ZEFLAVON 60CPR RIV 500MG

ZEFLAVON 500 MG COMPRESENT RIVES WITH FILM

active ingredients

Each film-coated tablet contains 500 mg of micronized flavonoids, 450 mg of diosmine and 50 mg of other flavonoids expressed as esperidine. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Microcrystalline cellulose (Type 102) Gelatin Corn starch Magnesium stearate Coating: Poly (vinyl alcohol) partially hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talco Yellow iron oxide (E172) Red iron oxide (E172)

Therapeutic indications

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

Contraindications

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

Population

Population Adults Chronic venous insufficiency The usual dose is 1 tablet twice a day (mezzogiorno and evening) for 2 months. Treatment may be continued for another 2 months if justified by the persistence of symptoms. Acute Hemorrhoidaria Crisis During the first 4 days of treatment the daily dose is 6 tablets, i.e. 3 tablets twice daily. During the next 3 days the recommended daily dose is 4 tablets, i.e. 2 tablets twice a day. In this indication Zeflavon is intended for short-term use, i.e. 7 days (see paragraph 4.4). Pediatric population The safety and effectiveness of Zeflavon in children and adolescents under the age of 18 have not been established. Therefore, use in the pediatric population is not recommended. Hepatic and/or renal comprogation The safety and effectiveness of micronized flavonoids have not been studied in patients with kidney or liver impairment. Data is not available to date indicating the need to change the dose in these subgroups. Seniors The safety and effectiveness of micronized flavonoids have not been studied in the elderly. Data is not available to date indicating the need to change the dose in these subgroups. Method of administration For oral use. Tablets should be taken during meals.

Conservation

This medicine does not require any special condition for conservation.

Warnings

The use of this medicine for symptomatic treatment of acute hemorrhoidaria crisis does not replace other specific treatments of the pathological conditions of the rectum. The duration of treatment must be limited to a short period of time, i.e. 7 days. If the symptoms do not resolve as a result of short-term treatment, a proctological examination is recommended and treatment should be revised. With regard to the treatment of chronic venous insufficiency, the most favorable effect could be ensured by a proper lifestyle. Avoid prolonged exposure to sunlight, prolonged standing and overweight. Walking and using compression socks can improve the circulation of lower limbs. We recommend special attention if the condition worsens with the treatment. This can occur as inflammation of the skin, inflammation of the veins, subcutaneous hardening, strong pain, skin ulcers or atypical symptoms, e.g. instant swelling of one or both legs. Zeflavon is not effective in reducing swelling of the lower limbs caused by heart, liver, or kidney diseases.

Interactions

Interaction studies have not been carried out. The extensive post-marketing experience has not revealed any interaction between other micronized medicines and flavonoids.

Effects

Summary of security profile In clinical studies conducted with micronized flavonoids, moderate intensity side effects were reported, mainly gastrointestinal events (nausea, vomiting, diarrhea, dyspepsia). Tabular list of side effects The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, Organic systemic classification Frequency Preferred term Diseases of the nervous system Rare headache dizziness malaise Gastrointestinal diseases Town nausea vomiting diarrhea dyspepsia Not common colitis Notable abdominal pain Pathologies of skin and subcutaneous tissue Rare skin rash itching hives Immune system disorders Notable isolated edema of the face, lips and eyelids related to hypersensitivity reactions, in exceptional cases edema of Quincke * post-marketing experience 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 risk/benefit 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

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

Pregnancy

There is no data on the use of micronized flavonoids in pregnant women. Animal studies show no direct or indirect harmful effects on reproductive toxicity (see paragraph 5.3). For precautionary purposes, it is preferable to avoid the use of Zeflavon during pregnancy.

Food

It is not known whether the active ingredient/metabolites are excreted in breast milk. A risk for infants/ infants cannot be excluded. The decision must be taken if you stop breastfeeding or stop the therapy/ refrain from therapy with Zeflavon taking into consideration the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility

Reproductive toxicity studies have shown no effect on fertility in rats or males or females (see paragraph 5.3). Clinical data on the effect of micronized flavonoids on fertility are not available.

Source: Farmadati