Venoruton forte

Package Leaflet: Information for the Patient

Venoruton Forte

500 mg, Tablets

O-(beta-hydroxyethyl)-rutoside (Oxerutins)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient 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.

Table of Contents of the Leaflet

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

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

Venoruton Forte contains o-(beta-hydroxyethyl)-rutosides, which belong to a group of medicines that protect the veins (systemic venous protectors).
Venoruton Forte stabilizes the venous wall, leading to a reduction in vessel permeability and consequently a reduction in swelling.
In patients with varicose veins and other diseases of the lower limb vessels, the capillaries are characterized by excessive exudation, which causes leg swelling.
Venoruton Forte reduces the permeability of the smallest blood vessels (capillaries) by reducing the permeability of the capillary wall to fluids and morphotic blood elements.
It is used in the symptomatic treatment of chronic venous insufficiency (varicose veins of the lower limbs).
The medicine reduces swelling and alleviates subjective symptoms such as:
disorders of sensation (burning and tingling), pain and muscle cramps, feeling of heavy, swollen, and painful legs.
The medicine is also used in the symptomatic treatment of hemorrhoids and may be used as an adjunct in microangiopathies in diabetes .

2. Important information before taking Venoruton Forte

When not to take Venoruton Forte

If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Venoruton Forte, a doctor or pharmacist should be consulted in the following cases:

• in the presence of swelling in the ankle area caused by heart, liver, or kidney disease, as the medicine is not effective in these cases.

Children and adolescents

Venoruton Forte is not recommended for use in children.

Venoruton Forte and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
O-(beta-hydroxyethyl)-rutosides are not recommended during the first three months of pregnancy.

Driving and using machines

Venoruton Forte has no influence or negligible influence on the ability to drive and use machines.
In rare cases, patients taking this medicine have experienced fatigue and dizziness.
If such symptoms occur, the patient should not drive or operate machines.

3. How to take Venoruton Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, a doctor or pharmacist should be consulted.
Initially, the dose is 1 tablet of 500 mg twice a day until the symptoms completely disappear, usually for about 2 to 4 weeks.
However, it is recommended to continue treatment as maintenance therapy for several more weeks to enhance the therapeutic effect, either by maintaining the same dosage or using a maintenance dose of 1 tablet once a day.

Use in children and adolescents

Venoruton Forte is not recommended for use in children.

Use in the elderly

There are no specific data on dosing in elderly patients.

Taking a higher dose of Venoruton Forte than recommended

In case of accidental ingestion of a higher dose of the medicine than recommended, a doctor should be contacted.

Missing a dose of Venoruton Forte

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Venoruton Forte

In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious and occur very rarely (may occur in less than 1 in 10,000 patients taking the medicine).
Treatment with Venoruton Forte should be stopped and medical help sought if any of the following side effects occur, which may be signs of an allergic reaction:

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

If any of the above symptoms occur, treatment with this medicine should be stopped and immediate medical attention sought.
Other side effects are usually mild.
Rare side effects(may occur in less than 1 in 1,000 patients taking the medicine).

• gastrointestinal disorders (including: bloating, diarrhea, abdominal pain, stomach discomfort, stomach disorders, indigestion):
• itching.

Very rare side effects(may occur in less than 1 in 10,000 patients taking the medicine):

• dizziness, headaches, fatigue, sudden flushing of the face.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Venoruton Forte

The medicine should be stored out of sight and reach of children.
It should be stored in the original packaging to protect it from moisture.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste.
A pharmacist should be asked how to dispose of unused medicines.
This will help protect the environment.

6. Contents of the pack and other information

What Venoruton Forte contains

• The active substance of Venoruton Forte is o-(β-hydroxyethyl)-rutoside
• -The other ingredients of the medicine are: polyethylene glycol 6000, magnesium stearate.

What Venoruton Forte looks like and contents of the pack

The carton contains 30 or 60 tablets packed in AL/PCV/PE/PVdC blisters, each containing 10 tablets.

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Importer

GlaxoSmithKline

Manufacturer:

Sweden
Date of last revision of the leaflet:September 2020