Belogent

Package Leaflet: Information for the User

BELOGENT, (0.5 mg + 1 mg)/g, ointment

Betamethasone + Gentamicin

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

• Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 strong anti-inflammatory, antipruritic and vasoconstrictive effects.
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, as well as some penicillinase-producing strains) 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, 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, 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 visual disturbances, they should contact their doctor.
The medicine should not be used on the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy and acne.
In the case of a skin infection, the doctor will use appropriate antibacterial or antifungal treatment.
Since corticosteroids and gentamicin are absorbed through the skin, during the use of Belogent ointment, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and gentamicin (hearing damage and kidney damage, especially in people with impaired kidney function). Therefore, the use of the medicine on a large surface area of the body, damaged skin, in large doses, long-term treatment, and use in patients with liver function disorders and in children should be avoided.
The ointment should only be used on the armpits and groin area in cases where it is absolutely necessary, due to increased absorption.
Belogent ointment should be used with special 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 leads to excessive growth of insensitive 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.
The use of the medicine is not recommended 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 local use of potent corticosteroids.

Belogent and other medicines

Inform 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 baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of Belogent ointment in pregnant women is allowed only in cases where 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 local 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 baby and the benefits of treatment for the mother.
The medicine should not be used 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 acting corticosteroids pass into breast milk.
Gentamicin may be absorbed into the body after topical application.

Driving and using machines

Belogent ointment has no effect on 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, ask 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.
An occlusive dressing (sealing) should not be used. In some cases, the doctor may recommend less frequent use of the medicine.

Use in children

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

Using more than the recommended dose of Belogent

During prolonged use of the medicine (more than 2 weeks), use on large areas of the skin, or on damaged skin, in the case of occlusive dressings, and in the case of use in children, due to increased absorption of the active substances into the bloodstream, 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 damage, tinnitus, and kidney damage, especially when used with nephrotoxic drugs, as well as in the case of existing kidney function disorders.
In the event of using a higher dose of the medicine than recommended, consult your doctor 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 systemically acting corticosteroid.

Missing a dose of Belogent

Do not use a double dose to make up for a missed dose.

Stopping the use of Belogent

If you have any further questions about the use of this 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 changes in the skin, irreversible striae, dryness of the 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 the occurrence of secondary infections.
Local 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 occur rarely (in no more than 1 in 1000 people), mainly in the case of prolonged use of the medicine, use on a large area of the skin, under an occlusive dressing, and use 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 not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Belogent

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the tube: 3 months when stored at a temperature 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Belogent ointment 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 aluminum tubes containing 15 g or 30 g of ointment, placed in a cardboard box.

Marketing authorization holder

Belupo s.r.o.
Cukrová 14,
81108 Bratislava, Slovakia
Phone: +421 2 5932 4330
Fax: +421 2 5932 4331

Manufacturer

BELUPO Pharmaceuticals & Cosmetics
Ulica Danica 5
48 000 Koprivnica
Croatia

Date of last revision of the package leaflet: