Instructions Normoven film-coated tablets 450 mg + 50 mg blister No. 60
Composition
active ingredient: 1 tablet contains 500 mg of flavonoid fraction, which contains 450 mg of diosmin, 50 mg of hesperidin;
excipients: sodium starch glycolate (type A), microcrystalline cellulose, hydroxypropylmethylcellulose, cyclodextrin, magnesium stearate;
shell: Opadry II Yellow film-coating mixture (hydroxypropylmethylcellulose; lactose monohydrate; polyethylene glycol; triacetin; quinoline yellow (E 104); titanium dioxide (E 171); indigo carmine (E 132); sunset yellow FCF (E 110)).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a film coating from yellow to brownish-yellow in color.
Pharmacotherapeutic group
Capillary stabilizing agents. Bioflavonoids. Diosmin, combinations. ATX code C05C A53.
Pharmacological properties
Pharmacodynamics
Normoven 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.
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 as hesperidin. The reduction 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 have been confirmed in double-blind, placebo-controlled 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 when taking 2 tablets.
Venotonic activity. The drug increases venous tone: a decrease in venous outflow time was demonstrated using venous occlusion plethysmography.
Microcirculatory activity. 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. 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 to any of the excipients.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted. Interactions with other medicinal products have not been reported to date (taking into account the extensive post-marketing experience with the medicinal product).
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; walk and, in some cases, wear special stockings to improve blood circulation.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Due to the content of "Yellow Sunset FCF" in the composition of the drug, allergic reactions are possible.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect of the flavonoid fraction on the ability to drive or use machines have not been conducted. However, given the overall safety profile of the flavonoid fraction, no significant effect on this ability is expected. Caution should be exercised if adverse drug reactions occur (see section 4.8).
Use during pregnancy or breastfeeding
Pregnancy. The drug should be used with caution in pregnant women. Consult a doctor before use.
It is known that the combination of active substances included in the medicinal product does not exhibit teratogenic effects; no side effects have been reported.
Breastfeeding. Due to the lack of data on the penetration of the drug into breast milk, use during breastfeeding should be avoided.
Fertility: Reproductive toxicity studies in animals have shown no effect on fertility.
Method of administration and doses
For oral use. For adults.
Venolymphatic insufficiency.
The recommended dose is 2 tablets per day: 1 tablet in the afternoon and 1 tablet in the evening with meals. After a week of use, you can take 2 tablets per day once with meals.
Hemorrhoidal disease.
Treatment of acute hemorrhoid episodes: 6 tablets per day for 4 days, then 4 tablets per day for the next 3 days. Take with meals. Divide the daily dose into 2-3 doses. Maintenance therapy - 2 tablets 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 in children.
Overdose
No cases of overdose have been reported.
Adverse reactions
From the nervous system: dizziness, headache, malaise.
Gastrointestinal: diarrhea, dyspepsia, nausea, vomiting; colitis, abdominal pain.
Skin and subcutaneous tissue disorders: rash, itching, urticaria; isolated swelling of the face, lips, eyelids. In exceptional cases - Quincke's edema.
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. 6 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
