PACKAGE LEAFLET: INFORMATION FOR THE USER

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 this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it 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 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 class 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 is indicated for the symptomatic treatment of corticosteroid-responsive inflammatory skin conditions complicated by secondary infections caused by microorganisms (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, tinea pedis, and tinea of non-hairy skin. Clotrimazole applied to the skin 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 strains of streptococci (group A: β-haemolytic, α-haemolytic), 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 medicines in the corticosteroid group, imidazole derivatives, aminoglycoside antibiotics, or to any of the other components 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 areas;
in perioral dermatitis;
for prolonged periods.

Warnings and precautions
Before starting treatment with Triderm, discuss this with 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 an increase in microbial strains resistant to gentamicin and other aminoglycoside antibiotics.
Hypersensitivity to aminoglycoside antibiotics has been reported.
Triderm should not be used in or 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 absorption is enhanced under occlusive dressings (e.g. diapers).
With 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, particularly in patients with impaired kidney function).
Therefore, avoid using the medicine over large areas of the body, using high doses, or applying dressings.
Particular caution should be exercised by patients with psoriasis, as use of the medicine in psoriasis may be dangerous, including due to disease recurrence caused by development of tolerance, 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 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 the patient is currently using or has 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 child, she should consult a doctor or pharmacist before using this medicine.
There are no data on the safety of using the 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 of the medicine during pregnancy should be short-term and limited to a small area of skin.
The doctor will decide whether breastfeeding should be discontinued or administration of the medicine stopped, taking into account the benefits of treatment for the mother and potential adverse effects in the infant.
During breastfeeding, the medicine 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 vehicles or operate machinery.

3. How to use Triderm

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your 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 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 the medicine may lead to suppression of the
hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, and the occurrence of
adverse effects typical of corticosteroids, including Cushing's syndrome, as well as the development of
gentamicin-resistant bacterial strains and may lead to hearing damage and kidney toxicity.
Missed dose of Triderm
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning 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.
Very rarely (occurring in less than 1 in 10,000 patients), adverse reactions have been observed during the use of Triderm; these include skin discoloration, anaemia, burning sensation, erythema, exudation, and itching of the skin.
Adverse reactions may also occur that have been observed following topical use of corticosteroids, clotrimazole, and gentamicin.
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 characteristic of corticosteroids may also occur. These effects are particularly likely 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 stopped immediately and a doctor should be contacted.
Due to the presence of clotrimazole in the medicine, erythema, burning sensation, formation of blisters, desquamation of the stratum corneum, 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 based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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, 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 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 properly dispose of medicines no longer in use. 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 are: liquid paraffin, white soft paraffin.

What Triderm looks like and contents of the pack
Triderm is an ointment.
Available pack:
Aluminium tube in a cardboard box containing 15 g of ointment.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popişteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1
Bucharest
Romania
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 by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Romania, country of export: 7214/2014/01
Parallel import licence number: 372/19