Mashh pzheciv odciskom i zgrubieniom skuri Rekord Vushhi

Leaflet attached to the packaging: patient information

Corn and callus skin cream "Rekord Łuszczy", 200 mg/g, cream

Acidum salicylicum

Please read the contents of the leaflet carefully before using the Corn and callus skin cream "Rekord Łuszczy", 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 doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please contact a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 2 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Corn and callus skin cream "Rekord Łuszczy" and what is it used for
• 2. Important information before using Corn and callus skin cream "Rekord Łuszczy"
• 3. How to use Corn and callus skin cream "Rekord Łuszczy"
• 4. Possible side effects
• 5. How to store Corn and callus skin cream "Rekord Łuszczy"
• 6. Package contents and other information

1. What is Corn and callus skin cream "Rekord Łuszczy"

and what is it used for
Corn and callus skin cream "Rekord Łuszczy" is intended for topical use.
The medicine contains the active substance salicylic acid, which, when applied topically to thickened skin, has a keratolytic effect, softens and loosens the skin, making it easier to remove.

Indications:

Removal of corns and calluses.

2. Important information before using Corn and callus skin cream "Rekord Łuszczy"

When not to use Corn and callus skin cream "Rekord Łuszczy":

• if the patient is allergic to salicylic acid, 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 corn (or callus) is injured or inflamed;
• on large areas of skin;
• in the eyes;
• on the skin of the face, groin;
• in the anal and genital areas;
• on mucous membranes;
• in children.

Warnings and precautions

Before starting to use Corn and callus skin cream "Rekord Łuszczy", the patient should discuss it with their doctor, pharmacist, or nurse.
Treatment should be discontinued if excessive skin irritation occurs.
Eyes and mucous membranes should be protected from contact with the medicine.
The medicine should only be applied to the corn or callus - it should not be used on healthy, unaffected skin or damaged skin, as salicylic acid is absorbed through the skin and may cause systemic effects. If the medicine comes into contact with the surrounding healthy skin, it should be washed off immediately with water.

Children and adolescents

The medicine should not be used in children .

Corn and callus skin cream "Rekord Łuszczy" and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines have been reported to date.
Since salicylic acid is absorbed through intact skin, the medicine may interact with systemically and topically acting preparations. Salicylic acid enhances the effect of, among others, oral antidiabetic drugs from the sulfonylurea group, lithium preparations, anticoagulants, and may also enhance the effect of phenytoin and valproic acid. Drugs metabolized by cytochrome P-450, such as cimetidine, inhibit the metabolism of salicylic acid. Salicylic acid may reduce the effect of blood pressure-lowering drugs, such as ACE inhibitors, and diuretics.

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.
Salicylic acid crosses the placenta, so the medicine should not be used in pregnant women.
There is no data on the use of the medicine in breastfeeding women.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

3. How to use Corn and callus skin cream "Rekord Łuszczy"

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Before starting treatment, the feet should be soaked in warm water. Then, the cream should be applied to the corn and secured with a plaster. The patient should replenish the cream daily, taking care not to get it on healthy skin. Treatment lasts for one week.
After this time, the feet should be soaked again. The corn should be easy to remove. Calluses are treated in the same way.
In the case of very old changes, treatment should be repeated. The medicine should not be used for more than 2 weeks.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor .

Use in children and adolescents

The medicine should not be used in children.

Discontinuation of Corn and callus skin cream "Rekord Łuszczy"

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

4. Possible side effects

Like all medicines, Corn and callus skin cream "Rekord Łuszczy" can cause side effects, although not everybody gets them.
The medicine may cause local skin irritation, skin inflammation, allergic reactions, and excessive skin dryness. Applying the medicine to healthy skin, large areas of skin, or mucous membranes may cause irritation symptoms such as redness. With chronic use of the medicine, systemic side effects of salicylic acid may occur.
Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 Corn and callus skin cream "Rekord Łuszczy"

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the package – 2 years.
Do not use this medicine 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. Package contents and other information

What does Corn and callus skin cream "Rekord Łuszczy" contain

The active substance of the medicine is salicylic acid.
1 g of cream contains 200 mg of salicylic acid.
The other ingredient (excipient) is: yellow petrolatum.

What Corn and callus skin cream "Rekord Łuszczy" looks like and what the package contains

The medicine is a cream.

Packaging:

An aluminum tube containing 15 g of cream in a cardboard box with a patient information leaflet (leaflet) attached.

Marketing authorization holder and manufacturer:

Zakład Farmaceutyczny "Amara" sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Tel.: 12 657 40 40
Fax: 12 657 40 40 wew. 34
e-mail: amara@amara.pl

Date of the last update of the leaflet: