Package leaflet: Information for the patient

Warning! Keep this 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 the entire leaflet carefully before using this 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 another person, 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

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 effects 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 imidazole group of antifungal agents. It inhibits the growth of fungi causing skin diseases. Clotrimazole acts on the fungal cell wall.

Indications
Triderm ointment for topical use is indicated in the symptomatic treatment of inflammatory skin conditions responsive to corticosteroids, complicated by secondary infections caused by microorganisms—bacteria and fungi—susceptible to gentamicin and clotrimazole.

The efficacy of clotrimazole has been demonstrated in the topical treatment of tinea cruris, tinea of the groin, tinea pedis, and tinea of glabrous skin. Topically applied clotrimazole exhibits 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 susceptible to gentamicin include streptococcal strains (Group A: β-hemolytic, α-hemolytic), 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.

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);
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 area;
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 treatment.
Prolonged use of the medicine may lead to the emergence of microbial strains 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 substances of the medicine – betamethasone dipropionate and gentamicin – are absorbed through the skin into the body, and their absorption increases under occlusive dressings (e.g. diapers).
During excessive and prolonged use of the medicine, there is a risk of systemic adverse effects typical of corticosteroids (including suppression of adrenal cortex function) and of gentamicin (such as hearing and kidney damage, especially in patients with impaired kidney 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 its use 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, contact a doctor.

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

Triderm and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, 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 have a baby, 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 doctor's opinion, the benefit to the mother outweighs the risk to the mother, fetus, or newborn.
Use during pregnancy should be short-term and limited to a small skin area.
The doctor will decide whether to discontinue breastfeeding or discontinue the medicine, taking into account the benefits of treatment for the mother and potential adverse effects in the child.
During breastfeeding, Triderm should not be applied to the breast skin.

Driving and operating machinery
There are no data 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 as directed by a physician. If in doubt, consult a doctor 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 skin lesions and the patient's response to therapy. If there is no improvement after three to four weeks, the physician will reassess the diagnosis.

Use of a higher than recommended dose of Triderm
If more than the recommended dose is used, consult a doctor or pharmacist immediately.
Excessive or prolonged use may suppress the hypothalamic-pituitary-adrenal axis, lead to secondary adrenal insufficiency, cause adverse effects typical of corticosteroids (including Cushing's syndrome), promote the development of gentamicin-resistant bacterial strains, and may result in 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 doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rarely (occurring in less than 1 in 10,000 patients), adverse effects have been observed during the use of Triderm; these include skin discoloration, anaemia, burning sensation, erythema, exudation, and itching of the skin.
Adverse reactions that have been observed following 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, swelling or maceration of the skin, secondary infections, skin atrophy, striae, and miliaria may occur.
As a result of systemic absorption of betamethasone dipropionate into the bloodstream, general adverse effects of betamethasone dipropionate characteristic of corticosteroids may also occur. These effects occur primarily with prolonged use of the medicine, application over large areas of skin, and use in children.
Hypersensitivity reactions may occur. If symptoms of hypersensitivity occur, treatment should be stopped immediately and a doctor should be contacted.
Due to the presence of clotrimazole in the medicine, erythema, burning sensation, blistering, desquamation, swelling, itching, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the medicine, skin irritation (erythema and itching) 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects allows further information on the safety of the medicine to be collected.
5. How to store Triderm
Store below 25°C.
The medicine should be stored 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 a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Triderm contains

The active substances in Triderm are betamethasone dipropionate, clotrimazole and gentamicin. Each gram of ointment contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone), 10 mg of clotrimazole and 1 mg of gentamicin (as gentamicin sulfate).
The other ingredients are: 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 more detailed 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:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Bulgaria, country of export: 9800133
Parallel Import Licence Number: 138/20