Patient Information Leaflet

Medispirant stepspray
(10 mg + 10 mg + 20 mg)/g, skin liquid
Mentholum + Acidum salicylicum + Methenaminum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult a 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

What Medispirant stepspray is and what it is used for
Important information before using Medispirant stepspray
How to use Medispirant stepspray
Possible side effects
How to store Medispirant stepspray
Contents of the pack and other information

1. What Medispirant stepspray is and what it is used for

Medispirant stepspray is a liquid for skin application, formulated as an ethanolic solution containing active substances with disinfectant, antifungal, anti-inflammatory, and drying properties. Medispirant stepspray reduces excessive sweating by inhibiting the activity of sweat glands. It eliminates unpleasant odour associated with sweating by suppressing bacterial growth. Medispirant stepspray exerts mild local anaesthetic action, induces a cooling sensation, and reduces skin discomfort such as itching.

Indications
The product is intended for topical use in cases of excessive sweating of the feet and helps eliminate the associated unpleasant odour.

2. Important information before using Medispirant stepspray

When not to use Medispirant stepspray

if the patient is allergic to menthol, salicylic acid, methenamine, or any of the other ingredients of this medicine (listed in section 6);
on damaged skin;
on mucous membranes;
for prolonged periods or on large areas of skin;
in children under 12 years of age.

Warnings and precautions
Before starting to use Medispirant stepspray, discuss this with your doctor or pharmacist.
While using Medispirant stepspray, observe the following warnings:

discontinue use if there are signs of hypersensitivity;
avoid contact with the mucous membranes of the eyes, mouth, and nose; if contact occurs, rinse thoroughly with warm water.

Children
Do not use in children under 12 years of age.
Medispirant stepspray and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Due to lack of safety data, use of this medicine is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Medispirant stepspray contains ethanol
This medicine contains 376.04 mg of alcohol (ethanol) per 1 g of spray solution.
It may cause stinging on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Medispirant stepspray

Always use this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
This is a medicine for topical use on the skin.
Adults and adolescents over 12 years of age
Spray the feet with the solution for several days, preferably in the evening after washing the feet.
Children
Do not use in children under 12 years of age.
Use of more than the recommended dose of Medispirant stepspray
If any disturbing symptoms occur, discontinue use and contact your doctor.
Missed dose of Medispirant stepspray
Continue using the medicine as prescribed, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Allergic skin reactions may occur. If such symptoms appear, discontinue use of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continuous monitoring of the medicine’s safety and helps collect further information on its safe use.

5. How to store the medicine Medispirant stepspray

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and
the cardboard box. The expiry date refers to the last day of the stated month.
Store the medicine below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the package and other information

What Medispirant stepspray contains

The active substances in the medicine are menthol, salicylic acid, and methenamine. 1 g of the skin solution contains 10 mg of menthol, 10 mg of salicylic acid, and 20 mg of methenamine.
Other ingredients are: ethanol 96%, purified water.

What Medispirant stepspray looks like and contents of the package
Medispirant stepspray is a skin solution, an ethanolic, clear, optically homogeneous liquid with a characteristic odour of its components.
The medicine package consists of a polyethylene (HDPE) bottle with a spray pump made of the following materials: polypropylene (PP), polyethylene (LDPE, LDPE/HDPE, LDPE(EPE)), polyoxymethylene (POM), colourless glass, and steel, containing 100 g of liquid, placed in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Pharmaceutical and Cosmetic Production Enterprise
"Profarm" Sp. z o.o.
ul. Słupska 18
84-300 Lębork