Venoruton 500 mg - venous insufficiency treatment 60 coated tablets

Product Description

Treatment for venous insufficiency and capillary fragility.

Indications

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

Composition

Active ingredients

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.

Excipients

Venoruton 1000 mg powder: mannitol; sodium saccharin; citric acid monohydrate. Venoruton 500 mg coated tablets: 30% polyacrylate dispersion; 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 for use and Dosage

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 hemorrhoidal plexus.

Warnings

Patients suffering from edema in 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 discontinued and your doctor should be consulted to establish appropriate therapy. Important information about some of the ingredientsVenoruton 1000 mg powder contains: - saccharin sodium: 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 benzalkonium chloride per dose equivalent to 0.05 mg/g. Benzalkonium chloride may irritate the skin. If you are breastfeeding, do not apply this medicine to your breasts as it may cause allergic reactions. the child could swallow it with his milk.

Contraindications

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

Undesirable effects

Venoruton oral formulations: Summary of the safety profileVenoruton may in rare cases cause gastrointestinal side effects or skin reactions such as gastrointestinal disturbances, flatulence, diarrhoea, abdominal pain, stomach discomfort, dyspepsia, rash, itching or urticaria. Very rarely, dizziness, headache, flushing, tiredness or hypersensitivity reactions such as anaphylactoid reactions occur. Tabulation of adverse reactionsUndesirable 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 order of decreasing seriousness.

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 when treatment is stopped. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

No case of overdose has ever been reported.

Pregnancy and breastfeeding

Pregnancy: the safety of the drug in pregnancy has not been established, therefore it is not recommended during pregnancy.

Breastfeeding: in animal studies, traces of oxerutine have been found in breast milk. It is presumed that the small amounts of oxerutine that pass into breast milk can be considered without clinical relevance for humans.

Fertility: Animal studies have not shown any effects on fertility after administration of oxerutine.

Format

60 Coated Tablets