Venescin

Leaflet attached to the packaging: patient information

VENESCIN

Hippocastani seminis extractum siccum + Rutosidum trihydricum + Aesculinum
(25 mg + 15 mg + 0.5 mg)/tablet, sugar-coated tablets

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 after 21 days the symptoms worsen, do not improve, or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Venescin and what is it used for
• 2. Important information before using Venescin
• 3. How to use Venescin
• 4. Possible side effects
• 5. How to store Venescin
• 6. Contents of the packaging and other information

1. What is Venescin and what is it used for

Venescin is a medicinal product containing an extract of horse chestnut seeds, rutoside, and aesculin in its composition. It is assumed that the use of the product increases venous tone and reduces permeability and increases the mechanical resistance of capillaries. The medicine is used to alleviate symptoms of chronic venous insufficiency. If after 21 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before using Venescin

When not to use Venescin

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6), such as arabic gum,
• during the first trimester of pregnancy.

Warnings and precautions

One sugar-coated tablet of Venescin contains 34.49 mg of sucrose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. Children and adolescents should not use this medicine.

Venescin and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Using Venescin in children

This medicine should not be used in children.

Pregnancy, breastfeeding, and fertility

Do not use during the first trimester of pregnancy. Due to the lack of studies confirming the safety of use during the remaining period of pregnancy and breastfeeding, the preparation may only be used when, in the doctor's opinion, the benefit to the mother is greater than the potential risk to the fetus. The effect on fertility is unknown.

Driving and using machines

No adverse effect of Venescin on the ability to drive and use machines has been found.

3. How to use Venescin

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist. Oral administration. Adults2 sugar-coated tablets 3 times a day. Children and adolescentsshould not use this medicine.

Using a higher dose of Venescin than recommended

There are no known symptoms of overdose.

Missing a dose of Venescin

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are presented according to the classification of organs and systems according to MedDRA and frequency of occurrence: rare - side effects may occur in 1 to 10 patients out of 10,000 patients using the medicine. During the use of the Venescin medicinal product, the following may occur:

• gastrointestinal disorders (nausea, abdominal pain) - rare. If side effects occur, you should stop the treatment, and if the symptoms do not disappear, consult a 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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Venescin

The medicine should be stored at a temperature not exceeding 25°C, out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste containers. 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 Venescin contains

The active substances of the medicine are: Dry extract of horse chestnut seeds (Hippocastani seminis extractum siccum) (5.5-8:1) containing on average 22% triterpenoid saponins calculated as anhydrous escin 25 mg, extraction solvent: ethanol 70% (V/V), Rutoside trihydrate (Rutosidum trihydricum), 15 mg, Aesculin (Aesculinum (6-glucoside of 6,7-dihydrocoumarin)) 0.5 mg. The excipients are: potato starch, magnesium stearate, shellac, castor oil, arabic gum, talc, sucrose, indigotine (E 132), quinoline yellow (E 104).

What Venescin looks like and what the pack contains

Al/PVC foil blister in a cardboard box with an information leaflet. The blister contains 30 sugar-coated tablets.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie "Herbapol" S.A. 50-951 Wrocław, ul. Św. Mikołaja 65/68 Tel: +48 71 33 57 225 Fax: +48 71 37 24 740 E-mail: herbapol@herbapol.pl For more detailed information about the medicine, you should contact the marketing authorization holder, tel. 71 321 86 04, ext. 123

Date of last revision of the leaflet: