Venoruton - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Oxerutina

VENORUTON 500 mg effervescent tablets
VENORUTON 1000 mg effervescent tablets

Venoruton package inserts are available for pack sizes:
  • VENORUTON 500 mg effervescent tablets, VENORUTON 1000 mg effervescent tablets
  • VENORUTON 1000 mg granules for oral solution, VENORUTON 500 mg film-coated tablets, VENORUTON 2% gel

Why is Venoruton used? What is it for?

What is it

VENORUTON is a vasoprotector based on oxerutin, a substance obtained from the flowers and leaves of Sophora Japonica.

Why is it used

VENORUTON is indicated in the treatment of symptoms attributable to venous insufficiency; states of capillary fragility.

Contraindications When Venoruton should not be used

Hypersensitivity to oxerutin or to any of the excipients.

Patients suffering from lower extremity edema due to heart, kidney or liver disease should not take Venoruton as the effect of Venoruton is not proven in these indications.

Venoruton is not recommended for use in children.

Precautions for use What you need to know before taking Venoruton

Venoruton is not recommended for use in children.

Interactions Which drugs or foods may change the effect of Venoruton

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

To date, no specific interaction of oxerutin with other drugs has been reported. The laboratory data on a possible modulation of the activity of liver enzymes by the components of oxerutin (quercetin and rutin present in traces) are discordant.

Warnings It is important to know that:

What to do during pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. The safety of the drug in pregnancy has not been determined, therefore it is not recommended in pregnancy. In animal studies, traces of oxerutin were found in breast milk. It is assumed that the small amounts of orexutin that pass into breast milk can be considered of no clinical relevance for humans.

Animal studies have shown no effects on fertility after oxerutin administration.

Effects on ability to drive and use machines

Venoruton has no or negligible influence on the ability to drive and use machines.

In rare cases, fatigue and dizziness have been reported in patients who were taking the product. Affected patients are advised not to drive or operate machinery.

Important information about some of the excipients

This medicinal product contains 10.15 mmol (396 mg) of potassium per tablet. To be taken into consideration in people with reduced kidney function or who follow a low potassium diet.

This medicinal product contains 3.56 mmol (82 mg) sodium per tablet. To be taken into consideration in people on a low sodium diet

Dosage and method of use How to use Venoruton: Dosage

How many

Venoruton 1000 mg effervescent tablets: 1 tablet per day.

Venoruton 500 mg effervescent tablets: 2 tablets per day.

Warning: do not exceed the indicated doses without medical advice.

When and for how long

Warning: use only for short periods of treatment. In case of exacerbation of symptoms it is recommended to use the product in cycles.

Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

Like

Each tablet should be carefully dissolved in a glass of water and taken before or during meals.

Overdose What to do if you have taken too much Venoruton

No signs or symptoms of Venoruton overdose have ever been reported.

In case of accidental ingestion / intake of an overdose of Venoruton, notify your doctor immediately or go to the nearest hospital.

If you have any questions about the use of Venoruton, ask your doctor or pharmacist

Side Effects What are the side effects of Venoruton

Like all medicines, VENORUTON can cause side effects, although not everybody gets them.

Venoruton may in rare cases cause gastrointestinal side effects or skin reactions such as gastrointestinal upset, flatulence, diarrhea, abdominal pain, stomach upset, dyspepsia, rash, itching or hives. Very rare is the occurrence of dizziness, headache, hot flashes, fatigue or hypersensitivity reactions such as anaphylactoid reactions.

Undesirable effects are listed below by organ system classification and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 a

Disorders of the immune system

Very rare Anaphylactoid reactions

Very rare Hypersensitivity reactions

Nervous system disorders

Very rare Dizziness

Very rare Headache

Vascular pathologies

Very rare Flushing

Gastrointestinal disorders

Rare Gastrointestinal disorders

Rare Flatulence

Rare Diarrhea

Rare Abdominal pain

Rare Stomach upset

Rare Dyspepsia

Skin and subcutaneous tissue disorders

Rare Rash

Rare Pruritus

Rare Urticaria

General disorders and administration site conditions

Very rare Tiredness

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Expiry: see the expiry date printed on the package.

The expiry date refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date shown on the package.

Store at a temperature below 30 ° C.

Keep the container tightly closed to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

KEEP THIS MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition

Venoruton 500 mg effervescent tablets: One tablet contains: active ingredient oxerutin 500 mg Excipients: anhydrous citric acid; potassium carbonate; potassium bicarbonate; sodium bicarbonate; macrogoli; acesulfame potassium; povidone; orange flavor (supported on maltodextrin), magnesium stearate.

Venoruton 1000 mg effervescent tablets: One tablet contains: active ingredient oxerutin 1000 mg Excipients: anhydrous citric acid; potassium carbonate; potassium bicarbonate; sodium bicarbonate; macrogoli; acesulfame potassium; povidone; orange flavor (supported on maltodextrin), magnesium stearate.

How it looks

VENORUTON comes in the form of 500 mg or 1000 mg effervescent tablets, packed in a tube with a drying cap. The contents of the package are:

  • 20 effervescent tablets of 500 mg.
  • 30 effervescent tablets of 1000 mg (2 tubes of 15 tablets each).

