Triderm

Leaflet attached to the packaging: patient information

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
Read the leaflet carefully before using the medicine, as it contains important information for the patient.
for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section
• 4.

Table of contents of the leaflet

• 1. What is Triderm and what is it 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 packaging and other information

1. What is Triderm and what is it used for

The properties of Triderm result from the action of its active substances: betamethasone dipropionate, gentamicin, and clotrimazole.
Betamethasone dipropionate belongs to a group of corticosteroids with strong action, used locally it has a rapid and long-lasting anti-inflammatory, anti-itching, and vasoconstrictive effect.
Gentamicin is an aminoglycoside antibiotic with antibacterial action.
Clotrimazole belongs to a group of imidazoles with antifungal action. It inhibits the growth of fungi that cause skin diseases. Clotrimazole acts on the fungal cell wall.

Indications

Triderm ointment is indicated for the symptomatic treatment of inflammatory skin changes that respond to corticosteroids, complicated by secondary infections caused by microorganisms, i.e. bacteria and fungi sensitive to gentamicin and clotrimazole.
The effectiveness of clotrimazole has been demonstrated in the local treatment of jock itch, groin, feet, and non-hairy skin. Clotrimazole applied to the skin has an antifungal effect on Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis, candidiasis caused by Candida albicans, and pityriasis versicolor caused by Malassezia furfur(Pityrosporum orbiculare).
The bacteria sensitive to gentamicin include 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, on damaged skin;
• on facial skin;
• in the anal and genital areas;
• in perioral dermatitis;
• for a long time.

Warnings and precautions

Before starting treatment with Triderm, the patient should discuss it with their doctor or pharmacist.
In case of irritation, allergy, or infection during treatment, the use of Triderm should be discontinued and the doctor should be consulted, who will apply appropriate treatment.
Prolonged use of the medicine may lead to the growth of gentamicin-resistant and other aminoglycoside antibiotic-resistant microorganisms.
Hypersensitivity to aminoglycoside antibiotics has been reported.
Triderm should not be used in the eyes and around the eyes, as well as on mucous membranes.
The active substances of the medicine, betamethasone dipropionate and gentamicin, are absorbed through the skin into the body, and the intensity of their absorption occurs under occlusive dressing (e.g. diaper).
During excessive and prolonged use of the medicine, there is a risk of systemic side effects characteristic of corticosteroids (including adrenal suppression) and gentamicin (such as hearing loss, kidney damage, especially in people with kidney function disorders).
Therefore, the use of the medicine on a large surface of the body, in large doses, and under dressings should be avoided.
Patients with psoriasis should use the medicine with special caution, as the use of the medicine in psoriasis can be dangerous, including the risk of disease recurrence due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin damage.
If the patient experiences blurred vision or other vision disturbances, they should consult their doctor.

Children

In children, more often than in adults, suppression of the hypothalamic-pituitary-adrenal axis occurs after local use of corticosteroids due to greater absorption of betamethasone dipropionate into the body than in adults.
In children who have used topical corticosteroids, the following have been reported: suppression of the hypothalamic-pituitary-adrenal axis, adrenal insufficiency, Cushing's syndrome (adrenal hyperfunction), growth retardation, decreased weight gain, and increased intracranial pressure (e.g. bulging fontanelle, headaches).

Triderm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 doctor's opinion, the benefit to the mother outweighs the risk to the mother, fetus, or newborn.
The use of the medicine during pregnancy should be short-term and limited to a small skin surface area.
The doctor will decide whether to stop breastfeeding or stop using the medicine, taking into account the benefit of treatment for the mother and the adverse reaction in the child.
The medicine should not be used on the breast skin during breastfeeding.

Driving and using machines

There are no data on the effect of Triderm on the ability to drive and use machines.

3. How to use Triderm

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
This medicine is intended for use on the skin.
A thin layer of Triderm should be applied to the affected areas and surrounding skin twice a day, 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, it can be used for no more than 5 days.
The treatment time depends on the size and location of the lesions and the patient's response to treatment. If there is no improvement after 3-4 weeks, the doctor will verify the diagnosis.

Using more than the recommended dose of Triderm

In case of using more than the recommended dose of the medicine, the patient should immediately consult their doctor or pharmacist.
Excessive or prolonged use of the medicine may cause suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, and side effects characteristic of corticosteroids, including Cushing's syndrome, as well as the development of gentamicin-resistant bacterial strains and damage to hearing and kidneys.

Missing a dose of Triderm

The patient should not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Triderm can cause side effects, although not everybody gets them. During treatment with Triderm, very rare (occurring in less than 1 in 10,000 patients) side effects have been observed; these include skin discoloration, anemia, burning sensation, redness, exudate, and itching of the skin.
Side effects that have been observed after local use 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 petechiae may occur.
As a result of the absorption of betamethasone dipropionate into the blood, general side effects of betamethasone dipropionate, characteristic of corticosteroids, may also occur. These symptoms occur mainly in the case of prolonged use of the medicine, its use on a large skin surface area, and its use in children.
Hypersensitivity reactions may occur. If hypersensitivity reactions occur, treatment should be discontinued immediately and the doctor should be consulted.
Due to the presence of clotrimazole in the medicine, redness, burning sensation, blistering, 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.
During the use of corticosteroids, blurred vision (frequency not known - cannot be estimated from the available data) has been observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Triderm

Store at a temperature below 25°C.
The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Triderm contains

• The active substances of the medicine 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 sulfate).
• The other ingredients are: liquid paraffin, white petrolatum.

What Triderm looks like and contents of the packaging

Triderm is an ointment.
Available packaging:
Aluminum tube in a cardboard box containing 15 g of ointment.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
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

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Marketing authorization number in Bulgaria, the country of export:9800133

Parallel import authorization number: 276/23

Date of leaflet approval: 28.11.2023

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