Tanakan Film-Coated Tablets 40 mg, 90 pcs

Pharmacological Properties

Pharmacodynamics

The numerous mechanisms underlying the therapeutic effect have not yet been studied in humans.

Pharmacokinetics

The active substance is a standardized Ginkgo biloba extract containing 24% flavone glycosides and 6% di- and sesquiterpenes (ginkgolides A, B, and C, and bilobalide).

In humans, only the pharmacokinetic parameters of the terpene fractions have been described.

The oral bioavailability of ginkgolides A, B, and bilobalide is 80–90%. Maximum plasma concentration (C_max) is reached 1–2 hours after administration. The half-life (T_½) is approximately 4 hours for bilobalide and ginkgolides A, and about 10 hours for ginkgolide B.

These substances are not metabolized in the body and are almost completely excreted in the urine, with a small amount eliminated in the feces.

Indications

Symptomatic treatment of cognitive impairment in elderly patients, excluding patients with confirmed dementia, Parkinson’s disease, cognitive disorders of iatrogenic origin, or those resulting from complications of depression, vascular disorders, or metabolic disorders; adjunctive treatment of vestibular vertigo in combination with vestibular rehabilitation; symptomatic treatment of tinnitus.

Dosage and Administration

Tablets

For oral use. Take 1 tablet 3 times daily with meals, swallowing with half a glass of water.

Oral Solution

Use the dosing device: 1 dose = 1 ml of oral solution = 40 mg of pure extract.

Take 1 dose of the solution 3 times daily with meals. The dose should be diluted in half a glass of water.

The duration of treatment is determined individually by the physician.

Contraindications

Hypersensitivity to the components of the medicinal product.

Adverse Reactions

Rarely, the following reactions may occur:

• Gastrointestinal disorders: indigestion, dyspepsia, diarrhea, abdominal pain, nausea, vomiting;
• Immune system disorders: hypersensitivity reactions, including angioedema, urticaria, dyspnea;
• Skin disorders: skin inflammation, redness, swelling, rash, itching, eczema;
• Central nervous system disorders: headache, dizziness, syncope (including vasovagal).

Special Warnings and Precautions

Careful monitoring is recommended in patients concomitantly taking medicinal products metabolized by cytochrome P450 3A4. There are no data on abuse of Ginkgo biloba (EGb 761). According to its pharmacological properties, Ginkgo biloba extract (EGb 761) has no abuse potential.

The medicinal product contains lactose; therefore, patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not use this product.

Oral Solution

Warning: The alcohol content of the medicinal product is 57% (i.e., 0.45 g of alcohol per dose). The product may be harmful to patients with alcoholism. The ethanol content should be taken into account when used in pregnant or breastfeeding women, children, and high-risk patients, such as those with liver disease or epilepsy.

Use During Pregnancy and Breastfeeding

This medicinal product is intended primarily for elderly patients, in whom the risk of pregnancy is absent. Due to the lack of adequate clinical data, use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Not recommended for use in children.

Effects on Ability to Drive and Use Machines

Studies on the effects on the ability to drive vehicles or operate machinery have not been conducted. However, dizziness may impair the ability to drive or use machinery.

Drug Interactions

Clinical interaction studies with Ginkgo biloba (EGb 761) have demonstrated potentiation or inhibition of cytochrome P450 isoenzymes. Changes in midazolam plasma levels after concomitant administration of Ginkgo biloba (EGb 761) suggest a possible interaction via CYP3A4. Therefore, medicinal products that are primarily metabolized by CYP3A4 and have a narrow therapeutic index should be used with caution.

Oral Solution – Due to Alcohol Content

Because the product contains alcohol (0.45 g per dose), compatibility should be considered with:

• Medicinal products causing a disulfiram-like reaction with alcohol (fever, flushing, vomiting, tachycardia): disulfiram, cefamandole, cefoperazone, cephalosporin antibiotics, chloramphenicol, chlorpropamide, glibenclamide, glipizide, tolbutamide (antidiabetic sulfonylureas), griseofulvin (antifungal agents), 5-nitroimidazole derivatives (metronidazole, ornidazole, secnidazole, tinidazole), ketoconazole, procarbazine (cytotoxic agents);
• Central nervous system depressants.

Overdose

No information on overdose is available.

Storage Conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.