Package leaflet: Information for the patient

Clotrimazolum Medana, 10 mg/ml, solution for skin use
Clotrimazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
You must always use this medicine exactly as described in this patient leaflet or as directed by your
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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents

What Clotrimazolum Medana is and what it is used for
Important information before using Clotrimazolum Medana
How to use Clotrimazolum Medana
Possible side effects
How to store Clotrimazolum Medana
Contents of the pack and other information

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

The active substance in Clotrimazolum Medana is clotrimazole, a member of the imidazole derivative group
with broad-spectrum antifungal activity. At low concentrations, it exerts a fungistatic effect (inhibits fungal growth) against dermatophytes (fungi of the genera Epidermophyton,
Trichophyton, Microsporum), yeasts (such as Candida albicans and other species of the genus Candida,
Cryptococcus neoformans, Malassezia furfur), Aspergillus spp., molds, and dimorphic fungi
(Blastomyces dermatidis, Coccidioides immitis, Sporotrichum schenckii). At higher concentrations, the drug has a fungicidal effect.
Indications
Fungal skin infections caused by dermatophytes or yeasts, pityriasis versicolor, and fungal infections of the nail folds.

2. Important information before using Clotrimazolum Medana

When not to use Clotrimazolum Medana:

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

Warnings and precautions
Before starting treatment with Clotrimazolum Medana, discuss this with your doctor or pharmacist.

Avoid contact of the medicine with eyes and mucous membranes.
Do not scratch itchy, affected skin areas, as this may spread the fungal infection.
Avoid wearing clothing and footwear that do not allow moisture and heat to escape.
After washing or bathing, thoroughly dry the affected areas.
Clothing and towels that come into contact with affected areas should be changed daily and washed at 90°C (the use of disposable towels is recommended).

Children and adolescents
Clotrimazolum Medana should be used in children under 11 years of age only under medical supervision and on a doctor's advice.
Clotrimazolum Medana and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Clotrimazole may inhibit the action of other topically applied antifungal medicines, especially polyene antibiotics such as nystatin and natamycin, and may reduce the effectiveness of amphotericin B.
Topically applied corticosteroids may reduce the effectiveness of clotrimazole.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use during the first trimester of pregnancy.
During the second and third trimesters of pregnancy, the medicine should be used only on the explicit recommendation of a doctor.
Breastfeeding
In women who are breastfeeding, the medicine may be used only on the explicit recommendation of a doctor.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.

3. How to use Clotrimazolum Medana

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is intended for topical application to the skin.
Unless otherwise advised by a doctor, apply a few drops of the solution gently to the affected areas of skin 2 to 3 times daily.
After acute symptoms have subsided, treatment should be continued for at least 4 weeks, until symptoms have completely resolved.
In the case of athlete's foot, the medicine should be used for an additional two weeks after all symptoms have disappeared to prevent recurrence.
Use of a higher than recommended dose of Clotrimazolum Medana
There are no reports of cases of overdose with topical clotrimazole.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Rarely (occurring in less than 1 in 1,000 patients): allergic reactions, including local allergic reaction, burning, itching, stinging, transient irritation at the site of application.
Very rarely (occurring in less than 1 in 10,000 patients): generalized erythema, rash, swelling, urticaria, skin desquamation, skin cracking.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Clotrimazolum Medana

Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
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 cutaneous solution contains 10 mg of clotrimazole.
The other components are: isopropyl myristate, anhydrous ethanol.

What Clotrimazolum Medana looks like and contents of the pack
Clotrimazolum Medana is a cutaneous solution.
An amber glass bottle with a polyethylene (HDPE) cap with a tamper-evident ring and a dropper made of polyethylene (LDPE), containing 15 ml of cutaneous solution, placed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplinska Street 19, 83-200 Starogard Gdanski
Phone: +48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
Wladyslawa Lokietka Street 10, 98-200 Sieradz