Zeflavon 500 mg - venous insufficiency treatment 60 tablets

Product Description

Drug for the treatment of venous insufficiency

Indications

Zeflavon is indicated in adults for the 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 haemorrhoidal crisis.

Composition

Active ingredients

Each film-coated tablet contains 500 mg of micronized flavonoids, 450 mg of diosmin and 50 mg of other flavonoids expressed as hesperidin.

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

Chronic venous insufficiency: the usual dose is 1 tablet twice a day (midday and at night).

Hemorrhoidal crisis: in the first 4 days of treatment the daily dose is 6 tablets (i.e. 3 tablets twice a day). In the following 3 days the recommended dose is 4 tablets, i.e. 2 tablets twice a day. For maintenance treatment, the daily dose is 1 tablet twice a day.

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.

Particular caution is advised if the condition worsens with treatment. This may lead to serious complications. manifest as inflammation of the skin, inflammation of the veins, hardening under the skin, severe pain, skin ulcers, or atypical symptoms, e.g., 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 listed.

Undesirable effects

* Post-marketing experience

Overdose

Experience with overdose of micronized flavonoids is limited. The most frequently reported adverse events in overdose cases were gastrointestinal events (such as diarrhea, nausea, abdominal pain) and skin events (such as pruritus, rash).

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 the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy with Zeflavon 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. There are no clinical data available on the effect of micronized flavonoids on fertility.

Format

60 tablets.