Triderm

Package Leaflet: Information for the Patient

Triderm, (0.64 mg + 10 mg + 1 mg)/g, Ointment

Betamethasone Dipropionate + Clotrimazole + Gentamicin

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Package 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 the group of corticosteroids with strong action, used locally it has a quick and long-lasting anti-inflammatory, anti-itching, and vasoconstrictive effect.
Gentamicin is an aminoglycoside antibiotic with antibacterial action.
Clotrimazole belongs to the group of imidazoles with antifungal action. It inhibits the growth of fungi that cause skin diseases. Clotrimazole acts on the cell wall of the fungus.

Indications

Triderm in the form of an ointment for topical use is indicated for the symptomatic treatment of inflammatory skin changes responding to corticosteroids, complicated by secondary infections caused by microorganisms, i.e., bacteria and fungi sensitive to gentamicin and clotrimazole.
Clotrimazole has been shown to be effective in the local treatment of fungal infections of the groin, perineal area, feet, and non-hairy skin. Clotrimazole used on 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 medication (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 prolonged periods.

Warnings and Precautions

Before starting to use Triderm, discuss it with your doctor or pharmacist.
In case of irritation, allergy, or infection during treatment, discontinue the use of Triderm and contact your doctor, who will apply appropriate treatment.
Prolonged use of the medication may lead to the growth of gentamicin-resistant microorganisms and other aminoglycoside antibiotics.
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 medication - betamethasone dipropionate and gentamicin - are absorbed through the skin into the body, and the intensity of their absorption occurs under occlusive dressings (e.g., diaper).
During excessive and prolonged use of the medication, 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, it is recommended to avoid using the medication on a large surface area of the body, using it in large doses, and using dressings.
Patients with psoriasis should use the medication with special caution, as its use in psoriasis can be dangerous, among other things, due to the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin damage.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

In children, more often than in adults, suppression of the hypothalamic-pituitary-adrenal axis occurs after topical 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 Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
No interactions with other medications are known.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.
There are no data on the safety of using the medication in pregnant women.
The medication 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 medication during pregnancy should be short-term and limited to a small skin surface area.
The doctor will decide whether to discontinue breastfeeding or discontinue the medication, taking into account the benefit of treatment for the mother and the adverse effect on the child.
During breastfeeding, do not use the medication on the breast skin.

Driving and Operating Machines

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

3. How to Use Triderm

Always use this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
This medication is for use on the skin.
Apply a thin layer of Triderm to the affected areas and surrounding skin twice a day, in the morning and evening.
Use Triderm regularly.

Use in Children

Do not use in children under 2 years of age.
In children over 2 years of age, use for no more than 5 days.
The duration of treatment 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 medication, contact your doctor or pharmacist immediately.
Excessive or prolonged use of the medication 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 lead to the development of gentamicin-resistant bacterial strains and cause hearing loss and kidney damage.

Missing a Dose of Triderm

Do not use a double dose to make up for a missed dose.
In case of any further doubts about using this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Triderm can cause side effects, although not everybody gets them.
During the use of 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 topical use of corticosteroids, clotrimazole, and gentamicin may also occur.
Due to the presence of betamethasone dipropionate in the medication, 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 medication, its use on a large surface area of the skin, and its use in children.
Hypersensitivity reactions may occur. If hypersensitivity reactions occur, discontinue treatment and contact your doctor immediately.
Due to the presence of clotrimazole in the medication, redness, burning sensation, blistering, peeling, swelling, itching, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the medication, 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 you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. 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:
Aleje 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.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Triderm

Store at a temperature below 25°C.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and aluminum tube after: "EXP". The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Triderm Contains

• -The active substances of the medication 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 What the Package Contains

Triderm is an ointment.
Available packages:
An aluminum tube in a cardboard box containing 15 g or 30 g of ointment.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Organon Polska Sp. z o.o.
Marszałkowska 126/134 Street
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of Last Revision of the Package Leaflet: 11/2022