it with your doctor or pharmacist.
Do not apply Belogent ointment to hairy 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 eyes.
If blurred vision or other visual disturbances occur, contact your doctor.
Use of the medicine on the facial skin is not recommended due to the risk of steroid-induced dermatitis (resembling acneiform eruptions), perioral dermatitis, skin atrophy, and acne.
If a skin infection is present, the doctor will initiate appropriate treatment with antibacterial or antifungal agents.
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 (ototoxicity and nephrotoxicity, especially in patients with impaired renal function) during treatment with Belogent ointment.
Therefore, avoid using the medicine over large body surface areas, on damaged skin, in high doses, for prolonged periods, and in patients with impaired liver function or in children.
Apply the ointment to the axillae 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 hazardous, including the risk of disease rebound due to development of tolerance, 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 ointment is indicated for use in adults and children above 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 if the patient is currently taking, has recently taken, or might take any other medicines.
No interactions with other topically applied medicines are known.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 potential risk to the fetus. However, such use should be short-term and limited to small body surface areas.
There are no data available from studies 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 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 sufficient to pass into breast milk. Systemically administered corticosteroids are known to pass into human milk.
Gentamicin may be absorbed into the systemic circulation after topical application.

Driving and using machines
Belogent ointment has no effect on the ability to drive or operate machinery.

3. How to use Belogent medicine

This medicine should always be used exactly as directed by a doctor or pharmacist. In case of doubt,
consult your doctor 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 an occlusive (sealed) dressing. In some cases, your doctor may recommend less frequent application.
Use in children
Use of this 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 Belogent
Prolonged use (more than 2 weeks), application over large skin areas, use on damaged skin, application under occlusive dressings, or use in children may lead to increased systemic absorption of the active substances into the bloodstream, resulting in overdose and general adverse effects associated with corticosteroids and gentamicin.
Symptoms of corticosteroid overdose may include suppression of the hypothalamic–pituitary–adrenal (HPA) axis, Cushing's syndrome, benign intracranial hypertension, growth and development retardation in children, increased blood glucose levels (hyperglycemia), and glucosuria.
Symptoms of gentamicin overdose may include risk of hearing damage, tinnitus, and kidney damage, particularly when used concomitantly with nephrotoxic drugs or in patients with impaired renal function.
In case of accidental overdose, seek immediate medical advice. The doctor will decide whether treatment with the medicine should be discontinued.
If symptoms such as fever, muscle pain, joint pain, or general weakness occur, the doctor may consider administering a systemic corticosteroid.
Missed dose of Belogent
Do not apply a double dose to make up for a missed dose.
Stopping Belogent
If you have any further questions or uncertainties regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Local application of betamethasone dipropionate may cause:
skin atrophy, irreversible striae, skin dryness, dilation of small arteries,
folliculitis, hypertrichosis, acneiform eruptions, allergic
contact dermatitis (burning sensation, 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, among others,
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).
General adverse effects are rare (occurring in no more than 1 in 1,000 individuals), primarily occurring
after prolonged use, application over large skin areas, use under occlusive dressings, and 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Belogent

Keep this medicine out of sight and reach of children.
Do not store above 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.
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 ointment contains

The active substances are betamethasone and gentamicin. 1 g of ointment contains 0.5 mg betamethasone as betamethasone dipropionate and 1 mg gentamicin as gentamicin sulfate.
Other components of the medicine are: liquid paraffin, white soft paraffin.

What Belogent looks like and contents of the pack
Belogent is an ointment.
The available pack is 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
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
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation number in the Czech Republic, country of export: 46/285/00-C
Parallel import authorisation number: 206/22