Venescin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Venescin

(Hippocastani seminis extractum spissum + Troxerutinum)
(118 mg + 20 mg)/g, gel

It is necessary to 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 information leaflet or as directed by a doctor or pharmacist.

• 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 or pharmacist. See section 4.
• If there is no improvement after 21 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Venescin gel contains a dense extract of horse chestnut seed (Hippocastani seminis extractum spissum)
and troxerutin. It is assumed that the gel containing a combination of escin (the main component of the horse chestnut seed extract) and troxerutin affects the veins, among other things, by reducing their permeability and affecting venous tension. It is assumed that it has an anti-edema effect.
Venescin gel is used in the initial symptoms of chronic venous insufficiency (in pain, feeling of heaviness and swelling of the legs, calf cramps) and in the case of symptoms that occur after injuries (swelling, bruising).
If there is no improvement after 21 days or the patient feels worse, they should consult a 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, and skin areas that have undergone radiation therapy.

Warnings and precautions

Before starting to use Venescin gel, the patient should discuss it with their doctor or pharmacist.
Do not use on damaged skin.

Venescin gel contains:

• propylene glycol - may cause skin irritation,
• methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) - may cause allergic reactions (possible late reactions),
• ethanol - may cause burning of damaged skin. The medicine contains about 50 mg of alcohol (ethanol) in one dose (about 2 cm of gel).

Children and adolescents under 18 years of age

The medicine should not be used in children and adolescents under 18 years of age.

Venescin gel and other medicines

No studies have been conducted on interactions with 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.

Pregnancy, breastfeeding, and fertility

Pregnancy
Venescin gel should not be used during pregnancy without consulting a doctor.
Breastfeeding
Venescin gel should not be used during breastfeeding without consulting a doctor.
Fertility.
There are no data available.

Driving and using machines

Venescin gel does not affect the ability to drive and use machines.

3. HOW TO USE VENESCIN GEL

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Dosage and administration

Adults
Venescin gel should be used externally, locally on the skin.
A small amount (about 2 cm) of gel should be applied to the skin, 2 times a day. 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 gel have not been established in this age group.
The medicine should not be used in children and adolescents under 18 years of age.

Using a larger dose of Venescin gel than recommended

The gel should not be applied to the skin in a larger amount than recommended.

Stopping the use of Venescin gel

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency of side effects.
Unknown frequency - cannot be estimated from the available data.
During the use of Venescin gel, the following may occur:
Disorders of the skin and subcutaneous tissue: skin irritation and dryness, urticaria - unknown frequency.
Disorders of the immune system: generalized delayed hypersensitivity reactions, such as contact dermatitis, sometimes immediate reactions with urticaria and bronchospasm - unknown frequency.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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,
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49-21-301
fax: +48 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE VENESCIN GEL

The medicine should be stored out of 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their 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 gel contains

100 g of the medicine contains:
Active substances
Dense extract of Aesculus hippocastanumL., semen(horse chestnut seed) 11.8 g
extractant: ethanol 70 % ( V/V)
Troxerutin (Troxerutinum)2.0 g
Excipients are:
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 what the packaging contains

Venescin gel is a homogeneous, transparent, and non-greasy mass, brown in color with a characteristic odor.
The immediate packaging of the medicine is an aluminum tube, internally lacquered, with a membrane and a polyethylene cap, in a cardboard box. The packaging contains 40 g of gel.

Marketing authorization 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]
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder: tel. 71 321 86 04 w. 123

Date of the last update of the leaflet: