PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Venescin
(Hippocastani seminis extractum spissum + Troxerutinum)
(118 mg + 20 mg)/g, gel
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects 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 you feel worse, consult your doctor.

Table of contents

What Venescin gel is and what it is used for
What you need to know before using Venescin gel
How to use Venescin gel
Possible side effects
How to store Venescin gel
Contents of the pack and other information

1. WHAT VENESCIN GEL IS AND WHAT IT IS USED FOR

Venescin gel contains a dry extract from horse chestnut seed (Hippocastani seminis extractum spissum) and troxerutinum. It is believed that the combination of escin (the main component of horse chestnut seed extract) and troxerutin exerts effects on venous vessels, including reducing their permeability and improving venous tone. A reduction in oedema is also expected.
Venescin gel is indicated for the initial symptoms of chronic venous insufficiency (such as pain, sensation of heaviness and swelling of the legs, calf cramps), as well as for symptoms following trauma (oedema, bruising).
If there is no improvement after 21 days of treatment, or if you feel worse, consult your doctor.

2. IMPORTANT INFORMATION BEFORE USING VENESCIN GEL

When not to use Venescin gel

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
on open wounds, mucous membranes, or areas of skin treated with radiation therapy.

Warnings and precautions
Before starting to use Venescin gel, discuss this with your doctor or pharmacist.
Do not apply to damaged skin.
Venescin gel contains:

propylene glycol – may cause skin irritation,
methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) – may cause allergic reactions (including delayed-type reactions),
ethanol – may cause a burning sensation on damaged skin. The medicine contains approximately 50 mg of alcohol (ethanol) per single dose (approx. 2 cm of gel).

Children and adolescents under 18 years of age
Venescin gel must not be used in children and adolescents under 18 years of age.
Venescin gel and other medicines
No studies on interactions with other medicines have been conducted.
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Pregnancy, breastfeeding and fertility
Pregnancy
Venescin gel should not be used during pregnancy without medical advice.
Breastfeeding
Venescin gel should not be used during breastfeeding without medical advice.
Fertility
No data available.
Driving and operating machinery
Venescin gel has no effect on the ability to drive or operate machinery.

3. HOW TO USE VENESCIN GEL

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Dosage and method of administration
Adults
Venesin gel should be applied externally, locally to the skin.
Apply a small amount (approx. 2 cm) of gel to the skin, twice daily. After application, gently rub in.
It is recommended to use in the morning and evening.
Children and adolescents under 18 years of age
The safety and efficacy of Venescin have not been established in this age group.
Do not use this medicine in children and adolescents under 18 years of age.
Use of more than the recommended amount of Venescin gel
Do not apply more gel to the skin than recommended.
Discontinuation of Venescin gel use
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
Frequency of adverse reactions.
Frequency unknown – cannot be determined from available data.
The following may occur during the use of Venescin gel:
Skin and subcutaneous tissue disorders: skin irritation and dryness, urticaria – frequency unknown.
Immune system disorders: generalized delayed hypersensitivity reactions such as contact dermatitis, sometimes immediate reactions with urticaria and bronchospasm – frequency unknown.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
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 enables continued monitoring of the medicine's safety and helps provide more information on the safe use of the product.

5. HOW TO STORE VENESCIN GEL

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging after: expiry date.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Venescin gel contains
100 g of the medicinal product contains:
Active substances
Dry extract of Aesculus hippocastanum L., semen (horse chestnut seed) 11.8 g
Extraction solvent: ethanol 70% (V/V)
Troxerutin (Troxerutinum) 2.0 g
Excipients:
Carbomer (carbopol 5984)
Sodium hydroxide
Glycerol (E422)
Propylene glycol
Methyl parahydroxybenzoate (E 218)
Propyl parahydroxybenzoate (E 216)
Ethanol
Purified water

What Venescin gel looks like and contents of the pack
Venescin gel is a homogeneous, transparent and non-greasy mass, brown in colour with a characteristic odour.
The immediate packaging of the medicinal product is an aluminium tube internally lacquered, closed with a membrane and a polyethylene cap, placed in a cardboard box. The pack contains 40 g of gel.

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 71 372 47 40
e-mail: [email protected]

For further information on this medicinal product, please contact the Marketing Authorisation Holder: tel. 71 321 86 04 ext. 123