VENESICIN FORTE

Package leaflet: Information for the patient

VENESCIN FORTE
Hippocastani seminis extractum siccum + Rutosidum trihydricum
(100 mg + 60 mg)/tablet, film-coated tablets
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 21 days of treatment, or if your condition worsens, consult your doctor.

Leaflet contents

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

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

The dry extract of horse chestnut seed (Aesculus hippocastanum L.) contained in this medicine exerts anti-edematous effects and increases venous tone (tension). Rutosid reduces capillary permeability and increases their mechanical resistance.
This medicine is indicated in chronic venous insufficiency of various origins, manifested by edema, calf cramps, itching, pain, and a sensation of heaviness in the legs, and under medical supervision in varicose veins (varices).
If there is no improvement after 21 days of treatment, or if your condition worsens, consult your doctor.

2. Important information before using Venescin forte

When not to use Venescin forte

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
Use in varicose veins requires prior consultation with a doctor.
Venescin forte contains sucrose and monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Children and adolescents
Do not use in children and adolescents under 18 years of age.
Venescin forte with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Venescin forte with food and drink
This medicine should be taken during or after a meal.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
In clinical studies involving pregnant women, no adverse effects were observed after administration of horse chestnut seed extract; however, in accordance with general medical practice, this medicine should be used during pregnancy and breastfeeding only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the foetus.
The effect on fertility is unknown.
Driving and operating machinery
No adverse effect of Venescin forte on the ability to drive or operate machinery has been observed.

3. How to use Venescin forte

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally. It should be taken during or after a meal.
Adults
1 to 2 coated tablets three times daily.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Venescin forte
Symptoms of overdose are unknown.
Missed dose of Venescin forte
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
The adverse reactions associated with this medicine are listed according to frequency: unknown (cannot
be estimated from the available data).
The following adverse reactions may occur during the use of Venescin forte:

• Gastrointestinal disorders (gastric irritation),
• Nervous system disorders (headaches and dizziness),
• Skin and subcutaneous tissue disorders (itching, allergic reactions). The frequency of these symptoms is unknown. If any of the above symptoms occur, treatment should be discontinued and, if symptoms persist, medical advice should be sought. Reporting of adverse reactions If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, Website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Venescin forte

The medicine should be stored at a temperature not exceeding 25°C.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton following EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Package contents and other information
What Venescin forte contains
One coated tablet contains the following active substances:
Dry extract of Aesculus hippocastanum L. semen (horse chestnut seed) (5.5-8:1),
containing on average 22% triterpene saponins calculated as anhydrous aescin 100 mg
extraction solvent: ethanol 70% (V/V),
Rutosid trihydrate (Rutosidum trihydricum) 60 mg

Excipients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, magnesium stearate, sucrose, talc, Arabic gum, colophony, castor oil, quinoline yellow (E 104), indigo carmine (E 132).

What Venescin forte looks like and contents of the pack
Venescin forte is a green, shiny, round, biconvex coated tablet with a yellowish cross-section and white and green edges.
The immediate packaging consists of an Al/PVC foil blister in a cardboard box with an instruction leaflet. Each blister contains 30 coated tablets.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
Tel: +48 71 33 57 225
Fax: +48 71 37 24 740
E-mail: [email protected]

For further information about this medicine, please contact the Marketing Authorisation Holder at tel. +48 71 321 86 04 ext. 123