Reparil gel n

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer 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 physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days of treatment, or if you feel worse, consult your doctor.

Table of contents:

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 symptoms of 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 has chronic kidney disease or renal failure. Do not apply the gel on mucous membranes or on 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, asthma attacks, local swelling of the skin and mucous membranes (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 any medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding:
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Due to lack of data on the effects of the medicine on the pregnant woman’s body and its teratogenic or embryotoxic potential, Reparil Gel N should not be used during pregnancy, especially for prolonged periods or over large skin areas (maximum 3 weeks, only after consulting a doctor). Use during the first trimester of pregnancy is contraindicated.
Do not use the medicine during breastfeeding.
Avoid applying the gel on the chest area in 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, D-limonene, and farnesol (ingredients of lavender essential oil and bitter orange flower essential oil). Linalool, D-limonene, and farnesol may cause allergic reactions. Allergic reactions may occur both in sensitized patients and in patients not previously known to be allergic.

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 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, 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 spread or gently rubbed into the skin. Allow the gel 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 medicine can cause adverse reactions, although not everyone will experience them.
Very rarely (occurring in less than 1 in 10,000 patients): hypersensitivity reactions at the application site with 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, asthma, may also occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. 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.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continuous monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Reparil Gel N

Keep this 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 helps protect the environment.

6. Contents of the package and other information

What Reparil Gel N contains

• The active substances in the 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.
• Other components are: lavender essential oil (linalool), bitter orange flower essential oil (D-limonene, farnesol, linalool) (see also section 2. "The medicinal product contains lavender essential oil and bitter orange flower essential oil"), carbomers, caprylic/capric macrogol glycerides (Softigen 767), disodium edetate, trometamol, isopropyl alcohol, purified water.

What Reparil Gel N looks like and contents of the pack
Reparil Gel N is a gel.
The packaging consists of a coated aluminium tube with a cap made of HDPE, or a tube made of 5-layer laminate (inner layer HDPE) with a PP cap, or a tube made of 7-layer laminate (inner layer HDPE) with a 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
Dublin, Ireland
Manufacturer:
MADAUS GmbH
51101 Cologne
Germany
Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in the Czech Republic, country of export: 85/335/95-C
Parallel import authorisation number: 43/25