TRIDERM

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is 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 the patient.

• Keep this leaflet to be able to 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 the patient experiences 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 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 cream for topical use is indicated in 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, tinea pedis, tinea of glabrous skin, and candidiasis caused by Candida albicans, as well as pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare).
Clotrimazole acts topically against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.
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 medicines in the corticosteroid, imidazole derivatives, or aminoglycoside antibiotic groups, or to any of the other ingredients of this medicine (listed in section 6);
• in viral skin infections (e.g. chickenpox, herpes simplex);
• 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, 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 the emergence of microbial strains resistant to gentamicin and other aminoglycoside antibiotics.
Hypersensitivity reactions to aminoglycoside antibiotics have been reported.
Triderm must 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 when used 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 or kidney damage, especially in patients with impaired kidney function).
Therefore, the medicine should not be used over large areas of the body, in high doses, or under occlusive 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 tolerance development, risk of generalized pustular psoriasis, and systemic toxic effects resulting from skin damage.
If blurred vision or other visual disturbances occur, consult a doctor.

Children
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis occurs more frequently in children 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 HPA axis, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperactivity), growth retardation, reduced weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headache).

Triderm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or 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 Triderm 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 breastfeeding should be discontinued or treatment stopped, taking into account the benefits of treatment for the mother and the potential adverse effects in the infant.
During breastfeeding, Triderm must not be applied to the skin of the breasts.

Driving and operating machinery
There is no information available on the effect of Triderm on the ability to drive or operate machinery.

Triderm cream contains cetostearyl alcohol, propylene glycol, and benzyl alcohol. Due to the presence of cetostearyl alcohol, this 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 its propylene glycol content, 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 according to the doctor's instructions. 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.
The duration of treatment depends on the size and location of the lesions, as well as the patient's response to treatment.
If there is no improvement 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 axis, cause secondary adrenal insufficiency, lead to corticosteroid-related adverse effects such as Cushing's syndrome, promote the development of gentamicin-resistant bacterial strains, and may result in hearing and kidney damage.

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 depigmentation, anaemia, burning sensation, erythema, exudation, and pruritus.
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, pruritus, irritation, dryness of the skin, folliculitis, hypertrichosis, acne, skin depigmentation, perioral dermatitis, allergic contact dermatitis, maceration or swelling 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 typical 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 hypersensitivity symptoms 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, 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 based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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.
Reporting adverse reactions enables further accumulation of information on the safety of the medicine.

5. How to store Triderm

Store below 25°C. Keep 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 container.
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Triderm contains

• The active substances are: betamethasone dipropionate, clotrimazole, and gentamicin. Each gram of cream 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 sulfate).
• Other ingredients: liquid paraffin, white soft paraffin, cetostearyl alcohol, propylene glycol, macrogol cetostearyl ether, benzyl alcohol, disodium dihydrogen phosphate 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 the parallel importer.
Responsible party 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Romania, country of export: 7215/2014/01
Parallel Import Licence Number: 350/19