Triderm

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

TRIDERM,(0.64 mg + 10 mg + 1 mg)/g, cream
Betamethasone dipropionate + Clotrimazole + Gentamicin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 rapid 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 cream is indicated for the symptomatic treatment of inflammatory skin changes that respond to corticosteroids, complicated by secondary infections caused by microorganisms, i.e., bacteria and fungi sensitive to gentamicin and clotrimazole.
The effectiveness of clotrimazole has been demonstrated in the local treatment of fungal infections of the groin, perineal area, feet, and non-hairy skin. Clotrimazole applied to 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 strains of 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 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, on damaged skin;
• on facial skin;
• in the anal and genital areas;
• in perioral dermatitis;
• for a long time.

Warnings and precautions

Before starting to use Triderm, you should discuss it with your doctor or pharmacist.
If irritation, allergy, or infection occurs during treatment, you should stop using Triderm and contact your doctor, who will apply appropriate treatment.
Long-term use of the medicine may lead to the growth of microorganisms resistant to gentamicin 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 medicine - betamethasone dipropionate and gentamicin - are absorbed through the skin into the body, and the intensity of their absorption occurs under occlusive dressing (e.g., diaper).
During excessive and long-term use of the medicine, there is a risk of systemic side effects characteristic of corticosteroids (including adrenal cortex suppression) and gentamicin (such as hearing loss, kidney damage, especially in people with kidney function disorders).
Therefore, you should avoid using the medicine on a large surface of the body, using it in large doses, and using dressings.
Patients with psoriasis should use the medicine with special caution, as using it in psoriasis can be dangerous, among other things, due to the risk of disease recurrence 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 disorders, they should contact their doctor.

Children

In children, more often than in adults, suppression of the hypothalamic-pituitary-adrenal axis occurs after local use of corticosteroids due to greater absorption of betamethasone dipropionate into the body than in adults.
In children who have used corticosteroids locally, the following have been reported: suppression of the hypothalamic-pituitary-adrenal axis, adrenal insufficiency, Cushing's syndrome (adrenal cortex hyperfunction), growth retardation, decreased weight gain, and increased intracranial pressure (e.g., bulging fontanelle, headaches).

Triderm and other medicines

You should tell your doctor or pharmacist about all medicines you are currently using or have recently used, as well as about medicines you plan to use. No interactions with other medicines are known.

Pregnancy and breastfeeding

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

Driving and using machines

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

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. Due to the presence of propylene glycol, the medicine should not be used on open wounds or large areas of damaged or damaged skin (e.g., burned) 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 your doctor. If you have any doubts, you should consult your doctor or pharmacist.
This medicine is intended for use on the skin.
A thin layer of Triderm should be applied to the affected areas and surrounding skin twice a day, in the morning and evening.
Triderm should be used regularly.
The treatment time depends on the size and location of the lesions and the patient's response to treatment. If there is no improvement after three to four weeks, the doctor will verify the diagnosis.

Using a higher dose of Triderm than recommended

In case of using a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
Excessive or long-term use of the medicine may cause suppression of the hypothalamic-pituitary-adrenal axis, secondary adrenal insufficiency, side effects characteristic of corticosteroids, including Cushing's syndrome, and lead to the development of gentamicin-resistant bacterial strains and damage to hearing and kidneys.

Missing a dose of Triderm

You should not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 local 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, edema or skin maceration, secondary infections, skin atrophy, striae, and telangiectasias may occur.
As a result of the absorption of betamethasone dipropionate into the blood, systemic side effects characteristic of corticosteroids may also occur. These symptoms occur mainly in the case of long-term use of the medicine, using it on a large skin surface, and using it in children.
Allergic reactions may occur. If allergic reactions occur, treatment should be stopped immediately and a doctor consulted.
Due to the presence of clotrimazole in the medicine, redness, burning sensation, blistering, peeling, edema, itching, urticaria, and general skin irritation may occur.
Due to the presence of gentamicin in the medicine, 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 any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Triderm

Store at a temperature below 25°C, in the original packaging.
The medicine should be stored 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Triderm contains

• The active substances of the medicine 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).
• The other ingredients are: liquid paraffin, white petrolatum, cetostearyl alcohol, propylene glycol, macrogol cetostearyl ether, benzyl alcohol, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide, purified water.

What Triderm looks like and what the packaging contains

Triderm is a cream.
Available packages:
An aluminum tube in a cardboard box containing 15 g of cream.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

MERCK SHARP & DOHME ROMANIA S.R.L.
Bulevardul Poligrafiei, Nr. 1A, Etaj 5, Sectorul 1, Bucharest
Romania

Manufacturer:

Schering-Plough Labo N.V.
Industriepark 30
Heist-op-den-Berg, Antwerp, B-2220
Belgium

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Romanian marketing authorization number: 7215/2014/01

Parallel import authorization number: 311/12 Date of leaflet approval: 28.04.2022

[Information about the trademark]