Glyvenol (Capsules) Instructions for Use

Marketing Authorization Holder

Novartis Pharma AG (Switzerland)

Manufactured By

R.P. Scherer, GmbH & Co. KG (Germany)

ATC Code

C05CX01 (Tribenoside)

Active Substance

Tribenoside (Rec.INN registered by WHO)

Dosage Form

Glyvenol

Capsules 400 mg: 20, 40, or 100 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Venotonic agent

Pharmacological Action

A drug for the treatment of venous circulation disorders. It acts on various links in the regulation of venous blood flow. It has a venodynamic effect, i.e., it directly increases venous tone and reduces venous congestion.

It improves microcirculation, reduces pathologically increased vascular permeability and fragility. It also has anti-inflammatory, antianaphylactic, and analgesic activity, especially for pain caused by edema or inflammation, and reduces the ability of platelets to adhere.

The mechanism of action of tribenoside has not been fully elucidated. The occurrence of a number of tribenoside effects is associated with its antagonism towards certain biogenic amines (including bradykinin, histamine, serotonin) and other humoral factors involved in the development of processes such as vasodilation, increased vascular permeability, endothelial damage, edema, inflammation, and anaphylactic reactions.

At the same time, tribenoside does not exhibit antagonism towards biologically active substances that are physiological vasoconstrictors (including norepinephrine, epinephrine).

Pharmacokinetics

After oral administration, it is highly absorbed from the gastrointestinal tract. At a dose of 800 mg, the C_max in blood plasma is 100-400 ng/ml and is reached after 2 hours. The concentration in the walls of blood vessels is higher than in other tissues.

The main metabolite of tribenoside is benzoic acid, which is excreted in the form of hippuric acid, the concentration of which is 20% of the dose.

The initial T_1/2 is 2 hours, the terminal T_1/2 is 20 hours. It does not accumulate.

Indications

Venous circulation disorders, edema, pain sensations in the lower extremities, varicose veins, phlebitis, periphlebitis, thrombophlebitis, varicose ulcers, trophic skin changes and dermatoses associated with venous stasis, hemorrhoids.

ICD codes

Dosage Regimen

Determine the dosage and administration schedule individually based on the clinical presentation and severity of venous insufficiency.

For oral administration of Glyvenol 400 mg capsules, the typical adult dose is one capsule (400 mg) taken two to three times daily.

Administer the capsules with a sufficient amount of water during or after a meal to improve gastrointestinal tolerance.

Do not exceed the maximum daily dose of 800 mg, equivalent to two capsules.

For acute conditions, initiate therapy at the higher end of the dosage range. Titrate to a lower maintenance dose following the resolution of acute symptoms.

Continue treatment for the duration prescribed. The therapeutic course for chronic venous disorders is typically long-term.

For hemorrhoidal crises, combine oral administration with topical tribenoside formulations for a comprehensive treatment effect.

Adhere strictly to the prescribed regimen. Do not adjust the dosage without consulting a physician.

Adverse Reactions

From the digestive system nausea, vomiting, gastralgia, heartburn, diarrhea, constipation.

Allergic reactions skin rash, itching, urticaria.

With rectal administration rarely – mild burning at the site of tribenoside application.

Contraindications

Hypersensitivity to tribenoside; first trimester of pregnancy (especially for rectal administration).

Use in Pregnancy and Lactation

Tribenoside is contraindicated for use in the first trimester of pregnancy.

In the second and third trimesters of pregnancy and during the lactation period (breastfeeding), Tribenoside is used only for strict indications, in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or infant.

Special Precautions

It has been noted that Tribenoside is more effective when used in the initial stage of venous diseases and less effective in complicated forms of phlebopathology.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.