MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
INSTRUCTIONS for the use of the medicinal product for medical use Bilobil® forte Bilobil® forte
Registration number: Trade name: Bilobil® forte International non-proprietary or generic name: ginkgo biloba leaf extract Dosage form: capsules
Composition 1 capsule contains: Active component: Ginkgo biloba leaf extract 80.00 mg (Ginkgo biloba leaf extract dry*) Excipients: liquid dextrose [dextrose, oligo- and polysaccharides], lactose monohydrate, corn starch, talc, colloidal silicon dioxide, magnesium stearate Composition of hard gelatin capsule (body and cap) : black iron oxide dye (E172), red iron oxide dye (E172), titanium dioxide (E171), azorubine dye (E122), gelatin * Ginkgo biloba leaves dry extract from Ginkgo biloba leaves (Ginkgo biloba L., Ginkgoaceae family, folium). The ratio of the amount of medicinal plant material to the amount of the original extract: 35-67:1. Extractant - acetone/water.
Description Hard gelatin capsules No. 2, pink body and cap. The contents of the capsules are light brown to dark brown powder with darker colored particles. Small lumps are allowed. Pharmacotherapeutic group: angioprotective agent of plant origin ATC code: N06DX02
Pharmacological properties Pharmacodynamics The drug Bilobil® forte is a drug of plant origin. Increases the body's resistance to hypoxia, especially brain tissue. Inhibits the development of traumatic or toxic cerebral edema, improves cerebral and peripheral circulation, and improves the rheological properties of blood. It has a dose-dependent regulatory effect on the vascular wall, dilates small arteries, and increases the tone of the veins. Prevents the formation of free radicals and lipid peroxidation of cell membranes. Normalizes the release, re-uptake and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors. Improves metabolism in organs and tissues, promotes the accumulation of macroergs in cells, increases the utilization of oxygen and glucose, and normalizes mediator processes in the central nervous system. Pharmacokinetics Absorption After oral administration, the bioavailability of terpene lactones (ginkgolide A, ginkgolide B and bilobalide) is 80% for ginkgolide A, 88% for ginkgolide B and 79% for bilobalide. Distribution When administered orally, peak plasma concentrations were 16-22 ng/ml for ginkgolide A, 8-10 ng/ml for ginkgolide B and 27-54 ng/ml for bilobalide. Plasma protein binding is 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide. Elimination The half-life is 3.9 hours for ginkgolide A, 4-6 hours for ginkgolide B and 2-3 hours for bilobalide.
Indications for use
- Symptomatic treatment of cognitive impairment in adults.
- As part of complex therapy for dizziness of vestibular origin as an auxiliary treatment in addition to vestibular rehabilitation.
- Symptomatic treatment of tinnitus (ringing or noise in the ears).
Contraindications Hypersensitivity to the components of the drug, decreased blood clotting, erosive gastritis, peptic ulcer of the stomach and duodenum in the acute stage, acute cerebrovascular accidents, acute myocardial infarction, pregnancy, breastfeeding, children under 18 years of age (efficacy and safety have not been studied) , lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (Bilobil® forte contains lactose and dextrose).
with caution in patients with epilepsy and arterial hypotension.
Use during pregnancy and breastfeeding Bilobil® forte is contraindicated during pregnancy and breastfeeding due to the lack of sufficient clinical data.
Directions for use and dosage : Inside. Capsules should be swallowed whole with a small amount of water, regardless of meal time. Symptomatic treatment of cognitive impairment in adults Take 1 capsule 2-3 times a day. Complex therapy of dizziness of vestibular origin and symptomatic treatment of tinnitus (ringing or noise in the ears) Adults take 1 capsule 2 times a day (morning and evening). The first signs of improvement usually appear after 1 month. The course of treatment is at least 3 months (especially for elderly patients). A repeat course is possible after consultation with a doctor. If a dose of the drug was missed or an insufficient amount was taken, the subsequent dose should be taken as indicated in these instructions, without any changes.
Side effect Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): very often ≥ 1/10 often from ≥ 1/100 to < 1/10 infrequently from ≥ 1/1000 to < 1/100 rarely from ≥ 1 /10000 to < 1/1000 very rare < 1/10000 frequency unknown cannot be estimated from available data. Disorders of the blood and lymphatic system: very rarely - decreased blood clotting. There are reports of bleeding with long-term use of Ginkgo biloba preparations in patients who were simultaneously taking anticoagulants. Nervous system disorders: very rarely - headache, dizziness, insomnia. Hearing and labyrinthine disorders: frequency unknown - hearing impairment. Gastrointestinal disorders: very rarely - nausea, vomiting, diarrhea. General disorders and disorders at the injection site: very rarely - hyperemia, swelling, itching. If any adverse events occur, you should stop taking the drug and consult your doctor.
Overdose To date, no cases of overdose of Bilobil® forte have been reported. In case of overdose, treatment is symptomatic.
Interaction with other drugs The use of Bilobil® forte is not recommended for patients constantly taking acetylsalicylic acid, anticoagulants (direct and indirect action), as well as thiazide diuretics, tricyclic antidepressants, anticonvulsants, gentamicin. Isolated cases of bleeding are possible in patients simultaneously taking medications that reduce blood clotting. The cause-and-effect relationship of these bleedings with the use of Ginkgo biloba preparations has not been confirmed. When used with antihypertensive drugs, the antihypertensive effect may be potentiated. Concomitant use with efavirenz is not recommended, since a decrease in its concentration in the blood plasma is possible due to the induction of the CYP3A4 isoenzyme under the influence of Ginkgo biloba leaf extract. An interaction study with talinolol suggests that Ginkgo biloba leaf extract may inhibit intestinal P-glycoproteins. This may increase the intestinal exposure of P-gp-sensitive drugs such as dabigatran and should be used with caution during concomitant use.
Special instructions Do not exceed the recommended doses of Bilobil® forte. If a hypersensitivity reaction develops, the use of the drug must be discontinued. Before surgery, you must inform your doctor about the use of Bilobil® forte. If you experience frequent feelings of dizziness and tinnitus, you should consult a doctor. In case of sudden deterioration or loss of hearing, you should immediately consult a doctor. Patients with bleeding (with hemorrhagic diathesis) and patients receiving anticoagulant therapy should consult a doctor before starting therapy with Bilobil® forte. It is not recommended to use Bilobil® forte together with alcohol. When using Ginkgo biloba preparations, epileptic seizures may occur in patients with epilepsy. Special information on excipients Bilobil® forte contains lactose and dextrose, therefore it is contraindicated in patients with lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome. 1 capsule of Bilobil® forte contains 196 mg of digestible carbohydrates - dextrose, lactose, corn starch (see section "Composition"), which corresponds to 0.0163 bread units (XE); the maximum daily dose (3 capsules) corresponds to 0.049 XE. The drug Bilobil® forte contains the dye azorubine (E122), which can cause allergic reactions.
Effect on the ability to drive vehicles and machinery While taking Bilobil® forte, caution should be exercised when performing potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles and machinery). If adverse reactions develop, including dizziness, it is necessary to refrain from driving vehicles and machinery.
Release form Capsules, 80 mg. 10 capsules in a blister made of combined PVC/PVDC material and aluminum foil. 2 or 6 blisters along with instructions for use are placed in a cardboard pack.
Storage conditions At a temperature not exceeding 25 ° C, in the original packaging. Keep out of the reach of children.
Shelf life: 3 years. Do not use the drug after the expiration date.
Conditions of release Dispensed without a prescription.
Name of the legal entity in whose name the registration certificate was issued, address JSC "KRKA, d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia
, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Packer (Primary packaging) JSC "KRKA, d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Packer (Secondary (consumer) packaging) JSC "KRKA, d.d., Novo Mesto", Šmarješka cesta 6, 8501 Novo Mesto, Slovenia
Release quality control JSC "Krka d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Name and address of the organization receiving consumer complaints LLC KRKA-RUS, 125212, Moscow, Golovinskoe highway, building 5, building 1 Tel., fax
Bilobil Forte
Bilobil Forte is a herbal angioprotector. Increases the ability of brain tissue and the entire body to tolerate oxygen starvation. Inhibits the process of transudative impregnation of damaged (including due to traumatic or toxic damage) cerebral tissues with an increase in the permeability of dilated capillaries, release into the tissue and activation of intracellular hydrolytic enzymes. Improves cerebral circulation and blood flow in small arteries, arterioles, capillaries, post-capillary venules, arteriovenular anastomoses, venules and small veins. Normalizes the rheological characteristics of blood. Increases the lumen of arterioles, increases venous tone. Suppresses chemical reactions during which free radicals are generated and prevents the oxidative degradation of plasma membrane lipids. Normalizes the processes of release, reuptake and breakdown of neurotransmitters (norepinephrine, adrenaline, dopamine) and their ability to interact with receptors. Improves metabolism, promotes the accumulation of high-energy compounds in tissues, and promotes more active use of oxygen and glucose by cells. The active components of the drug, flavone glycosides, are absorbed in the small intestine. The peak blood level is observed after 2 hours, the half-life is 2-4 hours. Bilobil Forte is used for multifocal or diffuse vascular lesions of the brain of various etiologies, manifested in...
