Tanakan^® (Tablets, Solution) Instructions for Use

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

It increases the body’s resistance to hypoxia, especially of brain tissue. It improves cerebral and peripheral blood supply 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 lipid peroxidation of cell membranes.

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

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

C_max is 16-22 ng/ml for ginkgolide A, 8-10 ng/ml for ginkgolide B and 27-54 ng/ml for bilobalide after oral administration in tablet form.

Distribution

Plasma protein binding is: 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide.

Elimination

T_1/2 is 3.9 hours (ginkgolide A), 4-6 hours (ginkgolide B) and 2-3 hours (bilobalide).

Indications

• Symptomatic treatment of cognitive impairment in adults;
• As part of the complex therapy of vestibular vertigo as an auxiliary treatment in addition to vestibular rehabilitation;
• Symptomatic treatment of tinnitus (ringing or noise in the ears).

ICD codes

Dosage Regimen

Solution

It is prescribed to adults orally at a dose of 40 mg (1 tablet or 1 ml of oral solution) 3 times/day with meals.

The tablet should be taken with half a glass of water.

The oral solution should be dissolved in half a glass of water. When taking the drug in the form of an oral solution, the supplied dropper-dispenser should be used (1 dose = 1 ml of solution).

The minimum course of treatment is at least 3 months. Increasing the duration and conducting repeated courses of treatment is possible on the recommendation of a doctor.

Tablets

It is prescribed orally, with meals, the tablet should be taken with half a glass of water.

For adultsfor the symptomatic treatment of cognitive impairment, vestibular vertigo and symptomatic treatment of tinnitus – 3 tablets/day, distributed throughout the day.

The course of treatment is at least 3 months. Increasing the duration and conducting repeated courses of treatment is possible on the recommendation of a doctor.

Adverse Reactions

Clinical studies have demonstrated a favorable safety profile: the frequency of adverse reactions (AR) in the treatment group did not statistically exceed the frequency of AR in the placebo group.

The most frequent adverse reactions (>5%) during a five-year clinical study evaluating the efficacy and safety of taking 120 mg of Tanakan^® 2 times/day in patients over 70 years of age (the GuidAge study) were abdominal pain, diarrhea and dizziness.

Table 1 contains a list of ARs that were observed during clinical studies and during post-registration use of Tanakan^®. ARs are presented with the following frequency: common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000). The frequency of ARs is based on data obtained during the five-year GuidAge clinical study.

Table 1.

Contraindications

• Hypersensitivity to the components of the drug;
• Decreased blood clotting;
• Erosive gastritis in the acute phase;
• Peptic ulcer of the stomach and duodenum in the acute phase;
• Acute cerebrovascular accidents;
• Acute myocardial infarction;
• Lactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome;
• Age under 18 years (efficacy and safety have not been established).

With caution

• When taking EGb 761^® concomitantly with drugs metabolized by the CYP3A4 isoenzyme and having a low therapeutic index;
• In patients with epilepsy.

Use in Pregnancy and Lactation

Pregnancy

There are only limited data on the use of Tanakan^® in pregnant women. Experimental animal studies did not indicate any direct or indirect adverse effects regarding reproductive toxicity.

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

Breastfeeding period

It is not known whether Tanakan^® penetrates into the milk of animals or humans.

The decision to either discontinue breastfeeding or discontinue/abstain from therapy with the drug should be made taking into account the benefit of breastfeeding for the newborn/infant and the benefit of therapy for the woman.

Pediatric Use

The use of the drug in children and adolescents under 18 years of age is contraindicated (efficacy and safety have not been established).

Special Precautions

Do not exceed the recommended doses of the drug. Long-term use of the drug in courses is possible.

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

Before surgery, it is necessary to inform the doctor about the use of the drug.

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

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

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

Caution is recommended when taking drugs metabolized by cytochrome P450, including CYP3A4, concomitantly (see the “Drug Interactions” section).

Tanakan^® contains lactose. Patients with hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take the drug in this dosage form.

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

Effect on the ability to drive vehicles and mechanisms

No studies on the effect on the ability to drive vehicles or mechanisms have been conducted.

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), and if adverse reactions develop, including dizziness, it is necessary to refrain from driving vehicles.

Overdose

There is no significant experience with drug overdose. In case of overdose, treatment is symptomatic.

Drug Interactions

Caution should be exercised when using the drug in patients constantly taking acetylsalicylic acid, anticoagulants (direct and indirect action), as well as thiazide diuretics, tricyclic antidepressants, anticonvulsants, gentamicin.

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

Concomitant use of Ginkgo biloba preparations with efavirenz is not recommended, as a decrease in its plasma concentration is possible due to induction of cytochrome CYP3A4 under the influence of Ginkgo biloba extract. An interaction study with talinolol shows that Ginkgo biloba extract may inhibit intestinal P-glycoproteins. This may increase the exposure of P-glycoprotein-sensitive drugs in the intestine, such as dabigatran, and therefore 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

The shelf life is 3 years. Do not use after the expiration date printed on the package.

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.