Aescin

Package Leaflet: Information for the User

AESCIN, 20 mg, coated tablets

(Escinum)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their 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, 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 promotes faster absorption of post-traumatic hematomas and reduces the likelihood of their occurrence in the postoperative period (especially after surgical procedures on the musculoskeletal system). Additionally, 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 in the limbs and varicose veins of the lower limbs. If there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Aescin

When not to take Aescin

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe renal impairment
• in pregnant or breastfeeding women.

Warnings and precautions

If the patient experiences any of the following symptoms after taking Aescin, they should immediately contact their doctor:

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

In case of concomitant use of anticoagulant medicines, 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 treatment with Aescin, kidney function should be monitored. The medicine should not be taken by patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome. Note:taking Aescin does not replace other preventive measures such as cold water compresses or wearing compression stockings. Children and adolescents The use of this 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

The patient should inform their doctor about all medicines taken recently, including those available without a prescription. Aescin may enhance the effect of anticoagulant medicines. Some antibiotics, such as cephalosporins, may enhance the effect of Aescin. The 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, thinks they may be pregnant, or plans to have a child, they should consult their 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

If the patient has been diagnosed with an intolerance to some sugars, they should consult their 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 take Aescin

This medicine should always be taken exactly as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor 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 3 times a day, 2 tablets after a meal, with a large amount of fluid. 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) twice 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

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

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 medicine.

5. How to store Aescin

Store in a temperature below 25°C. Store in a place 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 stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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.
• The other ingredients of the medicine are: lactose monohydrate, potato starch, povidone, talc, magnesium stearate. Coating: talc, titanium dioxide (E 171), povidone, polysorbate 80, methacrylic acid copolymer, sodium carboxymethylcellulose, orange yellow S (E 110), simethicone emulsion 30%.

What Aescin looks like and contents of the pack

Coated tablets in Al/PCW blisters of 30, 90 in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

Teva Operations Poland Sp. z o.o. ul. Mogilska 80 31-546 Kraków

Date of last revision of the leaflet: