Ginkgo Biloba Evalar drops (Drops) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Dosage Form

Ginkgo Biloba Evalar drops

Oral drops: 30 ml, 50 ml, 75 ml, or 100 ml bottle.

Dosage Form, Packaging, and Product Composition

Composition ginkgo biloba leaf, rosa majalis fruit, extractant (40% alcohol solution).

30 ml – bottles.
50 ml – bottles.
75 ml – bottles.
100 ml – bottles.

Therapeutic Category

Preparation, improving cerebral and peripheral circulation

Indications

• For use as a dietary supplement to support cognitive function and memory, particularly in cases of age-related cognitive decline.
• As an adjunct to improve microcirculation and peripheral blood flow in the extremities.
• To support vascular health and provide antioxidant protection.

Contraindications

• Hypersensitivity or individual intolerance to any component of the dietary supplement, including ginkgo biloba or other flavonoid-rich plants.
• Pregnancy and breastfeeding due to the lack of sufficient safety data and the potential risk of bleeding complications.
• Patients with hemorrhagic diathesis or those with a predisposition to bleeding, as ginkgo biloba may affect platelet aggregation.
• Concomitant use with anticoagulant or antiplatelet medications (e.g., warfarin, aspirin, clopidogrel) unless under strict medical supervision due to a significantly increased risk of bleeding.
• Patients scheduled for surgical procedures should discontinue use at least two weeks prior to surgery to minimize bleeding risks.
• Epilepsy or a history of seizures, as there is a theoretical risk of reduced seizure threshold.

Dosage Regimen

The recommended dosage for adults and children over 14 years of age is 20-30 drops two to three times daily.

The drops should be taken orally, preferably diluted in a small amount (approximately 50-100 ml) of water, before or during a meal.

The duration of use is typically 2-3 months. If necessary, courses may be repeated after a 1-2 month break, following consultation with a healthcare provider.

It is important to shake the bottle well before each use to ensure a uniform suspension of the active components.

Do not exceed the recommended daily dose. The use of the product in children under 14 years of age is not recommended due to the alcohol content in the formulation and the lack of clinical data for this age group.

Adverse Reactions

Adverse reactions are generally mild and infrequent. The most commonly reported effects are related to the gastrointestinal system and may include nausea, dyspepsia, or epigastric discomfort.

Allergic reactions are possible, though rare, and may manifest as skin rash, itching, or urticaria. In individuals with a known sensitivity to plants of the Ginkgoaceae family, the risk is increased.

Due to its vasoactive properties, ginkgo biloba may, in isolated cases, cause headache or dizziness.

There is a potential for increased bleeding time and bleeding events (e.g., gingival bleeding, nosebleeds, ecchymosis), particularly with long-term use or in susceptible individuals.

If any adverse reactions occur, discontinuation of the supplement is recommended, and a healthcare professional should be consulted.

Drug Interactions

Anticoagulants and Antiplatelet Agents (e.g., Warfarin, Acenocoumarol, Aspirin, Clopidogrel): Ginkgo biloba may potentiate the effects of these drugs, significantly increasing the risk of bleeding and hemorrhage. Concurrent use requires extreme caution and close monitoring of coagulation parameters (INR, prothrombin time).

Selective Serotonin Reuptake Inhibitors (SSRIs) and other Antidepressants: There is a potential for pharmacodynamic interaction, which may lead to an increased risk of serotonin syndrome, characterized by agitation, confusion, and tachycardia.

Anticonvulsants (e.g., Carbamazepine, Valproic Acid, Phenytoin): Ginkgo biloba may reduce the plasma concentrations and efficacy of these medications, potentially leading to a loss of seizure control.

Hypoglycemic Agents (e.g., Insulin, Metformin, Sulfonylureas): Ginkgo biloba may alter blood glucose levels; careful monitoring of glycemia is advised in diabetic patients.

Drugs Metabolized by Cytochrome P450 Enzymes (e.g., Omeprazole, Diazepam, Nifedipine): Ginkgo biloba can induce or inhibit various CYP isoenzymes, potentially altering the metabolism and plasma levels of concomitant medications.

Patients are strongly advised to inform their physician about all medications and dietary supplements they are taking before starting Ginkgo Biloba Evalar drops.

Overdose

In case of a significant overdose, symptoms may be an exacerbation of the known adverse reactions. Severe gastrointestinal distress (nausea, vomiting, diarrhea) and pronounced headaches are possible.

Due to the antiplatelet activity of ginkgo biloba, a substantial overdose could theoretically lead to spontaneous bleeding and internal hemorrhage, which constitutes a medical emergency.

There is no specific antidote for ginkgo biloba overdose. Treatment is symptomatic and supportive. In the event of a suspected overdose, immediate medical attention should be sought. Gastric lavage or administration of activated charcoal may be considered if the ingestion was very recent.

It is crucial to bring the medication package to the hospital to assist healthcare professionals in identifying the ingested substance.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.