Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the outer packaging is 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 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 effects, including those 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 group of corticosteroids with potent 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 diseases. Clotrimazole acts on the fungal cell wall.

Indications
Triderm ointment for topical application 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 of the groin area, tinea pedis, and fungal infections of non-hairy skin. Topically applied clotrimazole exerts antifungal activity against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis, candidiasis caused by Candida albicans, as well as pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare).

Bacteria susceptible to gentamicin include streptococcal strains (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 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 perianal and genital areas;
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 growth of microorganisms 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 absorption increases 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, especially in patients with impaired kidney function).
Therefore, avoid using the medicine over large areas of the body, in high doses, or under 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 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 (adrenal cortex hyperactivity), growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headaches).

Triderm and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends 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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data 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 areas of skin.
The doctor will decide whether breastfeeding should be discontinued or treatment stopped, taking into account the benefits of treatment for the mother and potential adverse effects in the child.
During breastfeeding, Triderm must 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 as directed by a physician. 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 physician will reassess the diagnosis.
Use of more than the recommended dose of Triderm
In case of application of more than the recommended dose, consult a doctor or
pharmacist immediately.
Excessive or prolonged use of this medicine may suppress the hypothalamic-pituitary-adrenal axis, cause secondary adrenal insufficiency, produce adverse effects typical of corticosteroids, including Cushing's syndrome, and may lead to the development of gentamicin-resistant bacterial strains, as well as cause hearing impairment and nephrotoxicity.
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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
When Triderm is used, adverse effects have very rarely been observed (occurring in less than 1 in 10,000 patients); these include skin discolouration, anaemia, burning sensation, redness, exudation, and itching of the skin.
Adverse effects that have been 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, excessive hair growth, 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 characteristic of corticosteroids may also occur. These effects are mainly observed during 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 medical advice should be sought.
Due to the presence of clotrimazole in the medicine, redness, burning sensation, blistering, skin peeling, swelling, itching, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the medicine, skin irritation (redness 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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.
Reporting adverse effects 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 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 more detailed information, please contact the responsible party 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:
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, Antwerp, B-2220
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Romania, country of export: 7214/2014/01
Parallel import authorisation number: 250/15