Belogent

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Belogent

(0.5 mg + 1 mg)/g, ointment
Betamethasone + Gentamicin

You should carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.

• You should 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Belogent and what is it 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 packaging and other information

1. What is Belogent and what is it used for

Belogent ointment 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, which has a strong 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 bacterial infection-complicated skin diseases that respond to corticosteroid therapy, in patients over 13 years of age.
Belogent ointment is used in cases of suspected or bacteriologically confirmed skin infection caused by gentamicin-sensitive bacteria, such as sensitive strains of streptococci (streptococci group A: alpha- and beta-hemolytic), Staphylococcus aureus (coagulase-positive and coagulase-negative strains and some strains producing penicillinase) and Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli,
Proteus vulgarisand 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 tuberculosis of the skin,
• in viral skin infections,
• in acne, perioral dermatitis, rosacea,
• in the anal and genital areas,
• in diaper dermatitis,
• in fungal skin infections,
• in skin infections with gentamicin-resistant bacteria.

Warnings and precautions

Before starting to use Belogent, you should discuss it with your doctor or pharmacist.
Belogent ointment should not be used on hairy scalp skin.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Belogent ointment, you should inform your doctor. The doctor will decide whether to discontinue the medicine immediately.
Occlusive dressings and bandages should not be used, as they may enhance the absorption of the medicine through the skin.
Avoid contact of the medicine with the eyes and mucous membranes. Do not use the medicine in the eyes or around the eyes.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
It is not recommended to use the medicine on the skin of the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy, and rosacea.
In the case of a skin infection, the doctor will use appropriate antibacterial or antifungal treatment.
Due to the fact that corticosteroids and gentamicin are absorbed through the skin, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and gentamicin (hearing loss and kidney damage, especially in people with kidney function disorders) when using Belogent ointment.
Therefore, you should avoid using the medicine on a large area of the body, damaged skin, using large doses, prolonged treatment, and using it in patients with liver function disorders and in children.
The medicine should only be applied to the axillary and groin areas in cases where it is absolutely necessary, due to increased absorption.
Belogent ointment should be used with particular caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be hazardous, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin function disorders.
Prolonged local use of gentamicin sulfate can lead to overgrowth of non-sensitive microorganisms and may cause the emergence of antibiotic-resistant bacteria.

Children and adolescents

Belogent ointment is indicated for use in adults and children over 13 years of age.
It is not recommended to use the medicine in children under 12 years of age, due to frequent reports of side effects in the form of suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and increased intracranial pressure after topical use of potent corticosteroids.

Belogent and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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 child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Belogent ointment in pregnant women is only allowed when the doctor considers that the benefit to the pregnant woman outweighs the risk to the fetus. However, it should be short-term and limited to a small area of the body.
There are no results of studies on the safety of topical use of corticosteroids and gentamicin 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 stop using Belogent ointment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
You should not use the medicine on the breast skin before breastfeeding.
It is not known whether topically used corticosteroids, including betamethasone dipropionate, are absorbed through the skin to such an extent that they can pass into breast milk.
Systemic corticosteroids pass into breast milk.
Gentamicin may be absorbed into the body after topical application.

Driving and using machines

Belogent ointment does not affect the ability to drive and use machines.

3. How to use Belogent

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

Adults and children over 13 years of age

A thin layer of the medicine should be applied to the affected areas of the skin once or twice a day. Occlusive dressings should not be used. In some cases, the doctor may recommend less frequent use of the medicine.

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, you should consult your doctor.

Using more than the recommended dose of Belogent

When using the medicine for a longer period (more than 2 weeks), using it on large areas of skin, or on damaged skin, and in cases of using occlusive dressings, as well as in children, due to increased absorption of the active substances into the bloodstream, there may be an overdose and systemic side effects of corticosteroids and gentamicin may occur.
Overdose symptoms characteristic of corticosteroids include suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, mild intracranial hypertension, growth and development inhibition in children, increased blood sugar levels (hyperglycemia), and glycosuria.
Overdose symptoms of gentamicin include the risk of hearing loss, tinnitus, and kidney damage, especially when used with nephrotoxic drugs, as well as in cases of kidney function disorders.
If you have used more than the recommended dose of the medicine, 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 using a systemic corticosteroid.

Missing a dose of Belogent

You should not use a double dose to make up for a missed dose.

Stopping the use of Belogent

If you have any further doubts about using this 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.
Topical use of betamethasone dipropionate may cause:
atrophic skin changes, irreversible striae, skin dryness, widening of small blood vessels, folliculitis, excessive hair growth, 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.
Topical use of gentamicin may cause hypersensitivity reactions, including rash, itching, redness, and swelling.
Due to the absorption of the active substances into the blood, systemic side effects of betamethasone and gentamicin may also occur (see above - Using more than the recommended dose of Belogent).
Systemic side effects are rare (in no more than 1 in 1000 people), mainly in cases of prolonged use of the medicine, use on a large area of skin, under occlusive dressings, 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 the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly 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 gather more information on the safety of the medicine.

5. How to store Belogent

The medicine should be stored 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 specified month.
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 packaging and other information

What Belogent contains

• The active substances of the medicine are betamethasone and gentamicin. 1 g of ointment contains 0.5 mg of betamethasone in the form of betamethasone dipropionate and 1 mg of gentamicin in the form of gentamicin sulfate.
• The other ingredients of the medicine are: liquid paraffin, white petrolatum.

What Belogent looks like and contents of the pack

Belogent is an ointment.
The medicine is available in an aluminum tube containing 30 g of cream, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or 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:

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 authorization number in the Czech Republic, the country of export: 46/285/00-C

[Information about the trademark]