Clotrimazolum Amara

Package Leaflet: Information for the Patient

CLOTRIMAZOLUM AMARA,10 mg/g, cream
Clotrimazole

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, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is CLOTRIMAZOLUM AMARA and what is it used for

CLOTRIMAZOLUM AMARA cream is for topical use and contains the active substance clotrimazole, which has a broad spectrum of antifungal activity. Clotrimazole belongs to the imidazole derivatives and acts mainly on yeast and dermatophytes (fungi that grow on the skin, hair, and nails, causing various types of fungal infections).
CLOTRIMAZOLUM AMARA cream is indicated for the topical treatment of:

• fungal skin infections of the hands and feet, trunk, lower legs, and feet caused by dermatophytes,
• pityriasis versicolor
• yeast infections of the skin and mucous membranes of the external genital organs (vulva and penis). If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using CLOTRIMAZOLUM AMARA

When not to use CLOTRIMAZOLUM AMARA

• if the patient is hypersensitive to clotrimazole, other imidazole derivative antifungal medicines, or any of the other ingredients of this medicine listed in section 6).

Warnings and precautions

Before starting to use CLOTRIMAZOLUM AMARA, the patient should discuss it with their doctor, pharmacist, or nurse.
Local reactions, such as skin irritation, may occur. If hypersensitivity or irritation occurs, the use of the medicine should be discontinued.
If the patient is hypersensitive to other imidazole derivative antifungal medicines, they may also be hypersensitive to clotrimazole.
Clotrimazole used topically may damage latex contraceptives (condoms, diaphragms). Therefore, during treatment of the external genital organs and for at least 5 days after discontinuation of treatment, latex contraceptives should not be used.

Children and adolescents

Before using CLOTRIMAZOLUM AMARA in children, the patient should discuss it with their doctor, pharmacist, or nurse.

CLOTRIMAZOLUM AMARA and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
Clotrimazole may inhibit the activity of other topically used antifungal medicines, especially amphotericin and other antibiotics (nystatin, natamycin). Dexamethasone used in high doses may inhibit the antifungal activity of clotrimazole.

CLOTRIMAZOLUM AMARA with food, drink, and alcohol

No effect.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
The use of the medicine in pregnant women is possible only in justified cases on the doctor's prescription, as no clinical studies have been conducted on the use of the medicine in pregnant women.
Breastfeeding
The use of the medicine in breastfeeding women is possible only in justified cases on the doctor's prescription, as no clinical studies have been conducted on the use of the medicine in breastfeeding women.
Fertility
No studies have been conducted on the effect of clotrimazole on human fertility.
During treatment of vulvar infections, the medicine should not be inserted into the vagina.

Driving and using machines:

The medicine does not affect the ability to drive and use machines.
CLOTRIMAZOLUM AMARA containscetyl alcohol and stearyl alcohol. Due to the presence of cetyl alcohol and stearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
The medicine contains 1 g of benzyl alcohol in 100 g of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use CLOTRIMAZOLUM AMARA

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. The medicine is for topical use.
Unless the doctor has prescribed otherwise, a thin layer of the medicine should be applied to the affected areas two to three times a day, for a period of 2 to 4 weeks.
If there is no improvement after 7 days of using the medicine, the patient should consult their doctor.
In case of doubt, the patient should consult their doctor or pharmacist.

Using more than the recommended dose of CLOTRIMAZOLUM AMARA

No data available. No cases of clotrimazole overdose have been reported when used according to the indications.

Missing a dose of CLOTRIMAZOLUM AMARA

The patient should continue using the medicine without increasing the next dose.
The patient should not use a double dose to make up for a missed dose.

Stopping the use of CLOTRIMAZOLUM AMARA

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, CLOTRIMAZOLUM AMARA can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1000 people):
contact allergic dermatitis, blisters, erythema, edema, itching, burning pain, and stinging, urticaria, and skin fissures.
If these symptoms occur, the use of the medicine should be discontinued and the patient should consult their doctor. If any of the side effects get worse or any side effects not listed in the leaflet occur, the patient should inform their doctor or pharmacist.
Reporting suspected adverse reactions
If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Pharmacovigilance 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLOTRIMAZOLUM AMARA

CLOTRIMAZOLUM AMARA should be stored out of the reach and sight of children. Do not store above 25°C. Do not freeze. Store the tube tightly closed.
Do not use CLOTRIMAZOLUM AMARA after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What CLOTRIMAZOLUM AMARA contains

The active substance of the medicine is clotrimazole.
The other ingredients of the medicine are: cetyl alcohol, stearyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, sorbitan stearate, benzyl alcohol (E1519), purified water.

What CLOTRIMAZOLUM AMARA looks like and contents of the pack

The medicine is a cream.

Packaging:

Aluminum tube with a membrane and a PE cap containing 10 g, 15 g, 20 g, or 25 g of cream in a cardboard box.

Marketing authorization holder and manufacturer:

Zakład Farmaceutyczny „Amara” sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Tel. 12 657 40 40
Fax 12 657 40 40 wew. 34

Date of last revision of the leaflet: