Composition
Composition (per capsule):
active component: Â
double-lobed ginkgo extract dry, standardized with flavonol glycosides content of 22.0-27.0% and terpene lactones content of 5.0-12.0% – 80.0 mg
. auxiliary components:  cellulose microcrystalline – 184,6 mg, calcium stearate – 2.7 mg, silicon dioxide colloid – 2.7 mg;
capsules hard gelatin (capsules: titanium dioxide E 171 – 1,00%, iron oxide red E 172 – 0,50%, iron oxide black E 172 – 0,39%, iron oxide yellow E 172 – 0,27%, gelatin – up to 100%).
Pharmacological action
Pharmacotherapy group
Angioprotective agent of plant origin
ATX code: N06DX02
Pharmacological properties
Pharmacodynamics
Increases the body’s resistance to hypoxia, especially in brain tissues. Inhibits the development of traumatic or toxic brain 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, and increases vein tone. Prevents the formation of free radicals and lipid peroxidation of cell membranes.
Normalizes the release, reabsorption, and catabolism of neurotransmitters (norepinephrine, dopamine, and acetylcholine) and their ability to bind to receptors. Improves metabolism in organs and tissues, promotes the accumulation of macroergs in cells, increases the utilization of oxygen and glucose, and normalizes mediator processes in the central nervous system.
Pharmacokinetics
Suction
After oral use, the bioavailability of 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 use. Binding to plasma proteins is 43% for ginkgolide A,47% for ginkgolide B, and 67% for bilobalide.
Deduction
The elimination 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 impairment in adults (memory impairment, decreased concentration and intellectual abilities).
As part of the complex therapy of vertigo of vestibular origin as an auxiliary treatment in addition to vestibular rehabilitation.
Symptomatic treatment of tinnitus (ringing or tinnitus).
Use during pregnancy and lactation
Due to the lack of sufficient clinical data, the use of the drug is contraindicated during pregnancy and lactation.
Contraindications
Hypersensitivity to the components of the drug, reduced blood clotting, erosive gastritis, peptic ulcer of the stomach and duodenum in the acute stage, acute cerebrovascular disorders, acute myocardial infarction, pregnancy and lactation, children under 18 years of age (due to the lack of sufficient 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):
very common |
≥ 1/10 |
common |
≥ 1/100 to <1/10 |
uncommon |
≥ 1/1000 to <1/100 |
rare |
≥ 1/10000 to <1/1000 |
very rare |
< 1/10000 |
frequency unknown |
cannot be estimated based on available data. |
In each group, undesirable effects are presented in decreasing order of severity.
From the digestive system:
very rare: nausea, vomiting, diarrhea.
Nervous system disorders:
very rare: headache, dizziness, insomnia.
Allergic reactions:
very rare: hyperemia, edema, itching of the skin.
From the side of the hemostatic system:
very rare: decreased blood clotting. There have been reports of long-term use of Ginkgo bilabial hemorrhage in patients who simultaneously took drugs that reduce blood clotting.
From the side of the senses:
frequency unknown: hearing loss.
In case of any adverse events, the drug should be discontinued and consult your doctor.
Interaction
It is not recommended to use the drug in patients who are constantly taking acetylsalicylic acid, anticoagulants (direct and indirect action), as well as thiazide diuretics, tricyclic antidepressants, anticonvulsants, gentamicin. There may be isolated cases of bleeding in patients who are simultaneously taking medications that reduce blood clotting, the causal relationship of these bleeds with the use of ginkgo bilobate preparations is not confirmed.
When used with antihypertensive agents, the antihypertensive effect may be potentiated.
Concomitant use of ginkgo bilabialis with efavirenz is not recommended, as it is possible to reduce its concentration in blood plasma due to the induction of the CYP3A4 isoenzyme under the influence of ginkgo bilabialis extract.
A study of interaction with talinolol shows that ginkgo bilobate extract can inhibit intestinal P-glycoproteins. This may increase the exposure of P-glycoprotein-sensitive drugs in the gut, such as dabigatran, and caution should be exercised when using them simultaneously.
How to take, course of use and dosage
Inside. Capsules should be swallowed whole, washed down with a small amount of water, regardless of the time of meal.
Symptomatic treatment of cognitive impairment in adults (memory loss, decreased concentration and intellectual abilities)Â take 1 capsule 2-3 times a day.
Complex therapy of vertigo of vestibular origin and symptomatic treatment of tinnitus (ringing or tinnitus)Â for adults, take 1 capsule 2 times daily (morning and evening).
The first signs of improvement usually appear after 1 month.
The course of treatment is not less than 3 months (especially for elderly patients). A second course is possible after consulting a doctor.
If the drug was missed or an insufficient amount of it was taken, its subsequent intake should be carried out as indicated in these instructions without any changes.
Overdose
No cases of overdose of the drug have been reported so far. In case of overdose, treatment is symptomatic.
Special instructions
Do not exceed the recommended dose of the drug.
If a hypersensitivity reaction develops, the drug should be discontinued. Before surgery, it is necessary to inform the doctor about the use of the drug.
If you often experience dizziness and tinnitus, you should consult a doctor. In case of sudden deterioration or loss of hearing, you should immediately consult a doctor.
Patients with bleeding disorders (hemorrhagic diathesis) and patients receiving anticoagulant therapy should consult a doctor before starting therapy with the drug.
It is not recommended to use the drug together with ethanol.
Against the background of the use of the drug in patients suffering from epilepsy, epileptic seizures may occur.
Influence on the ability to drive vehicles and mechanisms
During the period of taking the drug, care should be taken when performing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms), and if undesirable reactions develop, including dizziness, it is necessary to refrain from driving vehicles.
Form of production
Capsules
Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep out of reach of children.
Shelf
life is 3 years.
Active ingredient
Ginkgo Bilabial Leaf Extract
Dosage form
Capsules
Purpose
Children as prescribed by a doctor, For adults, Children over 12 years of age
Indications
Consequences of stroke, Prevention of thrombosis, Concussion and other traumatic brain injuries, Impaired cerebral circulation
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Side effects of Ginkoum, capsules 80mg, 60pcs.
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