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

Keep this leaflet, as you may need to read it again.
If you have any doubts, please 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Triderm is and what it is used for
Important information before using Triderm
How to use Triderm
Possible side effects
How to store Triderm
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 anti-inflammatory 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 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 of the groin, tinea pedis, and fungal infections of non-hairy skin. Topically applied clotrimazole is active 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 strains of streptococci (Group A: β-haemolytic, α-haemolytic), 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 any of the other ingredients of this medicine (listed in section 6);
in viral skin infections (e.g. chickenpox, herpes simplex);
in rosacea;
in common acne;
in primary bacterial or 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 overgrowth of microorganisms 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 substances of the medicine – betamethasone dipropionate and gentamicin – are absorbed through the skin into the body, and absorption is enhanced 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, particularly in patients with impaired kidney function).
Therefore, avoid using the medicine over large areas of the body, in high doses, or under occlusive dressings.
Patients with psoriasis should use the medicine with particular caution, as its use in psoriasis may be hazardous, including due to disease recurrence 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 systemic absorption of betamethasone dipropionate 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 potential adverse effects in the infant.
During breastfeeding, Triderm should 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 cetostearyl alcohol, propylene glycol, and benzyl alcohol.
Due to the presence of cetostearyl alcohol, the 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 its propylene glycol content, the medicine should not be applied to 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 a physician. In case of 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 affected areas and the 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 a higher than recommended dose of Triderm
In case of using a higher than recommended dose of Triderm, seek immediate advice from a doctor or pharmacist.
Excessive or prolonged use of the medicine may lead to suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, development of corticosteroid-related adverse effects including Cushing's syndrome, and may promote the emergence of gentamicin-resistant bacterial strains, potentially leading to 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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When using Triderm, very rare adverse effects (occurring in less than 1 in 10,000 patients) have been observed; these include skin discoloration, anaemia, burning sensation, erythema, exudation, and itching of the skin.

Adverse effects 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, itching, irritation, dryness of the skin, folliculitis, hypertrichosis, acne, skin discoloration, perioral dermatitis, allergic contact dermatitis, skin maceration or swelling, secondary infections, skin atrophy, striae, and miliaria may occur.

As a result of systemic absorption of betamethasone dipropionate into the bloodstream, general adverse effects characteristic 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 symptoms of hypersensitivity occur, treatment should be stopped immediately and a doctor should be contacted.

Due to the presence of clotrimazole in the medicine, erythema, burning sensation, blistering, desquamation, oedema, itching, urticaria, and general skin irritation may occur.

Due to the presence of gentamicin in the medicine, skin irritation (erythema and itching) may occur, which usually does not require discontinuation of treatment.

Blurred vision has been reported during corticosteroid use (frequency unknown – cannot be estimated based on available data).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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 .

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Triderm

Store below 25°C 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 packaging. The expiry date refers to the last day of the month indicated.
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 package and other information

What Triderm contains

The active substances in this medicinal product 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 components 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 with a protective membrane, with a plastic cap containing a piercing device,
in a cardboard box containing 15 g of cream.
For more detailed information, please contact the Marketing Authorisation Holder
or the Parallel Importer.
Marketing Authorisation Holder in Romania, the country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popișteanu, Nr 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel Importer:
Polypharm S.A.
Barska Street 33
02-315 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Marketing Authorisation Number in Romania, the country of export: 7215/2014/01
Parallel Import Licence Number: 274/24