Triderm

Package leaflet: Information for the patient

Warning! Keep the package leaflet, information on the immediate packaging in a foreign language!
Triderm
(0.64 mg + 10 mg + 1 mg)/g, cream
Betamethasone dipropionate + Clotrimazole + Gentamicin
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• 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

1. What Triderm is and what it is used for
2. Important information before using Triderm
3. How to use Triderm
4. Possible side effects
5. How to store Triderm
6. 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 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 infections. Clotrimazole acts on the fungal cell wall.

Indications
Triderm cream for topical application is indicated for 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 any other medicines in the corticosteroid group, 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;
• around the anus and genital organs;
• 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 development of microbial strains resistant to gentamicin and other aminoglycoside antibiotics.
Hypersensitivity reactions to aminoglycoside antibiotics have 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, particularly in patients with impaired kidney function).
For this reason, avoid applying the medicine over large areas of the body, using high doses, or applying occlusive dressings.
Particular caution is required in patients with psoriasis, as use of the medicine in psoriasis may be dangerous, including due to disease relapse 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 (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, cases of suppressed HPA axis function, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperactivity), growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headache) have been reported.

Triderm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 Triderm in pregnant women.
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 breastfeeding should be discontinued or treatment stopped, taking into account the benefit of treatment for the mother and the potential adverse effects on the infant.
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 or operate machinery.

Triderm cream contains cetearyl alcohol, propylene glycol, and benzyl alcohol.
Due to the presence of cetearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 100 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation. Because of the presence of propylene glycol, the medicine should not be used on open wounds or large areas of injured or damaged skin (e.g. burned skin) without consulting a doctor or pharmacist.
This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Triderm

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician 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.
The duration of treatment depends on the size and location of the lesions, as well as the patient's response to therapy.
If there is no improvement after three to four weeks, the physician will re-evaluate 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 physician 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 emergence of gentamicin-resistant bacterial strains, as well as cause hearing and kidney damage.
Missed dose of Triderm
Do not use a double dose to make up for a missed dose.
In case of any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When using Triderm, very rare adverse reactions (occurring in less than 1 in 10,000 patients) have been observed; these include skin depigmentation, anaemia, burning sensation, erythema, exudation, and pruritus.
Adverse reactions associated with the topical use of corticosteroids, clotrimazole, and gentamicin may also occur.
Due to the presence of betamethasone dipropionate in the medicine, burning sensation, pruritus, irritation, dryness of the skin, folliculitis, hypertrichosis, acne, skin depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration or swelling, secondary infections, skin atrophy, striae, and miliaria may occur.
Systemic absorption of betamethasone dipropionate may also lead to general 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 occur. If symptoms of hypersensitivity appear, 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, pruritus, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the medicine, skin irritation (erythema and pruritus) 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Triderm medicine

Store below 25°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and aluminium tube.
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 you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Triderm contains

• The active substances in this medicine are betamethasone dipropionate, clotrimazole and gentamicin (as gentamicin sulphate). Each gram of cream 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 vaseline, cetostearyl alcohol, propylene glycol, macrogol cetostearyl ether, benzyl alcohol, disodium dihydrogen diphosphate dihydrate, phosphoric acid, sodium hydroxide, purified water.

What Triderm looks like and contents of the pack
Triderm is a cream.
Available pack sizes:
Aluminium tube in a cardboard box containing 15 g of cream.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Bulgaria, the country of export: 9800149
Parallel import authorisation number: 165/24