Package leaflet: Information for the patient

BEDICORT G, (0.5 mg + 1 mg)/g, ointment
(Betamethasone + Gentamicin)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Bedicort G ointment is and what it is used for
Important information before using Bedicort G ointment
How to use Bedicort G ointment
Possible side effects
How to store Bedicort G ointment
Contents of the pack and other information

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

Bedicort G ointment is a topical medicine containing two active substances: betamethasone in the form of betamethasone dipropionate and gentamicin in the form of gentamicin sulfate.
Betamethasone dipropionate is a corticosteroid. When applied topically to the skin, it exerts potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin sulfate is an aminoglycoside antibiotic with antibacterial activity.

Indications
Bedicort G ointment is indicated for topical treatment of inflammatory skin conditions (dermatoses, particularly of allergic origin) that respond to corticosteroid therapy, are exudative, and complicated by secondary bacterial infection with organisms sensitive to gentamicin, especially when associated with excessive scaling, itching, or intense allergic reaction.
Bedicort G ointment is particularly used in atopic dermatitis, seborrheic dermatitis, chronic lichen simplex, keratotic eczema, psoriasis, allergic contact dermatitis, cutaneous forms of lupus erythematosus, and erythema multiforme.
Due to the presence of a potent corticosteroid, Bedicort G should be used at the beginning of treatment, for a short duration, and on small skin areas only.

2. Important information before using Bedicort G ointment

When not to use Bedicort G ointment:

if the patient is 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)
in fungal or bacterial (e.g. tuberculosis) skin infections
in skin cancers
in rosacea
in acne vulgaris
in perianal or genital inflammation or ulceration
on extensive skin lesions, especially those involving skin loss, e.g. burns
for prolonged periods
on facial skin
in children under 12 years of age
in the anal and genital areas
in perioral dermatitis
in skin infections caused by bacteria resistant to gentamicin.

Warnings and precautions

Before starting treatment with Bedicort G, consult a doctor or pharmacist.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Bedicort G ointment, discontinue use immediately and inform the doctor without delay.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Do not use occlusive dressings or bandages, as they may enhance the absorption of betamethasone dipropionate through the skin and may lead to secondary infections.
Avoid contact of the ointment with the eyes and mucous membranes. Do not apply to the eyes or around the eyes due to the risk of glaucoma or cataract.
If fungal skin infections occur, the doctor will initiate appropriate antifungal treatment.
Since betamethasone and gentamicin may be absorbed through the skin, there is a risk of systemic adverse effects when using Bedicort G ointment, including systemic corticosteroid effects (such as suppression of adrenal cortex function) and adverse effects of gentamicin (risk of ototoxicity and nephrotoxicity, especially in patients with impaired renal function).
Therefore, avoid using the ointment over large body surface areas, on damaged skin, in high doses, and in patients with impaired liver or kidney function, as well as in children.
Particular caution is required in patients with psoriasis, as topical use of corticosteroids in psoriasis may be hazardous, including the risk of disease rebound due to tolerance development, generalized pustular psoriasis, and systemic toxic effects resulting from impaired skin integrity.
Prolonged topical use of the antibiotic gentamicin may lead to overgrowth of resistant microorganisms and may result in the emergence of bacteria resistant to aminoglycoside antibiotics.
Do not apply the ointment to the face due to the risk of telangiectasia (dilation of capillaries and small blood vessels) or perioral dermatitis, even after short-term use.
Apply to the axillary and groin areas only when absolutely necessary, due to increased absorption through delicate skin.
Use with caution in conditions involving atrophy of subcutaneous tissue, especially in elderly patients.

Bedicort G ointment and other medicines
Inform the doctor about all medicines currently used, recently used, or planned for use.
The ointment may enhance or weaken the effects of drugs affecting the immune system.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Use in pregnant women is not recommended.
There are no studies on the safety of topical betamethasone dipropionate and gentamicin in pregnant women. However, it is known that these substances may be absorbed through the skin.
Animal studies have shown that potent corticosteroids applied topically may cause fetal harm. No studies have been conducted on fetal damage following topical application of betamethasone dipropionate in pregnant women.

