Reparil gel n

Package leaflet: Information for the patient

Warning! Keep this 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 medicinal product.
Please read 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 a doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days, or if the patient's condition worsens, consult a doctor.

Table of contents of the leaflet:

1. What Reparil Gel N is and what it is 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 pack and other information

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

Reparil Gel N is used topically as supportive treatment to relieve post-traumatic conditions such as contusions, bruises, crush injuries, 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 components 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 or renal failure. Do not apply the medicine to mucous membranes or skin areas exposed to radiation.

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, including skin redness, as well as skin peeling and dryness.
Patients who are hypersensitive to salicylates should not use this medicine without consulting a doctor. In such individuals, bronchial asthma attacks, local skin and mucous membrane swelling (angioedema), and urticaria may occur.
Avoid contact of the gel with the eyes.
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Reparil Gel N with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Due to lack of data on the effects of the medicine on the pregnant woman's body, teratogenic or embryotoxic effects, this medicine should not be used in pregnant women over prolonged periods or on large skin areas (maximum 3 weeks, after consulting a doctor). Use during the first trimester of pregnancy is contraindicated.
Do not use this medicine during breastfeeding.
Avoid applying the medicine to the chest area of women who are breastfeeding.
Driving and operating machinery
No special precautions are necessary, as the medicine does not affect the ability to drive or operate machinery.
The medicine contains lavender essential oil and bitter orange flower essential oil
This medicine contains fragrance substances including 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. Allergic reactions may occur in patients already sensitized as well as in previously non-sensitized patients.

3. How to use Reparil Gel N

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.
Unless otherwise advised by a physician, Reparil Gel N should be applied and spread over the affected area and its surroundings 1 to 3 times daily, until symptoms subside, i.e. for 1 to 2 weeks.
One dose of the medicine corresponds to an amount of gel the size of a hazelnut, which is approximately 6 g of gel (this dose contains about 195 mg of salicylate). The maximum daily dose of 20 g of gel (containing about 650 mg of salicylate) should not be exceeded.
This medicine is intended for external, local application to the skin.
The gel may be spread or gently rubbed into the skin. The gel should be left to dry on the skin for several minutes before applying a dressing. Occlusive dressings are not recommended.
Use in children and adolescents
The use of Reparil Gel N in children and adolescents under 12 years of age is not recommended.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody will experience them.
Very rare (occurring in less than 1 patient out of 10,000): hypersensitivity reactions at the site of application, including skin redness and dryness, rash, erythema, dermatitis, skin desquamation, urticaria.
Topical application of medicinal products containing salicylates, especially when applied to large areas of skin, may lead to systemic effects affecting the liver, kidneys, and gastrointestinal system. Systemic hypersensitivity reactions and asthma may also occur.
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Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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, tel.: 22-49-21-301, fax: 22-49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Reparil Gel N

Keep the medicine out of sight and reach of children.
Store 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.
Aluminium tube: Shelf-life after first opening – 6 months.
Laminated tube: Shelf-life after first opening – 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Reparil Gel N contains

• The active substances in this medicinal product are beta-escin (Escinum) and diethylamine salicylate (Diethylamini salicylas). 100 g of gel contains 1 g of beta-escin and 5 g of diethylamine salicylate.
• The other ingredients are: lavender essential oil (linalool), bitter orange flower essential oil (D-limonene, farnesol, linalool) (see also section 2. "This medicinal product contains lavender essential oil and bitter orange flower essential oil"), carbomers, caprylic/capric glycerides macrogolglycerides (Softigen 767), disodium edetate, tromethamine, isopropyl alcohol, purified water.

What Reparil Gel N looks like and contents of the pack
Reparil Gel N is a gel.
Packaging:
Aluminium tube with a lacquered coating and HDPE cap, in a cardboard box.
Tube made of 5-layer laminate (inner layer HDPE) with PP cap, in a cardboard box.
Tube made of 7-layer laminate (inner layer HDPE) with PP cap, in a cardboard box.
Pack size:
1 tube containing 40 g of gel.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
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Dublin, Ireland
Manufacturer:
MADAUS GmbH
51101 Cologne, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in the Czech Republic, country of export: 85/335/95-C
Parallel Import Authorisation number: 295/25
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