GINKGO BILOBA-ASTRAFARM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GINKGO BILOBA-ASTRAFARM

Composition:

Active ingredient:

1 capsule contains 40 mg or 80 mg of dry extract of ginkgo biloba (Ginkgo biloba L.) (ratio of raw material to extract obtained 50:1; extraction solvent ethanol 60%);

Excipients: lactose monohydrate; magnesium stearate;

Capsule shell composition: gelatin, titanium dioxide, azorubine (E 122), Ponceau 4R (E 124).

Dosage form. Capsules.

Main physicochemical properties: hard gelatin capsules size №1, cylindrical in shape with hemispherical ends; body – white, cap – red. The capsule contents – yellowish-brown powder with a specific odour.

Pharmacotherapeutic group.

Drugs used in dementia. ATC code N06D X02.

Pharmacological properties.

Pharmacodynamics.

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

Active substance – standardized extract of Ginkgo biloba: 24 % heterosides and 6 % di- and sesquiterpenes (ginkgolides A, B, and C and bilobalide).

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

Pharmacokinetics.

The bioavailability of ginkgolides A and B and bilobalide after oral administration is 80–90 %. Maximum concentration is reached within 1–2 hours; elimination half-lives range from approximately 4 hours (bilobalide, ginkgolide A) to 10 hours (ginkgolide B).

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

Clinical characteristics.

Indications.

• Symptomatic treatment of cognitive disorders in elderly patients, except for patients with confirmed dementia, Parkinson's disease, iatrogenic cognitive disorders, or those arising as a complication of depression, vascular disorders, or metabolic disorders.
• Concomitant treatment of vertigo of vestibular origin together with vestibular rehabilitation.
• Symptomatic treatment of tinnitus.

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interactions.

Results of interaction studies with Ginkgo biloba (EGb 761) have demonstrated potentiation or inhibition of cytochrome P450 isoenzymes. The plasma concentration level of midazolam changed after concomitant administration of Ginkgo biloba (EGb 761), suggesting a possible interaction via CYP3A4. Therefore, medicinal products that are primarily metabolized through CYP3A4 and have a narrow therapeutic index should be used with caution.

Special precautions for use.

Patients who are concurrently taking drugs metabolized by cytochrome P450 3A4 should be carefully monitored. There is no evidence of abuse potential with Ginkgo biloba (EGb 761). Based on the pharmacological profile of the drug, Ginkgo biloba (EGb 761) has no potential for abuse.

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

Use during pregnancy or breastfeeding.

Due to the lack of clinical data, the drug is not recommended for use during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Studies assessing the effect on reaction speed when driving or operating machinery have not been conducted. However, dizziness may impair the ability to drive or operate machinery.

Dosage and Administration.

For oral use.

Take 1 capsule three times a day during meals. Swallow with half a glass of water.

The treatment course is determined individually by a physician.

Children.

Do not use in children.

Overdose.

There is no information regarding overdose of the drug.

Adverse reactions.

Rarely observed reactions:

Gastrointestinal tract: digestive disorders, dyspepsia, diarrhea, abdominal pain, nausea, vomiting;

Immune system: hypersensitivity reactions, including angioneurotic edema, urticaria, dyspnea;

Skin: skin inflammation, redness, swelling, rashes, itching, eczema;

Nervous system: headache, dizziness, syncope (including vasovagal).

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 capsules per blister; 3 or 6 blisters per carton.

Availability category.

Over-the-counter.

Manufacturer.

ASTRAFARM LLC.

Manufacturer's address and place of business.

6 Kyivska Street, Vyshneve, Kyiv-Sviatoshyn district, Kyiv region, 08132, Ukraine.