Reparil

Package Leaflet: Information for the Patient

REPARIL

20 mg, enteric-coated tablets
Escinum

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after 7 days, you should contact your 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 you are allergic (hypersensitive) to escin or any of the other ingredients of this medicine (listed in section 6);
• if you have kidney failure or kidney disorders
• in children under 7 years of age;
• during pregnancy and breastfeeding.

Warnings and precautions

Before taking Reparil, you should discuss it with your doctor or pharmacist.
While taking the medicine, you should have your kidney function monitored.

Children

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

Reparil and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Reparil may enhance the effect of anticoagulant medicines.
You should avoid taking Reparil with aminoglycoside antibiotics 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 take 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Due to the lack of studies in pregnant women and insufficient data from animal studies, Reparil should not be taken during pregnancy.
Due to the lack of data on the penetration of escin into breast milk, Reparil should not be taken during breastfeeding.

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 you have been diagnosed with intolerance to some sugars, you should contact your 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 package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Unless your 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 more than the recommended dose of Reparil

If you have taken more than the recommended dose, you should contact your doctor or pharmacist immediately.

Missing a dose of Reparil

You should take the next tablet as scheduled.
You should not take a double dose 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.
If you experience a hypersensitivity reaction, you should stop taking Reparil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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.
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. You should ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Reparil contains

• -The active substance is beta-escin. Each enteric-coated tablet contains 20 mg of beta-escin.
• -The other ingredients 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, arabic gum, titanium dioxide (E 171), colloidal anhydrous silica, 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 contents of the pack

PVC/Aluminum blisters of 10 enteric-coated tablets in a cardboard box.
20 pieces - 2 blisters of 10 tablets
40 pieces - 4 blisters of 10 tablets
100 pieces - 10 blisters of 10 tablets

Marketing Authorization Holder

Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
Netherlands

Manufacturer

MADAUS GmbH
51101 Köln
Germany
To obtain more detailed information, please contact:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00

Date of last revision of the leaflet:

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