including depression of cognitive functions (memory, attention, concentration, mental activity) and sleep disturbances, peripheral circulatory disorders, neurosensory disorders, macular degeneration associated with biological aging, retinal damage in diabetes mellitus. The effect of the drug has not been studied in pregnant and lactating women. therefore, these categories of patients should refrain from taking the drug. The presence of food contents in the gastrointestinal tract does not affect the bioavailability of Bilobil Forte, therefore the drug is taken regardless of diet. Single dose – 1 capsule. Frequency of administration – 2-3 times a day. A noticeable improvement in the patient’s condition can usually be noticed after 1 month of regular drug therapy. Duration of treatment - from 3 months with the possibility of a second course of pharmacotherapy in agreement with the attending physician. Bilobil Forte should not be taken together with blood thinning medications (anticoagulants, aspirin and other NSAIDs), because as a result, the likelihood of developing prolonged bleeding increases. If reactions of individual intolerance occur, the medication course should be interrupted. The drug contains as an excipient the allergenic dye azorubine, which can cause bronchospasm.
Ginkgo biloba Forte 120 mg with glycine and vitamin B6, tab. No. 60
It is recommended as a dietary supplement with an additional source of flavonol glycosides and vitamin B6, containing glycine and terpene lactones, which helps improve cerebral circulation, strengthen cerebral blood vessels, improve memory, concentration, reduce headaches, eliminate dizziness and tinnitus.
The direction of action of the dietary supplement “Ginkgo biloba 120 mg with glycine and vitamin B6” is determined by its constituent components.
Ginkgo biloba L. –
Ginkgo family – Ginkgoaceae. A gymnosperm plant, a close relative of modern conifers. Ginkgo biloba is a relict plant, the only surviving representative of the Ginkgoaceae class.
Ginkgo was mainly used in Eastern medicine to restore circulatory disorders that appear during aging of the body, as well as memory loss, cancer, bronchial asthma and other lung diseases, visual impairment, and sexual disorders. Ginkgo preparations are actively used to treat a wide range of disorders - from asthenia to severe vascular lesions of the extremities
Ginkgo biloba leaves contain flavonoids, procyanidins, diterpenoids, gikgolide, and bilobalide. Due to the presence of acaloids, ginkgo biloba extract has the ability to absorb radicals, which explains its effect. Research shows that under the influence of ginkgo biloba extract, a decrease in blood viscosity is observed and, as a result, the rheological properties of the blood improve. Ginkgo biloba extract also strengthens the red blood cell membrane and prevents hemolysis, promotes the absorption and assimilation of oxygen and glucose in tissues, and ensures the maintenance of normal metabolism in cells.
Ginkgo biloba has an angioprotective effect and improves cerebral circulation.
Glycine is an amino acid.
Glycine is part of the amino acid composition of collagen, which, in turn, is part of tendons, skin, cartilage, and blood vessels. Glycine is a central inhibitory neurotransmitter. It has a sedative effect and improves metabolic processes in brain tissue.
Glycine has an anti-stress, nootropic effect, normalizes metabolic processes, reduces psycho-emotional tension, increases mental performance, reduces the toxicity of alcohol and other drugs that depress the function of the central nervous system, penetrates well into the central nervous system, is metabolized to water and carbon dioxide.
Vitamin B6.
Vitamin B6 accelerates metabolism, ensures the formation of energy from carbohydrates, relieves excitement in the central nervous system, triggers the conversion of amino acids into each other and is involved in the transport of iron, creating conditions for the synthesis of hemoglobin. Of great importance is the ability of vitamin B6 to ensure the conversion of amino acids into each other, since they are necessary for protein synthesis and the construction of muscles, bones, connective tissue, blood vessels, nerves, etc. Active protein synthesis is necessary for normal growth and harmonious physical development. And at any given moment in time, a deficiency of one or another amino acid may occur, without which protein cannot be built. And then, in the literal sense of the word, vitamin B6 comes to the rescue, which starts the process of converting one amino acid that is in excess into another - the one that is now lacking. That is, pyridoxine in children ensures normal physical development and full growth. The function of maintaining protein synthesis is important not only for growth, but also for normal immunity. After all, antibodies or immunoglobulins are protein structures that are constantly synthesized in the body to destroy various pathogenic bacteria, viruses, fungi, etc. And against the background of vitamin B6 deficiency, the synthesis of immunoglobulins may occur with insufficient intensity, which will manifest itself as a decrease in immunity. Vitamin B6 is also involved in the synthesis of insulin, a protein very important for the utilization of glucose, insufficient quantities of which cause a person to develop a severe, chronic metabolic disease - diabetes mellitus. In addition, vitamin B6 is necessary for the synthesis of a sufficient amount of hemoglobin, since it stimulates the formation of a protein that delivers iron to the bone marrow, where hemoglobin is assembled.
