Reparil Gel N

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Reparil Gel N (Reparil N)

(10 mg + 50 mg)/g, gel
Escinum + Diethylamini salicylas
Reparil Gel N and Reparil N are different trade names for the same medicine.

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 this patient leaflet, or as directed by
the doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Reparil Gel N and what is it used for

Reparil Gel N is used topically as an adjunctive treatment to alleviate post-traumatic conditions such as bruises, hematomas, contusions, and joint injuries.

2. Important information before using Reparil Gel N

When not to use Reparil Gel N

• if the patient is allergic to salicylates, escin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has open wounds,
• if the woman is in the first trimester of pregnancy,
• if the patient has chronic kidney disease, renal failure. Do not apply the medicine to mucous membranes, areas of skin that have been irradiated.

Warnings and precautions

Before starting to use Reparil Gel N, discuss it with your doctor or pharmacist.
Very rarely, hypersensitivity reactions may occur at the application site, along with redness of the skin and its dryness, as well as peeling and dryness of the skin.
Patients allergic to salicylates should not use the medicine without consulting a doctor. In these patients, asthma attacks, local skin and mucous membrane swelling (angioedema), and hives may occur.
Eye contact with the gel should be avoided.

Reparil Gel N and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding:

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.
Due to the lack of research results on the effect of the medicine on the pregnant woman's body, teratogenic, embryonic effects, the medicine should not be used in pregnant women, for a longer period, and on large areas (up to 3 weeks, after consulting a doctor). Use in the first trimester of pregnancy is contraindicated.
The medicine should not be used during breastfeeding.
The medicine should be avoided on the chest area of breastfeeding women.

Driving and using machines

No special precautions are necessary, as the medicine does not affect the ability to drive or operate machines.

The medicine contains lavender essential oil and bitter orange flower essential oil

The medicine contains fragrances with linalool, D-limonene, and farnesol (components of lavender essential oil and bitter orange flower essential oil). Linalool, D-limonene, and farnesol may cause allergic reactions. An allergic reaction may occur in patients who are allergic and in patients who have not been allergic before.

3. How to use Reparil Gel N

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise directed by the doctor, Reparil Gel N should be applied and spread on the affected area and its surroundings 1 to 3 times a day, until the symptoms disappear, i.e., 1 to 2 weeks.
One dose of the medicine is the application of a gel the size of a walnut, which corresponds to about 6 g of gel (this dose contains about 195 mg of salicylate). Do not exceed the maximum daily dose of 20 g of gel (containing about 650 mg of salicylate).
The medicine is intended for external use, locally on the skin.
The gel can be smeared or rubbed into the skin. The gel should be left to dry on the skin for a few minutes before applying a dressing. Occlusive dressing is not recommended.

Use in children and adolescents

Use of Reparil Gel N in children and adolescents under 12 years of age is not recommended.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare (occurring in less than 1 in 10,000 patients): hypersensitivity reactions at the application site, along with redness of the skin and its dryness, rash, erythema, skin inflammation, peeling of the skin, hives.
Local use of medicines containing salicylates, especially after application to large areas of skin, may cause systemic effects on the body related to the impact on the liver, kidneys, and digestive system; may also cause systemic hypersensitivity reactions, asthma.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Reparil Gel N

Keep the medicine out of the sight and reach of children.
Store in 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 specified month.
Aluminum tube: Shelf life after first opening the tube - 6 months.
Laminated tube: Shelf life after first opening the tube - 12 months.
Medicines should 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 packaging and other information

What Reparil Gel N contains

• The active substances of the medicine are beta-escin (Escinum) and diethylammine salicylate (Diethylamini salicylas). 100 g of gel contains 1 g of beta-escin and 5 g of diethylammine salicylate.
• Other ingredients are: lavender essential oil (linalool), bitter orange flower essential oil (D-limonene, farnesol, linalool) (see also section 2 "The medicine contains lavender essential oil and bitter orange flower essential oil"), carbomers, macrogolglycerides caprylocaprate (Softigen 767), disodium edetate, tromethamine, isopropyl alcohol, purified water.

What Reparil Gel N looks like and what the packaging contains

Reparil Gel N is a gel.
The packaging is an aluminum tube with an HDPE cap or a 5-layer laminated tube (inner layer HDPE) with a PP cap or a 7-layer laminated tube (inner layer HDPE) with a PP cap, in a cardboard box.
Pack size: 1 tube of 40 g of gel.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin, Ireland

Manufacturer:

MADAUS GmbH
51101 Cologne
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:85/335/95-C

Parallel import authorization number: 43/25

Date of leaflet approval: 30.01.2025

[Information about the trademark]