Tanakan

INSTRUCTION for medical use of the medicinal product TANAKAN® (TANAKAN®)

Composition:

Active substance: Ginkgo biloba

One tablet contains Ginkgo (Ginkgo biloba L.) (purified, quantified dry leaf extract) 40 mg, corresponding to:

• 8.8 – 10.8 mg flavonoids, expressed as flavonoid glycosides;
• 1.1 – 1.4 mg ginkgolides A, B and C;
• 1.0 – 1.3 mg bilobalide;

Primary extraction solvent: acetone 60% (m/m);

Ratio of active substance/extract: 35 – 67:1 per coated tablet;

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silicon dioxide, talc, magnesium stearate;

Tablet coating composition: macrogol 400, macrogol 6000, hypromellose (E 464), titanium dioxide (E 171), iron oxide red (E 172).

Pharmaceutical form. Coated tablets.

Main physico-chemical properties: round, biconvex coated tablets of dark red color, with a light brown core and characteristic odor when broken.

Pharmacotherapeutic group.

Agents used in nervous system disorders. Other agents for the treatment of dementia. ATC code N06D X02.

Pharmacological Properties.

Pharmacodynamics

The mechanism of action is unknown.

Pharmacological data indicate increased alertness in elderly patients based on electroencephalography findings, reduced blood viscosity and increased vascularization of certain areas of the brain in healthy men (aged 60–70 years), as well as decreased platelet aggregation. In addition, a vasodilatory effect on forearm blood vessels has been demonstrated, leading to an increase in circulating blood volume.

Pharmacokinetics

After oral administration of 120 mg of Ginkgo extract (in solution form), the mean bioavailability of terpene lactones was 80% for ginkgolide A, 88% for ginkgolide B, and 79% for bilobalide. Following administration of the medicinal product in tablet form, maximum plasma concentrations of terpene lactones reached 16–22 ng/mL for ginkgolide A, 8–10 ng/mL for ginkgolide B, and 27–54 ng/mL for bilobalide. The corresponding elimination half-life of ginkgolides A and B and bilobalide was 3–4, 4–6, and 2–3 hours, respectively. Plasma concentrations after administration of a solution containing 120 mg of Ginkgo extract were 25–33 ng/mL for ginkgolide A, 9–17 ng/mL for ginkgolide B, and 19–35 ng/mL for bilobalide. The elimination half-life of ginkgolide A was 5 hours, ginkgolide B — 9–11 hours, and bilobalide — 3–4 hours.

Clinical characteristics.

Indications.

The herbal medicinal product is indicated for symptomatic treatment of cognitive disorders in elderly patients, excluding patients with confirmed dementia, Parkinson's disease, iatrogenic cognitive disorders, or those caused by depression or metabolic disturbances.

TANAKAN® is indicated for use in adults and elderly patients.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients listed in the section "Composition".

Pregnancy (see section "Use during pregnancy or lactation").

Interaction with other medicinal products and other forms of interaction.

Concomitant use of this medicinal product with anticoagulants (phenprocoumon, warfarin) or antiplatelet agents (clopidogrel, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs) may affect the action of these agents.

In conducted studies with warfarin, no interaction between warfarin and Ginkgo-based medicinal products was detected; however, appropriate monitoring is recommended when starting or discontinuing concomitant treatment with warfarin and Ginkgo-based medicinal products, or when changing the medicinal product.

An interaction study with talinolol indicates a potential ability of Ginkgo to inhibit P-glycoproteins in the small intestine, which may increase exposure to medicinal products sensitive to P-glycoproteins in the gastrointestinal tract, such as dabigatran etexilate. Ginkgo should be used with caution when taken concomitantly with dabigatran.

Interaction studies have shown that the Cmax of nifedipine may increase by up to 100% during Ginkgo administration in some patients, who experienced dizziness and increased flushing.

Concomitant use of Ginkgo-containing medicinal products with efavirenz is not recommended due to the potential decrease in plasma concentrations of efavirenz resulting from induction of cytochrome CYP3A4 (see section "Special precautions for use").

Special precautions for use

The medicinal product contains lactose and therefore is not recommended for patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption (rare inherited disorders).

Patients with a tendency to bleeding (haemorrhagic tendency) who are receiving concomitant therapy with anticoagulants or antiplatelet medicinal products should consult their physician prior to using this medicinal product.

Medicinal products containing Ginkgo may increase the tendency to bleeding. As a precautionary measure, treatment with this medicinal product should be discontinued 3–4 days prior to surgical intervention.

In patients with epilepsy, the possibility of additional seizures during treatment with Ginkgo-containing medicinal products cannot be excluded.

Concomitant use of Ginkgo-containing medicinal products with efavirenz is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

Use during pregnancy or breastfeeding

Pregnancy

Ginkgo extract may reduce platelet aggregation ability, potentially increasing the risk of bleeding. Animal studies are insufficient to draw conclusions regarding reproductive toxicity.

The medicinal product is contraindicated during pregnancy.

Lactation

There are no data on whether Ginkgo metabolites are excreted in human breast milk. Risk to newborns and infants cannot be excluded.

Due to the lack of sufficient data, use of this medicinal product during breastfeeding is not recommended.

Fertility

No specific studies have been conducted on the effect of Ginkgo on human fertility. However, certain effects have been observed in female mice.

Ability to influence reaction speed when driving or operating machinery

No studies on the effect on the ability to drive or operate machinery have been conducted.

Dosage and method of administration.

Dosage

Three tablets per day, taken in divided doses throughout the day.

Method of administration

Orally.

Take the tablets during a meal, with half a glass of water.

Children.

Do not use in children.

Overdose.

There is no information available regarding overdose of this medicinal product.

Adverse reactions.

Summary of safety profile

In a 5-year clinical trial evaluating the efficacy and safety of the medicinal product TANAKAN® at a dose of 120 mg twice daily in patients aged over 70 years (GuidAge study 2-31-00240-011), the most commonly reported adverse reactions (≥ 5%) were abdominal pain, diarrhea, and dizziness.

Table of adverse reactions

Table 1 presents data on adverse reactions reported for the medicinal product TANAKAN® during clinical trials and the post-marketing period. The frequency of adverse reactions is categorized as follows: common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000).

The frequency is based on the number of adverse reactions reported during the 5-year clinical study assessing the efficacy and safety of TANAKAN® at a dose of 120 mg twice daily in patients aged over 70 years (GuidAge study 2-31-00240-011).

Table 1

Description of adverse reaction selection

Table 2 presents the comparative frequency of common adverse events identified in a 5-year clinical study evaluating the efficacy and safety of the medicinal product TANAKAN® at a dose of 120 mg twice daily in patients aged over 70 years (GuidAge study 2-31-00240-011):

Table 2

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after a medicinal product has been authorised is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions via the national reporting system.

Shelf life.

36 months.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of the reach and sight of children.

Packaging.

15 tablets in a blister, 2 or 6 blisters in a cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

BOUHIER IPSEN INDUSTRIE.

Manufacturer’s address.

Rue Hte Verron 28100 Dreux, France.

Marketing Authorisation Holder.

IPSEN CONSUMER HEALTHCARE,

Société par Actions Simplifiée.

Address of the Marketing Authorisation Holder.

65 Quai Georges Gorse 92100 Boulogne-Billancourt, France.