Ginkgo Biloba (Tablets, Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

N06DX02 (Ginkgo biloba leaves)

Active Substance

Ginkgo biloba (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation improving cerebral and peripheral circulation

Pharmacotherapeutic Group

Psychoanaleptics; agents for the treatment of dementia; other agents for the treatment of dementia

Pharmacological Action

A herbal preparation that normalizes cell metabolism, the rheological properties of blood, and microcirculation.

It improves cerebral circulation and the supply of oxygen and glucose to the brain, prevents erythrocyte aggregation, and inhibits the platelet-activating factor. It has a dose-dependent regulatory effect on the vascular system, stimulates the production of the endothelium-dependent relaxing factor, dilates small arteries, increases venous tone, thereby regulating vascular blood filling. It reduces vascular wall permeability (anti-edema effect – both at the brain level and peripherally).

It has an antithrombotic action (by stabilizing platelet and erythrocyte membranes, influencing Pg synthesis, reducing the action of biologically active substances and the platelet-activating factor). It prevents the formation of free radicals and lipid peroxidation of cell membranes. It normalizes the release, reuptake, and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors. It prevents an increase in the fibrinolytic activity of blood.

It has an antihypoxic effect, 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

After oral administration of the ginkgo extract, the terpene lactones (ginkgolide A, ginkgolide B and bilobalide) have high bioavailability, which is 100% (98%) for ginkgolide A, 93% (79%) for ginkgolide B and 72% for bilobalide.

After administration of 80 mg of the extract, the C_max in plasma are: 15 ng/ml for ginkgolide A, 4 ng/ml for ginkgolide B and approximately 12 ng/ml for bilobalide. Binding to plasma proteins is 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide.

T_1/2 is 3.9 h (ginkgolide A), 7 h (ginkgolide B) and 3.2 h (bilobalide).

Indications

Dyscirculatory encephalopathy (stroke, traumatic brain injury, old age), manifested by the following symptoms

Decreased attention;
Memory impairment;
Decreased intellectual abilities;
Feeling of fear;
Sleep disorders;
Peripheral circulation and microcirculation disorders (including arteriopathy of the lower extremities);
Raynaud’s syndrome;
Neurosensory disorders (dizziness, tinnitus, hypoacusis);
Senile macular degeneration;
Diabetic retinopathy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F07	Personality and behavioral disorders due to disease, damage or dysfunction of the brain
G93.4	Unspecified encephalopathy
H35.3	Degeneration of macula and posterior pole
H36.0	Diabetic retinopathy
H81	Vestibular function disorders
H93.0	Degenerative and vascular disorders of ear
I69	Sequelae of cerebrovascular diseases
I73.0	Raynaud's syndrome
I73.1	Obliterative thromboangiitis [Buerger's disease]
I73.9	Peripheral vascular disease, unspecified (including intermittent claudication, arterial spasm)
I79.2	Peripheral angiopathy in diseases classified elsewhere (including diabetic angiopathy)
T90	Sequelae of injuries of head

ICD-11 code	Indication
4A44.8	Thromboangiitis obliterans
6E68	Secondary emotionally labile personality disorder
6E6Z	Unspecified secondary mental or behavioral syndromes
8B25.Z	Sequelae of cerebrovascular disease, unspecified
8E47	Encephalopathy, not elsewhere classified
8E4A.0	Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord
8E63	Post-cardiopulmonary bypass encephalopathy
9B71.0Z	Diabetic retinopathy, unspecified
9B78.3Z	Degeneration of macula or posterior pole, unspecified
AB34.Z	Unspecified vestibular function disorders
AB71	Degenerative or vascular disorders of the ear
BD42.0	Raynaud's disease
BD42.1	Raynaud's syndrome
BD42.Z	Raynaud's phenomenon, unspecified
BD4Z	Chronic obliterative arterial diseases, unspecified
BD53.Y	Other specified secondary involvement of arteries and arterioles
NA0Z	Head injury, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally, 40 mg 3 times/day.

Capsules

Orally, with a small amount of water, regardless of meals.

Unless otherwise prescribed by a doctor, the following recommendations for taking the drug should be followed.

For the symptomatic treatment of cerebral circulation disorders

Dosage 40 mg: 1-2 capsules 3 times/day.

Dosage 80 mg: 1 capsule 2 times/day.

The duration of the treatment course is at least 8 weeks.

For peripheral circulation disorders:

Dosage 40 mg: 1 capsule 3 times/day or 2 capsules 2 times/day.

Dosage 80 mg: 1 capsule 2 times/day.

The duration of the treatment course is at least 6 weeks.

For vascular or involutional pathology:

Dosage 40 mg: 1 capsule 3 times/day or 2 capsules 2 times/day.

Dosage 80 mg: 1 capsule 2 times/day.

The duration of the treatment course is 6-8 weeks.

If a dose of the drug was missed or an insufficient amount was taken, the subsequent dose should be taken as indicated in the instructions, without any changes.

Adverse Reactions

Allergic reactions: redness, skin swelling, itching.

From the digestive system: nausea, vomiting, diarrhea.

From the nervous system: headache, dizziness.

Other: hearing impairment, decreased blood clotting.

If any adverse events occur, the drug should be discontinued and a doctor should be consulted.

Contraindications

Hypersensitivity;
Hypocoagulation;
Acute cerebrovascular accidents;
Acute myocardial infarction;
Gastric and duodenal ulcer;
Erosive gastritis;
Arterial hypotension;
Pregnancy;
Lactation period;
Age under 18 years;
Sucrase-isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Use in Pregnancy and Lactation

It is not recommended to use the drug during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for children and adolescents under 18 years of age.

Special Precautions

Improvement in condition is manifested 1 month after the start of treatment.

If dizziness and tinnitus occur frequently, the patient should consult a doctor. In case of sudden hearing deterioration or hearing loss, it is necessary to consult a doctor immediately.

Effect on the ability to drive vehicles and mechanisms

Given the possibility of developing side effects from the central nervous system, caution should be exercised when driving vehicles and other technical devices requiring increased concentration and speed of psychomotor reactions.

Drug Interactions

It is not recommended for use in patients constantly taking acetylsalicylic acid, anticoagulants (direct and indirect action), as well as drugs that reduce blood clotting.

Isolated cases of bleeding are possible in patients simultaneously taking agents that reduce blood clotting; a causal relationship of these bleedings with the intake of Ginkgo biloba preparations has not been confirmed.

When used with antihypertensive agents, potentiation of the antihypertensive effect is possible.

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

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Ginkgo Biloba [Apteki 36,6, CJS (Russia)]
Film-coated tablets, 40 mg: 20 or 30 pcs.

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Veropharm, JSC (Russia)

Dosage Form

Ginkgo biloba

Film-coated tablets, 40 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Dry extract of Ginkgo biloba leaves (standardized for the content of ginkgo flavonoglycosides and terpene lactones)	40 mg

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – dark glass jars (1) – cardboard packs.

Ginkgo Biloba [Atoll LLC (Russia)]
Film-coated tablets, 40 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.
Film-coated tablets, 60 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.
Film-coated tablets, 80 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.
Film-coated tablets, 120 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Ginkgo biloba	Film-coated tablets, 40 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.
		Film-coated tablets, 60 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.
		Film-coated tablets, 80 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.
		Film-coated tablets, 120 mg: 10, 20, 30, 60, 90, 180, or 270 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from pink to pink with a red tint, round, biconvex; on the cross-section of the tablet, the following are visible: a light brown core with inclusions from white to dark brown and a film coating; the cut tablets have a faint characteristic odor.

