Steper pro

Package Leaflet: Information for the Patient

Steper pro, 10 mg/g, cream

Bifonazol

Read the leaflet carefully 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
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of Contents of the Leaflet

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

Steper pro contains the active substance bifonazole with a broad spectrum of antifungal activity.
Steper pro is an antifungal medicine, in the form of a cream for application to the skin.

Indications for Use

Local treatment of fungal skin infections, such as: hand and foot fungus, body fungus,
skin fold fungus, pityriasis versicolor, superficial skin candidiasis, and local 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 to use Steper pro, the doctor or pharmacist should be consulted.
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 the symptoms of the disease persist or do not improve after stopping treatment, the doctor should be contacted.
Contact with the eyes should be avoided. Do not swallow.

Children

In infants and young children, the medicine can only be used on the doctor's prescription and under their control.

Steper pro and Other Medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Using Steper pro with warfarin increases the risk of bleeding. When using Steper pro and warfarin together, the patient should be under close medical supervision.

Pregnancy and Breastfeeding

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.
Steper pro should not be used during the first trimester of pregnancy.
If the doctor decides that Steper pro needs to be used during breastfeeding, breastfeeding should be stopped.

Driving and Operating Machines

Steper pro has no influence or negligible influence on the ability to drive and operate machines.

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 in 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 leaflet or as directed by
the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Recommended dose
The medicine should be used once a day, preferably in the evening, before bedtime. A small amount of medicine is usually sufficient to cover the skin with lesions the size of a hand.
Method of administration
A thin layer of the medicine should be applied to the area with lesions and gently massaged in.
Duration of treatment
Treatment with Steper pro should be carried out for a sufficient period. The medicine is usually used as presented in the table below.

Use in Children

In infants and young children, the medicine can only be used on the doctor's prescription and under their control.

Using More Than the Recommended Dose of Steper pro

There is no risk of acute overdose.

Missing a Dose of Steper pro

A double dose should not be used to make up for a missed dose.
The next dose should be used as soon as possible.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The Following Side Effects May Occur

Frequency not known (cannot be estimated from the available data):

• pain at the application site;
• peripheral edema (at the application site);
• contact dermatitis;
• allergic dermatitis;
• erythema (local redness of the skin);
• pruritus;
• rash (itchy, red bumps on the skin);
• urticaria (light red, itchy blisters on the skin);
• vesicles;
• desquamation;
• exanthema;
• dryness of the skin;
• irritation of the skin;
• maceration of the skin (softening of the skin under the influence of the medicine);
• burning sensation on the skin.

Side effects usually disappear after the end of treatment.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Steper pro

The medicine should be stored out of sight and reach of children.
Store at a temperature 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 month.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Steper pro Contains

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

What Steper pro Looks Like and What the Pack Contains

Steper pro is a white cream with a mild minty smell.
The pack contains an aluminum tube with a protective membrane and a polyethylene cap with a puncture device, containing 15 g of cream, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Date of Last Revision of the Leaflet: