Venoruton gel

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Venoruton Gel
20 mg/g, gel
O-(β-hydroxyethyl)-rutosides (Oxerutins)
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 for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after several days, or if you feel worse, consult your doctor.

Table of contents:

1. What Venoruton Gel is and what it is used for
2. What you need to know before using Venoruton Gel
3. How to use Venoruton Gel
4. Possible side effects
5. How to store Venoruton Gel
6. Contents of the pack and other information

1. What Venoruton Gel is and what it is used for

Venoruton Gel belongs to a group of medicines known as venoprotective agents.
Venoruton Gel acts on the smallest blood vessels (capillaries) by reducing the permeability of damaged capillary walls to fluids and blood cellular elements.
The product is indicated for topical application to the skin in painful conditions and swelling of the legs caused by chronic venous insufficiency and its symptoms, such as the sensation of "heavy legs" and lower limb pain, leg swelling, muscle cramps, and sensory disturbances.
It is also used for painful conditions following sclerotherapy of varicose veins.

2. Information before using Venoruton Gel

When not to use Venoruton Gel
If the patient is allergic to the active substance or to any of the other ingredients of this
medicinal product (listed in section 6.).
Warnings and precautions
Important information about some of the ingredients of Venoruton Gel
Due to the presence of benzalkonium chloride, the medicinal product may cause skin irritation.
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Venoruton Gel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
No influence on the ability to drive and use machines.

3. How to use Venoruton Gel

Venoruton Gel should be applied in the morning and evening to the affected area of skin,
gently rubbed in until the skin feels dry.
Venoruton Gel may be used under an elastic bandage or occlusive dressing.

4. Possible side effects
Like all medicines, this product can cause side effects, although not everyone experiences them.
Some side effects are rare (may occur in 1 out of 1,000 patients).
Rare cases of hypersensitivity with skin reactions have been observed.
All symptoms disappear after discontinuation of the medicine.

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet,
please inform your doctor or pharmacist. Side effects 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Venoruton Gel

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf life after first opening of the tube – 3 months.
Medicines must 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.
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6. Contents of the package and other information

The active substance of Venoruton Gel is o-(β-hydroxyethyl)-rutosides.
1 g of gel contains 20 mg of o-(β-hydroxyethyl)-rutosides.
Other ingredients of the medicine are: carbomer, sodium hydroxide, disodium edetate, benzalkonium chloride 0.05 mg/g, purified water.
What Venoruton Gel looks like and contents of the pack
The medicine is available in a lacquered aluminium tube containing 40 g of gel, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Austria, the country of export:
STADA Arzneimittel GmbH
1190 Vienna
Austria
Manufacturer:
STADA Arzneimittel GmbH
1190 Vienna
Austria
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Austria, the country of export: 15559
Parallel import authorisation number: 29/12
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