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 this 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, pharmacist or nurse.
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 effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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 combined action of its active ingredients: betamethasone dipropionate, gentamicin and clotrimazole.
Betamethasone dipropionate belongs to the group of corticosteroids with potent anti-inflammatory activity. When applied topically, it exerts rapid and prolonged anti-inflammatory, antipruritic (anti-itching), 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 infections. 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 (jock itch), tinea of the groin, tinea pedis (athlete's foot), and tinea of non-hairy skin. Topically applied clotrimazole exerts antifungal activity against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, 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-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);
in rosacea;
in acne vulgaris;
in primary bacterial or fungal skin infections;
on wounds or damaged skin;
on facial skin;
in the anal or 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 overgrowth of microorganisms 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, 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 applying the medicine over large areas of the body, using high doses, or applying occlusive dressings.
Patients with psoriasis should use this medicine with particular caution, as its use may be dangerous, 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.
In children treated with topical corticosteroids, cases of HPA axis suppression, adrenal insufficiency, Cushing's syndrome, 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 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 her doctor or pharmacist before using this medicine.
There are no data on the safety of using this medicine during pregnancy.
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 small skin areas.
The doctor will decide whether to discontinue breastfeeding or stop administering the medicine, taking into account the benefit of treatment for the mother and the potential adverse effects on the child.
During breastfeeding, do not apply the medicine to the skin of the breasts.

Driving and operating machinery
There is no information on the effect of Triderm on the ability to drive 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 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, Triderm may be used for no longer than 5 days.
The duration of treatment depends on the size and location of the skin 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 of Triderm is used, consult a doctor or pharmacist immediately.
Excessive or prolonged use of this medicine may suppress the hypothalamic-pituitary-adrenal (HPA) axis, lead to secondary adrenal insufficiency, cause corticosteroid-related adverse effects such as 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 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. During
the use of Triderm, very rare adverse effects (occurring in less than 1 patient in 10,000) have been observed; these
include skin discolouration, anaemia, burning sensation, erythema, exudation and itching of the skin.
Adverse effects 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 discolouration, perioral dermatitis, allergic contact dermatitis,
skin swelling or maceration, 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
during prolonged use of the medicine, application over a large skin surface area, 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, desquamation,
oedema, 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 the leaflet, inform your doctor,
pharmacist or nurse. 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Triderm

Store below 25°C.
Keep the medicine 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 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 the 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.
Available pack:
Aluminium tube in a cardboard box containing 15 g of ointment.
For further information, please contact the Marketing Authorisation Holder 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing Authorisation number in Bulgaria, country of export: 9800133
Parallel Import Authorisation number: 276/23