Terbinafine ziaja
Poland
Table of Contents
Package leaflet: Information for the patient
Terbinafina Ziaja, 10 mg/g, cream
Terbinafini hydrochloridum
Please read this 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 patient leaflet or as advised by
the doctor or pharmacist.
- Keep this leaflet, so that you can read it again if necessary.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 14 days of treatment, or if your condition worsens, consult your doctor.
Table of contents
- What Terbinafina Ziaja is and what it is used for
- Important information before using Terbinafina Ziaja
- How to use Terbinafina Ziaja
- Possible side effects
- How to store Terbinafina Ziaja
- Contents of the package and other information
1. What Terbinafina Ziaja is and what it is used for
Terbinafina Ziaja is a cream containing the active substance terbinafini hydrochloridum.
The medicine has local antifungal activity and is intended for topical application to the skin.
Terbinafina Ziaja acts fungicidally (causing fungal death) against dermatophytes and moulds responsible for human skin infections. Against yeasts, its activity is either fungicidal or fungistatic (inhibiting fungal growth), depending on the species.
Indications:
- Athlete's foot (tinea pedis),
- Plantar tinea pedis,
- Intertriginous fungal infection,
- Fungal infection of smooth skin,
- Pityriasis versicolor,
- Cutaneous candidiasis.
Athlete's foot – affects one or both feet, most commonly between the toes; may also occur on the soles or the sides of the feet. Fungal lesions between the toes cause maceration, fissuring, and scaling of the skin, and may also present with eruptions consisting of papules and vesicles. Warmth, moisture, and epidermal damage favor the development of infection. Acute flare-ups with numerous vesicles and blisters typically occur during hot weather. Itching, pain, inflammation, and vesicular eruptions may be mild or severe. Long-standing athlete's foot may lead to nail infection.
Intertriginous fungal infection – may develop in skin folds that are moist and warm, such as:
- Groin area,
- Inner thighs (lesions may be bilateral, but often more pronounced on one side; may spread to the buttocks or upwards towards the abdomen),
- Under the breasts,
- Armpits.
Fungal lesions in these areas cause redness, itching, and desquamation of the skin.
Fungal infection of smooth skin – may occur anywhere on the body, but is most commonly seen on the non-hairy skin of the head, neck, face, and arms. Characteristic lesions are ring-shaped, pink to red in color, covered with papules and scales, spreading peripherally, with a tendency to clear centrally.
Pityriasis versicolor – appears on the skin as scaly, plaque-like lesions. These lesions may become more visible only in summer, as the affected areas do not tan when exposed to sunlight, appearing as hypopigmented or hyperpigmented patches of varying size. Pityriasis versicolor mainly affects the trunk, neck, and arms, particularly during hot weather and increased sweating.
Cutaneous candidiasis – occurs mainly in skin folds, in moist areas prone to sweating, such as under the breasts and in the armpits, especially in obese individuals or those with diabetes. These lesions cause redness, itching, and skin desquamation.
If you are unsure about the cause of the infection, consult your doctor before using this medicine.
If there is no improvement after 14 days of treatment, or if your condition worsens, consult your doctor.
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 treatment with Terbinafina Ziaja, discuss it with your doctor or pharmacist.
Terbinafina Ziaja is for external use on the skin only.
Avoid contact with the eyes. If accidental contact occurs, rinse thoroughly with running water.
Children
Terbinafina Ziaja is not recommended for children under 12 years of age. Data on use in children are limited.
Terbinafina Ziaja and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
No interactions between Terbinafina Ziaja and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Terbinafina Ziaja should be used during pregnancy only on the advice of a doctor.
Breastfeeding
Do not use Terbinafina Ziaja during breastfeeding, as the active substance (terbinafine hydrochloride) passes into human milk. Infants and young children should not have access to skin treated with this medicine, including the breast area.
Driving and operating machinery
Terbinafina Ziaja has no effect on the ability to drive or operate machinery.
Terbinafina Ziaja contains cetyl alcohol and stearyl alcohol.
This medicine may cause local skin reactions (e.g. contact dermatitis).
Terbinafina Ziaja contains benzyl alcohol.
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 Terbinafina Ziaja
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Terbinafina Ziaja is for topical use only.
Instructions for use
- Before applying the medicine, wash and thoroughly dry the affected skin area.
- Apply a thin layer of cream to the affected skin and the surrounding area, gently rubbing it in.
- If the affected areas are located in skin folds (under the breasts, between the toes or fingers, in the groin, or under the buttocks), sterile gauze may be applied over the skin, especially at night.
- After applying the medicine, wash your hands unless the hands are the treated area.
Use in adults and children over 12 years of age
Athlete's foot – once daily for 1 week;
Plantar tinea pedis – twice daily for 2 weeks;
Cutaneous candidiasis – once daily for 1 week;
Tinea of smooth skin – once daily for 1 week;
Cutaneous candidiasis – once daily for 1 week;
Pityriasis versicolor – once daily for 2 weeks.
The medicine should be used according to the recommended dosing regimen.
Treatment should be continued even if symptoms of infection improve within a few days of starting treatment. This helps prevent recurrence of the infection, which may occur if the medicine is not used regularly or for a shorter duration than recommended.
If there is no improvement after 14 days of treatment, or if symptoms worsen, consult your doctor.
During treatment, the affected skin should be:
- kept clean by regular washing,
- gently patted dry, not rubbed,
- not scratched, as this may delay healing or spread the infection.
Use in children
Terbinafina Ziaja is not recommended for use in children under 12 years of age.
Use in elderly patients
There are no data indicating the need for dosage adjustment in elderly patients or the occurrence of different adverse reactions compared to younger patients.
Overdose of Terbinafina Ziaja
If more medicine is used than recommended, contact your doctor.
Adverse effects may occur, similar to those observed with oral terbinafine, such as headache, nausea, abdominal pain, and dizziness.
Missed dose of Terbinafina Ziaja
If a dose is missed, apply the medicine as soon as possible, then continue treatment according to the recommended dosing schedule. Do not use a double dose to make up for the missed dose. Regular use of Terbinafina Ziaja is essential for successful treatment and reducing the risk of infection recurrence.
4. Possible adverse reactions
Like any medicinal product, this medicine can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may occur in 1 out of 10 people)
Skin peeling, itching.
Uncommon adverse reactions (may occur in 1 out of 100 people)
Skin changes, crusts, skin disorders, pigmentation disorders, erythema, burning sensation of the skin, pain,
pain at the application site, irritation at the application site.
Rare adverse reactions (may occur in 1 out of 1000 people)
Eye irritation, dry skin, contact dermatitis, rash, worsening of disease symptoms.
Frequency not known (cannot be estimated from available data)
Hypersensitivity, rash.
At the site of application, symptoms such as itching, skin peeling, pain at the application site, irritation at the application site, pigmentation disorders, burning sensation of the skin, erythema, formation of crusts, etc., may occur.
However, these should not be confused with allergic (hypersensitivity) reactions, such as for example rash. If allergic reactions occur, treatment should be discontinued and a doctor should be consulted.
In case of accidental contact with eyes, the medicine may cause eye irritation.
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 at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Terbinafina Ziaja
Store below 25°C. Do not freeze.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging following "EXP".
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. Such measures help protect the environment.
6. Contents of the pack and other information
What Terbinafina Ziaja contains
- The active substance is terbinafine hydrochloride. One gram of cream contains 10 mg of terbinafine hydrochloride.
- The other ingredients are: myristyl isopropylate, cetyl alcohol, stearyl alcohol, sorbitan monostearate (Type 50), cetyl palmitate (15), polysorbate 60, benzyl alcohol, sodium hydroxide, purified water.
What Terbinafina Ziaja looks like and contents of the pack
Terbinafina Ziaja is a white or almost white cream.
Packaging: an aluminium tube internally coated with an epoxy-phenolic varnish, fitted with a polyethylene cap, containing 15 g of cream, accompanied by a patient information leaflet and packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Tel.: +48 58 521 34 00