Instructions for Venoplant delayed-release tablets No. 20
Composition
active ingredient: dry extract of horse chestnut seeds (Aesculus hippocastanum) (4.5-5.5:1) (extractant: ethanol 50% (m/m));
1 delayed-release tablet contains: 178.5 - 263.2 mg of dry extract of horse chestnut seeds (Aesculus hippocastanum) (4.5-5.5:1), corresponding to 21 mg of triterpene glycosides in terms of protoescigenin (extractant: ethanol 50% (m/m));
excipients: calcium hydrogen phosphate anhydrous, silicon dioxide colloidal anhydrous, ammonium methacrylate copolymer (type A), ammonium methacrylate copolymer (type B), triethyl citrate, polysorbate 80, povidone (K 25), crospovidone, magnesium stearate, hypromellose, macrogol 4000, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), antifoam emulsion SE 2, talc, sodium saccharin, vanillin.
Dosage form
Delayed-release tablets.
Main physicochemical properties: round tablets of orange-brown color.
Pharmacotherapeutic group
Capillary stabilizing agents.
ATX code C05C X03.
Pharmacological properties
Escin, the main active ingredient in horse chestnut seed extract, has anti-exudative and vasoconstrictive effects.
Pharmacodynamics.
Horse chestnut seed extract reduces the activity of lysosomal enzymes, which is increased in chronic venous diseases, as a result of which the degradation of glycocalyx (mucopolysaccharides) on the surface of capillary walls is inhibited. By reducing vascular permeability, it prevents the filtration of low-molecular proteins, electrolytes and water into the intracellular space.
The drug eliminates the symptoms of chronic venous insufficiency (fatigue, feeling of heaviness and tension, itching, pain and swelling of the legs).
Pharmacokinetics.
Data is missing.
Indication
Chronic venous insufficiency:
swelling;
nocturnal cramps of the calf muscles;
itching, as well as pain and a feeling of heaviness in the legs;
varicose veins.
Contraindication
Hypersensitivity to the active ingredient or to any of the excipients. Renal failure.
Interaction with other medicinal products and other types of interactions
The drug may enhance the effect of antithrombotic agents. Cephalosporin antibiotics increase the concentration of free escin in the blood and the risk of side effects. The simultaneous use of the drug with aminoglycoside antibiotics should be avoided due to increased toxic effects of aminoglycosides on the kidneys.
Application features
If you experience unusual symptoms in one leg, such as swelling, changes in skin color, a feeling of tightness or heat, or pain, you should see a doctor immediately, as these symptoms may indicate serious complications (deep vein thrombosis, i.e., blockage of the veins in the legs by a blood clot). You should definitely use other non-invasive treatments prescribed by your doctor, such as applying compresses to the legs, wearing supportive elastic stockings, or dousing them with cold water.
In case of skin inflammation, thrombophlebitis, subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs; heart or kidney failure, you should consult a doctor.
In case of dyspeptic symptoms, it is recommended to switch to taking the drug during meals.
When using the drug, kidney function should be monitored.
Use during pregnancy or breastfeeding
There are no or limited data on the use of Venoplant in pregnant women. Animal studies on reproductive toxicity are insufficient. The drug is not recommended for use during pregnancy or breastfeeding due to insufficient data on the safety of its use in this category of patients.
The safety of use during breastfeeding has not been studied. It is not known whether components of horse chestnut seed extract or its metabolites are excreted in human milk. Therefore, women who are breastfeeding should not take Venoplant.
Fertility studies have not been conducted.
The ability to influence the reaction speed when driving or working with other mechanisms
Unknown.
Method of administration and doses
Adults should take 1 delayed-release tablet twice a day, morning and evening, before meals, without chewing, with a small amount of water.
The duration of treatment is determined by the doctor individually depending on the severity of the disease and the clinical effectiveness of the drug. The average duration of treatment is 2-3 months.
Children
The drug is not used in children.
Overdose
Treatment: if there is no vomiting and a large amount of the drug has been used, gastric lavage (for example, with a 0.02% potassium permanganate solution) and the use of activated charcoal are recommended; symptomatic treatment.
Side effects
From the nervous system: headache, dizziness.
Skin and subcutaneous tissue/immune system disorders: hypersensitivity reactions, including rash, itching, feeling of heat, angioedema.
From the cardiovascular system: tachycardia, palpitations, arterial hypotension.
On the part of the digestive tract: dyspeptic phenomena, pain in the epigastric region, nausea, diarrhea, vomiting.
If other adverse reactions occur, you should consult a doctor.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the 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 Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
20 tablets in a blister; 1 blister in a cardboard box. 25 tablets in a blister; 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Wilmar Schwabe GmbH & Co. KG.
Location of the manufacturer and address of its place of business:
Wilmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.
