Patient Information Leaflet

PEDIPUR, 200 mg/g, medicinal powder
Methenaminum
Please read all of this leaflet carefully before using the 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 the physician or pharmacist.

Keep this leaflet, so that you may 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.
If your symptoms do not improve or if you feel worse, contact your doctor.

Table of Contents

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

1. What Pedipur is and what it is used for

Pedipur is a medicinal powder. Methenamine, the active substance in Pedipur, exerts its effect through formaldehyde released upon contact with acidic sweat. Formaldehyde impairs the function of sweat glands and inhibits bacterial activity, thereby reducing sweat secretion and preventing its bacterial breakdown.

Pedipur has a drying, bactericidal, and astringent action. It eliminates unpleasant odour of sweat.

Indications
Pedipur is indicated in the treatment of excessive sweating of the feet and hands.

2. Information before using Pedipur

When not to use Pedipur:

if the patient is allergic to methenamine or any of the other ingredients of this medicine (listed in section 6),
on mucous membranes,
on open wounds,
on denuded skin surfaces,
on ulcers.

Warnings and precautions
Before starting to use Pedipur, discuss this with your doctor or pharmacist.
Discontinue use if skin irritation or redness occurs. Contact your doctor.
Children and adolescents
No data available. Consult a doctor before use.
Pedipur with other medicines
Due to the risk of inactivation, do not use with oxidizing agents (potassium permanganate, nitrates), acids and acid salts, or carbonates (magnesium, calcium).
Pregnancy and breastfeeding
There is a low probability that the active substance in Pedipur may pose a risk to the fetus or pass into breast milk. However, due to lack of adequate studies, Pedipur should be used during pregnancy and breastfeeding only after consulting a doctor and only if the benefit outweighs the risk.
Driving and operating machinery
Pedipur has no influence on the ability to drive or operate machinery.

3. How to use Pedipur

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.
This is a topical medicine for skin application.
Shake the medicine well before use. Before applying the medicine, thoroughly wash and dry the skin of the feet or hands. Apply a small amount of Pedipur to the skin of the feet or hands, rub in, and leave to dry.
Use the medicine no more frequently than once or twice a week.
After improvement has been achieved, treatments may be continued prophylactically every 14 to 20 days.

Use in children and adolescents
No data available. Consult a doctor before using the medicine.

Use of a higher than recommended dose of Pedipur
Overdose with topically applied Pedipur is unlikely. If too much medicine is applied, wash it off the skin with water and inform a doctor or pharmacist.

Missed application of Pedipur
If a dose of Pedipur is missed, continue treatment as usual according to the recommendations.

In case of accidental ingestion of Pedipur, the following symptoms may occur: rash, kidney and bladder irritation, haematuria, nausea and vomiting. In case of accidental ingestion of Pedipur, seek immediate medical advice from a doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Prolonged use of Pedipur may cause local allergic skin reactions on hands and feet.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a 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 helps to provide more information on the safety of this medicine.

5. How to store Pedipur medicine

Keep this medicine out of the sight and reach of children.
Store the medicine in a tightly closed container, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Pedipur contains

The active substance is methenamine. 1 g of powder contains 200 mg of methenamine.
Other components of the medicine are: zinc oxide, talc, glycerol 86%, purified water.

What Pedipur looks like and contents of the pack
Pedipur is a thick, opaque, white powder suspension with a characteristic odour of methenamine.
The medicine is packed in a polyethylene container closed with a screw cap, or in an amber glass bottle closed with a screw cap, or in an internally lacquered aluminium tube with a membrane and a screw cap, or in a laminate tube with an inner layer of polyethylene and a polypropylene screw cap, containing 40 g or 60 g of the medicine, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47/51, 61-896 Poznań, Poland
tel. + 48 61 886 18 00
For further information, please contact the Marketing Authorisation Holder.