CLOTRIMAZOLE PROMEDO

Package leaflet: Information for the user

Clotrimazolum Promedo
10 mg/g cream
( Clotrimazolum )
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, you should consult your doctor.

Contents of the leaflet:

1. What Clotrimazolum Promedo is and what it is 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. Contents of the pack and other information

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

Clotrimazolum Promedo is a cream for topical application to the skin and mucous membranes and contains the active substance - clotrimazole.
Indications
Fungal skin infections caused by dermatophytes (e.g. of the genus Trichophyton), yeasts, and mould fungi, including tinea of the feet and hands, pityriasis versicolor.
Cutaneous and external genital mucous membrane candidiasis (Candida vulvitis and balanitis).

2. Important information before using Clotrimazolum Promedo

When not to use Clotrimazolum Promedo:

• if the patient is allergic to the active substance - clotrimazole, or to any of the other ingredients of this medicine (listed in section 6);
• for vaginal use.

Warnings and precautions
Before starting treatment with Clotrimazolum Promedo, consult your doctor or
pharmacist.
Topically applied clotrimazole may damage latex-based contraceptive devices
(such as condoms and diaphragms). Therefore, during application of clotrimazole to the mucous membranes of external genital organs and for at least 5 days after discontinuation of treatment, do not use mechanical contraceptives made of latex.
Avoid contact of the medicine with eyes and mouth.
Clotrimazolum Promedo and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
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, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should be used during pregnancy only if clearly needed and considered absolutely necessary by the physician.
During treatment of labial or vulvar infections, do not apply the medicine intravaginally.
The medicine should not be applied to the breasts of a woman who is breastfeeding.
Driving and operating machinery
Clotrimazolum Promedo has no influence on the ability to drive motor vehicles or operate mechanical equipment.
Clotrimazolum Promedo contains cetearyl alcohol, which may cause local skin reactions (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 a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
This medicine is intended for topical use only.
Recommended dose: apply two or three times daily, spreading a thin layer of the medicine over
the affected areas. When applying the medicine to the feet, wash and dry them thoroughly beforehand
(in particular the areas between the toes).
Treatment should be continued for one month after all symptoms have disappeared,
in order to prevent recurrence of infection.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions occurring rarely (occur in 1 to 10 patients per 10,000): skin reactions (redness, burning, irritation, sensation of pain).
Adverse reactions with unknown frequency (cannot be estimated from available data): systemic allergic reactions, itching, rash.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
ul. Al. Jerozolimskie 181C
PL - 02 222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to Store CLOTRIMAZOLUM PROMEDO

Store below 25°C.
Keep the medicine 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 stated month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Clotrimazolum Promedo contains

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

What Clotrimazolum Promedo looks like and contents of the pack
Clotrimazolum Promedo is a white cream.
The medicinal product is available in tubes containing 15 g or 20 g of cream, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Straße 28
10115 Berlin
Germany

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21, 58-500 Jelenia Góra
Poland

For further information, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00