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 so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. 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, pharmacist, or nurse. See section 4.

Leaflet 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 combined action of its active ingredients: betamethasone dipropionate, gentamicin, and clotrimazole.
Betamethasone dipropionate belongs to a class of drugs known as corticosteroids with potent anti-inflammatory activity. When applied topically, it exerts rapid and long-lasting 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 infections. Clotrimazole acts on the fungal cell wall.

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

The efficacy of clotrimazole has been demonstrated in the topical treatment of tinea cruris, tinea pedis, tinea of glabrous skin, and candidiasis caused by Candida albicans, as well as pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare). Clotrimazole is active against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.

Bacteria susceptible 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 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 it 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 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 ingredients of the medicine – betamethasone dipropionate and gentamicin – are absorbed through the skin into the body, and absorption is increased 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 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 occlusive dressings.
Patients with psoriasis should use the medicine with particular caution, as its use in psoriasis may be dangerous, including due to disease relapse 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 (HPA) 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 HPA axis, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperactivity), growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headaches).

Triderm with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 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 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 benefit of treatment for the mother and the potential adverse effects for the child.
During breastfeeding, do not apply the medicine to the skin of the breasts.

Driving and operating machinery
There are no data 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. In case of doubts, 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 physician should reassess the diagnosis.
Use of a higher than recommended dose of Triderm
In case of using more than the recommended dose, seek immediate advice from a doctor or pharmacist.
Excessive or prolonged use of this medicine may suppress the hypothalamic-pituitary-adrenal (HPA) axis, cause secondary adrenal insufficiency, lead to corticosteroid-related adverse effects such as Cushing's syndrome, and may promote the development of gentamicin-resistant bacterial strains, potentially causing 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 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 patient in 10,000) have been observed; these include skin discoloration, anaemia, burning sensation, erythema, exudation and itching of the skin.

Adverse reactions observed after 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 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 consulted.

Due to the presence of clotrimazole in the medicine, erythema, burning sensation, blistering, epidermal exfoliation, 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 reported during the use of corticosteroids (frequency unknown – cannot be estimated from the 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 for Monitoring Adverse Drug Reactions of 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 can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Triderm medication

Store below 25°C in the original packaging.
The medication should be stored in a place invisible and inaccessible to children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medications must not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 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 Romania, the 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
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 Romania, the country of export: 7214/2014/01
Parallel Import Licence Number: 118/24