PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Reparil
20 mg, enteric-coated tablets
Escinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your physician or pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
If there is no improvement after 7 days, or if the patient feels worse, consult a physician.

Table of contents of the leaflet:

What Reparil is and what it is used for
Important information before taking Reparil
How to take Reparil
Possible side effects
How to store Reparil
Contents of the pack and other information

1. What Reparil is and what it is used for

Reparil is a medicine used for oedema following local injuries.

2. Important information before taking Reparil

When not to take Reparil

if the patient is allergic (hypersensitive) to aescin or any of the other ingredients of this medicine (listed in section 6);
if the patient has kidney failure or kidney disorders;
in children under 7 years of age;
during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Reparil, discuss it with your doctor or pharmacist.
Renal function should be monitored during treatment.
Children
Administration of Reparil to children under 7 years of age is contraindicated.
Reparil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Reparil may enhance the effect of anticoagulant drugs.
Concomitant use of Reparil with aminoglycoside antibiotics should be avoided due to the potential for increased nephrotoxicity of these antibiotics.
Antibiotics such as cephalothin and ampicillin may increase serum concentrations of aescin; therefore, concomitant administration of these drugs with Reparil is not recommended.
Taking Reparil with food and drink
Reparil should be taken after meals. The tablet should be swallowed whole with water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to lack of studies in pregnant women and insufficient data from animal studies, Reparil should not be used during pregnancy.
Due to lack of data on the passage of aescin into breast milk, Reparil should not be used in breastfeeding women.
Driving and operating machinery
Reparil has no effect or has negligible effect on the ability to drive motor vehicles and operate mechanical equipment.
Reparil contains monohydrate lactose, sucrose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Reparil
This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise advised by a doctor, Reparil should be taken as follows:

adults and adolescents from 14 years of age: 2 tablets three times daily; in mild cases and as maintenance dose: 1 tablet three times daily.

Use in children and adolescents

children from 7 to 14 years of age: 1 tablet two or three times daily.

Reparil should be taken after meals. The tablet should be swallowed whole with water.
Overdose of Reparil
In case of overdose, seek immediate advice from a doctor or pharmacist.
Missed dose of Reparil
Take the next tablet according to the recommended schedule.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur:

uncommonly (in less than 1 in 100 patients);
very rarely (in less than 1 in 10,000 patients).

The following adverse reactions have been reported:

very rarely: hypersensitivity reactions such as urticaria;
uncommonly: gastrointestinal disturbances.

If hypersensitivity reactions occur, Reparil should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for 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 helps to provide more information on the safety of this medicine.

5. How to store Reparil

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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Reparil contains

The active substance is escin. Each enteric-coated tablet contains 20 mg of escin.
The other ingredients are: lactose monohydrate, povidone K 30, magnesium stearate, sucrose, talc, methacrylic acid and ethyl acrylate copolymer (1:1), gum arabic, titanium dioxide (E 171), macrogol 8000, triethyl citrate, colloidal anhydrous silica, sodium carmellose, sodium hydroxide, white wax, carnauba wax, simethicone emulsion.

What Reparil looks like and contents of the pack
Al/PVC blisters in a cardboard box.
Pack contains:
20 tablets – 2 blisters with 10 enteric-coated tablets each
or
40 tablets – 4 blisters with 10 enteric-coated tablets each

For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Austria, country of export:
Mylan Österreich GmbH
Guglgasse 15
1110 Vienna, Austria
Manufacturer:
MADAUS GmbH
D-51101 Cologne, Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
Marketing authorisation number in Austria, country of export: 12.947
Parallel import authorisation number: 58/20