Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Triderm
(0.64 mg + 10 mg + 1 mg)/g, ointment
Betamethasone dipropionate + Clotrimazole + Gentamicin
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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.

Table of contents of the leaflet

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

1. What Triderm is and what it is used for

The therapeutic properties of Triderm result from the action of its active ingredients: betamethasone dipropionate, gentamicin, and clotrimazole.
Betamethasone dipropionate belongs to the group of corticosteroids with potent activity. When applied topically, it exerts rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin is an aminoglycoside antibiotic with antibacterial activity.
Clotrimazole belongs to the group of imidazole antifungal agents. It inhibits the growth of fungi causing skin diseases. Clotrimazole acts on the fungal cell wall.
Indications
Triderm ointment for topical application is indicated for the symptomatic treatment of corticosteroid-responsive inflammatory skin conditions complicated by secondary infections caused by microorganisms, i.e. bacteria and fungi, sensitive to gentamicin and clotrimazole.
The efficacy of clotrimazole has been demonstrated in the topical treatment of tinea cruris, tinea of the groin area, tinea pedis, and non-hairy skin. Topically applied clotrimazole exerts antifungal activity against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis, candidiasis caused by Candida albicans, and pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare).
Bacteria sensitive to gentamicin include streptococcal strains (group A: β-hemolytic, α-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and some penicillinase-producing strains), and Gram-negative bacteria such as Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae.

2. Important information before using Triderm

When not to use Triderm

if the patient is allergic to betamethasone dipropionate, clotrimazole, or gentamicin, or to other corticosteroids, imidazole derivatives, aminoglycoside antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
in viral skin infections (e.g. chickenpox, herpes simplex);
in rosacea;
in acne vulgaris;
in primary bacterial and fungal skin infections;
on wounds or damaged skin;
on facial skin;
in the anal and genital areas;
in perioral dermatitis;
for prolonged use.

Warnings and precautions
Before starting treatment with Triderm, consult a doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, discontinue use of Triderm and contact a doctor who will initiate appropriate treatment.
Prolonged use of the medicine may lead to overgrowth of microorganisms resistant to gentamicin and other aminoglycoside antibiotics.
Hypersensitivity to aminoglycoside antibiotics has been reported.
Triderm must not be used in the eyes, around the eyes, or on mucous membranes.
The active ingredients of the medicine – betamethasone dipropionate and gentamicin – are absorbed through the skin into the body, and absorption is enhanced under occlusive dressings (e.g. diapers).
With excessive and prolonged use, there is a risk of systemic adverse effects typical of corticosteroids (including suppression of adrenal cortex function) and of gentamicin (such as ototoxicity, nephrotoxicity, especially in patients with impaired renal function).
Therefore, avoid using the medicine over large areas of the body, using high doses, or applying occlusive dressings.
Particular caution should be exercised by patients with psoriasis, as the use of this medicine in psoriasis may be dangerous, including due to disease recurrence caused by tolerance development, risk of generalized pustular psoriasis, and systemic toxic effects resulting from skin damage.
If the patient experiences blurred vision or other visual disturbances, consult a doctor.

Children
In children, suppression of the hypothalamic-pituitary-adrenal (HPA) axis occurs more frequently than in adults after topical application of corticosteroids, due to greater systemic absorption of betamethasone dipropionate compared to adults.
In children treated with topical corticosteroids, cases of HPA axis suppression, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperfunction), growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headache) have been reported.

Triderm with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no data on the safety of using Triderm in pregnant women.
The medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the mother, fetus, or newborn.
Use during pregnancy should be short-term and limited to small skin areas.
The doctor will decide whether breastfeeding should be discontinued or treatment with the medicine stopped, taking into account the benefit of treatment for the mother and the potential adverse effects in the child.
During breastfeeding, Triderm should not be applied to the skin of the breasts.

Driving and operating machinery
There are no data on the effect of Triderm on the ability to drive or operate machinery.

3. How to use Triderm

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
This medicine is intended for topical use on the skin.
A thin layer of Triderm should be applied to the affected areas and surrounding skin twice daily,
in the morning and evening.
Triderm should be used regularly.
Use in children
Do not use in children under 2 years of age.
In children over 2 years of age, treatment should not exceed 5 days.
The duration of treatment depends on the size and location of the lesions, as well as the patient's response to therapy.
If no improvement is observed after three to four weeks, the physician should reassess the diagnosis.
Use of a higher than recommended dose of Triderm
In case of overdose, seek immediate medical advice from a physician or pharmacist.
Excessive or prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, occurrence of adverse effects typical of corticosteroids, including Cushing's syndrome, and may promote the development of gentamicin-resistant bacterial strains and lead to hearing and kidney damage.
Missed dose of Triderm
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When using Triderm cream, very rare adverse reactions (occurring in less than 1 in 10,000 patients) have been observed; these include skin discoloration, anaemia, burning sensation, erythema, exudation, and pruritus.
Adverse reactions associated with topical application of corticosteroids, clotrimazole, and gentamicin may also occur.
Due to the presence of betamethasone dipropionate in the medicine, burning sensation, itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acne, skin discoloration, perioral dermatitis, allergic contact dermatitis, skin maceration or swelling, secondary infections, skin atrophy, striae, and miliaria may occur.
Systemic absorption of betamethasone dipropionate may lead to general adverse effects typical of corticosteroids. These effects are more likely to occur with prolonged use, application over large areas of skin, and use in children.
Hypersensitivity reactions may occur. If signs of hypersensitivity appear, treatment should be stopped immediately and a physician should be consulted.
Due to the presence of clotrimazole in the medicine, erythema, burning sensation, blistering, desquamation, oedema, pruritus, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the medicine, skin irritation (erythema and pruritus) may occur, which usually does not require discontinuation of treatment.
Blurred vision has been reported with corticosteroids (frequency unknown – cannot be estimated from available data).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Triderm

Store below 25°C.
Keep the medicine in a place out of 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.
Medicines must 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 packaging and other information

What Triderm contains

The active substances in this medicine are: betamethasone dipropionate, clotrimazole and gentamicin. Each gram of ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), 10 mg clotrimazole and 1 mg gentamicin (as gentamicin sulphate).
Other ingredients: liquid paraffin, white soft paraffin.

What Triderm looks like and contents of the pack
Triderm is an ointment.
Pack size available: Aluminium tube in a cardboard box containing 15 g of ointment.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Bulgaria, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization number in Bulgaria, country of export: 9800133
Parallel import licence number: 179/24