Reparil gel n

Patient Information Leaflet

Warning! Keep the leaflet – the packaging information in a foreign language!
Reparil Gel N (Feparil)
(10 mg + 50 mg)/g, gel
Escinum + Diethylamini salicylas
Reparil Gel N and Feparil are different trade names for the same medicine.
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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if the patient feels worse, 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 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 suffers from chronic kidney disease or renal failure. Do not apply the gel to mucous membranes or irradiated skin areas.

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, scaling, and skin dryness.
Patients who are hypersensitive to salicylates should not use this medicine without consulting a doctor. In such individuals, asthma attacks, local skin and mucous membrane swelling (angioedema), and urticaria may occur.
Avoid contact of the gel with the eyes.

Reparil Gel N and other medicines
Tell 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 is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to lack of data from clinical studies on the effects of the medicine on the pregnant woman’s organism, teratogenic and embryonic effects, this medicine should not be used during pregnancy, especially for prolonged periods or over large skin areas (maximum 3 weeks, only after consultation with a doctor). Use during the first trimester of pregnancy is contraindicated.
Do not use this medicine during breastfeeding.
Avoid applying the gel to the chest area of women who are breastfeeding.

Driving and operating machinery
Special precautions are not required, 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 components linalool, limonene, and farnesol (ingredients of lavender essential oil and bitter orange flower essential oil). Linalool, limonene, and farnesol may cause allergic reactions. Allergic reactions may occur in both sensitized and 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 doctor, apply Reparil Gel N to the affected area and surrounding skin and spread evenly 1 to 3 times daily, until symptoms subside, i.e. for 1 to 2 weeks.
One dose 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) must not be exceeded.
This medicine is intended for external, topical use on the skin.
The gel may be smeared or gently rubbed into the skin. Leave the gel to dry on the skin for several minutes before applying a dressing. The use of occlusive dressings is 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 effects

Like all medicines, this product may cause adverse effects, although not everyone will experience them.
Very rare (occurring in less than 1 in 10,000 patients): 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, including asthma, may also occur.
Reporting of adverse effects
If any adverse symptoms occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of additional information on the safety of using the medicine.

5. How to store Reparil Gel N

Keep the medicine out of the 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.
Shelf-life after first opening the aluminium tube: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 escin and 5 g of diethylamine salicylate.
• Other ingredients are: lavender essential oil, bitter orange flower essential oil (see also section 2, "The medicine contains lavender essential oil and bitter orange flower essential oil"), carbomers, caprylic-capric macrogol glycerides (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.
Aluminium tube in a cardboard box.
Pack size: 1 tube containing 40 g of gel.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
The Netherlands
Manufacturer:
Madaus GmbH
Lutticher Strasse 5
53842 Troisdorf
Germany
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation Number in Spain, the country of export: 660447.2
Parallel Import Licence Number: 350/25