Clotrimazolum Ziaia

Package Leaflet: Information for the Patient

Clotrimazolum Ziaja, 10 mg/g, Cream

Clotrimazolum

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.

• This 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 any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

• 1. What is Clotrimazolum Ziaja and what is it 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 package and other information

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

Clotrimazolum Ziaja contains the active substance clotrimazole, which is an imidazole derivative with antifungal activity. After local application of the clotrimazole cream to the skin, clotrimazole penetrates the epidermis. Clotrimazole exhibits a broad spectrum of antifungal activity - it acts on dermatophytes Trichophyton, Microsporum, Epidermophyton; yeast - Candida, mold fungi, and dimorphic fungi.

Indications for Use

Fungal infections of the skin caused by various species of dermatophytes, including jock itch, athlete's foot, fungal infections between the fingers, and ringworm.
Cutaneous and mucosal candidiasis of the external genitalia.
If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

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),
• vaginally.

Warnings and Precautions

Before starting to use Clotrimazolum Ziaja, the doctor or pharmacist should be consulted.
The medicine used on the mucous membranes of the external genitalia may damage latex contraceptives (condoms and diaphragms), so they should not be used during treatment with this medicine.
Latex contraceptives should not be used for at least 5 days after using the medicine.
Contact of the medicine with the eyes and mouth should be avoided.

Children

Data are not available.

Clotrimazolum Ziaja and Other Medicines

The doctor or pharmacist should be informed about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Clotrimazole may inhibit the action of other locally applied antifungal medicines, especially polyene antibiotics, such as nystatin, natamycin. Clotrimazole reduces the therapeutic effect of amphotericin B.

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
The medicine should not be used during the first trimester of pregnancy. In the remaining period of pregnancy, it should be used only if the doctor believes that the expected benefits to the mother outweigh the potential risk to the fetus.
Breastfeeding
There are no results of studies that could determine the penetration of clotrimazole into human milk.
Caution should be exercised when using during breastfeeding.

Driving and Operating Machines

No studies have been conducted on the effect of Clotrimazolum Ziaja on the ability to drive and operate machines.

Clotrimazolum Ziaja Contains Cetostearyl Alcohol

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

Clotrimazolum 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 Clotrimazolum 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, the doctor or pharmacist should be consulted.
Clotrimazolum Ziaja is intended for local use on the skin.
Recommended dose
Unless the doctor has prescribed otherwise, the diseased areas should be smeared with a thin layer of the medicine 2 to 3 times a day, gently rubbing it in.
The average duration of treatment varies depending on the size of the lesions and their location. After the symptoms of the disease have disappeared, treatment should be continued for at least 4 weeks.

Using a Higher Than Recommended Dose of Clotrimazolum Ziaja

No data are available.
No cases of overdose have been reported.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely (may occur in up to 1 in 1000 patients) skin reactions (redness, burning, irritation) may occur; additionally, systemic allergic reactions, pain, and local reactions, such as itching and rash, may occur.

Reporting Side Effects

If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed. 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Clotrimazolum Ziaja

Store in a temperature below.
Store 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 after: "EXP".
The expiry date refers to the last day of the given 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 Clotrimazolum Ziaja Contains

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

What Clotrimazolum Ziaja Looks Like and What the Package Contains

Clotrimazolum Ziaja is a cream.
Packaging: aluminum tube with an internally lacquered membrane, with a latex ring and a polyethylene cap with a piercer, containing 20 g of cream, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

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

Date of Last Update of the Package Leaflet: