STEPER PRO

Patient Information Leaflet

Steper pro, 10 mg/g, cream
Bifonazole
Please read all of this leaflet carefully before using this medicine, because 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 so that you can read it again if necessary.
• If you need advice or further information, please contact 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, consult your doctor.

Contents of the leaflet

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

1. What Steper pro is and what it is used for

Steper pro contains the active substance bifonazole, which has a broad spectrum of antifungal activity.
Steper pro is an antifungal medicine and is available as a cream for topical application.
Indications
Topical treatment of fungal skin infections such as tinea manuum and tinea pedis, tinea corporis,
tinea intertriginosa, pityriasis versicolor, superficial candidal skin infections, and topical treatment of seborrhoeic dermatitis.

2. Important information before using Steper pro

When not to use Steper pro

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

Warnings and precautions
Before starting treatment with Steper pro, discuss this with your doctor or pharmacist.
Patients who have previously experienced hypersensitivity reactions to other imidazole-derived antifungals (e.g. econazole, clotrimazole, miconazole) should use bifonazole-containing medicines with caution.
If symptoms persist or do not improve after discontinuing treatment, contact your doctor.
Avoid contact of the medicine with the eyes. Do not swallow.

Children
Steper pro should be used in infants and young children only on the advice and under supervision of a doctor.

Steper pro and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Concomitant use of Steper pro with warfarin may increase the risk of bleeding. If Steper pro and warfarin are used together, the patient must be under strict medical supervision.

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.
Do not use Steper pro during the first trimester of pregnancy.
If a doctor decides that treatment with Steper pro is necessary during breastfeeding, breastfeeding should be discontinued.

Driving and operating machinery
Steper pro has no effect or has negligible effect on the ability to drive and operate machinery.

Steper pro contains cetyl alcohol, stearyl alcohol, and benzyl alcohol

Cetyl alcohol, stearyl alcohol
The medicine may cause local skin reactions (e.g. contact dermatitis).

Benzyl alcohol
The medicine contains 20 mg of benzyl alcohol per 1 g of cream.
Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Steper pro

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
The medicine should be applied once daily, preferably in the evening before going to sleep. A small amount of the medicine is usually sufficient to cover an affected skin area the size of the palm of the hand.
Method of administration
Apply a thin layer of the medicine to the affected area and gently massage it in.
Duration of treatment
Treatment with Steper pro should be continued for an appropriately long period. The medicine is usually used as shown in the table below.

Use in children
The medicine may be used in infants and young children only on a doctor's prescription and under medical supervision.
Use of a higher than recommended dose of Steper pro
There is no risk of acute poisoning.
Missed dose of Steper pro
Do not use a double dose to make up for a missed dose.
Apply the next dose as soon as possible.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur
Frequency unknown (cannot be estimated from the available data):

• pain at the application site;
• marginal swelling (at the application site);
• contact dermatitis;
• allergic dermatitis;
• erythema (local redness of the skin);
• pruritus (itching);
• rash (itchy red bumps on the skin);
• urticaria (pale red, itchy wheals on the skin);
• vesicles;
• skin desquamation;
• eruption;
• dry skin;
• skin irritation;
• skin maceration (softening of the skin due to the effect of the medicine);
• burning sensation on the skin.

Adverse reactions usually resolve after discontinuation of treatment.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Steper pro

Keep the medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the tube: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Steper pro contains

• The active substance is bifonazole. 1 g of cream contains 10 mg of bifonazole (Bifonazolum).
• Other ingredients are: cetyl alcohol, stearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan stearate, benzyl alcohol, peppermint essential oil with reduced menthol content, purified water.

What Steper pro looks like and contents of the pack
Steper pro is a white cream with a mild minty odour.
The medicine is packed in an aluminium tube with a protective membrane and a polyethylene cap with a piercing device, containing 15 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100