VENORUTON * OS 30BUST 1000MG
Therapeutic indications
VENORUTON is indicated in the treatment of symptoms related to venous insufficiency; states of capillary fragility.
Dosage and method of use
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 dissolved carefully 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 let the medicine penetrate until completely absorbed, that is until you feel that the skin is dry in contact with your hands. Do not exceed the recommended dose. Use only for short periods of treatment.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Side effects
Venoruton oral formulations:Summary of the safety profileVenoruton 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.Table of adverse reactionsUndesirable effects are listed below by organ system classification and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 a
| Organ Systems Classes/ Frequency | Adverse reactions |
| 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 | Flushes |
| Gastrointestinal disorders | |
| Rare | Gastrointestinal disorders |
| Rare | Flatulence |
| Rare | Diarrhea |
| Rare | Abdominal pain |
| Rare | Upset stomach |
| Rare | Dyspepsia |
| Skin and subcutaneous tissue disorders | |
| Rare | Rash |
| Rare | Itching |
| Rare | Urticaria |
| General disorders and administration site conditions | |
| Very rare | Tiredness |
Venoruton gel:Summary of the safety profileVenoruton 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 reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.
Special warnings
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. Pediatric population Venoruton is not recommended for use in children.Venoruton gel: The use, especially if prolonged, of the products to be applied on the skin can give rise to sensitization phenomena. In this case it is necessary to stop the treatment and contact your doctor to establish a suitable therapy. Important information about some of the ingredients Venoruton 1000 mg powder contains: - sodium saccharin: this medicinal product contains less than 1 mmol (23 mg) sodium per dose, ie essentially 'sodium-free'. Venoruton 500 mg film-coated tablets contain the azo coloring agent: - sunset yellow aluminum lake (E 110): may cause allergic reactions. Venoruton gel contains: - benzalkonium chloride: this medicinal product contains 0.391 mg of benzalkonium chloride per dose equivalent to 0.05 mg / g. Benzalkonium chloride can irritate the skin. If you are breastfeeding, do not apply this medicine to your breasts as your baby may swallow it with his / her milk.
Pregnancy and breastfeeding
PregnancyThe safety of the drug in pregnancy has not been determined, therefore it is not recommended in pregnancy.Feeding timeIn animal studies, traces of oxerutin were found in breast milk. It is assumed that the small amounts of oxerutin which pass into breast milk can be considered of no clinical relevance for humans.FertilityAnimal studies have shown no effects on fertility after oxerutin administration.
Expiry and retention
This medicinal product does not require any special storage conditions.
Interactions with other drugs
To date, no specific interaction of oxerutin with other medicinal products has been reported. In vitro data on a possible modulation of CYP3A activity by oxerutin components (trace amounts of quercetin and rutin) are inconsistent. Venoruton gel: No drug interactions have been reported.
Overdose
No case of overdose has ever been reported.
Active principles
Venoruton 1000 mg powder: One sachet contains - Active ingredient: oxerutin 1000 mg.Venoruton 500 mg coated tablets: One tablet contains: Active ingredient oxerutin 500 mg. Excipients with known effects: sunset yellow aluminum lake (E 110) (2.68 mg / tablet).Venoruton 2% gel: 100 g of gel contain: Active ingredient oxerutin 2 g. Excipients with known effects: benzalkonium chloride 0.05 mg / g. For the full list of excipients, see section 6.1.
Excipients
Venoruton 1000 mg powder: mannitol; sodium saccharin; citric acid monohydrate.Venoruton 500 mg coated tablets: polyacrylate dispersion 30 per cent; talc; magnesium stearate; macrogoli; copovidone;sunset yellow aluminum lacquer (E 110); titanium dioxide.Venoruton 2% gel for cutaneous use:carbomers; sodium hydroxide; edetate disodium;benzalkonium chloride; purified water.
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