Belogent

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 action. 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 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 bacteria resistant to gentamicin.

Warnings and precautions

Before starting to use Belogent, you should discuss it with your doctor or pharmacist. Belogent ointment should not be used on the hairy scalp. 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 increase 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 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 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, you should avoid using the medicine on a large surface 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, the ointment should be used only in absolutely necessary cases, 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 dangerous, including the risk of disease recurrence due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin function disorders. Prolonged local use of gentamicin sulfate can lead to excessive growth of insensitive microorganisms and may cause the 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. 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 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. There are no known interactions with other locally used medicines.

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 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 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 During 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 use.

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 exactly as your doctor or pharmacist has told you. If you are not sure, you should 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. 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, you should 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 the case of using occlusive dressings, as well as in the case of using the medicine in children, due to increased absorption of the active substances into the bloodstream, an overdose may occur and systemic side effects of corticosteroids and gentamicin may appear. Symptoms of overdose 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. Symptoms of gentamicin overdose include the risk of hearing damage, tinnitus, and kidney damage, especially when used with nephrotoxic drugs, as well as in the case of impaired kidney function. 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 the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Belogent can cause side effects, although not everybody gets them. Topical use of betamethasone dipropionate may cause atrophic skin changes, irreversible striae, dry 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 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 the case of prolonged use of the medicine, use on a large surface 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 side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 provide more information on the safety of this medicine.

5. How to store Belogent

The medicine should be stored out of the sight and reach of children. Store in a temperature 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 month stated. 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 required. 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 are liquid paraffin and white petrolatum.

What Belogent looks like and contents of the pack

Belogent is an ointment. The available packaging of the medicine is an aluminum tube with a membrane, closed with an HDPE cap with a puncture device, containing 30 g of ointment, 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:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Marketing authorization number in the Czech Republic, the country of export:46/285/00-C Parallel import authorization number:81/18 Date of leaflet approval: 07.02.2023
[Information about the reserved trademark]