Aescin

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 trade names for the same medicine.

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Aescin and what is it 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 post-traumatic hematomas and edema.

Aescin works as an anti-edema and anti-inflammatory agent and improves the tone of blood vessels. It reduces the permeability of blood vessel walls. It has been shown to be effective in the treatment of postoperative and post-traumatic edema.
Aescin also promotes faster absorption of post-traumatic hematomas and reduces the likelihood of their occurrence in the postoperative period (especially after orthopedic surgery).
Furthermore, by sealing the blood vessel endothelium, it improves lymphatic-venous circulation. The medicine is also used to prevent postoperative thrombophlebitis and to treat disorders of venous circulation and varicose veins of the lower limbs.
If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before taking Aescin

When not to take Aescin:

• in pregnant or breastfeeding women.

Warnings and precautions

If you experience any of the following symptoms after taking Aescin, you should contact your doctor immediately:

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

In case of concomitant use of anticoagulant medicines, it is necessary to frequently monitor blood coagulation parameters.
It is essential to follow all other non-invasive measures recommended by your doctor, such as bandaging legs, wearing compression stockings, or applying cold water compresses.
During treatment with Aescin, kidney function should be monitored.
The medicine should not be used in patients with rare hereditary galactose intolerance,
lactase deficiency (Lapp type) or glucose-galactose malabsorption syndrome.
Warning!Taking Aescin does not replace other preventive measures such as cold water compresses or wearing compression stockings.

Children and adolescents

The use of the medicine is not recommended in children and adolescents under 18 years of age due to the lack of sufficient data confirming its safety in this age group.

Aescin and other medicines

You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
Aescin may enhance the effect of anticoagulant medicines. Some antibiotics - cephalosporins may enhance the effect of the medicine.
You should avoid taking Aescin with aminoglycoside antibiotics due to the possible increased toxic effect of aminoglycosides on the kidneys.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

There are no clinical data on the use of alpha-escin in pregnant women.
Animal studies do not show any direct or indirect harmful effects of alpha-escin on pregnancy and fetal development.

Breastfeeding

There are no clinical data on the use of alpha-escin in breastfeeding women.

Driving and using machines

Aescin does not affect the ability to drive and use machines.

The medicine contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

The medicine contains orange yellow S

Due to the presence of orange yellow S (E 110), the medicine may cause allergic reactions.

The medicine contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Aescin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Aescin enteric-coated tablets are intended for oral use.
Use in children and adolescents:
The use of the medicine is not recommended in children and adolescents under 18 years of age.
Adults:
The usual dose of Aescin is 2 tablets 3 times a day, after meals, with a large amount of liquid.
Prophylactically, it can be taken at least 16 hours before surgery.
After 2-3 months of treatment, maintenance therapy can be applied at a dose of 40 mg (2 tablets) 2 times a day.
In case of the use of contraceptive measures, a double dose of alpha-escin can be taken.
Elderly patients:
no dose adjustment is necessary.

Missing a dose of Aescin

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Aescin can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:

• very common - more than 1 in 10 patients
• common - between 1 in 10 and 1 in 100 patients
• uncommon - between 1 in 100 and 1 in 1000 patients
• rare - between 1 in 1000 and 1 in 10,000 patients
• very rare - less than 1 in 10,000 patients
• not known - frequency cannot be estimated from the available data.

Rarely:allergic skin inflammation (itching, rash, redness, eruption, urticaria).
Very rarely:severe allergic reactions (in some cases with bleeding); tachycardia, arterial hypertension; hypersensitivity reactions; genital tract bleeding.
Uncommonly:dizziness, headache; nausea, vomiting, diarrhea, discomfort in the stomach.
In case of the above reactions, especially bleeding and the first hypersensitivity reactions (skin rash), you should stop taking the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department for 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aescin

Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Store out of sight and reach of children.
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. This will help protect the environment.

6. Contents of the pack and other information

What Aescin contains

• The active substance of the medicine is alpha-escin. Each tablet contains 20 mg of alpha-escin (Escinum).
• The other ingredients of the medicine are: lactose monohydrate, potato starch, povidone 25, talc, magnesium stearate. Coating: talc, titanium dioxide (E 171), povidone 25, polysorbate 80, methacrylic acid and methyl methacrylate copolymer (1:1), dispersion 30%, sodium carmellose, aluminum lake of orange yellow S (E 110), simethicone emulsion 30%.

What Aescin looks like and contents of the pack

Enteric-coated tablets in Al/PVC blisters of 30 or 90 tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the 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:

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
Marketing authorization number in the Czech Republic, the country of export:85/262/92-C
Parallel import authorization number:415/15

Date of leaflet approval: 24.06.2025