Troxevasin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Troxevasin® (Troxevasin®)

Composition:

Active substance: troxerutin;

1 capsule contains troxerutin 300 mg;

Excipients: magnesium stearate, lactose monohydrate; quinoline yellow (E 104), sunset yellow (E 110), titanium dioxide (E 171), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical characteristics: hard cylindrical gelatin capsules, size № 1, yellow color (body – yellow; cap – yellow); contents of capsules – powder from yellow to yellowish-brown, presence of agglomerates which disintegrate upon pressure is permitted.

Pharmacotherapeutic group. Angioprotectors. Capillary stabilizing agents. Bioflavonoids. Troxerutin. ATC code C05CA04.

Pharmacological Properties.

Pharmacodynamics.

Troxevasin is a mixture of bioflavonoids containing not less than 95% troxerutin; a capillary- and venotonic agent. It exhibits anti-inflammatory and antioxidant effects and inhibits hyaluronidase. It prevents oxidation of hyaluronic acid, ascorbic acid, and adrenaline, and inhibits lipid peroxidation. Troxerutin reduces increased capillary permeability and fragility, prevents damage to the basal membrane of endothelial cells by various factors, and additionally possesses antioxidant, membrane-stabilizing, antihemorrhagic, anti-inflammatory, and venotonic effects. It reduces edema, improves trophism, enhances microcirculation and microvascular perfusion, and reduces other symptoms associated with venous insufficiency or impaired lymphatic drainage.

Pharmacokinetics.

Maximum plasma concentrations are achieved within 1–9 hours after oral administration. Plasma concentration decline is biexponential. Protein binding in plasma ranges from 27–29%. It accumulates predominantly in endothelial tissue. It does not penetrate the blood-brain barrier, crosses the placental barrier in negligible amounts, and passes into breast milk in minimal quantities. It is metabolized in the liver via glucuronidation. It is primarily excreted via bile, with a minor amount eliminated in urine.

Clinical characteristics.

Indications.

Troxevazin capsules are indicated for symptomatic treatment of the following conditions:

• pre-varicose and varicose syndrome, varicose ulcers;
• superficial thrombophlebitis, phlebitis, and postphlebitic conditions;
• chronic venous insufficiency;
• hemorrhoids;
• as part of combination therapy for diabetic retinopathy;
• edema and pain associated with injuries and varicose veins, varicose dermatitis;
• combined treatment of contusions, sprains, dislocations, and symptoms of muscle cramps (calf muscle cramps).

Contraindications.

Troxevazin is contraindicated in patients with hypersensitivity to troxerutin or to any excipient of the drug; in patients with peptic ulcer disease of the stomach and duodenum, and with chronic gastritis (in the phase of exacerbation).

Interaction with other medicinal products and other forms of interaction.

The drug enhances the effect of ascorbic acid on strengthening the structure and reducing the permeability of the vascular wall.

Special precautions for use.

The drug Troxevasin is ineffective for edema caused by liver, kidney or cardiovascular diseases.

The drug should be prescribed with caution to patients with severe liver and gallbladder diseases.

Since the drug may irritate the gastric mucosa, Troxevasin should be taken during meals.

The drug contains lactose; therefore, it should not be administered to patients with lactase deficiency, galactosemia, or glucose/galactose malabsorption syndrome.

Due to the presence of a dye (E 110), treatment with the drug may cause an allergic reaction.

Use during pregnancy or breastfeeding.

Pregnancy

There are no data regarding negative effects of troxerutin in pregnant or breastfeeding women; however, despite this, its use during the first trimester of pregnancy is not recommended. The medicinal product may be used during pregnancy only under strict medical supervision due to insufficient data on the use of troxerutin during pregnancy.

Breastfeeding

The drug passes into breast milk in minimal amounts, but there are no data indicating that these amounts have caused clinically significant reactions in newborns. A decision regarding the possibility of using the drug in this category of women should be made by a physician based on the benefit of treatment for the mother versus the potential risk to the fetus or infant.

Ability to influence reaction rate when driving vehicles or operating machinery.

Troxevasin does not affect the ability to drive a vehicle or operate other machinery.

Dosage and Administration.

Troxevasin, capsules, should be taken orally during meals. The dosage and duration of treatment are determined by a physician depending on the nature, severity, and course of the disease.

The usual dose is 2 capsules per day. Maintenance therapy – 1 capsule daily for 3–4 weeks. This treatment may be combined with concomitant use of Troxevasin gel. The efficacy of Troxevasin treatment depends on regular administration, correct dosage, and treatment duration. Clinical experience shows that sometimes the desired effect is achieved with doses exceeding 600 mg (2 capsules) per day.

Children.

Experience with the use of the drug in children (under 18 years of age) is limited; therefore, the use of this medicinal product is not recommended.

Overdose.

Cases of overdose have not been reported.

Symptoms: The manifestations of adverse reactions may intensify.

Treatment: Discontinue the drug. Induction of vomiting or gastric lavage is recommended, along with symptomatic treatment. If necessary, peritoneal dialysis may be administered.

Adverse reactions.

Unwanted reactions occur rarely during treatment with Troxevasin capsules.

Adverse reactions are categorized by frequency as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); frequency not known (cannot be estimated from available data).

Immune system disorders: very rare – anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions.

Skin and subcutaneous tissue disorders: rare – rash; frequency not known – allergic dermatitis (itching, urticaria).

Psychiatric disorders: frequency not known – sleep disturbances.

Nervous system disorders: very rare – dizziness, headache.

Vascular disorders: very rare – ecchymosis.

Gastrointestinal disorders: rare – stomach pain, epigastric discomfort, dyspepsia, flatulence, diarrhea; frequency not known – nausea, vomiting.

General disorders: very rare – increased fatigue.

Reporting of suspected adverse reactions. All suspected adverse reactions and cases of lack of drug efficacy should be reported via the following link: https://aisf.dec.gov.ua/.

Shelf life. 5 years.

The product should not be used after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 capsules per blister; 5 or 10 blisters per cardboard box.

Supply classification. Over-the-counter.

Balkanpharma-Razgrad AD

Manufacturer's location and address of its business operations.

68 Aprilskogo Vosstaniya Blvd., Razgrad 7200, Bulgaria