Ciclopirox ziaja

Package leaflet: Information for the patient

Ciclopirox Ziaja, 10 mg/g, cream
Ciclopirox olamine
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 directed by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions 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 you feel worse, consult your doctor.

Table of contents

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

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

Ciclopirox Ziaja cream contains the active substance ciclopirox olamine, which has antifungal properties. Ciclopirox olamine is an antifungal agent with broad-spectrum antifungal activity.
Indications
Topical treatment of all fungal skin infections:

• Cutaneous candidiasis (yeast infection typically occurring between the toes, under the breasts, and in skin folds),
• Tinea corporis, tinea cruris, tinea pedis (between the toes of one or both feet, sometimes on the sole or sides of the feet),
• Pityriasis versicolor (yellowish-brown patches typically appearing on the skin of the chest).

2. Information before using Ciclopirox Ziaja

When not to use Ciclopirox Ziaja:

• if the patient is allergic to ciclopirox olamine or to any of the other ingredients of this medicine (listed in section 6),
• during breastfeeding,
• on open wounds.

Warnings and precautions
Before starting treatment with Ciclopirox Ziaja, discuss it with your doctor or pharmacist.
Avoid contact of the medicine with the eyes, skin around the eyes, and mucous membranes. During treatment, strictly follow the hygienic recommendations provided by your doctor.
Ciclopirox Ziaja contains paraffin, which may damage (puncture) latex condoms. Contact between latex condoms and Ciclopirox Ziaja should be avoided due to the risk of condom damage.
Children
Do not use in newborns, infants, and young children under 6 years of age.
Ciclopirox 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 with other medicines have been reported to date.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Ciclopirox Ziaja should not be used during pregnancy unless your doctor considers it absolutely necessary.
Ciclopirox Ziaja must not be used during breastfeeding. It is not known whether ciclopirox olamine passes into human milk; therefore, the medicine must not be used during breastfeeding.
Driving and operating machinery
Ciclopirox Ziaja has no effect or has a negligible effect on the ability to drive and operate machinery.
Ciclopirox Ziaja contains cetyl alcohol and stearyl alcohol
This medicine may cause local skin reactions (e.g. contact dermatitis).
Ciclopirox Ziaja contains benzyl alcohol
The medicine contains 4 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Ciclopirox Ziaja

This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Ciclopirox Ziaja is intended for topical use on the skin.
Instructions for use
Adults and children over 6 years of age
Apply a small amount of cream to the affected areas of skin and gently rub in, or leave to dry. The medicine is usually applied twice daily.
Ciclopirox Ziaja should be used until skin lesions have resolved – typically for 2 weeks. To prevent recurrence of fungal infection, continuation of treatment for 1 to 2 weeks is recommended.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Children
Do not use Ciclopirox Ziaja in newborns, infants, or young children under 6 years of age.
Use of more than the recommended dose of Ciclopirox Ziaja
There is no information available regarding overdose of ciclopirox olamine.
General adverse effects are not expected even when the medicine is applied over large areas or applied too frequently.
If you use more of the medicine than recommended, consult your doctor or pharmacist immediately.
Missed dose of Ciclopirox Ziaja
If you miss a dose, apply it as soon as possible unless it is almost time for your next dose. Do not apply a double dose to make up for a missed dose.
If you are unsure, consult your doctor.
Stopping treatment with Ciclopirox Ziaja
Do not stop treatment without consulting your doctor.
If you have any further questions 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.
After using Ciclopirox Ziaja medicine, the following may occur:

• Rare (not more frequently than in 1 patient per 1,000): allergic contact dermatitis.
• Frequency unknown (cannot be estimated based on available data): local hypersensitivity reactions (irritation, itching, burning).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ciclopirox Ziaja

Do not freeze.
Shelf life after first opening of the tube: 2 years, but not beyond the expiry date stated on the
packaging after "EXP".
The medicine should be stored in a place inaccessible and not visible to 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 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 will help protect the environment.

6. Contents of the pack and other information

What Ciclopirox Ziaja contains

• The active substance is ciclopirox olamine. Each gram of cream contains 10 mg of ciclopirox olamine.
• Other ingredients are: cetyl alcohol, stearyl alcohol, octyldodecanol, myristyl alcohol, polysorbate 60, sorbitan stearate (type I), light liquid paraffin, benzyl alcohol, (S)-lactic acid, purified water.

What Ciclopirox Ziaja looks like and contents of the pack
Ciclopirox Ziaja is a white or almost white cream.
Packaging: an aluminium tube with a membrane, internally coated with an epoxy-phenolic varnish, fitted with a HDPE cap with a piercing device, in a cardboard box.
Pack size: 20 g.
Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Tel.: +48 58 521 34 00
{logo of the marketing authorisation holder}
Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Przemysłowa 12
83-050 Kolbudy