Aescin

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. 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 drug

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

This medicinal product should always be used exactly as described in the patient information leaflet or as directed by the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

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 has anti-edematous and anti-inflammatory effects and improves the tone of blood vessels. It reduces the permeability of blood vessel walls. It is 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 in the postoperative period (especially after orthopedic surgery). Additionally, by sealing the endothelium of blood vessels, it improves lymphatic-venous circulation. The drug is also used to prevent thrombophlebitis in the postoperative period, as well as to treat disorders of venous circulation and varicose veins of the lower limbs.
If there is no improvement or the patient feels worse, the doctor should be contacted.

2. Important information before using Aescin

When not to use Aescin

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicinal product (listed in section 6);
• if the patient has severe renal impairment;
• in women during pregnancy and breastfeeding.

Warnings and precautions

If the patient experiences any of the following symptoms after using Aescin, the doctor should be contacted immediately:

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

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

Children and adolescents

The use of the drug 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 drugs

The doctor should be informed about all recently taken drugs, including those available without a prescription.
Aescin may enhance the effect of anticoagulant drugs. Some antibiotics - cephalosporins may enhance the effect of the drug.
Concomitant administration of Aescin with aminoglycoside antibiotics should be avoided due to the possible increased toxic effect of aminoglycosides on the kidneys.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.

Pregnancy

There are no clinical data on the use of alpha-escin in pregnant women.
Animal studies do not show a direct or indirect harmful effect 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 drug contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the drug.

The drug contains orange yellow S (E 110)

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

The drug contains sodium

This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which means that the drug is considered "sodium-free".

3. How to use Aescin

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

Missing a dose of Aescin

A double dose should not be taken 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

Rare: allergic skin inflammation (itching, rash, redness, eruption, urticaria).
Very rare: severe allergic reactions (in some cases with bleeding); tachycardia, arterial hypertension; hypersensitivity reactions; genital tract bleeding.
Uncommon: dizziness, headache; nausea, vomiting, diarrhea, discomfort in the stomach.
In the case of the above reactions, especially bleeding and the first hypersensitivity reactions (skin rash), the drug should be discontinued and the doctor should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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
By reporting side effects, more information can be gathered on the safety of the drug.

5. How to store Aescin

Store in a temperature below 25°C in the original packaging to protect from moisture.
Store in a place out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Aescin contains

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

What Aescin looks like and what the packaging contains

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

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 Krakow

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 85/262/92-C

Parallel import authorization number: 929/12 Date of approval of the leaflet: 15.12.2022

[Information about the trademark]