Anti-pressure sore and skin callus ointment rekord łuszczy

Package leaflet: Information for the user

Rekord Łuszczy Ointment for calluses and skin callosity, 200 mg/g, ointment
Acidum salicylicum
Please read all of this leaflet carefully before using this medicine, Rekord Łuszczy Ointment, because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• 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, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 weeks of treatment, or if you feel worse, consult your doctor.

Leaflet contents:

1. What Rekord Łuszczy Ointment is and what it is used for
2. What you need to know before using Rekord Łuszczy Ointment
3. How to use Rekord Łuszczy Ointment
4. Possible side effects
5. How to store Rekord Łuszczy Ointment
6. Contents of the pack and other information

1. What Rekord Łuszczy Ointment is and what it is used for

Rekord Łuszczy Ointment for calluses and skin callosity is intended for topical use.
The medicine contains the active substance Acidum salicylicum (salicylic acid), which, when applied locally to thickened, keratinized skin, exerts a keratolytic effect, softens and loosens the skin, facilitating desquamation.

Therapeutic indications:
Removal of calluses and skin callosity.

2. Important information before using the medicinal product "Rekord Łuszczy" Anti-callus and Anti-corns Ointment

When not to use "Rekord Łuszczy" Anti-callus and Anti-corns Ointment:

• if the patient is allergic to salicylic acid, salicylates, or any of the other ingredients of this medicinal product (listed in section 6);
• in patients with diabetes or circulatory disorders;
• if the skin in the area of the callus (or corn) is injured or inflamed;
• for large surface areas;
• in the eyes;
• on facial skin or genital areas;
• around the anus and genital organs;
• on mucous membranes;
• in children.

Warnings and precautions

Before starting treatment with "Rekord Łuszczy" Anti-callus and Anti-corns Ointment, consult your doctor, pharmacist, or nurse.
Discontinue treatment if excessive skin irritation occurs.
Protect the eyes and mucous membranes from contact with the medicinal product.
The ointment should be applied only to calluses or corns – it must not be used on healthy, unaltered skin or damaged skin, as salicylic acid is absorbed through the skin and systemic effects may occur. If the ointment spreads to healthy skin surrounding the callus, wash it off immediately and thoroughly with water.

Children and adolescents
Do not use in children.

"Rekord Łuszczy" Anti-callus and Anti-corns Ointment and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently used or recently used, as well as any that are planned for future use.
No interactions with other medicinal products have been reported so far.
Since salicylic acid is absorbed through intact epidermis, the ointment may interact with systemically or locally acting preparations. Salicylic acid may enhance the effects of, among others, oral antidiabetic drugs of the sulfonylurea group, lithium-containing drugs, anticoagulants, and may also intensify the effects of phenytoin and valproic acid. Medicinal products metabolized by cytochrome P-450, such as cimetidine, inhibit the metabolism of salicylic acid. Salicylic acid may reduce the effectiveness of antihypertensive drugs, e.g., angiotensin-converting enzyme inhibitors, and diuretics.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicinal product.
Salicylic acid crosses the placenta; therefore, the product should not be used during pregnancy.
There are no data available on the use of this medicinal product during breastfeeding.

Driving and operating machinery
This medicinal product has no influence on the ability to drive vehicles or operate machinery.

3. How to use the medicine "Rekord Łuszczy" Ointment for Corns and Calloused Skin

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Before starting treatment, soak the feet thoroughly in warm water. Then apply the ointment to the corn and cover with a plaster. Daily, replenish the ointment in the cavity, taking care not to let it come into contact with healthy skin. Treatment lasts one week. After this time, soak the feet again thoroughly. The corn should then be easily removable. Calloused skin is treated in the same way.

In case of very long-standing lesions, treatment may be repeated. Do not use the medicine for longer than 2 weeks.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use in children and adolescents
Do not use in children.

Discontinuation of use of Rekord Łuszczy Ointment for Corns and Calloused Skin
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like any medicinal product, Maść przeciw odciskom i zgrubieniom skóry Rekord Łuszczy may cause adverse effects, although not everyone experiences them.
The product may cause local skin irritation, skin inflammation, allergic reactions, and excessive skin dryness. Application of the product to healthy skin, large skin areas, or mucous membranes may cause irritation symptoms such as redness. With chronic use of the product, general adverse effects of salicylic acid may occur.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicinal product.

5. How to store the medicinal product Rekord Łuszczy Ointment for Calluses and Skin Hardening

Keep the medicine out of sight and reach of children.
Store below 25°C.
Shelf-life after first opening of the container: 2 years.
Do not use this medicinal product after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Maść przeciw odciskom i zgrubieniom skóry Rekord Łuszczy contains
The active substance is salicylic acid.
Each 1 g of the ointment contains 200 mg of salicylic acid.
The other ingredient (excipient) is: yellow soft paraffin.

What Maść przeciw odciskom i zgrubieniom skóry Rekord Łuszczy looks like and contents of the pack
The medicine is in the form of an ointment.

Packaging:
Aluminium tube containing 15 g of ointment, placed in a cardboard box with a patient information leaflet.

Marketing Authorisation 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 ext. 34
e-mail: [email protected]