Terbiderm

Package Leaflet: Information for the Patient

Terbiderm, 10 mg/g, Cream

Terbinafine Hydrochloride

Read the Package Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in the package leaflet or as advised by your doctor or pharmacist or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.
• If after 14 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Terbiderm and what is it used for
• 2. Important information before using Terbiderm
• 3. How to use Terbiderm
• 4. Possible side effects
• 5. How to store Terbiderm
• 6. Contents of the pack and other information

1. What is Terbiderm and what is it used for

Terbiderm is a white or almost white cream with a mild odor for application to the skin, containing the active substance - terbinafine hydrochloride. This medication has antifungal properties, acting on various species of fungi that cause skin diseases. The terbinafine in Terbiderm has a fungicidal effect (causes the death of fungal cells) on dermatophytes and molds. On yeasts, depending on the species, it has a fungicidal or fungistatic effect (inhibits fungal growth).
Terbiderm is an antifungal medication for topical use in the treatment of the following fungal infections:

• athlete's foot,
• foot infection (moccasin-type foot infection),
• fungal infection of skin folds and smooth skin,
• pityriasis versicolor,
• cutaneous candidiasis. Athlete's foot- occurs on one or both feet, most commonly between the toes. In the case of foot infection, it also appears on the sole, heel, or other parts of the foot. Fungal changes between the toes are characterized by maceration, peeling, and may also have a vesicular character. Sudden exacerbations with the eruption of numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and the eruption of vesicles may be mild or severe. In the case of long-standing athlete's foot, nail infection (fungal infection on the surface or under the nail plate) may occur. The nails become thickened, dull, and there is an accumulation of horny masses under their edge. The nail plate becomes layered, and the nail may be destroyed. If the above-mentioned changes occur in the nails, you should consult a doctor, as Terbiderm is NOT effective in the treatment of nail fungus. In this case, it is necessary to take other medications available at the pharmacy with a doctor's prescription.

in the area of the nails. If the above-mentioned changes occur in the nails, you should consult a doctor, as Terbiderm is NOT effective in the treatment of nail fungus. In this case, it is necessary to take other medications available at the pharmacy with a doctor's prescription.
Fungal infection of skin folds– may appear on skin areas that are folded and moist, i.e.:

• in the groin,
• on the inner surface of the thighs (bilateral changes, but often more severe on one side; these changes may spread to the buttocks or up the abdomen),
• under the breasts,
• in the armpits. Fungal changes that appear on the skin in these areas cause redness, itching, and peeling of the epidermis. Fungal infection of smooth skin- may occur on the entire body, most commonly found on non-hairy skin of the head, neck, face, and arms. Characteristic are ring-shaped foci of pink to red color. They are covered with grains and scales, spread peripherally, and tend to regress in the central part. Pityriasis versicolor- occurs on the skin in the form of peeling, plaque-like foci. These changes may appear only in the summer, as the foci of the fungus do not tan under the influence of sunbathing, they appear as spots of various sizes. Pityriasis versicolor mainly occurs on the torso, neck, and arms, especially during heatwaves and increased skin sweating. Cutaneous candidiasis- occurs mainly in skin folds, in moist areas prone to sweating, e.g. under the breasts and in the armpits, especially in obese or diabetic individuals. These changes cause redness, itching, and peeling of the skin. If after 14 days there is no improvement or you feel worse, you should consult a doctor.

2. Important Information Before Using Terbiderm

When Not to Use Terbiderm

Warnings and Precautions

Before starting to use Terbiderm, discuss it with your doctor or pharmacist or nurse.

• Terbiderm is intended for topical use on the skin only.
• Do not use this medication in the mouth, do not swallow it.
• Avoid contact of the medication with the eyes. If the medication accidentally gets into the eyes, rinse them with running water. If discomfort persists in the eyes, consult a doctor.
• Infants should not have access to the treated skin, including breast skin.

Children and Adolescents

Do not use in children under 12 years of age.

Terbiderm and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
No interactions of Terbiderm with other medications are known.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.
During pregnancy, Terbiderm can be used only in justified cases.
Do not use Terbiderm during breastfeeding. Infants and young children should not have access to the skin treated with this medication, including breast skin.

Driving and Operating Machines

Terbiderm has no effect on the ability to drive vehicles and operate machines.

Terbiderm Contains Cetyl Alcohol, Cetostearyl Alcohol, and Benzyl Alcohol

Cetyl alcohol and cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
The medication contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause mild local irritation. Benzyl alcohol may cause allergic reactions.

3. How to Use Terbiderm

This medication should always be taken exactly as advised by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
In the case of fungal nail infection(fungal infection inside the nail plate or under the nail), occurring with discoloration and change in the structure of the nail (thickening, peeling), consult a doctor, as Terbiderm is NOT effective in the treatment of this type of infection. In this case, oral products available at the pharmacy with a doctor's prescription should be used.
Terbiderm is intended for application to the skin.
The following dosing regimen is recommended:

• Athlete's foot (excluding the sole and lateral surfaces of the feet): apply once a day for 1 week.
• Moccasin-type foot infection (involving the soles and lateral surfaces of the feet): apply twice a day for 2 weeks.

The medication should be used in the recommended doses for the recommended period, even if the symptoms of the infection disappear after a few days of using the cream. This will prevent the recurrence of the disease, which may occur if the medication is not used regularly or is used for a shorter period than recommended. After using Terbiderm, improvement should occur within a few days. After completing the 7-day therapy, the medication continues to have a fungicidal effect on the skin. Therefore, even after completing the treatment, further improvement should be observed. If there is no improvement after 2 weeks from the start of treatment, consult a doctor.

• Fungal infection of skin folds: apply once a day for 1 week.
• Fungal infection of smooth skin: apply once a day for 1 week.
• Cutaneous candidiasis: apply once a day for 1 week.
• Pityriasis versicolor: apply once a day for 2 weeks. The medication should be used in the recommended doses for the recommended period, even if the symptoms of the infection disappear after a few days of using the cream. This will prevent the recurrence of the disease, which may occur if the medication is not used regularly or is used for a shorter period than recommended. After using Terbiderm, improvement should occur within a few days. After completing the 7-day therapy, the medication continues to have a fungicidal effect on the skin. Therefore, even after completing the treatment, further improvement should be observed. If there is no improvement after 2 weeks from the start of treatment, consult a doctor.

How to Proceed During Treatment with Terbiderm Cream

During treatment, the affected skin should be:

• kept clean by regular washing,
• wiped gently, not rubbed,
• avoid scratching the treated areas, as this may slow down the healing process or spread the infection. The basis for the prevention of fungal skin diseases is the use of your own towel, personal clothes, and frequent washing. If you feel that the effect of the medication is too strong or too weak, consult a doctor.

Using More Than the Recommended Dose of Terbiderm

In case of using more than the recommended dose of the medication, consult a doctor.

Missing a Dose of Terbiderm

In case of missing a dose, use it as soon as possible and then use the medication according to the dosing regimen. Do not use a double dose to make up for the missed dose. You should regularly use Terbiderm, as using it according to the recommendations is the basis for the success of the therapy and reduces the risk of re-infection.

4. Possible Side Effects

Like all medications, Terbiderm can cause side effects, although not everybody gets them.

If You Experience Any of the Following Side Effects, Which May Indicate an Allergic Reaction, STOP Using Terbiderm and Consult a Doctor Immediately:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue, or throat,
• persistent itching with a red rash or bumps.

Common Side Effects (May Occur in Less Than 1 in 10 People)

Peeling of the skin, itching.

Uncommon Side Effects (May Occur in Less Than 1 in 100 People)

Skin changes, crusts, skin disorders, changes in skin color, redness, burning, pain, pain at the application site, irritation at the application site.

Rare Side Effects (May Occur in Less Than 1 in 1000 People)

Dryness of the skin, eczema.
In case of contact of Terbiderm with the eyes, irritation may occur.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Terbiderm

Keep the medication out of the sight and reach of children.
Store in the original packaging.
Do not use this medication after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Terbiderm Contains

• The active substance of the medication is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride.
• The other ingredients are: sodium hydroxide, benzyl alcohol, cetostearyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, sorbitan stearate, purified water.

What Terbiderm Looks Like and What the Pack Contains

Terbiderm is a white or almost white cream with a mild odor.
The medication is available in an aluminum tube containing 15 g of cream with a polyethylene cap, placed in a carton.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information about the medication, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
lekalert@grodzisk.rgnet.org
Fax: +48 (22) 755 96 24

Date of Last Revision of the Leaflet: