PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Aescin (Aescin Teva),
20 mg, enteric-coated tablets
Escinum
Aescin and Aescin Teva are different brand names for 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
the physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your physician or pharmacist. See section 4.
If your condition does not improve or worsens, contact your physician.

Table of contents:

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

1. What Aescin is and what it is used for

Treatment of chronic venous insufficiency, varicose veins of the lower limbs, and hemorrhoids.
Treatment of phlebitis of the lower limbs.
Prevention and treatment of postoperative and traumatic hematomas and edema.

Aescin has anti-edematous and anti-inflammatory effects and improves vascular tone. It reduces the permeability of blood vessel walls. It is effective in the treatment of postoperative and traumatic edema.
Aescin promotes faster resorption of traumatic hematomas and reduces the likelihood of their occurrence in the postoperative period (especially after orthopedic and trauma surgery). Furthermore, by sealing the endothelium of blood vessels, it improves venous and lymphatic circulation. The medicine is also used in the prevention of postoperative thrombophlebitis, as well as in the treatment of circulatory disorders in the limbs and varicose veins of the lower limbs.
If your condition does not improve or worsens, contact your physician.

2. Important information before using Aescin

When not to use Aescin

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if the patient has severe renal insufficiency
in women during pregnancy and breastfeeding.

Warnings and precautions
If any of the following symptoms occur after using Aescin, contact a doctor immediately:

skin inflammation
thrombophlebitis
subcutaneous indurations (lumps under the skin)
skin ulcers
acute pain associated with skin disorders
sudden swelling of one or both legs
heart or kidney failure.

When using anticoagulant drugs concomitantly, blood coagulation parameters should be monitored frequently.
It is important to follow any other non-invasive measures recommended by the physician, such as leg bandaging, wearing compression stockings, cold compresses.
Renal function should be monitored during treatment with Aescin.
This medicine should not be used in patients with rare hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome.
Note: The use of Aescin does not replace other preventive measures such as cold compresses or wearing compression stockings.
Children and adolescents
Aescin is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety in this age group.
Aescin with other medicines
Inform your doctor about all medicines you are currently taking, including those obtained without a prescription.
Aescin may enhance the effect of anticoagulant drugs. Some antibiotics – cephalosporins – may increase the effect of Aescin.
Concomitant administration of Aescin with aminoglycoside antibiotics should be avoided due to possible increased nephrotoxic effects of aminoglycosides.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
There are no clinical data on the use of alpha-aescin in pregnant women. Animal studies do not indicate a direct or indirect harmful effect of alpha-aescin on pregnancy progression or fetal development.
Breastfeeding
There are no clinical data on the use of alpha-aescin in women during breastfeeding.
Driving and operating machinery
Aescin does not affect the ability to drive or operate machinery.
This medicine contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains sunset yellow FCF
Due to the presence of sunset yellow FCF (E 110), this medicine may cause allergic reactions.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Aescin

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Aescin coated tablets are intended for oral use.
Use in children and adolescents:
The use of this medicine is not recommended in children and adolescents under 18 years of age.
Adults:
The usual dose of Aescin is 2 tablets three times daily, taken after meals with a large amount
of liquid.
Prophylactically, treatment may be started at least 16 hours before a surgical procedure. After 2–3
months of treatment, maintenance therapy may be applied at a dose of 40 mg (2 tablets) twice
daily.
When using oral contraceptives, a double dose of alfa-escin may be taken.
Elderly patients:
no dosage adjustment is necessary.
Missed dose of Aescin
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.

The frequency of adverse reactions is defined as follows:
very common – more than 1 in 10 patients
common – 1 to 10 in 100 patients
uncommon – 1 to 10 in 1,000 patients
rare – 1 to 10 in 10,000 patients
very rare – less than 1 in 10,000 patients
unknown – frequency cannot be estimated from the available data

Rare: allergic skin reactions (itching, rash, erythema, exanthema, urticaria)
Very rare: severe allergic reactions (in some cases with bleeding); tachycardia,
hypertension; hypersensitivity reactions; vaginal bleeding
Uncommon: dizziness, headache; nausea, vomiting, diarrhoea, gastric discomfort

If any of the above reactions occur, especially bleeding or first signs of hypersensitivity (skin rash), the medicine should be discontinued and a doctor should be contacted immediately.

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 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 helps to provide more information on the safety of the medicine.

5. How to store Aescin

Store below 25°C.
Keep in the original packaging to protect from moisture.
Store in a place invisible and inaccessible to children.
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 package and other information

What Aescin contains

The active substance is alpha-aescin.
The other ingredients are: Tablet core: monohydrate lactose, potato starch, povidone 25, talc, magnesium stearate. Tablet coating: polysorbate 80, copolymer of methacrylic acid and methyl methacrylate (1:1), 30% dispersion, sodium carmellose, titanium dioxide (E 171), aluminium lake of orange yellow dye (E 110), povidone 25, talc, simethicone emulsion 30%.

What Aescin looks like and contents of the pack
Enteric-coated tablets, in Al/PVC blisters, packs of 30 tablets, 90 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:
Teva Pharmaceuticals CR, s.r.o.
Radlická 3185/1c
150 00 Prague 5
Czech Republic
Manufacturer:
TEVA Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Marketing authorisation number in the Czech Republic, country of export: 85/262/92-C
Parallel import authorisation number: 18/19