Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Triderm (Тридерm), (0.64 mg + 10 mg + 1 mg)/g, ointment
Betamethasone dipropionate + Clotrimazole + Gentamicin
Triderm and Тридерm are the same trade names of the same medicine written in Polish and Bulgarian.
Please read the 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 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 effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 package 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 corticosteroids with potent activity and, when applied topically, exerts rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effects.
Gentamicin is an aminoglycoside antibiotic with antibacterial activity.
Clotrimazole belongs to the imidazole group of antifungal agents. It inhibits the growth of fungi causing skin diseases. Clotrimazole acts on the fungal cell wall.

Indications
Triderm ointment 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-haemolytic, α-haemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative strains, and some penicillinase-producing strains), and Gram-negative bacteria such as Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae.

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2. 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 the face;
in the anal and genital areas;
in perioral dermatitis;
for prolonged periods.

Warnings and precautions

Before starting treatment with Triderm, consult your doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, discontinue use of Triderm and contact your doctor, who will initiate appropriate therapy.
Prolonged use of the medicine may lead to overgrowth of microorganisms resistant to gentamicin and other aminoglycoside antibiotics.
Hypersensitivity reactions to aminoglycoside antibiotics have 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 their absorption is enhanced when used 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 and 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.
Patients with psoriasis should use the medicine with particular caution, as treatment may be hazardous, including due to disease rebound 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 hypothalamic-pituitary-adrenal (HPA) axis suppression, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperactivity), 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
There are no data on the safety of using this medicine 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 administration of the medicine stopped, taking into account the benefit of treatment for the mother and the potential adverse effects in the infant.
During breastfeeding, do not apply the medicine to the skin of the breasts.

Driving and operating machinery
There is no information available on the effect of Triderm on the ability to drive vehicles or operate machinery.

3. How to use Triderm

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
This medicine is for topical use only.
A thin layer of Triderm should be applied to the affected areas and the 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, Triderm should not be used for longer than 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 doctor will
reassess the diagnosis.
Use of more than the recommended dose of Triderm
If more than the recommended dose is used, consult your doctor or pharmacist immediately.
Excessive or prolonged use of this medicine may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, secondary adrenal insufficiency, and adverse effects typical of corticosteroids, including Cushing's syndrome. It may also lead to the emergence of gentamicin-resistant bacterial strains and cause damage to hearing and kidneys.
Missed dose of Triderm
Do not use a double dose to make up for a missed dose.
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If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During the use of Triderm, 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 observed following topical application of corticosteroids, clotrimazole, and gentamicin may also occur.

Due to the presence of betamethasone dipropionate in the medicine, burning sensation, pruritus, irritation, dry skin, folliculitis, hypertrichosis, acne, skin discoloration, perioral dermatitis, allergic contact dermatitis, swelling or maceration of the skin, secondary infections, skin atrophy, striae, and sweating may occur.

As a result of systemic absorption of betamethasone dipropionate into the bloodstream, general adverse effects characteristic of corticosteroids may also occur. These effects occur primarily with prolonged use, application over large areas of skin, and use in children.

Hypersensitivity reactions may occur. If symptoms of hypersensitivity occur, treatment should be discontinued immediately and medical advice should be sought.

Due to the presence of clotrimazole in the medicine, erythema, burning sensation, blistering, epidermal 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 observed during the use of corticosteroids (frequency unknown – cannot be estimated from available data).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Triderm

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the stated month.
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Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Triderm contains

The active substances 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).
The other ingredients are: liquid paraffin, white soft paraffin.

What Triderm looks like and contents of the pack
Triderm is an ointment.
Available pack sizes
Aluminium tube in a cardboard box containing 15 g of ointment.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Manufacturer:
Schering-Plough Labo n.v.
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Bulgaria, country of export: 9800133
Parallel import authorisation number: 315/18
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