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Venoruton can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VENORUTON EFFERVESCENT TABLETS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Venoruton 500 mg effervescent tablets: One tablet contains: active ingredient oxerutin 500 mg. Excipients with known effects: potassium carbonate, potassium bicarbonate, sodium bicarbonate, acesulfame potassium.

Venoruton 1000 mg effervescent tablets: One tablet contains: active ingredient oxerutin 1000 mg. Excipients with known effects: potassium carbonate, potassium bicarbonate, sodium bicarbonate, acesulfame potassium.

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Effervescent tablets

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

VENORUTON is indicated in the treatment of symptoms attributable to venous insufficiency; states of capillary fragility.

04.2 Posology and method of administration

Venoruton 1000 mg effervescent tablets: 1 tablet per day.

Venoruton 500 mg effervescent tablets: 2 tablets per day.

Each tablet should be carefully dissolved in a glass of water and taken before or during meals.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

04.4 Special warnings and appropriate precautions for use

Important information about some of the excipients

This medicinal product contains 10.15 mmol of potassium per tablet. To be taken into consideration in people with reduced kidney function or who follow a low potassium diet.

This medicinal product contains 3.56 mmol sodium per tablet. To be taken into consideration in people on a low sodium diet.

04.5 Interactions with other medicinal products and other forms of interaction

None known so far.

04.6 Pregnancy and breastfeeding

The safety of the drug in pregnancy has not been established, therefore it is advisable not to administer the product during pregnancy.

There are no restrictions on the use of the preparation during lactation.

04.7 Effects on ability to drive and use machines

No effect.

04.8 Undesirable effects

Even when the treatment was continued for several months, no noteworthy undesirable effects were never reported.

04.9 Overdose

No case of overdose has ever been reported.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: capillary protective substances - bioflavonoids;

ATC code C05CA49.

Oxerutin [O- (β-hydroxyethyl) -rutosidea], the active ingredient contained in Venoruton, belongs to the flavonoid family and due to its molecular characteristics has an antioxidant action. It has also been shown that it has tropism for the venous endothelium.

Its presence at the capillary level allows, especially when in the presence of venous insufficiency the decreased blood speed induces local hypoxia, to antagonize and intercept the free radicals present. The latter are known to be capable of causing cell damage, the starting point for the adhesion of neutrophilic granulocytes to the endothelium with triggering of the inflammatory reaction which results in the increase in capillary permeability and the formation of edema in the lower limbs.

The antioxidant action of oxerutin on the membrane of the endothelium cells and on the erythrocytes in the microcirculation as well as the inhibitory effect on the lipoxygenase of neutrophils are associated with the decrease in capillary permeability, with reduction of edema formation, with a reduced stimulus to adhesion. to the endothelium for neutrophil granulocytes and platelets and to the restoration of the rheological characteristics of red blood cells at the capillary level.

In particular, these latter phenomena are correlated with the demonstrated improvements in the local oxygenation situation and venous tone.

The specific pharmacodynamic properties of oxerutin are therefore transferable also to syndromes with pathogenesis similar to that of venous insufficiency such as that of the haemorrhoidal plexus.

05.2 Pharmacokinetic properties

Venoruton effervescent tablets is a pharmaceutical form characterized by rapid dissolution and relative rapid absorption of the active ingredient. In fact, it has the advantage of allowing the achievement of a high pharmacoemia in a short time thanks to the speed with which it releases the active principle in biological liquids. Absorbed in the gastrointestinal tract, the drug is mainly excreted via the biliary route.

05.3 Preclinical safety data

The toxicology of oxerutin [O- (β-hydroxyethyl) -rutosidea] has been evaluated in several animal species.

The LD50 in rats is between 24,000 and 27,000 mg / kg, depending on the route of administration.

In the chronic toxicity tests in the rat, conducted with doses of 2,850 mg / kg / day for 90 days, no toxic action of the drug was found.

Tests of teratogenesis, fertility and peri-postnatal toxicity did not reveal any anomalies in the offspring.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Anhydrous citric acid; potassium carbonate; potassium bicarbonate; sodium bicarbonate; macrogoli; acesulfame potassium; povidone; orange flavor (supported on maltodextrin), magnesium stearate.

06.2 Incompatibility

None.

06.3 Period of validity

4 years

06.4 Special precautions for storage

Store at a temperature below 30 ° C. Keep the container tightly closed to protect from light and moisture.

06.5 Nature of the immediate packaging and contents of the package

Polypropylene tube with polyethylene cap filled with silica gel as a drying agent.

Venoruton 500 mg effervescent tablets: 1 tube of 20 tablets

Venoruton 1000 mg effervescent tablets: n. 2 tubes of 15 tablets each.

06.6 Instructions for use and handling

Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

Novartis Consumer Health S.p.A., Origgio (Varese).

08.0 MARKETING AUTHORIZATION NUMBER

Venoruton 500 mg effervescent tablets, 20 tablets: A.I.C. n. 017076112

Venoruton 1000 mg effervescent tablets, 30 tablets: A.I.C. n. 017076124

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of most recent renewal: 1.6.2010

10.0 DATE OF REVISION OF THE TEXT

AIFA Determination of April 16, 2013

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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