Breastfeeding
During breastfeeding, the doctor will decide whether to discontinue breastfeeding or to discontinue/abstain from using the medicine, taking into account the risk of adverse effects in breastfed infants and the benefits of treatment for the mother.
Due to insufficient data on the passage of betamethasone and gentamicin into human milk, a risk to newborns/infants who are breastfed cannot be excluded.

Driving and operating machinery
Bedicort G has no effect or negligible effect on the ability to drive and operate machinery.

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 butylated hydroxyanisole (E 320)
The medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Bedicort G ointment

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor.
This medicine is intended for topical use on the skin.
Recommended dose:
Typically, a small amount of the medicine should be applied to the affected area once or twice daily.
Do not use the medicine under occlusive (closed) dressings.
Treatment should not be continued uninterrupted for longer than 2 weeks.
Use in children and adolescents
Bedicort G should not be used in children under 12 years of age.
Use of a higher than recommended dose of Bedicort G ointment
If more than the recommended dose is used, seek immediate medical advice from a doctor or
pharmacist.
Prolonged or inappropriate use of the medicine may result in systemic corticosteroid adverse effects, including suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth and development retardation in children, elevated blood glucose levels, glycosuria, edema, hypertension, and systemic adverse effects of gentamicin such as ototoxicity and nephrotoxicity.
In case of overdose, the physician will administer appropriate treatment.
Missed dose of Bedicort G ointment
Do not apply a double dose to make up for a missed dose.
Discontinuation of Bedicort G ointment
If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any of the following symptoms of hypersensitivity occur, discontinue use of this
medicine immediately and contact your doctor without delay: swelling of the hands, feet, ankles, face, lips, mouth
or throat, difficulty swallowing or breathing, rash or urticaria.
Frequency unknown (frequency cannot be determined from available data):
The following adverse effects may occur in connection with the use of this medicine:

Acneiform skin changes, steroid-induced purpura, inhibition of epidermal growth, subcutaneous tissue atrophy, dry skin, skin depigmentation or hyperpigmentation, skin atrophy and striae, folliculitis, hirsutism, allergic contact dermatitis, urticaria or maculopapular rash.
Perioral dermatitis – after application to the facial skin.
Systemic adverse effects characteristic of corticosteroids such as, among others, suppression of the hypothalamic-pituitary-adrenal axis function, Cushing's syndrome, growth and development suppression in children, increased blood glucose concentration, glycosuria, oedema, arterial hypertension, decreased immunity – may occur during prolonged use (over 2 weeks), application over large skin areas or damaged skin, when using occlusive dressings, and in children (due to enhanced systemic absorption of betamethasone).
Worsening of glaucoma symptoms or acceleration of cataract development – may occur after local application to the eyelid skin.
Blurred vision.
Increased blood sugar (hyperglycaemia).
Dilation of superficial blood vessels.
Hearing impairment (due to gentamicin content), especially when the medicine is applied over large skin areas or damaged skin.
Kidney damage (due to gentamicin content), particularly when used concomitantly with medicines toxic to the kidneys, as well as in cases of impaired kidney function.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting of adverse effects helps to gather further information on the safety of the 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 stated month.
After first opening the tube, Bedicort G medicine can be stored for a maximum of 30 days.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Bedicort G ointment contains

The active substances are 0.5 mg of betamethasone (as betamethasone dipropionate) and 1 mg of gentamicin as gentamicin sulphate in 1 g of ointment.
The other ingredients are: liquid paraffin, lanolin sterol alcohols, cetostearyl alcohol, butylhydroxytoluene (E321), butylhydroxyanisole (E 320), white vaseline.

What Bedicort G ointment looks like and contents of the pack
Bedicort G is a white or almost white, semi-transparent ointment.
The medicinal product is available in an aluminium tube containing 15 g or 30 g of ointment, placed in a cardboard box with a patient information leaflet.
Marketing Authorisation 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