	1 caps.
Ginkgo biloba leaf dry extract*	40 mg

* Ginkgo biloba leaf dry extract is a substance containing not less than 24% of the sum of flavone glycosides; not less than 2.8% of ginkgolides A, B and C and not less than 2.6% of bilobalide, ((10-60):1, extractant – aqueous acetone (60-70%))

Excipients: microcrystalline cellulose (MCC-102) – 76 mg, lactose monohydrate – 51.2 mg, corn starch – 9.5 mg, croscarmellose sodium – 9.5 mg, colloidal silicon dioxide – 1.9 mg, magnesium stearate – 1.9 mg.

Coating composition: hypromellose – 3.6 mg, titanium dioxide – 1.32 mg, macrogol-4000 – 0.9 mg, iron oxide red dye – 0.18 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (6) – cardboard packs.
30 pcs. – blister packs (9) – cardboard packs.

Film-coated tablets from yellow to yellow with a light brown tint, round, biconvex; on the cross-section of the tablet, the following are visible: a light brown core with inclusions from white to dark brown and a film coating; the cut tablets have a faint characteristic odor.

	1 caps.
Ginkgo biloba leaf dry extract*	60 mg

Excipients: microcrystalline cellulose (MCC-102) – 114 mg, lactose monohydrate – 76.8 mg, corn starch – 14.25 mg, croscarmellose sodium – 14.25 mg, colloidal silicon dioxide – 2.85 mg, magnesium stearate – 2.85 mg.

Coating composition: hypromellose – 5.4 mg, titanium dioxide – 1.98 mg, macrogol-4000 – 1.35 mg, iron oxide yellow dye – 0.27 mg.

	1 caps.
Ginkgo biloba leaf dry extract*	80 mg

Excipients: microcrystalline cellulose (MCC-102) – 152 mg, lactose monohydrate – 102.4 mg, corn starch – 19 mg, croscarmellose sodium – 19 mg, colloidal silicon dioxide – 3.8 mg, magnesium stearate – 3.8 mg.

Coating composition: hypromellose – 7.2 mg, titanium dioxide – 2.64 mg, macrogol-4000 – 1.8 mg, iron oxide red dye – 0.36 mg.

	1 caps.
Ginkgo biloba leaf dry extract*	120 mg

Excipients: microcrystalline cellulose (MCC-102) – 228 mg, lactose monohydrate – 153.6 mg, corn starch – 28.5 mg, croscarmellose sodium – 28.5 mg, colloidal silicon dioxide – 5.7 mg, magnesium stearate – 5.7 mg.

Coating composition: hypromellose – 10.8 mg, titanium dioxide – 3.96 mg, macrogol-4000 – 2.7 mg, iron oxide yellow dye – 0.54 mg.

Ginkgo Biloba [Vertex, JSC (Russia)]
Capsules 40 mg: 20, 30, 40, 60 or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Ginkgo biloba

Capsules 40 mg: 20, 30, 40, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size #3, yellow in color; the capsule contents are a powder or compacted mass of a yellowish-brown color with brown and white particles, which disintegrates when pressed.

	1 caps.
Dry extract of Ginkgo biloba leaves	40 mg,
Containing
Flavonoid glycosides	Not less than 22%
Terpene lactones	Not less than 5.4%

Excipients: lactose monohydrate – 95 mg, croscarmellose sodium – 7.5 mg, colloidal silicon dioxide – 3 mg, talc – 3 mg, magnesium stearate – 1.5 mg.

Composition of the hard gelatin capsules titanium dioxide – 2%, yellow iron oxide dye (iron oxide) – 0.6286%, gelatin – up to 100%.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.

Ginkgo Biloba [Vertex, JSC (Russia)]
Capsules 80 mg: 20, 30, 40, 60 or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Ginkgo biloba

Capsules 80 mg: 20, 30, 40, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size #0, yellow in color; the capsule contents are a powder or compacted mass of a yellowish-brown color with brown and white particles, which disintegrates when pressed.