Zeflavon 1000 mg - venous insufficiency treatment 30 tablets

Product Description

Treatment of chronic venous insufficiency and acute hemorrhoidal crisis.

Indications

Zeflavon is indicated in adults for: Treatment of chronic venous insufficiency of the lower limbs in case of the following functional symptoms: heavy legs and swelling; pain; night cramps of the lower limbs. Symptomatic treatment of acute hemorrhoidal crisis.

Composition

Active ingredients

Each film-coated tablet contains 1000 mg of micronized flavonoids, 900 mg of diosmin and 100 mg of other flavonoids expressed as hesperidin. For a full list of excipients, see the following:

Excipients

Tablet core: microcrystalline cellulose (Type 102), gelatin, maize starch, talc, magnesium stearate. Coating: partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Directions for use and Dosage

The usual dose is 1 tablet twice a day (midday and evening) for 2 months. Treatment may be continued for another 2 months if justified by the persistence of symptoms. Acute haemorrhoidal crisis: during the first 4 days of treatment, the daily dose is 6 tablets, i.e. 3 tablets twice a day. For the next 3 days, the recommended daily dose is 4 tablets, i.e., 2 tablets twice daily. In this indication, Zeflavon is intended for short-term use, i.e., 7 days. Pediatric population: The safety and efficacy of Zeflavon in children and adolescents under 18 years of age have not been established. Therefore, use in the pediatric population is not recommended. Hepatic and/or renal impairment: The safety and efficacy of micronized flavonoids have not been studied in patients with renal or hepatic impairment. To date, no data are available to indicate the need for dose modification in these subgroups. Elderly: The safety and efficacy of micronized flavonoids have not been studied in the elderly. To date, no data are available to indicate the need for dose modification in these subgroups. Method of administration: For oral use. The tablets should be taken during meals.

Warnings

The use of this medicine for the symptomatic treatment of acute hemorrhoidal crisis does not replace other specific treatments for pathological conditions of the rectum. The duration of treatment should be limited to a short period of time, i.e., 7 days. If symptoms do not resolve following short-term treatment, a proctological examination is recommended and the treatment should be reviewed. Regarding the treatment of chronic venous insufficiency, the most favorable effect may be ensured by an appropriate lifestyle. Avoid prolonged exposure to sunlight, prolonged standing, and excess weight. Walking and the use of compression stockings can improve circulation in the lower limbs. Special caution is advised if the condition worsens with treatment. This may manifest as skin inflammation, inflammation of the veins, subcutaneous hardening, severe pain, skin ulcers, or atypical symptoms, e.g., redness. sudden swelling of one or both legs. Zeflavon is not effective in reducing swelling of the lower limbs caused by heart, liver, or kidney disease.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Undesirable effects

Summary of the safety profile: In clinical studies conducted with micronized flavonoids, moderate-intensity side effects have been reported, mainly gastrointestinal events (nausea, vomiting, diarrhea, dyspepsia). List of side effects. The frequency of adverse reactions listed below is defined using the following convention: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Nervous system disorders. Rare: headache, dizziness, malaise. Gastrointestinal disorders. Common: nausea, vomiting, diarrhoea, dyspepsia; uncommon: colitis; not known*: abdominal pain. Skin and subcutaneous tissue disorders. Rare: rash, pruritus, urticaria. Immune system disorders. Not known*: isolated swelling of the face, lips and eyelids related to hypersensitivity reactions, in exceptional cases Quincke's edema. * Post-marketing experience Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

Pregnancy: There are no data on the use of micronized flavonoids in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Zeflavon during pregnancy. Breastfeeding: It is not known whether the active substance/metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Zeflavon therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Fertility: Reproductive toxicity studies have shown no effects on fertility in either male or female rats. No clinical data are available on the effect of micronized flavonoids on fertility.

Format

30 film-coated tablets