Aescin

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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 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 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 there is no improvement 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 using Aescin
• 3. How to use Aescin
• 4. Possible side effects
• 5. How to store Aescin
• 6. Contents of the packaging 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 it improves the condition of blood vessel tension. 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 causes faster absorption of post-traumatic hematomas and reduces the likelihood of their occurrence during the postoperative period (especially after orthopedic surgery). Additionally, by sealing the blood vessel endothelium, it improves lymphatic-venous circulation. The medicine is also used to prevent postoperative thrombophlebitis, as well as to treat disorders of venous circulation and varicose veins of the lower limbs.
If there is no improvement or if you feel worse, you should contact your doctor.

2. Important information before using Aescin

When not to use Aescin

• in pregnant or breastfeeding women.

Warnings and precautions

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

• skin inflammation
• phlebitis
• 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 medications, you should frequently monitor blood coagulation parameters.
It is essential to follow any other non-invasive measures recommended by your doctor, such as bandaging your legs, wearing compression stockings, or applying cold water compresses.
During treatment with Aescin, you should monitor your kidney function.
The medicine should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.
Warning:using Aescin does not replace other preventive measures, such as cold water compresses or wearing compression stockings.

Children and adolescents

The use of Aescin 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 medications. Some antibiotics - cephalosporins may enhance the effect of Aescin.
You should avoid concomitant administration of 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 using 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 considered "sodium-free".

3. How to use Aescin

This medicine should always be used 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:
Aescin is not recommended for use in children and adolescents under 18 years of age.
Adults:
The usual dose of Aescin is 3 times a day, 2 tablets, after meals, with a large amount of fluid.
Prophylactically, it can be used at least 16 hours before surgery. After 2-3 months of treatment, maintenance therapy can be used in a dose of 40 mg (2 tablets) 2 times a day.
In case of concomitant use of oral contraceptives, 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 - 1 to 10 patients in 100 patients
• uncommon - 1 to 10 patients in 1000 patients
• rare - 1 to 10 patients in 10,000 patients
• very rare - less than 1 in 10,000 patients
• not known - frequency cannot be estimated from the available data

Rare: allergic skin inflammation (itching, rash, redness, eruption, urticaria)
Very rare: severe allergic reactions (in some cases with bleeding); tachycardia, hypertension; hypersensitivity reactions; genital tract bleeding
Uncommon: 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 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 of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Aescin

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Keep out of the 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aescin contains

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

What Aescin looks like and what the pack contains

Enteric-coated tablets, in Al/PVC blisters, 30 tablets, 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.
Mogilska 80
31-546 Krakow
Poland

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o. o.
Jagiellońska 76
03-301 Warsaw
Marketing authorization number in the Czech Republic, the country of export: 85/262/92-C
Parallel import authorization number: 18/19

Date of leaflet approval: 18.01.2024

[Information about the trademark]