Ginkgoba®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GINKGOBA®

Composition:

Active substance: ginkgo dry extract (Folium Ginkgo) (39.6–49.5:1) (extractant – ethanol 50 %);

1 capsule contains ginkgo dry extract (Folium Ginkgo) (39.6–49.5:1) (extractant – ethanol 50 %) 40 mg, 80 mg or 120 mg;

Excipients: StarLac® (monohydrate lactose, corn starch), colloidal anhydrous silicon dioxide, talc, magnesium stearate, gelatin, titanium dioxide (E 171).

Pharmaceutical form. Capsules.

Main physicochemical characteristics: opaque hard gelatin capsules, body – white, cap – white. The contents of the capsules – yellow-brown powder.

Pharmacotherapeutic group.

Drugs used in dementia. ATC code N06D X02.

Pharmacological Properties

Pharmacodynamics

A plant-derived medicinal product that normalizes cellular metabolism, blood rheological properties, microcirculation, and mediator processes in the central nervous system.

The medicinal product increases blood flow, particularly in the microcirculation area, enhances tolerance to hypoxia—especially in brain tissues—and prevents erythrocyte aggregation and inhibits platelet-activating factor. It exerts a dose-dependent regulatory effect on the vascular system by stimulating the production of endothelium-derived relaxing factor (nitric oxide – NO), dilating small arteries, and increasing venous tone, thereby regulating vascular blood filling. It reduces vascular wall permeability (exerting anti-edematous effects both in the brain and peripherally), decreases retinal edema and corneal damage, and improves compensation of balance disorders. It has antithrombotic activity due to stabilization of platelet and erythrocyte membranes and antagonism of platelet-activating factor. It prevents the formation of free radicals and lipid peroxidation of cellular membranes. It normalizes the release, reuptake, and catabolism of neurotransmitters (noradrenaline, dopamine, acetylcholine) and their ability to bind to receptors. It improves memory and learning capacity. It exhibits anti-hypoxic effects, enhances metabolism in organs and tissues, promotes accumulation of macroergic compounds in cells, increases oxygen and glucose utilization, and provides neuroprotective action.

Pharmacokinetics

Following oral administration, the bioavailability of ginkgolides A, B, and bilobalide (the biologically active components of Ginkgo extract) is 80–90%. Maximum plasma concentration is reached within 1–2 hours after administration. Elimination half-lives are approximately 4 hours (ginkgolide A, bilobalide) and 10 hours (ginkgolide B). Ginkgolides A and B and bilobalide are not metabolized in the body and are almost completely excreted unchanged in urine, with a minor amount eliminated in feces.

Clinical characteristics.

Indications.

Symptomatic treatment of cognitive disorders in elderly patients, excluding patients with confirmed dementia, Parkinson's disease, cognitive disorders of iatrogenic origin, or those caused by depression or metabolic disorders.

Adjunctive treatment of vertigo of vestibular origin as an addition to vestibular rehabilitation.

Symptomatic treatment of tinnitus.

Contraindications.

Hypersensitivity to any component of the medicinal product. Pregnancy period.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of medicinal products based on ginkgo with coumarin anticoagulants (phenprocoumon, etc.) or antiplatelet agents (clopidogrel, acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs) may enhance the effect of these medicinal products, thereby increasing the risk of bleeding. Studies with warfarin have shown no interaction between warfarin and ginkgo preparations; however, appropriate monitoring is recommended when initiating or discontinuing concomitant use of warfarin with ginkgo-based medicinal products, as well as in case of dose adjustment or substitution of the medicinal product.

A study on the interaction with talinolol indicates a potential ability of ginkgo extract to inhibit the activity of intestinal P-glycoproteins, which may increase exposure to medicinal products that are substrates of intestinal P-glycoproteins, such as dabigatran etexilate. Concomitant use of medicinal products containing ginkgo extract with dabigatran should be approached with caution.

An interaction study with nifedipine demonstrated that the maximum plasma concentration of nifedipine (Cmax) may increase when used concomitantly with ginkgo-based medicinal products. In some patients, the increase in nifedipine Cmax may reach 100% and clinically manifest as dizziness and increased flushing.

Interaction between ginkgo extract-containing medicinal products and drugs metabolized by the cytochrome P450 enzyme system cannot be completely ruled out (in isolated cases, inhibition or induction of certain isoenzymes is possible). Ginkgo extract-containing medicinal products accelerate the metabolism of antiepileptic drugs (valproate, phenytoin) metabolized by the CYP2C9 enzyme system. When used concomitantly with antiepileptic drugs, the seizure threshold may decrease, increasing the risk of epileptic seizures. Changes in midazolam concentration were observed after concomitant administration of ginkgo-based medicinal products, suggesting a possible interaction via CYP3A4. Therefore, medicinal products primarily metabolized by CYP3A4 and having a narrow therapeutic index should be used with caution when administered concomitantly with ginkgo preparations. Concomitant use of ginkgo preparations and efavirenz is not recommended due to the potential reduction in efavirenz plasma concentration resulting from induction of cytochrome CYP3A4 (see section "Special precautions for use").

