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Leaflet attached to the packaging: patient information

CALLUS OINTMENT

500 mg/g, ointment
Acidum salicylicum

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 advised 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, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is M and what is it used for
• 2. Important information before using M
• 3. How to use M
• 4. Possible side effects
• 5. How to store M
• 6. Contents of the packaging and other information

1. What is M and what is it used for

M is a medicine for use on the skin. After application to the thickened skin, it acts keratolytically (removes dead skin cells), softens and loosens the thickened skin, making it easier to remove.

• The indication for use of this medicine is the removal of calluses and corns.

2. Important information before using M

When not to use M:

• if the patient is allergic to the active substance, salicylates or any of the other ingredients of this medicine (listed in section 6);
• in patients with diabetes or circulatory disorders;
• if the skin in the area of the callus (corn) is injured or inflamed;
• on deep or large areas;
• in children.

Warnings and precautions

Before starting to use this medicine, the patient should discuss it with their doctor or pharmacist.
The medicine should be applied only to the callus. It should not be used on unchanged healthy skin,
or on damaged skin, as systemic side effects of salicylic acid may occur.
Treatment should be discontinued if signs of skin irritation or allergy occur.
Contact with the eyes and mucous membranes should be avoided.

Children and adolescents

This medicine should not be used in children.

M and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken and about medicines they plan to take.
No data available.

Pregnancy, breastfeeding, and fertility

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.
No data available on the safety of use during pregnancy and breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use M

This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
For use on the skin (only on the callus).
Feet should be soaked in water with soap and dried. Hands should be washed thoroughly before and after applying the medicine.
Before use, the box with the ointment should be lightly warmed in the hands to soften it and make it easier to apply. A thin layer of ointment should be applied to the callus and covered with a plaster. The treatment should be repeated for several days, morning and evening, without washing the treated areas with water. Feet should be soaked in hot water, and then the callus should be removed or scraped off with a pumice stone. Calluses should not be cut or torn off.
If necessary, the treatment can be repeated after 3 days.
A callus that is not removed properly will return.

Children and adolescents

This medicine should not be used in children.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using more than the recommended dose of M

No data available.
In case of using a larger dose of the medicine than recommended, the excess ointment should be removed.

Missing a dose of M

A double dose should not be used to make up for a missed dose.

Stopping the use of M

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions and skin inflammation may occur.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions

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
e-mail: ndl@urpl.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 M

The medicine should be stored out of sight and reach of children.
It should be stored at a temperature below 25°C, in a closed packaging.
Shelf life after first opening the packaging: 1 year.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What M contains

• The active substance of the ointment is salicylic acid.

1 g of ointment contains 500 mg of salicylic acid.

• The other ingredient (excipient) is a nostrzyk plaster with the composition: nostrzyk herb, rapeseed oil, yellow wax, colophony.

What M looks like and what the packaging contains

M is a greenish-yellow ointment with a characteristic smell.
The packaging of the medicine is a polyethylene container containing 10 g of ointment, in a cardboard box.

Marketing authorization holder and manufacturer:

Przedsiębiorstwo Produkcji Farmaceutycznej „GEMI” Grzegorz Nowakowski
ul. Mickiewicza 36
05-480 Karczew
tel. 22 780 83 05 w. 70
e-mail: gemi@gemi.pl

Date of last update of the leaflet: