Ginkgoum^® (Capsules) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

Evalar, CJSC (Russia)

ATC Code

N06DX02 (Ginkgo biloba leaves)

Active Substance

Ginkgo biloba (BP British Pharmacopoeia)

Dosage Forms

	Ginkgoum®	Capsules 40 mg: 30, 60, or 90 pcs.
		Capsules 80 mg: 60 pcs.
		Capsules 120 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, from light brown to dark brown in color; the capsule contents are a powder or partially clumped powder from yellow to light brown in color with whitish and dark specks.

Excipients: microcrystalline cellulose, calcium stearate.

Capsule composition: capsule body components iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin; capsule cap components iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin.

15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.

Capsules hard gelatin, size No. 0, brown in color; the capsule contents are a powder or partially clumped powder from yellow to light brown in color with whitish and dark specks.

Excipients: microcrystalline cellulose, calcium stearate, colloidal silicon dioxide.

Capsule composition titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), gelatin.

15 pcs. – blister packs (4) – cardboard packs.

Capsules hard gelatin, size No. 0, brown in color; the capsule contents are a powder or partially clumped powder from yellow to light brown in color with whitish and dark specks.

Excipients: microcrystalline cellulose, calcium stearate, colloidal silicon dioxide.

Capsule composition titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), gelatin.

15 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Angioprotector

Pharmacotherapeutic Group

Angioprotective agent of plant origin

Pharmacological Action

It increases the body’s resistance to hypoxia, especially of brain tissue, inhibits the development of traumatic or toxic brain edema, improves cerebral and peripheral circulation, and improves blood rheology.

It has a dose-dependent regulatory effect on the vascular wall, dilates small arteries, and increases venous tone.

It prevents the formation of free radicals and the peroxidation of cell membrane lipids.

It normalizes the release, reuptake, and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors.

It 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

Absorption

The bioavailability of terpene lactones (ginkgolide A, ginkgolide B and bilobalide) after oral administration is 100% (98%) for ginkgolide A, 93% (79%) for ginkgolide B and 72% for bilobalide.

C_max in blood plasma are: 15 ng/ml for ginkgolide A, 4 ng/ml for ginkgolide B and approximately 12 ng/ml for bilobalide.

Distribution

Binding to blood plasma proteins is: 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide.

Elimination

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

Indications

For adults

• Symptomatic treatment of cognitive impairments (memory impairment, decreased concentration and intellectual abilities);
• Adjunctive treatment of vestibular vertigo;
• Symptomatic treatment of tinnitus (ringing or noise in the ears).

ICD codes

Dosage Regimen

Orally. The capsules should be swallowed whole with a small amount of water, regardless of meal time.

The drug is intended for adults.

Symptomatic treatment of cognitive impairments (memory impairment, decreased concentration and intellectual abilities)

Capsules 40 mg – take 1-2 capsules 3 times/day.

Capsules 80 mg – 1 capsule 2-3 times/day.

Capsules 120 mg – 1 capsule 1-2 times/day

Complex therapy of vestibular vertigo and symptomatic treatment of tinnitus (ringing or noise in the ears)

Capsules 40 mg – 3 capsules/day, distributed throughout the day.

Capsules 80 mg – 1 capsule 2 times/day (morning and evening).

Capsules 120 mg – daily dose 120 mg.

The first signs of improvement usually appear after 1 month. The course of treatment is at least 3 months (especially for elderly patients). A repeat course is possible after consultation with a doctor.

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

For a twice-daily regimen, take in the morning and evening; for a once-daily regimen, preferably in the morning.

Children

The drug Ginkgoum^® is contraindicated in children under 18 years of age (see section “Contraindications”).

Adverse Reactions

Classification of the frequency of side effects according to WHO recommendations: very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (from <1/10000, frequency unknown (cannot be estimated from the available data). In each group, adverse effects are presented in order of decreasing severity.

Blood and lymphatic system disorders very rare – decreased blood clotting. There are reports of bleeding (eye hemorrhage; nasal, cerebral, gastrointestinal bleeding) with long-term use of Ginkgo biloba leaf extract preparations in patients simultaneously taking blood-thinning agents.

Immune system disorders frequency unknown – hypersensitivity reactions, incl. anaphylactic shock.

Nervous system disorders very rare – headache, dizziness, insomnia.

Ear and labyrinth disorders frequency unknown – hearing impairment.

Gastrointestinal disorders very rare – nausea, vomiting, diarrhea, abdominal pain.

Skin and subcutaneous tissue disorders very rare – allergic skin reactions (hyperemia, swelling, skin itching, skin rash).

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Decreased blood clotting (see section “Special Precautions”);
• Erosive gastritis;
• Peptic ulcer of the stomach and duodenum in the acute phase;
• Acute cerebrovascular accidents;
• Acute myocardial infarction;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years (efficacy and safety have not been studied).

With caution

Use in patients with epilepsy; arterial hypotension.

Use in Pregnancy and Lactation

Pregnancy

The use of the drug during pregnancy is contraindicated (due to the lack of sufficient clinical data).

Breastfeeding

The use of the drug during breastfeeding is contraindicated (due to the lack of sufficient clinical data). If it is necessary to prescribe the drug during breastfeeding, the issue of its discontinuation should be decided.

Fertility

No data available

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

The recommended doses of the drug should not be exceeded.

If a hypersensitivity reaction develops, the use of the drug must be discontinued.

Preparations containing Ginkgo biloba leaf extract may increase the tendency to bleed.

As a precaution, the use of the drug Ginkgoum^® should be discontinued 3-4 days before surgery.

In case of frequently occurring sensations of dizziness and tinnitus, it is necessary to consult a doctor. In case of sudden deterioration or loss of hearing, you should immediately consult a doctor.

Patients with decreased blood clotting, pathologically increased tendency to bleeding (hemorrhagic diathesis) and patients with concomitant anticoagulant and antiplatelet therapy should use the drug Ginkgoum^® only under medical supervision.

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

During the use of the drug, epileptic seizures may occur in patients suffering from epilepsy.

Effect on the ability to drive vehicles and mechanisms

During the period of taking the drug, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Drug Interactions

Concomitant use of the drug Ginkgoum^® with anticoagulants (including phenprocoumon, warfarin) or antiplatelet agents (including clopidogrel, acetylsalicylic acid), as well as with NSAIDs, may affect the action of these drugs, so their simultaneous use is not recommended.

Concomitant use with thiazide diuretics, tricyclic antidepressants, anticonvulsants, and gentamicin is also not recommended.

Isolated cases of bleeding are possible in patients simultaneously taking drugs that reduce blood clotting. A causal relationship of these bleedings with the use of preparations containing Ginkgo biloba leaf extract has not been confirmed. If concomitant use with warfarin is necessary, adequate monitoring of blood coagulation parameters is recommended at the beginning of treatment with Ginkgoum^®, when changing the dose, when completing therapy with Ginkgoum^®, and when switching to another preparation containing Ginkgo biloba leaf extract.

When taken concomitantly with antihypertensive agents, potentiation of the hypotensive effect is possible. One interaction study showed that Ginkgo biloba leaf extract may increase the maximum plasma concentration of nifedipine. Some study participants showed an increase in maximum concentration of up to 100%, leading to dizziness and increased severity of hot flashes.

Concomitant use with efavirenz is not recommended, as a decrease in its plasma concentration is possible due to induction of the CYP3A4 isoenzyme under the influence of Ginkgo biloba leaf extract.

An interaction study with talinolol shows that Ginkgo biloba leaf extract may inhibit intestinal P-glycoproteins. This may increase the exposure of P-glycoprotein-sensitive drugs in the intestine, such as dabigatran, so caution should be exercised when using them concomitantly.

Storage Conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.