Reparil

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Reparil

20 mg, enteric-coated tablets
Escinum

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
the doctor or pharmacist.

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

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. Package contents and other information

1. What is Reparil and what is it used for

Reparil is 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 doctor or pharmacist should be consulted.
Kidney function should be monitored during treatment with the medicine.

Children

Administration of the medicine to children under 7 years of age is contraindicated.

Reparil and other medicines

The doctor or pharmacist should be informed about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Reparil may enhance the effect of anticoagulant medicines.
Concomitant use of Reparil with aminoglycoside antibiotics should be avoided due to the possible 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 concomitantly 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 she may be pregnant, or plans to have a child, she should consult her 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, the patient should consult the doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means 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. In case of doubt, the doctor or pharmacist should be consulted.
Unless the doctor recommends 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 taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of Reparil

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

4. Possible side effects

Like all medicines, this medicine 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Reparil contains

• The active substance of the medicine is escin (Escinum), 20 mg.
• The excipients are: lactose monohydrate, povidone (K 30), magnesium stearate, sucrose, talc, gum arabic, titanium dioxide (E 171), colloidal silica anhydrous, methacrylic acid - ethyl acrylate copolymer (Eudragit L 100-55), macrogol 8000, sodium hydroxide, sodium carmellose, triethyl citrate, simethicone emulsion, white wax, carnauba wax.

What Reparil looks like and what the pack contains

PVC/Al blisters in a cardboard box.
20 pieces - 2 blisters of 10 enteric-coated tablets
40 pieces - 4 blisters of 10 enteric-coated tablets
100 pieces - 10 blisters of 10 enteric-coated tablets
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Austria, the country of export:

Mylan Österreich GmbH
Guglgasse 15
1110 Vienna
Austria

Manufacturer:

Madaus GmbH
51101 Cologne
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, country of export:12.947
Parallel import authorization number:59/13
Date of leaflet approval: 28.10.2022
[Information about the trademark]