Instructions Normoven 1000 film-coated tablets blister pack No. 30
Composition
active ingredient: micronized purified flavonoid fraction/MOFF;
1 tablet contains 1000 mg of micronized purified flavonoid fraction, in the form of diosmin and hesperidin (the name hesperidin refers to a mixture of flavonoids: hesperidin, isorhoifolin, linarin, diosmetin) in a ratio of 9:1;
excipients: microcrystalline cellulose, gelatin, magnesium stearate, sodium starch glycolate (type A), talc, purified water;
shell: sodium lauryl sulfate; glycerin; Opadry II Orange film coating mixture: (hypromellose (hydroxypropylmethylcellulose); lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol (macrogol); iron oxide yellow (E 172); iron oxide red (E 172).
Dosage form
Film-coated tablets.
Main physicochemical properties: oval-shaped tablets with a biconvex surface, film-coated from light orange to light brown, with a score on one side.
Pharmacotherapeutic group
Angioprotectors. Capillary stabilizing agents.
Bioflavonoids. Diosmin, combinations. ATX code C05C A53.
Pharmacological properties
Pharmacodynamics
The drug has a venotonic and angioprotective effect, reduces venous distensibility and venostasis, improves microcirculation, reduces capillary permeability and increases their resistance, and also improves lymphatic drainage, increasing lymphatic outflow.
It is known that experimental studies on animals using the ischemia/reperfusion model have shown that the use of a micronized purified flavonoid fraction has a more pronounced effectiveness in reducing vascular wall permeability and blood plasma leakage compared to simple diosmin. This result is due to the presence of a protective effect on microcirculation of flavonoids, such as hesperidin, diosmetin, linarin and isoroifolin, which are part of the fraction and are expressed in the form of hesperidin. The decrease in vascular wall permeability and blood plasma leakage observed with the use of a micronized purified flavonoid fraction is more significant than that observed with the use of simple diosmin and each component of the flavonoid fraction separately. The above pharmacological properties were confirmed in studies using methods that can determine the effect of the drug on venous hemodynamics.
Dose-effect relationship. A statistically significant dose-dependent effect of the drug was established according to the following venous plethysmographic parameters: venous volume, venous distensibility and venous outflow time. The optimal dose-effect relationship was achieved at 1000 mg per day.
Venotonic activity. The drug increases venous tone: a decrease in venous outflow time was demonstrated using venous occlusion plethysmography.
Microcirculatory activity. It is known that studies have demonstrated a statistically significant difference between the use of the drug and placebo. In patients with symptoms of capillary fragility, treatment increased their resistance, which was determined by angiostereometry.
The drug also reduces the interaction of leukocytes and endothelium, leukocyte adhesion in postcapillary venules. This reduces the damaging effect of inflammatory mediators on the walls of veins and leaflets of venous valves.
In clinical practice. It is known that studies have shown the therapeutic activity of the drug in phlebology in the treatment of functional and organic chronic venous insufficiency of the lower extremities, as well as in proctology in the treatment of hemorrhoids.
Pharmacokinetics
The active substance is excreted mainly in the feces. An average of 14% of the dose is excreted in the urine.
The half-life is 11 hours.
The drug is actively metabolized, as confirmed by the presence of various phenolic acids in the urine.
Indication
Symptomatic treatment of venolymphatic insufficiency (heaviness in the legs, pain, night cramps, edema, trophic disorders, including varicose ulcers).
Symptomatic treatment of hemorrhoids.
Contraindication
Hypersensitivity to the active substance or any of the excipients.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted. During post-marketing use of the drug, there have been no reports of any clinically significant drug interactions.
Application features
The use of this medicinal product for acute hemorrhoids does not replace specific therapy and does not interfere with the treatment of other proctological diseases. If the symptoms do not disappear quickly during a short course of treatment, a proctological examination should be performed and the therapy reviewed.
In cases of venous circulation disorders, it is more effective to combine therapy with adherence to the following lifestyle recommendations:
- avoid too much sun exposure, prolonged standing, and excess body weight;
The medicinal product contains lactose and should not be used in patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption syndrome.
Use during pregnancy or breastfeeding
Pregnancy: There are no or limited amount of data from the use of micronized purified flavonoid fraction in pregnant women.
Animal studies have not demonstrated a teratogenic effect.
As a precautionary measure, it is advisable to avoid using the drug during pregnancy.
Breastfeeding: It is not known whether the active substance or its metabolites pass into breast milk.
A risk to newborns/infants cannot be excluded.
A decision on whether to discontinue breast-feeding or to discontinue/abstain from therapy with this medicinal product should be made taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Fertility: Reproductive toxicity studies in animals have shown no effect on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies of the effect of the flavonoid fraction on the ability to drive or operate other mechanisms have not been conducted. However, in accordance with the general safety profile of the flavonoid fraction, Normoven 1000 has no or negligible effect on such ability. In case of detection of side effects of the drug (see section "Adverse reactions"), caution should be exercised.
Method of administration and doses
For oral use. For adult patients.
Venolymphatic insufficiency
The recommended dose of the drug is 1 tablet per day in the morning with a meal.
Hemorrhoid disease
Treatment of acute hemorrhoid episodes: 3 tablets per day for 4 days, then 2 tablets per day for the next 3 days. Take with meals. Divide the daily dose into 2-3 doses. Maintenance therapy - 1 tablet per day.
Treatment course
The duration of therapy is determined by the doctor depending on the indication for use and the course of the disease.
Children
There are no data on the use of Normoven 1000 in children.
Overdose
Symptoms: There is limited data on cases of overdose with this medicinal product. The most common adverse reactions reported in cases of overdose were gastrointestinal reactions (such as diarrhoea, nausea, abdominal pain) and skin reactions (such as pruritus, rash).
Treatment: Treatment of overdose should include therapy of clinical symptoms.
Adverse reactions
When using micronized purified flavonoid fraction, side effects of moderate intensity were observed, mainly from the gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting).
The following adverse reactions have been reported and are classified according to frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated from the available information).
Nervous system: rarely: dizziness, headache, malaise.
Gastrointestinal disorders: common: diarrhea, dyspepsia, nausea, vomiting; uncommon: colitis; frequency unknown*: abdominal pain.
Skin and subcutaneous tissue disorders: rarely: itching, rash, urticaria; frequency unknown*: isolated swelling of the face, lips, eyelids, in exceptional cases - Quincke's edema.
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and address of its place of business.
04073, Ukraine, Kyiv, Kopylivska St., 38.
