Clotrimazolum Medana

Package Leaflet: Information for the Patient

Clotrimazolum Medana, 10 mg/ml, Skin Solution

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 the package leaflet for the patient or as advised 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 possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be contacted.

Table of Contents of the Leaflet

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

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

The active substance of Clotrimazolum Medana is clotrimazole, a medicine from the imidazole derivative group with a broad spectrum of antifungal activity. At low concentrations, it exhibits fungistatic activity (inhibiting the growth of fungi) against dermatophytes (bacteria from the genera Epidermophyton,Trichophyton, Microsporum), yeast (such as Candida albicansand other species of the genus Candida,Cryptococcus neoformans, Malassezia furfur), Aspergillusspp., molds, and dimorphic fungi (Blastomyces dermatidis, Coccidioides immitis, Sporotrichum schenckii). At high concentrations, the medicine has a fungicidal effect.

Indications for Use

Fungal skin infections caused by dermatophytes, yeast, pityriasis versicolor, and onychomycosis.

2. Important Information Before Using Clotrimazolum Medana

When Not to Use Clotrimazolum Medana:

• if the patient is allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6);
• in the first trimester of pregnancy;
• under an occlusive dressing;
• in the eye area;
• orally.

Warnings and Precautions

Before starting to use Clotrimazolum Medana, the patient should discuss it with a doctor or pharmacist.

• Contact with the eyes and mucous membranes should be avoided.
• Scratching itchy areas of the skin should be avoided, as it can spread the fungal infection.
• Wearing clothes and shoes that do not allow moisture and heat to escape should be avoided.
• After washing and bathing, the affected areas of the skin should be dried thoroughly.
• Clothing and towels that come into contact with the affected areas should be changed daily and washed at 90°C (single-use towels are recommended).

Children and Adolescents

In children under 11 years of age, the medicine should only be used on the advice of a doctor.

Clotrimazolum Medana and Other Medicines

The patient should inform the doctor or pharmacist about all medicines being taken or planned to be taken.

Clotrimazole may inhibit the action of other locally applied antifungal medicines, especially polyene antibiotics, such as nystatin and natamycin, and may weaken the effect of amphotericin B. Topically applied corticosteroids may weaken the effect of clotrimazole.

Pregnancy and Breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before using this medicine.

Pregnancy

Do not use in the first trimester of pregnancy.

In the second and third trimesters of pregnancy, the use of the medicine is only possible on the explicit advice of a doctor.

Breastfeeding

In breastfeeding women, the use of the medicine is only possible on the explicit advice of a doctor.

Driving and Operating Machines

The medicine does not affect the ability to drive or operate machines.

3. How to Use Clotrimazolum Medana

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.

The medicine is intended for topical use on the skin.

Unless otherwise advised by a doctor, a few drops of the solution should be lightly rubbed into the affected areas of the skin 2 to 3 times a day. After the acute symptoms of the disease have subsided, treatment should be continued for at least 4 weeks, until the symptoms have completely disappeared.

In the case of foot fungus, the medicine should be used for another 2 weeks after all symptoms have disappeared to prevent recurrence.

Using a Higher Dose of Clotrimazolum Medana Than Recommended

There are no reports of cases of overdose of clotrimazole used topically.

4. Possible Side Effects

Like all medicines, Clotrimazolum Medana can cause side effects, although not everybody gets them.

Rarely (occurring in less than 1 in 1,000 patients): allergic reactions, including local allergic reactions, burning, itching, stinging, and transient irritation at the site of application.

Very rarely (occurring in less than 1 in 10,000 patients): generalized redness, rash, swelling, urticaria, peeling of the skin, cracking of the skin.

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in the 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, 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 Clotrimazolum Medana

The medicine should be stored out of sight and reach of children.

Do not store above 25°C. Do not store in the refrigerator. Protect from light.

Do not use this medicine 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. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Clotrimazolum Medana Contains

• The active substance is clotrimazole. Each ml of skin solution contains 10 mg of clotrimazole.
• The other ingredients are isopropyl myristate and anhydrous ethanol.

What Clotrimazolum Medana Looks Like and What the Package Contains

The medicine is a solution for application to the skin.

A brown glass bottle with a polyethylene (HDPE) cap and a polyethylene (LDPE) dropper, containing 15 ml of skin solution, packed in a cardboard box.

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Medana Branch in Sieradz, ul. Władysława Łokietka 10, 98-200 Sieradz

Date of Last Revision of the Leaflet: