Venescin forte

Package Leaflet: Information for the Patient

VENESCIN FORTE

Hippocastani seminis extractum siccum + Rutosidum trihydricum
(100 mg + 60 mg)/tablet, sugar-coated tablets

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

Table of Contents of the Leaflet

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

1. What is Venescin forte and what is it used for

The dry extract of horse chestnut seeds contained in the medicine has anti-edema and vein-toning effects. Rutoside reduces the permeability of capillaries and increases their mechanical resistance.
The medicine is used in chronic venous insufficiency of various origins, manifested by edema, calf cramps, itching, pain, and a feeling of heaviness in the legs, under medical supervision in varicose veins (varices).

2. Important information before using Venescin forte

When not to use Venescin forte

Warnings and precautions

Use in varicose veins requires prior consultation with a doctor.
Venescin forte contains sucrose and lactose monohydrate. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
Children and adolescents
Do not use in children and adolescents below 18 years of age.

Venescin forte and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

Venescin forte with food and drink

Take the medicine during or after a meal.

Pregnancy, breastfeeding, and fertility

In clinical trials involving pregnant women, no adverse effects were observed after using the horse chestnut seed extract, but in accordance with general medical practice, the medicine should be used during pregnancy and breastfeeding only if the doctor considers that 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 forte on the ability to drive and use machines has been observed.

3. How to use Venescin forte

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the medicine orally. Take the medicine during or after a meal.
Adults
From 1 to 2 sugar-coated tablets 3 times a day.
Children and adolescents
Do not use the medicine in children and adolescents below 18 years of age.

Using more than the recommended dose of Venescin forte

There are no known symptoms of overdose.

Missing a dose of Venescin forte

Do 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 listed by frequency: rare - side effects may occur in 1 to 10 patients out of 10,000 patients using the medicine.
The following side effects may occur when using Venescin forte:

• gastrointestinal disorders (gastric irritation) - rare,
• skin and subcutaneous tissue disorders (itching) - rare. If you experience any of the above symptoms, stop the treatment and consult your doctor if the symptoms do not disappear.

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 for Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will allow more information to be collected on the safety of the medicine.

5. How to store Venescin forte

Store the medicine 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 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 Venescin forte contains

The active substances 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 100 mg
extraction solvent: ethanol 70% (V/V),
Trihydrate Rutoside ( Rutosidum trihydricum)
60 mg
The excipients are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, magnesium stearate, sucrose, talc, arabic gum, shellac, castor oil, quinoline yellow (E 104), indigo carmine (E 132).

What Venescin forte looks like and contents of the pack

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
Phone: +48 71 33 57 225
Fax: +48 71 37 24 740
Email: herbapol@herbapol.pl
To obtain more detailed information about the medicine, contact the marketing authorization holder, phone 71 321 86 04, ext. 123

Date of last revision of the leaflet: