Bedicort G

Package Leaflet: Information for the Patient

BEDICORT G, (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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What Bedicort G ointment is and what it is used for
• 2. Important information before using Bedicort G ointment
• 3. How to use Bedicort G ointment
• 4. Possible side effects
• 5. How to store Bedicort G ointment
• 6. Contents of the pack and other information

1. What Bedicort G ointment is and what it is used for

Bedicort G ointment is a medicine for use on the skin, containing two active substances: betamethasone as betamethasone dipropionate and gentamicin as gentamicin sulfate.
Betamethasone dipropionate is a corticosteroid. When applied topically to the skin, it has strong anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin sulfate is an aminoglycoside antibiotic with antibacterial activity.

Indications for Use

Bedicort G ointment is used topically in the treatment of inflammatory skin conditions that respond to corticosteroids (dermatoses, especially those with an allergic background), characterized by excessive keratinization, itching, or severe allergic reaction, and complicated by secondary bacterial infection sensitive to gentamicin.
Bedicort G ointment is used especially in atopic dermatitis, seborrhoeic dermatitis, chronic simple lichen, hyperkeratotic eczema, psoriasis, allergic contact dermatitis, cutaneous lupus erythematosus, and erythema multiforme.
Due to the content of a potent corticosteroid, Bedicort G should be used at the beginning of treatment, for a short time, and on small skin surfaces.

2. Important Information Before Using Bedicort G Ointment

When Not to Use Bedicort G Ointment:

• if you are allergic to betamethasone dipropionate, gentamicin, or any of the other ingredients of Bedicort G ointment (listed in section 6)
• in viral skin infections (e.g., chickenpox, herpes simplex)
• in fungal or bacterial (e.g., tuberculosis) skin infections
• in skin tumors
• in rosacea
• in acne vulgaris
• in venous leg ulcers
• on extensive skin lesions, especially those with skin loss, e.g., in burns
• for prolonged periods
• on the face
• in children under 12 years of age
• in the anal and genital areas
• in perioral dermatitis
• in skin infections with bacteria resistant to gentamicin.

Warnings and Precautions

Before starting to use Bedicort G, discuss it with your doctor or pharmacist.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Bedicort G ointment, stop using the medicine and inform your doctor immediately.

If you experience blurred vision or other vision disturbances, contact your doctor.

Do not use occlusive dressings, as they may enhance the absorption of betamethasone dipropionate through the skin and lead to secondary infections.
Avoid contact with the eyes and mucous membranes. Do not use in or around the eyes, due to the risk of glaucoma or cataracts.
In case of fungal skin infections, the doctor will use appropriate antifungal treatment.
Since betamethasone and gentamicin are absorbed through the skin, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and gentamicin (risk of hearing loss and kidney damage, especially in patients with impaired kidney function).
Therefore, avoid using the medicine on large areas of the body, damaged skin, in high doses, in patients with liver or kidney impairment, and in children.
Be particularly cautious when using the medicine in patients with psoriasis, as local use of corticosteroids in psoriasis can be hazardous, including the risk of relapse of the disease due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin barrier disruption.
Prolonged local use of the antibiotic gentamicin leads to overgrowth of non-susceptible microorganisms and may result in the emergence of bacteria resistant to aminoglycoside antibiotics.
Do not use the medicine on the face, due to the risk of telangiectasia (dilation of blood vessels) or perioral dermatitis, even after short-term use.
On the skin of the armpits and groin, use the ointment only in cases where it is absolutely necessary, due to increased absorption of the medicine through the delicate skin.
Use cautiously in atrophic conditions of the subcutaneous tissue, especially in elderly patients.

Bedicort G Ointment and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, and about medicines you plan to use.
The medicine may enhance or weaken the effect of medicines that affect the immune system.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
It is not recommended to use the medicine in pregnant women.
There are no studies on the safety of using betamethasone dipropionate and gentamicin on the skin in pregnant women. However, it is known that these substances can be absorbed through the skin.
In animal studies, it has been shown that potent corticosteroids used on the skin can harm the fetus. No studies have been conducted on the harmful effects of betamethasone dipropionate on the fetus in pregnant women.
Breastfeeding
The doctor will consider whether to stop breastfeeding or using the medicine, taking into account the risk of side effects in children and the benefits of treatment for the mother.
Due to the lack of sufficient data on the penetration of betamethasone and gentamicin into breast milk, it cannot be ruled out that there is a risk to newborns/infants who are breastfed.

Driving and Using Machines

Bedicort G has no influence or negligible influence on the ability to drive and use machines.

Bedicort G Ointment Contains Cetostearyl Alcohol

The medicine may cause local skin reactions (e.g., contact dermatitis).

Bedicort G Ointment Contains Butylhydroxytoluene (E 321) and Butylhydroxyanisole (E 320)

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to Use Bedicort G Ointment

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.
The medicine is for use on the skin.
Recommended dose:
Usually, a small amount of the medicine is applied to the affected skin once or twice a day. Do not use the medicine under occlusive dressings.
Treatment should not be continued without interruption for more than 2 weeks.

Use in Children and Adolescents

Bedicort G should not be used in children under 12 years of age.

Using More Than the Recommended Dose of Bedicort G Ointment

If you use more than the recommended dose, contact your doctor or pharmacist immediately.
In case of prolonged or improper use of the medicine, systemic side effects of corticosteroids may occur, including adrenal suppression, Cushing's syndrome, growth retardation in children, hyperglycemia, glycosuria, edema, hypertension, and signs of systemic gentamicin toxicity, such as hearing loss and kidney damage.
In case of overdose, the doctor will use appropriate treatment.

Missing a Dose of Bedicort G Ointment

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

Stopping Use of Bedicort G Ointment

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms of hypersensitivity, stop using this medicine and contact your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash or urticaria.
Frequency not known (frequency cannot be estimated from the available data):

• Changes similar to acne on the skin, perioral dermatitis, inhibition of epidermal growth, subcutaneous tissue atrophy, skin dryness, skin depigmentation or hyperpigmentation, skin thinning and striae, folliculitis, hypertrichosis, allergic contact dermatitis, urticaria, or papulovesicular rash.
• Perioral dermatitis - after application to the face.
• Systemic side effects characteristic of corticosteroids, such as adrenal suppression, Cushing's syndrome, growth retardation in children, hyperglycemia, glycosuria, edema, hypertension, and decreased immunity - may occur during prolonged use (more than 2 weeks), use on large skin surfaces, or on damaged skin, as well as when using occlusive dressings and in children (due to increased absorption of betamethasone into the systemic circulation).
• Worsening of glaucoma or acceleration of cataract development - may occur after local use on the eyelids.
• Blurred vision.
• Hyperglycemia.
• Dilation of superficial blood vessels.
• Hearing loss (due to gentamicin content), especially when the medicine is used on large skin surfaces or damaged skin.
• Kidney damage (due to gentamicin content), especially when used with other nephrotoxic medicines, as well as in patients with impaired kidney function.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Bedicort G Ointment

Store below 25°C. Do not freeze.
Keep the medicine out of the sight and reach of children.
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.
After first opening the tube, the medicine can be stored for a maximum of 30 days.
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 Bedicort G Ointment Contains

• The active substances are 0.5 mg betamethasone (as betamethasone dipropionate) and 1 mg gentamicin (as gentamicin sulfate) in 1 g ointment.
• The other ingredients are liquid paraffin, lanolin alcohols, cetostearyl alcohol, butylhydroxytoluene (E321), butylhydroxyanisole (E320), and white petrolatum.

What Bedicort G Ointment Looks Like and Contents of the Pack

Bedicort G is a white or almost white, semi-transparent ointment.
The medicine is available in aluminum tubes containing 15 g or 30 g ointment, packaged in a cardboard box with a patient information leaflet.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of Last Revision of the Leaflet: