Instructions Normoven film-coated tablets 450 mg + 50 mg blister No. 30
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 venotonic and angioprotective effects, increases venous tone, reduces venous distensibility and venostasis, improves microcirculation, reduces capillary permeability and increases their resistance, improves lymphatic drainage, increasing lymphatic outflow.
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.
Pharmacokinetics
The half-life of the drug is 11 hours.
The active substance is excreted mainly through the intestines. An average of 14% of the administered dose is excreted in the urine.
Indication
Symptomatic treatment of venolymphatic insufficiency (heaviness in the legs, pain, swelling).
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 medicine for acute hemorrhoids does not replace specific treatment 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, more effective treatment is provided by combining therapy with adherence to the following lifestyle recommendations:
- avoid prolonged exposure to the sun, prolonged standing, and excess body weight;
- you should walk and in some cases wear special stockings to improve blood circulation.
Use during pregnancy or breastfeeding
Pregnant women should use the drug with caution. 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.
Due to the lack of data on the penetration of the drug into breast milk, the use of the drug during breastfeeding should be avoided.
Available data indicate no effect of the active substances on the fertility of rats.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles and work with various mechanisms. Caution should be exercised in case of signs of side effects of the drug (see section "Adverse reactions").
Method of administration and doses
For oral use.
Assign to adults.
Treatment of venolymphatic insufficiency (symptoms: swelling, pain, heaviness in the legs, night cramps, trophic ulcers, lymphedema).
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 during meals.
Treatment of chronic hemorrhoids
2 tablets per day (in two divided doses) with meals. After a week of use, you can take 2 tablets per day once with meals.
Treatment of acute hemorrhoids
6 tablets per day for 4 days, then 4 tablets per day for the next 3 days. Take with meals. Divide the daily amount of tablets into 2-3 doses.
Treatment course
The duration of treatment depends on the indication for use and the course of the disease. The average duration of treatment is 2-3 months.
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.
Skin and subcutaneous tissue disorders: rash, itching, urticaria; isolated swelling of the face, lips, eyelids. In exceptional cases - Quincke's edema.
Due to the content of sunset yellow FCF in the medicinal product, allergic reactions are possible.
Expiration date
2 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 or 6 blisters in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Kyiv Vitamin Plant".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
