Package leaflet: Information for the patient

Venoruton forte
500 mg, tablets
O-(beta-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 advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

What Venoruton forte is and what it is used for
Important information before taking Venoruton forte
How to take Venoruton forte
Possible side effects
How to store Venoruton forte
Contents of the package and other information

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

Venoruton forte contains O-(beta-hydroxyethyl)-rutosides, which belong to a group of medicines known as venous protectors (also called systemic venous protectants).
Venoruton forte stabilizes the venous wall, leading to reduced vessel permeability and consequently decreased swelling.
In patients with varicose veins and other venous disorders of the lower limbs, capillaries are characterized by excessive exudation, which causes leg edema.
Venoruton forte reduces the permeability of the smallest blood vessels (capillaries) by decreasing capillary wall permeability to fluids and formed blood elements.
It is used for the symptomatic treatment of chronic venous insufficiency (varicose veins of the lower limbs).
The medicine reduces edema and alleviates subjective symptoms such as sensory disturbances (burning and tingling sensations), muscle pain and cramps, and the feeling of heavy, swollen, and painful legs.
Venoruton forte is also used for the symptomatic treatment of hemorrhoids and may be used as an adjunctive treatment in microangiopathies associated with diabetes.

2. Information before using Venoruton forte

When not to use Venoruton forte
If the patient is allergic to the active substance or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before starting treatment with Venoruton forte, consult a doctor or pharmacist if:

swelling around the ankles occurs due to heart, liver or kidney diseases, as Venoruton forte is not effective in these cases.

Children and adolescents
Venoruton forte is not recommended for use in children.

Venoruton forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or might take in the future.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
The use of o-(beta-hydroxyethyl)-rutosides is not recommended during the first three months of pregnancy.

Driving and using machines
Venoruton forte has no effect or has a negligible effect on the ability to drive and operate machinery.
In rare cases, fatigue and dizziness have been observed in patients taking this medicine.
If such symptoms occur, do not drive or operate machinery.

3. How to use Venoruton forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a physician or pharmacist. In case of doubt, consult your doctor or pharmacist.
Initial dosage: 1 tablet of 500 mg twice daily, until complete relief of symptoms, usually for about 2 to 4 weeks.
However, it is recommended to continue treatment as maintenance therapy for several more weeks to consolidate the therapeutic effect, maintaining the same dosage or switching to a maintenance dosage of 1 tablet once daily.
Use in children and adolescents
Venoruton forte is not recommended for use in children.
Use in elderly patients
There are no specific dosage recommendations for elderly patients.
Accidental overdose of Venoruton forte
If you accidentally take more than the recommended dose, contact your doctor immediately.
Missed dose of Venoruton forte
Do not take a double dose to make up for a missed dose.
Stopping Venoruton forte
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some adverse reactions may be serious and occur very rarely (may occur in no more than 1 in 10,000 people taking the medicine).
You should stop taking Venoruton forte and seek medical help if any of the following adverse reactions occur, as they may be signs of an allergic reaction:

difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching with red rash, hives or lumps on the skin.

If any of the above symptoms occur, you should stop taking this medicine and seek medical help immediately.
Other adverse reactions are usually mild.

Uncommon adverse reactions (may occur in no more than 1 to 10 in 1,000 people taking the medicine):

gastrointestinal disorders (including: bloating, diarrhoea, abdominal pain, stomach discomfort, gastric disturbances, indigestion)
itching.

Very rare adverse reactions (occur in no more than 1 in 10,000 people taking the medicine):

dizziness, headache, fatigue, sudden flushing of the face.

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 at 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.
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Venoruton forte

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Venoruton forte contains

The active substance in Venoruton forte is o-(β-hydroxyethyl)-rutosides.
The other ingredients are: polyethylene glycol 6000, magnesium stearate.

What Venoruton forte looks like and contents of the pack
The cardboard box contains 30 or 60 tablets packed in AL/PCV/PE/PVdC blisters,
each containing 10 tablets.

Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:
Recipharm Uppsala AB
Björkgatan 30,
Uppsala, 751 82
Uppsala
Sweden

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 Munich
Germany

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany