Mastodon

Gingium (Tablets) Instructions for Use

ATC Code

N06DX02 (Ginkgo biloba leaves)

Active Substance

Ginkgo biloba (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation improving cerebral and peripheral circulation

Pharmacotherapeutic Group

Angioprotective agent of plant origin

Pharmacological Action

A herbal preparation. Its action is determined by the nature of its influence on metabolic processes in cells, the rheological properties of blood and microcirculation, as well as on the vasomotor reactions of large blood vessels.

It improves cerebral circulation and the supply of oxygen and glucose to the brain. It has a vasodilating effect and prevents platelet aggregation. It normalizes metabolic processes and has an antihypoxic effect on tissues.

It prevents lipid peroxidation and the formation of free radicals in cell membranes. It has a pronounced anti-edema effect at the level of the brain and in peripheral tissues. In various pathological conditions, it prevents an increase in the proteolytic activity of serum.

Indications

  • Use in geriatric patients for the management of symptoms arising from cerebrovascular disorders.
  • Treat cognitive deficits including disorders of attention and memory.
  • Address impairments in mental activity and subjective feelings of fear.
  • Alleviate dizziness, tinnitus, and sleep disorders.
  • Manage a general state of malaise associated with cerebral circulatory insufficiency.

ICD codes

ICD-10 code Indication
F07 Personality and behavioral disorders due to disease, damage or dysfunction of the brain
F51.2 Nonorganic disorders of the sleep-wake schedule
I69 Sequelae of cerebrovascular diseases
R42 Dizziness and giddiness
ICD-11 code Indication
6E68 Secondary emotionally labile personality disorder
6E6Z Unspecified secondary mental or behavioral syndromes
7B2Z Sleep-wake cycle disorders, unspecified
8B25.Z Sequelae of cerebrovascular disease, unspecified
MB48.Z Dizziness and giddiness, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the tablets orally. The standard adult dosage is 40 mg taken three times daily.

Adhere strictly to the prescribed dosing schedule. Do not exceed the recommended daily intake. The duration of therapy is determined by the physician based on the patient’s clinical response and underlying condition.

Adverse Reactions

Monitor patients for potential adverse effects during treatment. Gastrointestinal disturbances, such as dyspepsia or nausea, may occur.

Some individuals may experience headaches. Be aware of the possibility of allergic skin reactions, including rash and pruritus. Discontinue use immediately if signs of a hypersensitivity reaction develop.

Contraindications

  • Do not use in patients with known hypersensitivity to Ginkgo biloba or any component of the formulation.
  • Contraindicated in conditions associated with an increased risk of bleeding, such as reduced blood clotting.
  • Avoid use in patients with erosive gastritis or peptic ulcer disease in the acute phase.
  • Do not use following acute cerebrovascular accidents or acute myocardial infarction.
  • Contraindicated in cases of significant arterial hypotension.
  • Use is prohibited during pregnancy and lactation.
  • Not for use in children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Ginkgo biloba is contraindicated for use during pregnancy and during lactation (breastfeeding).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Avoid the use of Ginkgo biloba preparations in the presence of risk factors for the development of intracranial hemorrhage.

Drug Interactions

Exercise extreme caution with concomitant use of drugs affecting hemostasis. Concurrent administration with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., clopidogrel), or NSAIDs including acetylsalicylic acid may potentiate the risk of bleeding.

There are specific reports of an increased risk of cerebral hemorrhage when combined with thrombolytic therapy. Closely monitor patients for signs of bleeding.

Overdose

In case of suspected overdose, immediately discontinue the medication and institute supportive measures. Symptoms of overdose may be an exaggeration of known adverse reactions.

Given the pharmacological profile, be vigilant for signs of bleeding diathesis or severe gastrointestinal discomfort. There is no specific antidote; treatment should be symptomatic and directed at the clinical presentation.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Hexal AG (Germany)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Bottle OTC Icon Gingium Film-coated tablets, 80 mg: 30, 60, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow (ochre) in color, oblong; there is a score on both sides.

1 tab.
Dry standardized extract of Ginkgo biloba leaves (35-67:1)* 80 mg

* extraction solvent acetone 60% (w/w).

Excipients : lactose monohydrate – 240 mg, microcrystalline cellulose – 100 mg, corn starch – 50 mg, sodium carboxymethyl starch – 20 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 5 mg.

Shell composition lactose monohydrate – 6.6 mg, hypromellose – 5 mg, macrogol 4000 – 1.8 mg, titanium dioxide (E171) – 4.8 mg, yellow iron oxide dye (E172) – 1.8 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.

Marketing Authorization Holder

Hexal AG (Germany)

Manufactured By

Salutas Pharma, GmbH (Germany)

Packaging and Quality Control Release

LEK, S.A. (Poland)

Or

SALUTAS PHARMA, GmbH (Germany)

Dosage Form

Bottle Rx Icon Gingium Film-coated tablets, 120 mg: 30, 60, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, biconvex, oblong in shape, each side of the tablet has a score; color of the tablet on the break: light brown with lighter and darker inclusions; a yellow shell is visible along the contour.

1 tab.
Ginkgo biloba leaf dry extract (35-67:1) 120 mg

Excipients : lactose monohydrate – 360 mg, microcrystalline cellulose – 150 mg, corn starch – 75 mg, sodium carboxymethyl starch – 30 mg, colloidal silicon dioxide – 7.5 mg, magnesium stearate – 7.5 mg.

Shell composition Opadry white 27.21 mg [lactose monohydrate – 9.7956 mg, hypromellose – 7.6188 mg, macrogol 4000 – 2.721 mg, titanium dioxide (E171) – 7.0746 mg], yellow iron oxide dye (E172) – 2.79 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.

Marketing Authorization Holder

Sandoz CJS (Russia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Bottle OTC Icon Gingium Film-coated tablets, 120 mg: 30, 60, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, biconvex oblong in shape, each side of the tablet has a score; color of the tablet on the break: light brown with lighter and darker inclusions; a yellow shell is visible along the contour.

1 tab.
Dry extract of Ginkgo biloba leaves (35 – 67:1) 120 mg

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.

TABLE OF CONTENTS