Instructions Tebokan 120 mg film-coated tablets blister No. 20
Composition
active ingredient: dry extract of ginkgo biloba leaves (EGb 761®) (Ginkgo biloba L., folium);
1 film-coated tablet contains dry ginkgo biloba leaf extract (EGb 761®) (Ginkgo biloba L., folium) (35–67:1), extractant: acetone 60% (m/m) 120 mg, standardized to 26.4–32.4 mg of flavonoids in the form of flavone glycosides; 6.48–7.92 mg of terpene lactones, of which 3.36–4.08 mg are ginkgolides A, B and C and 3.12–3.84 mg of bilobalide and no more than 0.6 μg of ginkgolic acids;
excipients: lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 1500, titanium dioxide (E 171), red iron oxide (E 172), talc, antifoam emulsion SE 2: dimethicone, colloidal anhydrous silica, α-octadecyl-ω-hydroxypoly(oxyethylene)-5, sorbic acid.
Dosage form
Film-coated tablets.
Main physicochemical properties: red, round, smooth, film-coated tablets.
Pharmacotherapeutic group
Drugs used in dementia. ATX code N06D X02.
Pharmacological properties
Pharmacodynamics
In the course of pharmacological studies, it was proven that the standardized extract of Ginkgo biloba (EGb 761®), which is contained in Tebokan, increases the tolerance of hypoxia, especially in brain tissues; inhibits the development and accelerates the regression of brain edema caused by trauma or poisoning; reduces retinal edema and corneal damage; inhibits the age-related decrease in muscarinic cholinergic receptors and alpha-2-adrenergic receptors, as well as increasing choline consumption in the hippocampus; improves memory and learning ability; improves compensation for balance disorders; increases blood flow, especially in the microcirculation area; improves the rheological characteristics of blood; inactivates toxic oxygen radicals (due to flavonoids); exhibits antagonism (due to ginkgolides) to platelet activating factor and has a neuroprotective effect (due to ginkgolides A and B, bilobalide).
Pharmacokinetics
The cerebral bioavailability of the standardized extract of Ginkgo biloba (EGb 761®), contained in the drug Tebokan, in humans was demonstrated using pharmaco-EEG based on dose-dependent effects on electrical brain activity. After oral administration of 80 mg of standardized ginkgo extract, the terpene lactones ginkgolide A, ginkgolide B and bilobalide showed absolute bioavailability in humans, which was 98% for ginkgolide A, 79% for ginkgolide B and 72% for bilobalide. Maximum plasma concentrations of ginkgolide A were 15 ng/ml, ginkgolide B - 4 ng/ml, bilobalide - approximately 12 ng/ml. The half-lives were 3.9 hours (ginkgolide A), 7 hours (ginkgolide B) and 3.2 hours (bilobalide). Plasma protein binding is 43% for ginkgolide A, 47% for ginkgolide B, and 67% for bilobalide. The drug is excreted by the kidneys.
Indication
For the treatment of cognitive disorders due to impaired brain function, including primary degenerative dementia, vascular dementia and mixed forms, with the following main symptoms: memory impairment, decreased attention, depressed mood, dizziness, tinnitus and headache; to increase the distance that the patient can cover without pain as part of physiotherapy procedures, namely during walking training in cases of arterial peripheral circulation disorders of the II degree according to Fontaine (painful cramps, intermittent claudication, paresthesia of the lower extremities, etc.); dizziness, tinnitus of vascular and involutional origin.
Contraindication
Hypersensitivity to ginkgo biloba extract or to any of the components of the medicinal product listed in the "Composition" section. Pregnancy (see section "Use during pregnancy or breastfeeding").
Interaction with other medicinal products and other types of interactions
When used simultaneously with anticoagulants (e.g. phenprocoumon, warfarin) or antiplatelet agents (e.g. clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs), the effect of the latter may be enhanced.
The results of studies on concomitant use with warfarin do not indicate the presence of an interaction, however, appropriate monitoring is recommended at the beginning of therapy, when changing the dosage, discontinuing use or replacing the drug.
Application features
The first signs of improvement appear 1 month after the start of treatment.
Before starting treatment with Tebokan, it is necessary to determine whether the pathological symptoms observed are a consequence of an underlying disease that requires specific treatment.
If dizziness and tinnitus occur frequently, you should always consult a doctor. In case of sudden hearing loss or hearing impairment, you should consult a doctor immediately.
Preparations containing ginkgo biloba extract may increase the tendency to bleed, so their use should be discontinued 3–4 days before surgery.
In patients with epilepsy, an increase in epileptic seizures caused by taking drugs containing Ginkgo biloba leaf extract cannot be ruled out.
Since this medicinal product contains lactose, it is contraindicated in patients with congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency.
Ability to influence reaction speed when driving vehicles or other mechanisms
The ability of the drug to affect the reaction rate when driving vehicles or other mechanisms has not been reported.
Use during pregnancy or breastfeeding
Pregnancy. The drug is contraindicated during pregnancy.
Breastfeeding. There is no evidence that ginkgo metabolites are excreted in breast milk. A risk to newborns and infants cannot be excluded. Due to the lack of clinical data, the drug is not recommended for use during breastfeeding.
Fertility: Animal studies have not shown any harmful effects of Tebocan on fertility.
Method of administration and doses
For dementia, you should take 1 tablet (corresponding to 120 mg of ginkgo extract) 2 times a day.
In case of impaired arterial peripheral circulation and to increase the distance that the patient can cover without pain - 1 tablet 1-2 times a day.
In case of dizziness, tinnitus of vascular and involutional origin, take 1 tablet 1-2 times a day.
The film-coated tablets are taken orally, without chewing, with a small amount of liquid in the morning and evening (2 times a day). Taking the tablets does not depend on meals.
In dementia, the duration of treatment depends on the severity of the symptoms and should be at least 8 weeks. After 3 months of treatment, it is necessary to check whether further treatment is justified.
In case of impaired arterial peripheral circulation, the minimum treatment period is 6 weeks.
If dizziness persists after 6-8 weeks of treatment, as a rule, further relief of symptoms should not be expected.
For tinnitus, the duration of treatment should be at least 12 weeks. If there is no improvement after 6 months, further relief of symptoms should not be expected.
Children
The drug is not recommended for children.
Overdose
There are no known cases of overdose.
Adverse reactions
Possible side effects:
Blood and lymphatic system: bleeding in individual organs (frequency unknown); Gastrointestinal tract: mild gastrointestinal disorders such as abdominal pain, diarrhea, dyspeptic phenomena, nausea, vomiting (frequency unknown); Nervous system: headache (frequency unknown); Immune system: hypersensitivity reactions, urticaria, dyspnea (frequency unknown); Skin: allergic skin reactions such as redness, swelling, itching, rash, eczema (frequency unknown).
If any adverse reactions occur, you should stop taking the drug and consult a doctor.
Expiration date
5 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Does not require any special storage conditions. Keep out of the reach of children.
Packaging
20 film-coated tablets in a blister; 1 blister per pack.
Vacation category
Without a prescription.
Producer
Dr. Wilmar Schwabe GmbH & Co. KG.
Location of the manufacturer and its business address
Wilmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.
