Ginkoum, 120 mg capsules 30 pcs

Pharmacotherapeutic group Angioprotective agent of plant origin
ATX code: N06DX02

Pharmacological properties

Pharmacodynamics
Enhances the body’s resistance to hypoxia, especially brain tissue. Inhibits development of traumatic or toxic cerebral edema, improves cerebral and peripheral blood circulation, improves blood rheology (prevents thrombosis).
It has a dose-dependent regulating effect on the vascular wall, dilates small arteries, increases venous tone. Prevents the formation of free radicals and lipid peroxidation of cell membranes. Normalizes the release, re-uptake and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to combine with receptors. It improves metabolism in organs and tissues, promotes macroergic accumulation in cells, increased utilization of oxygen and glucose, normalization of mediator processes in the central nervous system.

Pharmacokinetics

absorption
. After oral administration, the bioavailability of the terpenlactones (ginkgolide A, ginkgolide B and bilobalide) is 80% for ginkgolide A, 88% for ginkgolide B and 79% for bilobalide.

Distribution
Peak plasma concentrations were 16-22 ng/mL for ginkgolide A, 8-10 ng/mL for ginkgolide B, and 27-54 ng/mL for bilobalide after oral tablets. Binding to plasma proteins is 43% for ginkgolide A, 47% for ginkgolide B and
67% for bilobalide.

Evolution
Half-life is 3.9 hours for ginkgolide A, 4-6 hours for ginkgolide B and 2-3 hours for bilobalide.

Indications

Symptomatic treatment of cognitive disorders in adults (memory impairment, decreased concentration and intellectual abilities).
As part of the complex therapy of vertigo of vestibular origin as an adjunctive treatment in addition to vestibular rehabilitation.
Symptomatic treatment of tinnitus (ringing or tinnitus).

Active ingredient

Ginkgo biloba leaf extract

Composition

active ingredient: Ginkgo biloba extract, dried, standardized with content of flavonol glycosides 22,0-27,0% and terpene lactones 5,0-12,0% -0,040 g.

auxiliary substances: microcrystalline cellulose – 0.109 g, calcium stearate – 0.001 g, hard gelatin capsules (capsule body components: iron oxide black dye E 172, iron oxide red dye E 172, titanium dioxide E 171, iron oxide yellow dye E 172, gelatin;

components of the capsule cap: iron oxide black dye E 172, iron oxide red dye E 172, titanium dioxide E 171, iron oxide yellow dye E 172, gelatin).

How to take, the dosage

Oral.

Symptomatic treatment of cognitive disorders in adults (memory impairment, decreased concentration and intellectual abilities) take 1-2 capsules 3 times a day.

Complex therapy of vertigo of vestibular origin and symptomatic treatment of tinnitus (tinnitus or tinnitus): 3 capsules a day, distributed throughout the day.

The first signs of improvement usually appear after 1 month.

Treatment course of at least 3 months (especially for elderly patients).

The repeated course is possible after consultation with the doctor.

If the drug was missed or an insufficient amount was taken, the subsequent reception should be carried out as specified in these instructions without any changes.

Interaction

It is not recommended to use the drug in patients who regularly take acetylsalicylic acid, anticoagulants (direct and indirect action), as well as thiazide diuretics, tricyclic antidepressants, anticonvulsants, gentamicin. Single cases of bleeding are possible in patients simultaneously taking medicines that reduce blood clotting, a causal connection of these bleedings with taking medications of ginkgo biloba is not confirmed.

In combination with hypotensive drugs the potentiation of antihypertensive effect is possible.

It is not recommended to use ginkgo biloba preparations with efavirenz as there is a possibility to decrease its concentration in plasma due to induction of CYP3A4 cytochrome isoenzyme under the influence of ginkgo biloba extract.

Study of interaction with thalinolol shows that ginkgo biloba extract may inhibit intestinal P-glycoproteins. This may increase the effect of intestinal P-glycoprotein-sensitive drugs such as dabigatran, so caution should be exercised when using them concomitantly.

Special Instructions

Do not exceed the recommended doses of the drug.

In case of hypersensitivity reactions the drug should be discontinued. Before surgical intervention it is necessary to inform the doctor about the use of the drug.

In case of frequent feelings of dizziness and tinnitus it is necessary to consult a doctor. In case of sudden deterioration or loss of hearing it is necessary to consult a physician immediately.

Patients with bleeding (hemorrhagic diathesis) and patients receiving anticoagulant therapy should consult a physician before starting therapy with the drug.

It is not recommended to take the drug together with ethanol.

Against the background of the drug in patients suffering from epilepsy, epileptic seizures may occur.

Influence on ability to drive vehicles and mechanisms
. During the use of the drug care should be taken when performing potentially hazardous activities requiring high concentration and rapid psychomotor reactions (including driving vehicles, operating moving mechanisms), and in case of adverse reactions, including dizziness, one should refrain from driving vehicles.

Synopsis

Solid gelatin capsules from light brown to dark brown in color, size 1. The contents of the capsules – powder or partially crumpled powder from yellow to light brown in color with whitish and dark blotches.
.

Contraindications

Hypersensitivity to the drug components, decreased blood clotting, acute erosive gastritis, acute gastric and duodenal ulcer, acute cerebral circulation disorders, acute myocardial infarction, pregnancy and breast-feeding, children under 18 years (due to insufficient clinical data).

With caution
Use in patients with epilepsy; with arterial hypotension.

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):

In each group, adverse effects are presented in decreasing order of severity.

Digestive system:
very rare: nausea, vomiting, diarrhea.

Nervous system disorders:
very rarely: headache, dizziness, insomnia.

Allergic reactions:
very rarely: hyperemia, edema, itching.

On the hemostatic system:
very rarely: decreased blood clotting. There have been reports of bleeding during prolonged use of Ginkgo bilobate in patients who simultaneously took agents that reduce blood clotting.

Sensory organs:
frequency is unknown: hearing impairment.

In case of any adverse events the drug should be discontinued and consult a physician.

Overdose

Cases of drug overdose have not yet been registered. In case of overdose, treatment is symptomatic.

Pregnancy use

Due to the lack of sufficient clinical data, the use of the drug is contraindicated during pregnancy and breastfeeding.

Similarities

Memoplant, Bilobil, Tanakan, Ginkgo Biloba, Bilobil Forte, Bilobil Intens 120