Instructions for Venosmil capsules 200 mg No. 60
Composition
active ingredient: hidrosmin
1 capsule contains 200 mg of hydrosmin;
excipient: magnesium stearate;
capsule shell: gelatin, erythrosine (E 127), quinoline yellow (E 104), titanium dioxide (E 171).
Dosage form
Capsules.
Main physicochemical properties: orange capsules filled with yellow powder.
Pharmacotherapeutic group
Angioprotectors. Capillary stabilizing agents. Bioflavonoids. Hydrosmin.
ATX code C05C A05.
Pharmacological properties
Pharmacodynamics
The active ingredient of Venosmil – hydrosmin – belongs to the flavonoid group in its chemical structure. It is a standard mixture consisting of 5 and 3'-mono-O-(β-hydroxyethyl)-diosmin and 5,3'-di-O-(β-hydroxyethyl)-diosmin. The mechanism of action of hydrosmin is not fully understood, but may be associated with inhibition of catecholamine degradation, mainly through inhibition of catechin-O-methyltransferase. Despite the fact that the exact mechanism of action is still unknown, four levels of action of hydrosmin can be distinguished:
a) effect on permeability: reduces capillary permeability caused by various substances such as histamine, bradykinin; reduces capillary fragility in case of malnutrition;
b) improves the hemorheological properties of erythrocytes, increases the ability of erythrocytes to deform and reduces blood viscosity;
c) effect on venomotor tone: stimulates gradual and constant contraction of the smooth muscles of the venous wall;
d) creates appropriate conditions for improving lymph circulation. Hydrosmin causes dilation of lymphatic ducts and increases the speed of lymphatic flow, thus improving lymphatic outflow.
Venosmil reduces the clinical symptoms of peripheral venous insufficiency (pain, heaviness, edema), which is significantly different from the effect of placebo. The active substance of the drug has a significant effect on the consequences of venous stasis caused by varicose dilatation of the vessels of the lower extremities.
Pharmacokinetics
After oral administration of a single dose of hydrasmin to healthy volunteers, the plasma concentration-time curve of the drug was observed to be biphasic. The initial peak after administration was observed after 15 min, after which it began to slowly decline. After 4 hours after administration, a new increase in levels was observed, reaching stability between 5 and 8 hours after administration, after which plasma levels decreased and were practically not observed after 24 hours after administration.
90% of the dose of gidrosmin is excreted within 48 hours. The active substance of the drug is excreted mainly through the intestines (80%). It is excreted in the urine on average
16-18% of the applied dose.
Indication
The drug is used for short-term reduction (within 2-3 months) of edema and symptoms associated with chronic venous insufficiency.
Contraindication
Hypersensitivity to the active substance or to other components of the drugs.
Interaction with other medicinal products and other types of interactions
Not known. Specific pharmacokinetic and pharmacodynamic studies of hydrasmin with other drugs or food have not been conducted.
Application features
Patients should be advised that they should not use the drug for a prolonged period without medical supervision.
Pediatric population
The use of Venosmil is not recommended for children.
Use during pregnancy or breastfeeding
Pregnancy
There are no clinical studies on the use of Venosmil in pregnant women.
Preclinical studies did not reveal any direct or indirect harmful effects with respect to pregnancy, fetal development, childbirth or postnatal development.
However, as a precautionary measure, the use of Venosmil is not recommended during pregnancy, except in cases where, in the opinion of the doctor, the expected benefit of its use outweighs the possible risks.
Lactation
There are no clinical data on the use of Hydrosmin in breastfeeding women. There is no data on the penetration of the drug into breast milk, therefore its use is not recommended during breastfeeding.
Fertility
There are no data on the effect on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Hydrosmin does not affect the reaction rate when driving or using other mechanisms.
Method of administration and doses
The drug should be taken orally during meals, with water.
Adults should be prescribed 1 capsule (200 mg) three times a day (every 8 hours). The duration of treatment is 2-3 months.
Children
The efficacy and safety of the drug in children have not been established.
Overdose
Due to the good tolerability of Venosmil, the possibility of intoxication is practically excluded, even in the event of an overdose.
Side effects
Treatment with the drug is usually well tolerated. Hypersensitivity reactions are possible in individuals with individual intolerance to any component of the drug.
from the digestive tract - stomach pain, nausea;
skin – rash, itching;
from the side of the central nervous system - weakness, dizziness, headache.
Expiration date
5 years.
Do not use after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister, 6 or 9 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Faes Pharma, S.A.
Address
Maximo Aguirre, 14, 48940 Leioa (Biscay), Spain
