Aescin

Package Leaflet: Information for the User

AESCIN, 20 mg + 50 mg + 50 IU, gel
(Escinum + Diethylamini salicylas + Heparinum)

Read the package 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 package leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, 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 pack and other information

1. What is Aescin and what is it used for

Aescin is used locally, as an adjunct treatment for:

• injuries such as bruises and sprains
• local inflammatory conditions with or without swelling
• phlebitis of the lower limbs
• hematomas and swelling after surgical procedures and injuries
• back pain with symptoms of nerve root compression.

Aescin gel is a medicine with anti-edematous, anti-inflammatory, and venoprotective effects.
It normalizes the permeability of capillary membranes, seals the endothelium of capillaries,
and reduces lymphatic effusion.
It is also used as an adjunct to reduce other unfavorable symptoms, such as:
pain and heaviness in the legs, skin itching, swelling of the lower limbs, and calf muscle cramps, occurring
in venous circulation disorders of the lower limbs.
Escin is the main saponin of horse chestnut seeds. Escin has anti-edematous and anti-inflammatory effects
and improves the tone of blood vessels, although its effect after local administration cannot be confirmed with certainty.
It reduces the permeability of blood vessel walls. Escin has anti-edematous and anti-inflammatory effects.
It normalizes the permeability of capillary membranes, seals the endothelium of capillaries, and reduces lymphatic effusion.
Heparin is a natural polyanionic polysaccharide. It has an inhibitory effect on all phases of blood coagulation.
When used locally, it has antithrombotic and anti-inflammatory effects.
Diethylammonium salicylate used locally has analgesic and anti-inflammatory effects.
If there is no improvement or if you feel worse, contact your doctor.

2. Important information before using Aescin

When not to use Aescin

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
• if you have chronic kidney disease and renal failure
• in women during the first three months of pregnancy
• locally on mucous membranes, on open wounds, and in cases of skin necrosis
• on areas of skin exposed to radiation.

Warnings and precautions

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

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

In case of concomitant use of anticoagulant medications, blood coagulation parameters should be frequently monitored.
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.
Note:using Aescin does not replace other preventive measures such as cold water compresses or wearing compression stockings.

Children and adolescents

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

Aescin and other medicines

There are no data on interactions with other medicines.
Tell your doctor about all medicines you have taken recently, including those available without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are no clinical data on the use of Aescin in pregnant women. Animal studies do not show a direct or indirect harmful effect of alpha-escin on pregnancy and fetal development.
Aescin should not be used in pregnant women for a long time and on large surfaces (up to 3 weeks after consulting a doctor).
Caution should be exercised when using Aescin in pregnant women.

Breastfeeding

There are no data on the safety of using Aescin in breastfeeding women.
Aescin should not be used in breastfeeding women on the chest area.

Driving and using machines

There are no data on adverse reactions that may affect the ability to drive and use machines.

The medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E

• 216)Due to the presence of methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), the medicine may cause allergic reactions (possible late-type reactions).

3. How to use Aescin

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Aescin gel is intended for external use, locally on the skin.
The medicine should be applied 3 to 5 times a day, by spreading a thin layer and then rubbing it into the affected area and its surroundings.
Massage before applying the gel accelerates the absorption of the active substance.

Use in children and adolescents

The use of Aescin in children and adolescents under 18 years of age is not recommended.
If you have any doubts about using the medicine, consult your doctor or pharmacist.

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, hypertension; hypersensitivity reactions
Uncommon: dizziness, headache
If you experience any of the above reactions, especially bleeding and first hypersensitivity reactions (skin rash), discontinue 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, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa
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 below 25°C.
Keep 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. 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 substances of Aescin are: alpha-escin, diethylammonium salicylate, and heparin.
• The other ingredients are: carbomers, tromethamine, isopropyl alcohol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate, purified water.

What Aescin looks like and contents of the pack

Gel.
Aluminum tube containing 40 g of gel, in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warszawa
Tel.(22) 345 93 00

Manufacturer

Nobilus Ent
ul. Zegrzyńska 22A
05-110 Jabłonna
Polska

Date of last revision of the leaflet: April 2022