Clotrimazolum Promedo

Leaflet attached to the packaging: patient information

Clotrimazolum Promedo

10 mg/g cream
( Clotrimazolum)

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 Promedo and what is it used for
• 2. Important information before using Clotrimazolum Promedo
• 3. How to use Clotrimazolum Promedo
• 4. Possible side effects
• 5. How to store Clotrimazolum Promedo
• 6. Package contents and other information

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

Clotrimazolum Promedo is a cream for application to the skin and mucous membranes and contains the active substance - clotrimazole.

Indications

Fungal skin infections caused by dermatophytes (including the genus Trichophyton), yeast, mold fungi, including athlete's foot and hand, pityriasis versicolor.
Candidiasis of the skin and mucous membranes of the external genital organs (Candida vulvitis and balanitis).

2. Important information before using Clotrimazolum Promedo

When not to use Clotrimazolum Promedo:

• vaginally.

Warnings and precautions

Before starting to use Clotrimazolum Promedo, the patient should discuss it with their doctor or pharmacist.
The medicine used locally may damage latex contraceptives (condoms and diaphragms). Therefore, during the use of clotrimazole on the mucous membranes of the external genital organs and at least 5 days after stopping its use, latex contraceptives should not be used.
Eye and mouth contact with the medicine should be avoided.

Clotrimazolum Promedo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (e.g. nystatin, natamycin).

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.
The medicine can be used during pregnancy only if, in the doctor's opinion, it is absolutely necessary.
During treatment of vulvar infection, the medicine should not be inserted vaginally.
The medicine should not be applied to the breast during breastfeeding.

Driving and using machines

The medicine has no effect on the ability to drive vehicles or operate machinery.
Clotrimazolum Promedo contains cetyl stearyl alcohol,so it may cause a local skin reaction (e.g. contact dermatitis).

Clotrimazolum Promedo contains 10 mg of benzyl alcohol in each 1 g of cream.

Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Clotrimazolum Promedo

This medicine should always be used as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for local use.
Recommended dose: apply two or three times a day, applying a thin layer of the medicine to the affected areas. When applying the medicine to the feet, they should be washed and dried beforehand (especially between the toes).
Treatment should be continued for another month after all symptoms of the disease have disappeared, to prevent the recurrence of the infection.

4. Possible side effects

Like all medicines, Clotrimazolum Promedo can cause side effects, although not everybody gets them.
Uncommon side effects (occurring in 1 to 10 patients out of 10,000): skin reactions (redness, burning, irritation, pain).
Side effects of unknown frequency (cannot be estimated from the available data): systemic allergic reactions, itching, rash.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should consult their doctor or pharmacist.
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
ul. Al. Jerozolimskie 181C
PL - 02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Clotrimazolum Promedo

Store at a temperature below 25°C.
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.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Clotrimazolum Promedo contains

• The active substance of the medicine is clotrimazole. 1 g of cream contains 10 mg of clotrimazole.
• The other ingredients are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetyl stearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

What Clotrimazolum Promedo looks like and what the package contains

Clotrimazolum Promedo is a white cream.
The available packaging of the medicine is tubes containing 15 g or 20 g of cream, placed in a cardboard box.

Responsible entity and manufacturer

Responsible entity

Promedo Pharma Products GmbH
Anklamer Straße 28
10115 Berlin
Germany

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21, 58-500 Jelenia Góra
To obtain more detailed information, please contact the representative of the responsible entity:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of the last update of the leaflet: