Terbinafina Ziaia

Package Leaflet: Information for the Patient

Terbinafina Ziaja, 10 mg/g, Cream

Terbinafine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 14 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Terbinafina Ziaja and what is it used for

Terbinafina Ziaja is a cream containing the active substance terbinafine hydrochloride. The medicine has a local antifungal effect and is intended for use on the skin. Terbinafina Ziaja has a fungicidal effect (causes the death of fungi) on fungi that cause skin infections in humans, such as dermatophytes and molds. On yeast, depending on the species, it has a fungicidal or fungistatic effect (inhibits the growth of fungi).

Indications:

• athlete's foot,
• plantar foot fungus,
• skin fold fungus,
• smooth skin fungus,
• pityriasis versicolor,
• cutaneous candidiasis.

Athlete's foot– occurs on one or both feet, most often between the toes; it also appears on the sole or sides of the feet. Fungal changes between the toes cause maceration of the skin, cracking, peeling of the epidermis, and may also be accompanied by rashes in the form of nodules and vesicles. The development of the infection is favored by heat, moisture, and damage to the epidermis. Sudden exacerbations with numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and rash may be mild or severe. In the case of long-standing athlete's foot, there may be an infection of the nails. Skin fold fungus– 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 also 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.

Smooth skin fungus– may occur on the entire body, most often found on non-hairy skin of the head, neck, face, and arms. Characteristic are ring-shaped foci with a pink to red color. They are covered with nodules and scales, spread outward, and tend to clear in the central part. Pityriasis versicolor– occurs on the skin in the form of scaly, patchy foci. These changes may only become visible in the summer, as the fungal foci do not tan under the influence of sunbathing, becoming visible as spots of various sizes. Pityriasis versicolor usually appears on the torso, neck, 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. In case of doubts about the cause of the infection, a doctor should be consulted before using the medicine. If there is no improvement after 14 days or the patient feels worse, a doctor should be consulted.

2. Important information before using Terbinafina Ziaja

When not to use Terbinafina Ziaja

If the patient is allergic to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Terbinafina Ziaja, the doctor or pharmacist should be consulted. Terbinafina Ziaja is intended for use on the skin only. Contact with the eyes should be avoided. If the medicine accidentally gets into the eyes, they should be rinsed with running water.

Children

Terbinafina Ziaja is not recommended for children under 12 years of age. Data on the use of the medicine in children are limited.

Terbinafina Ziaja and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any medicines planned to be used. No interactions between Terbinafina Ziaja and other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Pregnancy: Terbinafina Ziaja can be used during pregnancy only on the doctor's prescription. Breastfeeding: Terbinafina Ziaja should not be used during breastfeeding, as the active substance of the medicine (terbinafine hydrochloride) passes into human milk. Infants and young children should not have access to the skin treated with this medicine, including breast skin.

Driving and using machines

Terbinafina Ziaja does not affect the ability to drive or use machines.

Terbinafina Ziaja contains cetyl alcohol and stearyl alcohol.

The medicine may cause a local skin reaction (e.g., contact dermatitis).

Terbinafina Ziaja contains benzyl alcohol.

The 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 Terbinafina Ziaja

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor. In case of doubts, a doctor or pharmacist should be consulted. Terbinafina Ziaja is intended for use on the skin.

Method of use

• Before applying the medicine, the skin surface should be carefully washed and dried.
• A thin layer of cream should be applied to the affected skin and the surrounding areas, gently rubbing it in.
• If the affected areas are in a skin fold (under the breast, between the toes or fingers, in the groin, or under the buttocks), a sterile gauze can be applied to the skin, especially at night.
• After using the medicine, hands should be washed, unless they are the area being treated.

Use in adults and children over 12 years of age

Athlete's foot – once a day for 1 week; plantar foot fungus – twice a day for 2 weeks; skin fold fungus – once a day for 1 week; smooth skin fungus – once a day for 1 week; cutaneous candidiasis – once a day for 1 week; pityriasis versicolor – once a day for 2 weeks. The medicine should be used according to the recommended dosage regimen. Treatment should be continued even if the symptoms of the infection disappear after a few days of using the medicine. This will prevent the recurrence of the disease, which may occur if the medicine is not used regularly or is used for a shorter period than recommended. If there is no improvement after 14 days or the patient feels worse, a doctor should be consulted. 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.

Use in children

Terbinafina Ziaja is not recommended for children under 12 years of age.

Use in the elderly

There are no data indicating the need to change the dosage in the elderly or the possibility of other side effects than those observed in younger patients.

Using more than the recommended dose of Terbinafina Ziaja

In case of using more than the recommended dose of the medicine, a doctor should be consulted. Side effects may occur, such as those that occur after oral administration of terbinafine, e.g., headache, nausea, abdominal pain, and dizziness.

Missing a dose of Terbinafina Ziaja

In case of missing a dose, the medicine should be used as soon as possible and then used according to the dosage regimen. A double dose should not be used to make up for the missed dose. Terbinafina Ziaja should be used regularly, as this is the basis for the success of the treatment and reducing the risk of recurrence of the infection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people)Peeling of the skin, itching. Uncommon side effects (may affect up to 1 in 100 people)Skin changes, crusts, skin disorders, pigmentation disorders, redness, burning sensation of the skin, pain, pain at the application site, irritation at the application site. Rare side effects (may affect up to 1 in 1,000 people)Eye irritation, dryness of the skin, contact dermatitis, rash, exacerbation of disease symptoms. Frequency not known (cannot be estimated from the available data)Hypersensitivity, rash. At the application site, symptoms may occur, such as itching, peeling of the skin, pain at the application site, irritation at the application site, pigmentation disorders, burning sensation of the skin, redness, formation of crusts, etc. However, these should not be confused with allergic reactions (hypersensitivity), such as rash. If allergic reactions occur, treatment should be discontinued and a doctor consulted. In case of accidental contact with the eyes, the medicine may cause eye irritation.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. 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 Tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Terbinafina Ziaja

Store in a temperature below 25°C. Do not freeze. 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 after "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the package and other information

What Terbinafina Ziaja contains

• The active substance of the medicine is terbinafine hydrochloride. One gram of cream contains 10 mg of terbinafine hydrochloride.
• The other ingredients are: isopropyl myristate, cetyl alcohol, stearyl alcohol, sorbitan stearate (Type 50), cetyl palmitate (15), polysorbate 60, benzyl alcohol, sodium hydroxide, purified water.

What Terbinafina Ziaja looks like and contents of the package

Terbinafina Ziaja is a white or almost white cream. Packaging: aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with a polyethylene cap, containing 15 g of cream, placed with a package leaflet in a cardboard box.

Marketing authorization holder and manufacturer

ZIAJA Ltd Pharmaceutical Production Plant sp. z o.o. ul. Jesienna 9 80-298 Gdańsk Tel.: +48 58 521 34 00

Date of the last revision of the package leaflet: