Triderm

Package leaflet: information for the patient

Warning! Keep this 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 the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, 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 any adverse reactions occur in the patient, including any adverse reactions 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 strong 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 diseases. Clotrimazole acts on the fungal cell wall.

Indications
Triderm cream for topical use is indicated for symptomatic treatment of corticosteroid-responsive inflammatory skin conditions complicated by secondary infections caused by microorganisms—bacteria and fungi—susceptible 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 exerts antifungal activity on the skin against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.
Bacteria susceptible to gentamicin include streptococcal strains (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, aminoglycoside antibiotics group, 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 anal or genital area;
• 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 emergence of microbial strains 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 ingredients of the medicine – betamethasone dipropionate and gentamicin – are absorbed through the skin into the body, and absorption increases under occlusive dressings (e.g. diapers).
Excessive and prolonged use of the medicine may result in 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, avoid using the medicine over large body surface areas, 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 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 following 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 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, 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, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, 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 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 potential adverse effects in the infant.
During breastfeeding, Triderm should not be applied to the breast skin.

Driving and operating machinery
There is no data 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 per gram of cream. Propylene glycol may cause skin irritation. Because of 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 per 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. If in doubt, consult a 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 physician will reassess the diagnosis.

Use of a higher than recommended dose of Triderm
In case of application of a higher than recommended dose, consult a doctor or pharmacist immediately.
Excessive or prolonged use of this medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, and adverse effects typical of corticosteroids, including Cushing's syndrome. It may also lead to the development of gentamicin-resistant bacterial strains and cause damage to hearing and kidneys.

Missed dose of Triderm
Do not apply 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 (affecting 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 previously observed with topical 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 depigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration or swelling, secondary infections, skin atrophy, striae, and miliaria may occur.
Systemic adverse effects of betamethasone dipropionate, typical of corticosteroids, may also occur due to absorption into the bloodstream. These effects are particularly likely with prolonged use, 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 a doctor should be consulted.
Due to the presence of clotrimazole in the medicine, erythema, burning sensation, vesiculation, desquamation, swelling, 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 reported 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 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 helps provide more information on the safety of the medicine.

5. How to store Triderm

Store below 25°C.
Keep the medicine out of the 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 properly dispose of medicines no longer in use. This 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 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 sulphate).
• Other ingredients are: 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:
Aluminium tube in a cardboard box containing 15 g of cream.
For further information, please contact the responsible party or the 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
220 Heist-op-den-Berg
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Bulgaria, the country of export: 9800149
Parallel Import Authorisation Number: 140/20