Reparil

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Reparil (Reparil Dragées)

20 mg, enteric-coated tablets
Escinum
Reparil and Reparil Dragées are different trade names for the same drug.

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Reparil and what is it used for
• 2. Important information before taking Reparil
• 3. How to take Reparil
• 4. Possible side effects
• 5. How to store Reparil
• 6. Contents of the pack and other information

1. What is Reparil and what is it used for

Reparil is a medicine used for swelling after local injuries.

2. Important information before taking Reparil

When not to take Reparil:

• if the patient is allergic (hypersensitive) to escin 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 to take Reparil, the patient should discuss it with their doctor or pharmacist.
During treatment with Reparil, kidney function should be monitored.

Children

Administration of Reparil to children under 7 years of age is contraindicated.

Reparil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Reparil may enhance the effect of anticoagulant medicines.
Concomitant use of Reparil with aminoglycoside antibiotics should be avoided due to the potential increased toxic effect of these antibiotics on the kidneys.
Antibiotics such as cefalotin and ampicillin may increase the concentration of escin in serum, so it is not recommended to administer these medicines with Reparil.

Taking Reparil with food and drink

Reparil should be taken after a meal. The tablet should be swallowed whole, with a glass of water.

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 taking this medicine.
Due to the lack of studies in pregnant women and insufficient animal data, Reparil should not be used in pregnant women.
Due to the lack of data on the passage of escin into breast milk, Reparil should not be used in breastfeeding women.

Driving and using machines

Reparil has no influence or negligible influence on the ability to drive and use machines.

Reparil contains lactose monohydrate, sucrose, and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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 a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Unless the doctor has prescribed otherwise, Reparil should be taken as follows:

• adults and adolescents from 14 years: 2 tablets 3 times a day, in mild cases and as a maintenance dose: 1 tablet 3 times a day;

Use in children and adolescents

• children from 7 to 14 years: 1 tablet 2 or 3 times a day.

Reparil should be taken after a meal. The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Reparil than recommended

In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Reparil

The patient should take the next tablet as scheduled.
A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Reparil can cause side effects, although not everybody gets them.
Side effects may occur:

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

The following side effects have been reported:
very rarely: hypersensitivity reactions such as urticaria;
uncommonly: gastrointestinal disorders.
In case of a hypersensitivity reaction, Reparil should be discontinued.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 to gather more information on the safety of the medicine.

5. How to store Reparil

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Reparil contains

• The active substance is beta-escin (Escinum). Each enteric-coated tablet contains 20 mg of beta-escin (Escinum).
• The excipients are: lactose monohydrate (see section 2 "Reparil contains lactose monohydrate, sucrose, and sodium"), povidone (K 29-32), magnesium stearate; coating:sucrose (see section 2 "Reparil contains lactose monohydrate, sucrose, and sodium"), talc, gum arabic, titanium dioxide, colloidal silica, methacrylic acid, and ethyl acrylate copolymer (1:1), macrogol 8000, sodium hydroxide, sodium carmellose, triethyl citrate, simethicone emulsion SE 4, white wax, carnauba wax.

What Reparil looks like and contents of the pack

Blisters (PVC/Al) containing 10 enteric-coated tablets: 20, 40, or 100 enteric-coated tablets in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the 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:

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
Authorization number in the Czech Republic, the country of export: 85/186/71-C

Parallel import authorization number: 122/24

Date of leaflet approval: 20.03.2024

[Information about the trademark]