CLOTRIMAZOLE ZIAJA

Package leaflet: Information for the patient

Clotrimazolum Ziaja, 10 mg/g, cream
Clotrimazolum
Please read all of this leaflet carefully before using this medicine, because 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 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents of the leaflet

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

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

Clotrimazolum Ziaja contains the active substance clotrimazole, an imidazole derivative with
antifungal activity. When applied topically to the skin, clotrimazole cream penetrates into the epidermis. Clotrimazole has a broad spectrum of fungicidal activity – it acts against dermatophytes Trichophyton, Microsporum, Epidermophyton; yeasts – Candida, mould fungi, and dimorphic fungi.
Indications
Fungal skin infections caused by various dermatophyte species, including tinea cruris, tinea manuum, tinea pedis, interdigital fungal infection, pityriasis versicolor.
Cutaneous candidiasis and external genital mucosal candidiasis.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Clotrimazolum Ziaja

When not to use Clotrimazolum Ziaja

• if the patient is allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6),
• for vaginal use.

Warnings and precautions
Before starting treatment with Clotrimazolum Ziaja, discuss this with your doctor or
pharmacist.
When applied to the external mucous membranes of the genital organs, this medicine may damage latex-based contraceptive devices (e.g. condoms and diaphragms); therefore, their use is not recommended during treatment with this medicine.
Do not use latex-based contraceptives for at least 5 days after using this medicine.
Avoid contact of the medicine with eyes and mouth.
Children
Data are not available.
Clotrimazolum Ziaja and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Clotrimazole may inhibit the action of other locally applied antifungal medicines, especially polyene antibiotics such as nystatin and natamycin. Clotrimazole reduces the therapeutic effect of amphotericin B.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the first trimester of pregnancy. During the remainder of pregnancy, use only if, in the opinion of the physician, the expected benefits to the mother outweigh the potential risks to the fetus.
Breastfeeding
There are no study results available to determine whether clotrimazole passes into human milk.
Use with caution during breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of Clotrimazolum Ziaja on the ability to drive or operate machinery.
Clotrimazolum Ziaja contains cetostearyl alcohol
This medicine may cause local skin reactions (e.g. contact dermatitis).
Clotrimazolum 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 Clotrimazolum Ziaja

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Clotrimazolum Ziaja is intended for topical application to the skin.
Recommended dose
Unless otherwise advised by a doctor, affected areas should be treated with a thin layer of the medicine 2 to 3 times daily, gently rubbed in.
The average duration of treatment varies depending on the size and location of the lesions. After symptoms have resolved, treatment should be continued for at least 4 weeks.
Use of a higher than recommended dose of Clotrimazolum Ziaja
No data available.
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Skin reactions (skin redness, burning, irritation) may occur rarely (in no more than 1 in 1,000 patients); furthermore, systemic allergic reactions, pain, and local reactions such as itching and rash may occur.

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 Reactions of Medicinal Products at 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Clotrimazolum Ziaja

Store below .
Keep in the original, tightly closed packaging.
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 following "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Clotrimazolum Ziaja contains

• The active substance is clotrimazole. One gram of cream contains 10 mg of clotrimazole.
• Other ingredients: benzyl alcohol, sorbitan stearate, polysorbate 60, cetyl palmitate, octyldodecanol, cetostearyl alcohol, purified water.

What Clotrimazolum Ziaja looks like and contents of the pack
Clotrimazolum Ziaja is a cream.
Pack: an internally lacquered aluminium tube with a latex ring and a polyethylene screw cap with a piercing device, containing 20 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Jesienna Street 9
80-298 Gdańsk
Tel.: +48 58 521 34 00