BELOGENT 0.5 mg/1 mg Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. BELOGENT, (0.5 mg + 1 mg)/g, cream
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Belogent and what is it used for
4. Important information before using Belogent
   1. When not to use Belogent:
   2. Warnings and precautions
   3. Children and adolescents
   4. Belogent and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Belogent contains cetostearyl alcohol, chlorocresol
5. How to use Belogent
   1. Adults and children over 13 years of age
   2. Use in children
   3. Using more than the recommended dose of Belogent
   4. Missing a dose of Belogent
   5. Stopping the use of Belogent
6. Possible side effects
   1. Reporting side effects
7. How to store Belogent
8. Contents of the pack and other information
   1. What Belogent cream contains
   2. What Belogent looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

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

Betamethasone + Gentamicin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. 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 pack and other information

1. What is Belogent and what is it 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, which has a strong anti-inflammatory, antipruritic, and vasoconstrictive effect.
Gentamicin sulfate is an aminoglycoside antibiotic with antibacterial activity.
Indications
Belogent cream 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 cream 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 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 cream should not be used on hairy scalp skin.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Belogent cream, inform your doctor. The doctor will decide whether to discontinue the medicine immediately.
Do not use occlusive dressings, as they may enhance the absorption of the medicine through the skin.
Avoid contact 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 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, during the use of Belogent cream, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and gentamicin (hearing loss and kidney damage, especially in people with impaired kidney function). Therefore, it is recommended to avoid using the medicine on a large surface area of the body, damaged skin, using large doses, prolonged treatment, and using it in patients with liver function disorders and in children.
On the skin of the armpits and groin, use the cream only in absolutely necessary cases, due to increased absorption.
Belogent cream should be used with special caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be dangerous, 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 excessive growth of insensitive microorganisms and may cause the emergence of antibiotic-resistant bacteria.

Children and adolescents

Belogent cream 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 inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and increased intracranial pressure after local use of potent corticosteroids.

Belogent and other medicines

Tell your doctor or pharmacist about all medicines you are 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 cream 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 surface 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 discontinue Belogent cream, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.
Do not use the medicine on the breast skin before breastfeeding.
It is not known whether locally used corticosteroids, including betamethasone dipropionate, are absorbed through the skin to an extent that may 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 cream has no effect on the ability to drive and use machines.

Belogent contains cetostearyl alcohol, chlorocresol

Due to the presence of cetostearyl alcohol, the 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 your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Belogent cream 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.
Do not use an occlusive dressing. 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, and in cases of occlusive dressings, as well as in children, due to increased absorption of the active substances into the bloodstream, overdose and systemic side effects of corticosteroids and gentamicin may occur.
Overdose symptoms characteristic of corticosteroids include inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, mild intracranial hypertension, growth retardation in children, increased blood sugar levels (hyperglycemia), and glycosuria.
Overdose symptoms of gentamicin include the risk of hearing loss, tinnitus, and kidney damage, especially with concurrent use of nephrotoxic drugs, as well as in cases of impaired kidney function.
In case 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 using a systemic corticosteroid.

Missing a dose of Belogent

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

Stopping the use of Belogent

In case of any further doubts about the use of this medicine, consult 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.
Allergic reactions may also occur.
Due to the absorption of the active substances into the bloodstream, 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 surface area of the skin, under an occlusive dressing, and in children, and usually disappear after discontinuation of the medicine.
If you experience any side effects, including any not listed in this leaflet, consult your doctor or pharmacist.
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, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
Reporting side effects will help to gather 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Belogent cream contains

• The active substances of the medicine are betamethasone and gentamicin. 1 g of cream 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: chlorocresol, disodium phosphate monohydrate, phosphoric acid, white petrolatum, liquid paraffin, macrogol cetostearyl ether, cetostearyl alcohol, sodium hydroxide, purified water.

What Belogent looks like and contents of the pack

Belogent is a cream.
The medicine is available in aluminum tubes containing 15 g or 30 g of cream, 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
Danica Street 5
48 000 Koprivnica
Croatia

Date of last revision of the leaflet: