Package leaflet: information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, 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 you experience any adverse effects, including any not listed in this leaflet, inform your 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 effects of Triderm result from the action of its active ingredients: betamethasone dipropionate,
gentamicin, and clotrimazole.
Betamethasone dipropionate belongs to corticosteroid drugs 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 application 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. Clotrimazole applied to the skin exerts antifungal activity 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 streptococcal strains (group A: β-hemolytic, α-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative strains, 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 or damaged skin;
on the face;
in the anal and genital areas;
in perioral dermatitis;
for prolonged periods.

Warnings and precautions
Before starting treatment with Triderm, consult a doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, discontinue use of Triderm and contact a doctor who will initiate appropriate treatment.
Prolonged use of the medicine may lead to the development of gentamicin-resistant microorganisms and resistance to 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).
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 and kidney damage, particularly in patients with impaired kidney function).
Therefore, avoid using the medicine over large areas of the body, using high doses, or applying occlusive dressings.
Patients with psoriasis should use the medicine with particular caution, as its use may be hazardous due to possible disease rebound 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
Suppression of the hypothalamic-pituitary-adrenal axis occurs more frequently in children than in adults following topical corticosteroid use, due to greater systemic absorption of betamethasone dipropionate compared to adults.
In children treated with topical corticosteroids, cases of hypothalamic-pituitary-adrenal axis suppression, 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 with other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is a lack of 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 whether administration of the medicine should be stopped, taking into account the benefits of treatment for the mother and potential adverse effects in the child.
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 vehicles or operate machinery.

Triderm cream contains cetearyl alcohol, propylene glycol, and benzyl alcohol.
Due to the presence of cetearyl alcohol, the 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 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 exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for topical use only.
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 no improvement is observed after three to four weeks, the physician will re-evaluate the diagnosis.
Use of a higher than recommended dose of Triderm
In case of using more than the recommended dose, seek immediate advice from your doctor or
pharmacist.
Excessive or prolonged use of this medicine may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, secondary adrenal insufficiency, and the development of adverse effects typical of corticosteroids, including Cushing's syndrome. It may also promote the emergence of gentamicin-resistant bacterial strains and may cause hearing and kidney damage.
Missed dose of Triderm
Do not apply a double dose to make up for a missed dose.
If you have any further questions regarding 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 experiences 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 discoloration, anaemia, burning sensation, erythema, exudation, and itching of the skin.
Adverse reactions previously reported after topical application 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 swelling or maceration, 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 occur primarily with prolonged use of the medicine, application over large skin areas, 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 the use of corticosteroids (frequency unknown - cannot be estimated from available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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.
Reporting adverse reactions enables better assessment of the medicine's safety profile.

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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the packaging 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 betamethasone dipropionate (equivalent to 0.5 mg betamethasone), 10 mg clotrimazole and 1 mg gentamicin (as gentamicin sulfate).
Other components: liquid paraffin, white soft paraffin, cetostearyl alcohol, propylene glycol, cetomacrogol, 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 marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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:
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, Antwerp, B-2220
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 7215/2014/01
Parallel import authorisation number: 274/15