The medicinal product should not be used during prolonged treatment with thiazide diuretics.

Special precautions for use

Due to the presence of lactose, the medicinal product should not be administered to patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Before initiating treatment with Ginkgoba®, it should be confirmed that the pathological symptoms observed are not due to an underlying condition requiring specific treatment.

The first signs of improvement are usually observed approximately 1 month after the start of treatment.

If symptoms worsen during treatment, medical advice should be sought.

Patients with a predisposition to bleeding (hemorrhagic diathesis), patients receiving concomitant therapy with anticoagulants and antiplatelet agents, hypoglycemic or antihypertensive medicinal products, and patients with known intolerance to certain sugars should consult a physician before taking this medicinal product.

If hypersensitivity to any component of the medicinal product occurs, its use should be discontinued (see section "Contraindications").

Medicinal products containing ginkgo extract may increase the tendency to bleeding. Patients should inform their physician about the use of Ginkgoba® prior to any surgical procedure. As a precautionary measure, administration of this medicinal product should be discontinued 3–4 days before surgery.

Medicinal products containing ginkgo extract should be used with particular caution during concomitant therapy with drugs metabolized by cytochrome P450 3A4. Concomitant use of medicinal products containing ginkgo extract with efavirenz is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

In patients with epilepsy, the occurrence of additional seizures during treatment with ginkgo extract cannot be excluded. A causal relationship between seizure occurrence and ginkgo intake has not been established.

There are no reports of abuse with medicinal products containing ginkgo extract. Based on the pharmacological characteristics of ginkgo extract, ginkgo-containing products have no potential for abuse.

Use during pregnancy or breastfeeding

Pregnancy

Ginkgo extract may reduce platelet aggregation ability. This may increase the tendency to bleeding.

Due to insufficient data on the safety of ginkgo extract use in pregnant women, administration of the medicinal product during pregnancy is contraindicated (see section "Contraindications").

Breastfeeding

There are no data on whether metabolites of ginkgo extract are excreted in breast milk. A risk to newborns and infants cannot be excluded.

Use of the medicinal product during breastfeeding is not recommended due to the lack of sufficient data.

Fertility

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

Ability to influence reaction speed when driving or operating machinery

No studies evaluating the effect of ginkgo extract on reaction speed during driving or operating machinery have been conducted. Caution should be exercised during treatment when driving or engaging in other potentially hazardous activities requiring increased attention and rapid psychomotor reactions. Dizziness may impair the ability to drive or operate machinery.

Dosage and Administration

For oral use. Swallow the capsules whole with food, drinking ½ glass of water.

Cognitive Disorders

Dosage 40 mg

1–2 capsules three times daily.

Dosage 80 mg

1 capsule two to three times daily.

Dosage 120 mg

1 capsule once or twice daily, in the morning or in the morning and evening.

The treatment duration should be at least 8 weeks. The average course of treatment is 3 months. After 3 months of therapy, consult a physician regarding the need for continued use of the medicinal product.

Neurosensory Disorders, such as dizziness, tinnitus

Dosage 40 mg

1 capsule three times daily.

Dosage 80 mg

1 capsule twice daily, in the morning and evening.

Dosage 120 mg

1 capsule once daily in the morning.

The treatment duration should not exceed 6–8 weeks.

Children

There is insufficient experience with the use of medicinal products containing ginkgo extract in children; therefore, the use of this medicinal product is not recommended in this patient population.

Overdose

In case of single or repeated overdose, dyspeptic disorders, disturbances of consciousness, and headache may occur. Treatment is symptomatic.

Side effects.

Side effects associated with the use of medicinal products containing Ginkgo biloba extract are classified by organ systems and frequency. The frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).

Immune system disorders: common – hypersensitivity reactions, dyspnea; uncommon – urticaria; rare – angioedema.

Nervous system disorders: very common – headache; common – dizziness, syncope (including vasovagal).

Blood and lymphatic system disorders: frequency not known – hemorrhages (gastrointestinal, ocular, cerebral). The likelihood of these adverse effects may be increased when concomitant therapy with anticoagulants and nonsteroidal anti-inflammatory drugs is used.

Cardiovascular system disorders: isolated cases of cardiac arrhythmia have been reported during treatment with Ginkgo biloba extract-containing medicinal products.

Gastrointestinal disorders: common – abdominal pain, dyspepsia, diarrhea, nausea, vomiting; digestive disorders.

Skin and subcutaneous tissue disorders: common – eczema, pruritus; uncommon – rash; frequency not known – erythema, swelling; redness, skin inflammation.

If any adverse reactions occur, the use of the medicinal product should be discontinued and medical advice must be sought immediately.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 capsules per blister; 2 or 6 blisters per carton.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Limited liability company "INTERKHIM".

Manufacturer's address and place of business.

40-A, 21st km, Starokyivska Road, Odesa, Ukraine, 65025.