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, as you may need to read it again.
If you have any doubts, 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 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 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 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 corporis, 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 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 medicines in the corticosteroid, imidazole derivative, or aminoglycoside antibiotic groups, 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 or fungal skin infections;
on wounds or damaged skin;
on the face;
in the anal or genital area;
in perioral dermatitis;
for prolonged periods.

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 the development of microorganisms resistant to gentamicin and other aminoglycoside antibiotics.
Hypersensitivity reactions to aminoglycoside antibiotics have been reported.
Triderm must not be used in or 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, particularly in patients with impaired renal function).
Therefore, the medicine should not be used over large body surface areas, in high doses, or under occlusive dressings.
Particular caution is required in patients with psoriasis, as treatment with Triderm may be hazardous, including due to disease rebound caused by tolerance development, risk of generalized pustular psoriasis, and general toxic effects resulting from skin damage.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.

Children
In children, suppression of the hypothalamic-pituitary-adrenal 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, the following have been reported: suppression of the hypothalamic-pituitary-adrenal axis, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperactivity), growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headache).

Triderm with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future 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 available on the safety of using Triderm during pregnancy.
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 infant.
During breastfeeding, Triderm should not be applied 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 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 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 application of a higher than recommended dose, seek immediate advice from a doctor 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, as well as cause 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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Very rarely (occurring in less than 1 in 10,000 patients), adverse reactions have been observed during the use of Triderm; these include skin depigmentation, anaemia, burning sensation, erythema, exudation, and pruritus.
Adverse reactions associated with topical use of corticosteroids, clotrimazole, and gentamicin may also occur.
Due to the presence of betamethasone dipropionate in the product, burning sensation, pruritus, irritation, dryness of the skin, folliculitis, hypertrichosis, acne, skin depigmentation, perioral dermatitis, allergic contact dermatitis, edema or maceration of the skin, secondary infections, skin atrophy, striae, and miliaria may occur.
Systemic absorption of betamethasone dipropionate into the bloodstream may also lead to systemic adverse effects typical of corticosteroids.
These effects occur primarily with prolonged use, application over large areas of skin, and use in children.
Hypersensitivity reactions may also occur. If signs of hypersensitivity occur, treatment should be discontinued immediately and a physician should be consulted.
Due to the presence of clotrimazole in the product, erythema, burning sensation, blistering, desquamation, swelling, pruritus, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the product, skin irritation (erythema and pruritus) may occur, which usually does not require discontinuation of treatment.
Blurred vision has been reported during corticosteroid use (frequency unknown - cannot be estimated from available data).
Reporting of adverse reactions
If any adverse reactions occur, including those 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Adverse reactions may also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Triderm

Store below 25°C, in the original packaging.
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.
Medicines must not be disposed of via wastewater 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 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 are: liquid paraffin, white vaseline.

What Triderm looks like and contents of the pack
Triderm is an ointment.
Available pack:
Aluminium tube with a protective membrane, with a screw cap made of plastic material with a piercing device, in a cardboard box containing 15 g of ointment.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popișteanu, Nr 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel importer:
Polypharm S.A.
ul. Barska 33
02-315 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorisation number in Romania, country of export: 7214/2014/01
Parallel import authorisation number: 275/24