Triderm

Package leaflet: Information for the patient

Warning! Keep the 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, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• 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 reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 corticosteroid drugs with potent 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 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 corporis, and non-hairy skin. Topical clotrimazole 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 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 medicines in the corticosteroid group, 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 overgrowth of microorganisms resistant to gentamicin and to other aminoglycoside antibiotics.
Hypersensitivity to aminoglycoside antibiotics has been reported.
Triderm must not be used in or 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, especially in patients with impaired kidney function).
Therefore, use on large body surface areas, high doses, and occlusive dressings should be avoided.
Particular caution is required in patients with psoriasis, as treatment with this medicine may be dangerous, 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, consult a doctor.

Children
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis occurs more frequently in children 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: 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) have been reported.

Triderm with 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 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 are no data on the safety of using Triderm 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.
Use during pregnancy should be short-term and limited to a small skin surface area.
The doctor will decide whether breastfeeding should be discontinued or treatment stopped, taking into account the benefits of treatment for the mother and the potential adverse effects in the infant.
During breastfeeding, Triderm must 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 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 as directed by the physician. In case of doubts, consult your
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 therapy. If no improvement is observed after three to four weeks, the physician will reassess the diagnosis.
Use of more than the recommended dose of Triderm
If more than the recommended dose of Triderm is used, consult a doctor or pharmacist immediately.
Excessive or prolonged use of this medicine may suppress the hypothalamic-pituitary-adrenal axis, cause secondary adrenal insufficiency, lead to corticosteroid-related adverse effects including Cushing's syndrome, promote the development of gentamicin-resistant bacterial strains, and may result in 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them. When
using Triderm, very rare adverse reactions (occurring in less than 1 patient in 10,000) have been observed; these
include skin discolouration, anaemia, burning sensation, erythema, exudation and itching of the skin.
Adverse reactions which have been observed 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, dry
skin, folliculitis, hypertrichosis, acne, skin discolouration, perioral dermatitis, allergic contact dermatitis,
skin oedema 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 characteristic 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 signs of hypersensitivity occur, treatment should be discontinued
immediately and a doctor should be consulted.
Due to the presence of clotrimazole in the medicine, erythema, burning sensation, blistering, epidermal
desquamation, swelling, 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 a doctor,
pharmacist or nurse. 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.
Adverse reactions can also be reported to the responsible entity or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Triderm medicine

Store below 25°C in the original packaging.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to 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 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 sulphate).
• Other ingredients: 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 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing Authorisation number in Romania, the country of export: 7215/2014/01
Parallel Import Authorisation number: 117/24