Reparil

Package leaflet: information for the patient

Warning! Keep the leaflet. 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 of the same medicinal product.
Please read the 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, so that you can read it again if necessary.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, consult your doctor.

Table of contents of the leaflet:

1. What Reparil is and what it is 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 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 escin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has kidney insufficiency or kidney disorders;
• in children under 7 years of age;
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Reparil, consult a doctor or pharmacist.
Renal function should be monitored during treatment with this medicine.
Children
Administration of Reparil to children under 7 years of age is contraindicated.
Reparil and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Reparil may enhance the effect of anticoagulant medicines.
Concomitant use of Reparil with aminoglycoside antibiotics should be avoided due to the potential for increased nephrotoxicity of these antibiotics.
Antibiotics such as cefalotin and ampicillin may increase serum concentrations of escin; 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 might 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 passage of escin into breast milk, Reparil should not be used during breastfeeding.
Driving and operating machinery
Reparil has no effect or has a negligible effect on the ability to drive motor vehicles or 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 use Reparil

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
If the doctor has not prescribed a different dosage, Reparil should be taken as follows:

• Adults and adolescents from 14 years of age: 2 tablets 3 times daily; in mild cases and as maintenance dose: 1 tablet 3 times daily;

Use in children and adolescents

• Children from 7 to 14 years of age: 1 tablet 2 or 3 times daily.

Reparil should be taken after meals. The tablet should be swallowed whole with water.
Taking more Reparil than recommended
If you take more Reparil than you should, contact your doctor or pharmacist immediately.
Missing a dose of Reparil
Take the next tablet as scheduled.
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 everybody 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 a doctor, pharmacist, or nurse. 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 allows the collection of further information on the safety of medicine use.

5. How to store Reparil

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Reparil contains

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

What Reparil looks like and contents of the pack
Blister packs (PVC/Al) containing 10 enteric tablets: 20, 40 or 100 enteric tablets in a cardboard box.
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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 85/186/71-C
Parallel import authorisation number: 122/24