VENORUTON OS 30BUST 1000MG

VENORUTON

active ingredients

Venoruton 1000 mg powder: A sachet contains - Active ingredient: oxerutina 1000 mg. Venoruton 500 mg coated tablets: One tablet contains: Active ingredient oxerutina 500 mg. Excipients with known effects: yellow sunset aluminum lacquer (E 110) (2,68 mg/compressed). Venoruton 2% gel: 100 g gel contains: Oxerutine active ingredient 2 g. Excipients with known effects: benzalconio chloride 0.05 mg/g. For the full list of excipients, see paragraph 6.1.

Excellent

Venoruton 1000 mg powder: mannitol; sodium saccharin; monohydrate citric acid. Venoruton 500 mg coated tablets: polyacrylate dispersion 30 percent; talc; magnesium stearate; macrogols; copovidone; yellow sunset aluminum lacquer (E 110); titanium dioxide. Venoruton 2% gel for skin use: carbomers; hydroxide sodium; heaped disode; benzalconio chloride; purified water.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Venoruton 1000 mg powder: 2 to 3 sachets per day, depending on the severity of the symptom. The contents of each bag of powder must be dissolved thoroughly in a little water and taken before or during meals, even in the venous insufficiency of the hemorrhoid plexus. Venoruton 500 mg coated tablets: 2 - 3 tablets per day. The tablets should be ingested whole with a little water, without chewing, before or during meals, even in the venous insufficiency of the hemorrhoid plexus. Venoruton 2% gel for skin use: apply an adequate amount of gel both on the affected area and on the surrounding areas, 2 times a day (mattin and evening). Massage slightly to penetrate the medicine until full absorption, that is until you feel in contact with the hands that the skin is dry. Do not exceed the recommended doses. Use only for short period of treatment.

Conservation

This medicine does not require any special condition for conservation.

Warnings

Patients suffering from lower limbs from heart, kidney or liver disease should not take Venoruton because the effect of Venoruton is not demonstrated in these indications. Pediatric Population The use of Venoruton is not recommended in children. Venoruton gel: The use, especially if prolonged, of the products to be applied on the skin can give rise to phenomena of sensitization. In this case, you must stop the treatment and contact your doctor to establish suitable therapy. Important information about some excipients Venoruton 1000 mg powder contains: - sodium saccharin: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. Venoruton 500 mg tablets coated with film contains azoic coloring agent: - yellow sunset aluminum lacquer (E 110): can cause allergic reactions. Venoruton gel contains: - benzalconio chloride: this medicine contains 0.391 mg of benzalconio chloride per dose equivalent to 0.05 mg/g. The benzalconio chloride can irritate the skin. If you are breastfeeding do not apply this medicine on the breast because the child could ingest it with his milk.

Interactions

No specific interaction of oxyerutine with other medicines has been reported to date. The in vitro data on a possible modulation of the activity of CYP3A by the components of theoxerutina (quercetin and rutina present in traces) are discordant. Venoruton gel: no interaction with medicines has been reported.

Effects

Venoruton oral formulations: Summary of security profile Venoruton can cause in rare cases unwanted gastrointestinal effects or skin reactions such as gastrointestinal disorders, flatulence, diarrhea, abdominal pain, stomach disorders, dyspepsia, rash, itching or hives. Very rare is the appearance of dizziness, headaches, hot flashes, fatigue or hypersensitivity reactions such as anaphylactoid reactions. Table of adverse reactions Undesirable effects are listed below by classification for organ and frequency systems. The frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 a Organ Systems Classes / Frequency Adverse reactions Immune system disorders   Very rare Anaphylactic reactions Very rare Reactions of hypersensitivity Diseases of the nervous system   Very rare Heads Very rare Headache Vascular diseases   Very rare Vampires Gastrointestinal diseases   Rare Gastrointestinal disorders Rare Flatulence Rare Diarrea Rare Abdominal pain Rare Stomach disorders Rare Dispepsia Pathologies of skin and subcutaneous tissue   Rare Rash Rare Prudence Rare Orticaria Systemic pathologies and conditions for administration   Very rare Tired Venoruton gel: Summary of security profile Venoruton gel is well tolerated. Rare awareness cases were observed with the appearance of skin reactions. Such symptoms disappear with the interruption of treatment. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No case of overdose has ever been reported.

Pregnancy

The safety of the drug during pregnancy has not been determined, therefore it is not recommended in pregnancy.

Food

In animal studies, traces of oxerutine were found in breast milk. It is assumed that the small amounts of oxerutina passing into breast milk can be considered without clinical relevance to man.

Fertility

Animal studies have not shown effects on fertility after oxerutine administration.

Source: Farmadati