Steper pro

Package Leaflet: Information for the Patient

Steper pro, 10 mg/mL, Skin Spray, Solution

Bifonazole

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist.

• This Package Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, a Pharmacist Should be Consulted.
• If the Patient Experiences any Side Effects, Including those not Listed in this Package 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 Package 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. Package Contents 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 Medication, in the Form of a Solution for Skin Application.

Indications for Use

Local Treatment of Fungal Skin Infections, such as: Athlete's Foot and Hand, Body Ringworm, Skin Fold Ringworm, Pityriasis Versicolor, Superficial Candidiasis (Thrush) Caused by Dermatophytes, Yeasts, Molds, and other Fungal Species.
Local Treatment of Pityriasis Rubra.

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 Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Use Steper pro, the Doctor or Pharmacist Should be Consulted.
Patients who have Experienced Hypersensitivity Reactions to other Antifungal Imidazole Derivatives (e.g., Econazole, Clotrimazole, Miconazole) Should use Bifonazole-Containing Medications with Caution.
If the Symptoms of the Disease Persist or do not Subside after Discontinuation of Treatment, the Doctor Should be Contacted.
Contact of the Medication with the Eyes Should be Avoided. Do not Swallow.

Children

In Infants and Young Children, the Medication can only be Used on the Prescription and under the Supervision of a Doctor.
Caution Should be Exercised to Ensure the Medication does not Enter the Child's Mouth.

Steper pro and other Medications

The Doctor or Pharmacist Should be Informed about all Medications Currently being Taken by the Patient or Recently Taken, as well as any Medications Planned to be Used.
Concomitant Use of Steper pro and Warfarin Increases the Risk of Bleeding. If Steper pro and Warfarin are Used Together, the Patient Should be under Close Medical Supervision.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, or Thinks they may be Pregnant or are Planning to have a Child, they Should Consult a Doctor or Pharmacist before Using this Medication.
Pregnancy
Steper pro Should not be Used in the First Trimester of Pregnancy.
The Use of Steper pro in Pregnant Women is Decided by the Doctor after Assessing the Benefit-to-Risk Ratio.
Breastfeeding
If the Doctor Decides that Steper pro is Necessary during Breastfeeding, Breastfeeding Should be Discontinued.

Driving and Operating Machinery

Steper pro has no Influence or a Negligible Influence on the Ability to Drive and Operate Machinery.

Steper pro Contains Ethanol

This Medication Contains 301 mg of Alcohol (Ethanol) per mL of Solution.
Steper pro may Cause Burning of Damaged Skin.
In Newborns (Premature and Full-term Infants), High Ethanol Concentrations can Cause Severe Local and Systemic Toxicity due to Significant Absorption through the Immature Skin (especially under Occlusive Dressing).
The Medication is Flammable. It Should not be Used near Open Flames, Lit Cigarettes, or Certain Devices (e.g., Hair Dryers).

3. How to Use Steper pro

This Medication Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
Recommended Dose
The Medication Should be Used Once a Day, Preferably in the Evening, before Sleep. 1 or 2 Sprays of the Pump Usually Suffice to Cover the Affected Skin Area the Size of the Palm.
Method of Administration
The Medication is Intended for Skin Application.
A Thin Layer of the Medication Should be Sprayed onto the Affected Area and Gently Massaged in.
Duration of Treatment
Treatment with Steper pro Should be Continued for an Adequate Period. The Medication is Usually Used as Presented in the Following Table.

If the Symptoms of the Disease Persist or do not Subside after Discontinuation of Treatment, the Doctor Should be Contacted.
If the Patient Feels that the Medication's Effect is too Strong or too Weak, they Should Consult a Doctor or Pharmacist.

Use in Children

In Infants and Young Children, the Medication can only be Used on the Prescription and under the Supervision of a Doctor.

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.

Stopping the Use of Steper pro

In Order to Achieve Full Therapeutic Effect and Prevent Relapse, Treatment Should not be Stopped Prematurely or Discontinued without Consulting a Doctor. However, if this Happens, there is a Risk of Relapse of the Disease, as the Fungal Infection has not been Properly Cured. Treatment Should not be Stopped after the Symptoms have Subsided, but Should be Continued Consistently (as Recommended in the Section "Duration of Treatment").
In Case of any Further Doubts about the Use of this Medication, a Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medications, Steper pro can Cause Side Effects, although not Everybody gets them.

The Following Side Effects may Occur

Frequency of Occurrence Unknown(Cannot be Determined from 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 (Pale Red, Itchy Blisters on the Skin);
• Blisters;
• Desquamation;
• Exanthema;
• Dryness of the Skin;
• Irritation of the Skin;
• Maceration of the Skin (Softening of the Skin due to the Medication's Effect);
• Burning Sensation on the Skin.

Side Effects Usually Subside after Treatment is Discontinued.

Reporting Side Effects

If any Side Effects Occur, including those not Listed in this Package Leaflet, the Doctor or Pharmacist Should be Informed. 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
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 Medication.

5. How to Store Steper pro

The Medication Should be Stored out of Sight and out of Reach of Children.
Store in a Temperature below 25°C. Do not Store in the Refrigerator or Freeze.
Do not Use this Medication after the Expiration Date Stated on the Carton. The Expiration Date Refers to the Last Day of the Specified Month.
Shelf Life after First Opening the Bottle: 3 Months.
Medications Should not be Disposed of via Wastewater or Household Waste. A Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Steper pro Contains

• The Active Substance of the Medication is Bifonazole. 1 mL of Solution Contains 10 mg of Bifonazole (Bifonazolum).
• Other Ingredients are: Ethanol 96%, Isopropyl Myristate.

What Steper pro Looks like and what the Package Contains

Steper pro is a Colorless, Clear Solution.
The Medication's Packaging is a Type III Brown Glass Bottle with a Pump Spray made of PE/PP/Stainless Steel/POM/EVA and a Cap made of PP, in a Cardboard Box.
The Bottle Contains 30 mL of Solution.

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 the Last Update of the Package Leaflet: