Steper pro

Package leaflet: Information for the user

Steper pro, 10 mg/mL, cutaneous aerosol, solution
Bifonazole
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed by
the 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 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.

Table of contents

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, available as a solution for topical application to the skin.
Indications
Topical treatment of fungal skin infections, such as: tinea of hands and feet, tinea of the trunk,
fungal infections of skin folds, pityriasis versicolor, superficial candidiasis (fungal infections) caused by
dermatophytes, yeasts, molds, and other fungal species.
Topical treatment of seborrheic 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, consult your doctor or pharmacist.
Patients who have previously experienced hypersensitivity reactions to other antifungal imidazole derivatives (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 a doctor's advice and under medical supervision.
Care should be taken to prevent the medicine from entering the infant's/child's mouth.
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 the patient plans to use.
Concurrent use of Steper pro with warfarin increases the risk of bleeding. If Steper pro and warfarin are used together, the patient must be under close medical supervision.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Steper pro should not be used during the first trimester of pregnancy.
The decision to use Steper pro in pregnant women is made by the doctor after careful assessment of benefit versus risk.
Breastfeeding
If the 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 ethanol
This medicine contains 301 mg of alcohol (ethanol) per mL of solution.
Steper pro may cause a burning sensation on damaged skin.
In newborns (preterm and full-term infants), high ethanol concentrations may cause severe local and systemic toxicity due to significant absorption through immature skin (especially under occlusive dressing).
This medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Steper pro

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
The medicine should be used once daily, preferably in the evening before going to sleep. One or two pump presses are usually sufficient to cover an affected skin area the size of the palm of the hand.
Method of administration
This medicine is intended for topical use on the skin.
A thin layer of the medicine should be sprayed onto the affected area and gently massaged 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.

If symptoms persist or do not improve after discontinuing treatment, consult a doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should contact a doctor or pharmacist.

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

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.
Take the next dose as soon as possible.

Discontinuation of Steper pro treatment
To achieve full therapeutic effect and prevent recurrence, treatment should not be prematurely stopped or interrupted without consulting a doctor. However, if treatment is discontinued, there is a risk of recurrence, as the fungal infection has not been adequately cured. Treatment should not be stopped once symptoms subside, but should be consistently continued (as recommended in the section: "Duration of treatment").

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur
Frequency not known (cannot be estimated from the available data):

• pain at the application site;
• peripheral swelling (at the application site);
• contact dermatitis;
• allergic dermatitis;
• erythema (localised redness of the skin);
• itching;
• rash (itchy, red bumps on the skin);
• urticaria (pinkish, itchy wheals on the skin);
• blisters;
• skin desquamation;
• skin eruption;
• dry skin;
• skin irritation;
• skin maceration (softening and breaking down of skin due to the medicine);
• burning sensation on the skin.

Adverse symptoms usually resolve after discontinuation of treatment.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Steper pro

Keep this medicine out of sight and reach of children.
Brown glass bottle
Store below 25°C. Do not store in the refrigerator or freeze.
HDPE polyethylene bottle
Store below 25°C, in the original packaging, to protect from light. Do not store in the refrigerator or 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 bottle: 3 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Steper pro contains

• The active substance is bifonazole. 1 mL of solution contains 10 mg of bifonazole (Bifonazolum).
• The other components are: 96% ethanol, isopropyl myristate.

What Steper pro looks like and contents of the pack
Steper pro is a colourless, clear solution.
The medicine is packed in a brown glass bottle of type III, with a spray pump made of PE/PP/Stainless steel/POM/EVA and a PP cap, placed in a cardboard box,
or
a HDPE polyethylene bottle with a spray pump and a polypropylene cap. The spray pump is made of the following materials: polypropylene, LDPE polyethylene, a mixture (of LDPE polyethylene and polypropylene), and stainless steel SUS316, placed in a cardboard box.
The bottle contains 30 mL of solution.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. +48 42 22-53-100