CICLOPIROX 10 mg /G Cream

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Ciclopirox Ziaja, 10 mg/g, cream
   1. Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ciclopirox Ziaja and what is it used for
   1. Indications for use
4. Important information before using Ciclopirox Ziaja
   1. When not to use Ciclopirox Ziaja:
   2. Warnings and precautions
   3. Children
   4. Ciclopirox Ziaja and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Ciclopirox Ziaja contains cetyl alcohol and stearyl alcohol
   8. Ciclopirox Ziaja contains benzyl alcohol
5. How to use Ciclopirox Ziaja
   1. Adults and children over 6 years of age
   2. Children
   3. Using more than the recommended dose of Ciclopirox Ziaja
   4. Missing a dose of Ciclopirox Ziaja
   5. Stopping the use of Ciclopirox Ziaja
6. Possible side effects
   1. Reporting side effects
7. How to store Ciclopirox Ziaja
8. Contents of the packaging and other information
   1. What Ciclopirox Ziaja contains
   2. What Ciclopirox Ziaja looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

Ciclopirox Ziaja, 10 mg/g, cream

Ciclopirox olamine

Please read carefully the contents of the leaflet 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 a doctor or pharmacist.

• This 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 any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ciclopirox Ziaja and what is it 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 packaging and other information

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

Ciclopirox Ziaja cream contains the active substance ciclopirox olamine with antifungal action. Ciclopirox olamine is an antifungal medicine with a broad spectrum of antifungal activity.

Indications for use

Local treatment of all skin fungal infections:

• skin candidiasis (yeast infection that usually occurs between the toes, under the breasts, and in skin folds),
• body ringworm, foot ringworm, groin ringworm (between the toes of one or both feet, sometimes on the sole or sides of the feet),
• pityriasis versicolor (yellow-brown patches that usually occur on the chest skin).

2. Important information before using Ciclopirox Ziaja

When not to use Ciclopirox Ziaja:

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

Warnings and precautions

Before starting to use Ciclopirox Ziaja, the patient should discuss it with their doctor or pharmacist. The medicine should be kept away from the eyes, the skin around the eyes, and mucous membranes. During treatment, the patient should strictly follow the hygiene instructions given by their doctor. Ciclopirox Ziaja contains paraffin, which may cause damage (puncture) to latex condoms. The patient should avoid contact between latex condoms and Ciclopirox Ziaja due to the risk of condom damage.

Children

Ciclopirox Ziaja should not be used in newborns, infants, and young children under 6 years of age.

Ciclopirox Ziaja and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. So far, no interactions with other medicines have been reported.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Ciclopirox Ziaja should not be used during pregnancy, unless the doctor considers it absolutely necessary. Ciclopirox Ziaja should not be used during breastfeeding. It is not known whether ciclopirox olamine passes into breast milk, so the medicine should not be used during breastfeeding.

Driving and using machines

Ciclopirox Ziaja has no influence or negligible influence on the ability to drive and use machines.

Ciclopirox Ziaja contains cetyl alcohol and stearyl alcohol

The 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 leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Ciclopirox Ziaja is intended for use on the skin. Method of use

Adults and children over 6 years of age

A small amount of cream should be applied to the affected areas of the skin and gently rubbed in or left to dry. The medicine is usually applied twice a day. Ciclopirox Ziaja should be used until the skin changes disappear – usually for 2 weeks. To prevent recurrence of fungal infections, it is recommended to continue treatment for 1 to 2 weeks. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Children

Ciclopirox Ziaja should not be used in newborns, infants, and young children under 6 years of age.

Using more than the recommended dose of Ciclopirox Ziaja

There is no information on the overdose of ciclopirox olamine. It is not expected that general side effects will occur in case of application to a large area or too frequent application of the medicine. If a larger dose of the medicine is used than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Ciclopirox Ziaja

If the patient misses one application of the medicine, they should apply it as soon as possible, unless it is almost time for the next application. The patient should not apply a double dose to make up for the missed dose. In case of doubt, the patient should consult their doctor.

Stopping the use of Ciclopirox Ziaja

The patient should not stop treatment without consulting their doctor. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After using Ciclopirox Ziaja, the following side effects may occur:

• rarely (less than 1 in 1,000 patients): allergic contact dermatitis.
• frequency not known (cannot be estimated from the available data): local hypersensitivity reactions (irritation, itching, burning).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 gathered on the safety of the medicine.

5. How to store Ciclopirox Ziaja

Do not freeze. Shelf life after first opening the tube: 2 years, but no longer than the expiry date stated on the packaging. The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the stated month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ciclopirox Ziaja contains

• The active substance of the medicine is ciclopirox olamine. One gram of cream contains 10 mg of ciclopirox olamine.
• The 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 what the packaging contains

Ciclopirox Ziaja is a white or almost white cream. Packaging: aluminum tube with a membrane, coated with epoxy-phenolic lacquer from the inside, with a HDPE cap with a piercer, in a cardboard box. Packaging size: 20 g.

Marketing authorization holder

ZIAJA Ltd Pharmaceutical Plant sp. z o.o., ul. Jesienna 9, 80-298 Gdańsk, Tel.: +48 58 521 34 00, {logo of the marketing authorization holder}

Manufacturer

ZIAJA Ltd Pharmaceutical Plant sp. z o.o., ul. Przemysłowa 12, 83-050 Kolbudy

Date of the last update of the leaflet: