Esceven

Leaflet attached to the packaging: patient information

Esceven, 167 mg, coated tablets
Hippocastani seminis extractum siccum

Read the 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 patient leaflet or as advised by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 14 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Esceven and what is it used for
• 2. Important information before taking Esceven
• 3. How to take Esceven
• 4. Possible side effects
• 5. How to store Esceven
• 6. Package contents and other information

1. What is Esceven and what is it used for

The active substance of Esceven tablets is dry extract of horse chestnut seeds (Hippocastani seminis
extractum siccum), containing escin, which increases venous tension.
The medicine is traditionally used for symptoms of chronic venous insufficiency, such as: swelling, calf cramps,
itching, pain, and a feeling of heaviness in the legs, varicose veins.
The product is indicated for use in adults and adolescents over 12 years of age.
If there is no improvement or the patient feels worse after 14 days, they should consult their doctor.

2. Important information before taking Esceven

When not to take Esceven:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has renal failure.

Warnings and precautions

Children

Esceven should not be used in children under 12 years of age due to the lack of data confirming safety.

Esceven and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There is no data on interactions with other medicines.

Pregnancy and breastfeeding

Due to the lack of sufficient data, the medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery

There is no data on the effect of the medicine on the ability to drive and operate machinery.

3. How to take Esceven

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Use in children

Esceven should not be used in children under 12 years of age.

Use in adults and adolescents over 12 years of age

3 times a day, 1 tablet after meals.

Using a higher dose of Esceven than recommended

There is no data on cases of overdose.

Missing a dose of Esceven

A double dose should not be taken to make up for a missed dose.

Stopping the use of Esceven

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Esceven can cause side effects, although not everybody gets them.
Esceven may rarely cause gastrointestinal disorders, and occasionally dizziness, itching, nausea, vomiting, and headaches have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: ndl@urpl.gov.pl. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Esceven

Store at a temperature not exceeding 25°C.
The medicine should be stored 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 no longer needed. This will help protect the environment.

6. Package contents and other information

What Esceven contains

Active substance:
1 tablet contains 167 mg of dry extract of Aesculus hippocastanumL., semen (horse chestnut seeds),
Hippocastani seminis extractum siccum (5-9:1)
Extractant – ethanol 80% (v/v)
Excipients: microcrystalline cellulose, sodium carboxymethyl cellulose type C, magnesium stearate, povidone, colloidal silica.
Coating Opadry II 85F210063 Green: polyvinyl alcohol, macrogol 4000, talc, yellow iron oxide (E 172), titanium dioxide (E 171), quinoline yellow (E 104), aluminum lake, brilliant blue FCF (E 133), aluminum lake.

• The coating contains aluminum lake, brilliant blue FCF (E 133), and quinoline yellow (E 104).

What Esceven looks like and what the package contains

Esceven is in the form of coated tablets.
Available packages:
20 pieces – 1 blister pack of 20 tablets in a cardboard box with a leaflet,
40 pieces – 2 blister packs of 20 tablets in a cardboard box with a leaflet,
60 pieces – 3 blister packs of 20 tablets in a cardboard box with a leaflet,
80 pieces – 4 blister packs of 20 tablets in a cardboard box with a leaflet.
For more detailed information, the patient should contact the marketing authorization holder.

Marketing authorization holder and manufacturer

Poznańskie Zakłady Zielarskie Herbapol S.A.
ul. Towarowa 47/51, 61-896 Poznań, Poland
tel. +48 61 88 61 800, fax +48 61 85 36 058

Date of last update of the leaflet: