Venoruton 500mg 30 coated tablets

Venoruton 500mg 30 coated tablets is a drug formulated for the treatment of symptoms associated with venous insufficiency and capillary fragility . Each tablet contains oxerutin 500 mg , an active ingredient known for its vasoprotective properties. The tablets are coated to ensure better gastric tolerability. Venoruton is particularly indicated for those suffering from circulatory disorders, helping to improve the health of the veins and reduce symptoms such as swelling and heaviness in the legs. The formulation is enriched with excipients such as sunset yellow aluminum lake (E 110) , which gives the tablets their characteristic color. This product is a targeted choice for those looking for effective support in the management of venous problems.

ACTIVE INGREDIENTS

Active ingredients contained in Venoruton 500mg 30 coated tablets - What is the active ingredient in Venoruton 500mg 30 coated tablets?

Venoruton 1000 mg powder : One sachet contains - Active ingredient: oxerutine 1000 mg. Venoruton 500 mg coated tablets : One tablet contains: Active ingredient: oxerutine 500 mg. Excipients with known effect: sunset yellow aluminium lake (E 110) (2.68 mg/tablet). Venoruton 2% gel : 100 g of gel contain: Active ingredient: oxerutine 2 g. Excipients with known effect: benzalkonium chloride 0.05 mg/g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Venoruton 500mg 30 coated tablets - What does Venoruton 500mg 30 coated tablets contain?

Venoruton 1000 mg powder : mannitol; sodium saccharin; citric acid monohydrate. Venoruton 500 mg coated tablets : polyacrylate dispersion 30 per cent; talc; magnesium stearate; macrogols; copovidone; sunset yellow aluminium lake (E 110) ; titanium dioxide. Venoruton 2% gel for cutaneous use: carbomers; sodium hydroxide; disodium edetate; benzalkonium chloride ; purified water.

DIRECTIONS

Therapeutic indications Venoruton 500mg 30 coated tablets - Why is Venoruton 500mg 30 coated tablets used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Venoruton 500mg 30 coated tablets - When should Venoruton 500mg 30 coated tablets not be used?

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

DOSAGE

Quantity and method of taking Venoruton 500mg 30 coated tablets - How to take Venoruton 500mg 30 coated tablets?

Venoruton 1000 mg powder : 2 to 3 sachets per day, depending on the severity of the symptom. The contents of each sachet of powder should be carefully dissolved in a little water and taken before or during meals, even in venous insufficiency of the haemorrhoidal plexus. Venoruton 500 mg coated tablets : 2 - 3 tablets per day. The tablets should be swallowed whole with a little water, without chewing, before or during meals, even in venous insufficiency of the haemorrhoidal plexus. Venoruton 2% gel for cutaneous use : apply an adequate amount of gel both on the area affected by the disorder and on the surrounding areas, 2 times a day (morning and evening). Massage lightly to allow the medicine to penetrate until completely absorbed, that is, until you feel that the skin is dry when you touch it with your hands. Do not exceed the recommended doses. Use only for short periods of treatment.

CONSERVATION

Storage Venoruton 500mg 30 coated tablets - How to store Venoruton 500mg 30 coated tablets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Venoruton 500mg 30 coated tablets - About Venoruton 500mg 30 coated tablets it is important to know that:

Patients suffering from oedema of the lower limbs due to heart, kidney or liver disease should not take Venoruton as the effect of Venoruton has not been demonstrated in these indications. Paediatric population The use of Venoruton is not recommended in children. Venoruton gel : The use, especially if prolonged, of products to be applied to the skin may give rise to sensitization phenomena. In this case, treatment should be stopped and your doctor should be consulted to establish an appropriate therapy. Important information about some of the excipients Venoruton 1000 mg powder contains: - sodium saccharin: this medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'. Venoruton 500 mg film-coated tablets contain the azo colouring agent: - sunset yellow aluminium lake (E 110): may cause allergic reactions. Venoruton gel contains: - benzalkonium chloride: this medicine contains 0.391 mg of benzalkonium chloride per dose equivalent to 0.05 mg/g. Benzalkonium chloride may irritate the skin. If you are breast-feeding, do not apply this medicine to your breasts because the baby may swallow it with her milk.

INTERACTIONS

Interactions Venoruton 500mg 30 coated tablets - Which medicines or foods can modify the effect of Venoruton 500mg 30 coated tablets?

To date, no specific interaction of oxerutine with other medicinal products has been reported. In vitro data on a possible modulation of CYP3A activity by the components of oxerutine (quercetin and rutin present in trace amounts) are conflicting. Venoruton gel: no interaction with medicinal products has been reported.

SIDE EFFECTS

Like all medicines, Venoruton 500mg 30 coated tablets can cause side effects - What are the side effects of Venoruton 500mg 30 coated tablets?

Venoruton oral formulations: Summary of the safety profile Venoruton may in rare cases cause gastrointestinal side effects or skin reactions such as gastrointestinal disturbances, flatulence, diarrhoea, abdominal pain, stomach discomfort, dyspepsia, rash, pruritus or urticaria. Very rare are the occurrence of dizziness, headache, hot flushes, tiredness or hypersensitivity reactions such as anaphylactoid reactions. Tabulated list of adverse reactions Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1,000); very rare (< 1/10,000), or not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.

Classes Organ Systems / Frequency	Adverse reactions
Immune system disorders
Very rare	Anaphylactoid reactions
Very rare	Hypersensitivity reactions
Nervous system disorders
Very rare	Dizziness
Very rare	Heachache
Vascular pathologies
Very rare	Hot flashes
Gastrointestinal disorders
Rare	Gastrointestinal disorders
Rare	Flatulence
Rare	Diarrhea
Rare	Abdominal pain
Rare	Stomach problems
Rare	Dyspepsia
Skin and subcutaneous tissue disorders
Rare	Rash
Rare	Itching
Rare	Urticaria
Systemic disorders and conditions related to the administration site
Very rare	Tiredness

Venoruton gel: Summary of the safety profile Venoruton gel is well tolerated. Rare cases of sensitization with the appearance of skin reactions have been observed. These symptoms disappear with the interruption of treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Venoruton 500mg 30 coated tablets - What are the risks of Venoruton 500mg 30 coated tablets in case of overdose?

No case of overdose has ever been reported.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Venoruton 500mg 30 coated tablets.

Pregnancy The safety of the drug in pregnancy has not been determined, therefore it is not recommended during pregnancy. Breastfeeding In animal studies, traces of oxerutine were found in breast milk. It is assumed that the small quantities of oxerutine that pass into breast milk can be considered without clinical relevance for humans. Fertility Animal studies have not shown effects on fertility after administration of oxerutine.

DRIVING AND USE OF MACHINERY

Taking Venoruton 500mg 30 coated tablets before driving or using machines - Does Venoruton 500mg 30 coated tablets affect driving or using machines?

Venoruton has no or negligible influence on the ability to drive or use machines. In rare cases, tiredness and dizziness have been reported in patients taking the product. Affected patients are advised not to drive or use machines. Venoruton gel has no influence on the ability to drive or use machines.