Bilobil forte, 80mg capsules, 20pcs

Composition

1 capsule contains:

Active Ingredient:

Ginkgo Bilabial Leaf Extract 80.00 mg (Ginkgo Bilabial leaf extract dry*)

Auxiliary substances:

Liquid dextrose [dextrose, oligo-and polysaccharides], lactose monohydrate, corn starch, talc, colloidal silicon dioxide, magnesium stearate

Composition of solid gelatin capsule (body and lid):

Iron oxide black dye (E 172), iron oxide red dye (E 172), titanium dioxide (E 171), azorubin dye (E122), gelatin

* Ginkgo biloba leaf extract dry from Ginkgo biloba leaves (Ginkgo biloba L., Ginkgoaceae family, folium).

The ratio of the amount of medicinal plant raw materials to the amount of the initial extract: 35-67: 1. The extractant is acetone/water.

Pharmacological action

angioprotective agent of plant origin

Clinical pharmacology

The preparation Bilobil ® forte is a preparation of plant origin. Increases the body’s resistance to hypoxia, especially in brain tissues. It inhibits the development of traumatic or toxic brain edema, improves cerebral and peripheral blood circulation, and improves the rheological properties of blood.

It has a dose-dependent regulating effect on the vascular wall, dilates small arteries, and increases vein tone. Prevents the formation of free radicals and lipid peroxidation of cell membranes. Normalizes the release, reabsorption, and catabolism of neurotransmitters (norepinephrine, dopamine, and 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

Suction

After oral use, the bioavailability of terpenlactones (ginkgolide A, ginkgolide B, and bilobalide) is 80% for ginkgolide A,88% for ginkgolide B, and 79% for bilobalide.

Distribution

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 after oral use. Binding to plasma proteins is 43% for ginkgolide A,47% for ginkgolide B, and 67% for bilobalide.

Deduction

The elimination half-life is 3.9 hours for ginkgolide A,4-6 hours for ginkgolide B, and 2-3 hours for bilobalide.

Indications

* Symptomatic treatment of cognitive impairment in adults.

·  As part of the complex therapy of vertigo of vestibular origin as an auxiliary treatment in addition to vestibular rehabilitation.

* Symptomatic treatment of tinnitus (ringing or tinnitus).

Use during pregnancy and lactation

The drug Bilobil® forte is contraindicated during pregnancy and lactation, due to the lack of sufficient clinical data.

Contraindications

Hypersensitivity to the components of the drug, reduced blood clotting, erosive gastritis, acute peptic ulcer of the stomach and duodenum, acute cerebrovascular disorders, 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, as the composition of the drug Bilobil® forte includes lactose.

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):

very common ≥ 1/10

common ≥ 1/100 to < 1/10

uncommon ≥ 1/1000 to < 1/100

rare ≥ 1/10000 to < 1/1000

very rare < 1/10000

frequency unknown cannot be estimated based on available data.

In each group, undesirable effects are presented in decreasing order of severity.

From the digestive system:

very rare: nausea, vomiting, diarrhea.

Nervous system disorders:

very rare: headache, dizziness, insomnia.

Allergic reactions:

very rare: hyperemia, edema, itching of the skin.

From the side of the hemostatic system:

very rare: decreased blood clotting. There have been reports of long-term use of Ginkgo bilabial hemorrhage in patients who simultaneously took drugs that reduce blood clotting.

From the side of the senses:

frequency unknown: hearing loss.

In case of any adverse events, the drug should be discontinued and consult your doctor.

Interaction

The use of Bilobil®is not recommended forte for patients who are constantly taking acetylsalicylic acid, anticoagulants (direct and indirect action), as well as thiazide diuretics, tricyclic antidepressants, anticonvulsants, gentamicin. There may be isolated cases of bleeding in patients who are simultaneously taking medications that reduce blood clotting, the causal relationship of these bleeds with the use of Ginkgo bilobate preparations is not confirmed.

When used with antihypertensive agents, the antihypertensive effect may be potentiated.

Concomitant use of Ginkgo bilabialis with efavirenz is not recommended, as it is possible to reduce its concentration in blood plasma due to the induction of the CYP3A4 isoenzyme under the influence of Ginkgo bilabialis extract.

A study of interaction with talinolol shows that Ginkgo bilobate extract can inhibit intestinal P-glycoproteins. This may increase the exposure of P-glycoprotein-sensitive drugs in the gut, such as dabigatran, and caution should be exercised when using them simultaneously.

How to take, course of use and dosage

Inside. Capsules should be swallowed whole, washed down with a small amount of water, regardless of the time of meal.

Symptomatic treatment of cognitive impairment in adults

Take 1 capsule 2-3 times a day.

Complex therapy of vertigo of vestibular origin and symptomatic treatment of tinnitus (ringing or tinnitus)

For adults, take 1 capsule 2 times daily (morning and evening).

The first signs of improvement usually appear after 1 month.

The course of treatment is not less than 3 months (especially for elderly patients). A second course is possible after consulting a doctor.

If the drug was missed or an insufficient amount was taken, its subsequent intake should be carried out as indicated in these instructions, without any changes.

Overdose

Currently, cases of overdose of the drug Bilobil®have been reported forte was not reported. In case of overdose, treatment is symptomatic.

Description

Solid gelatin capsules No. 2, pink body and lid. The contents of the capsules are light brown to dark brown powder with darker colored particles. Small lumps are allowed.

Special instructions

Use in patients with epilepsy, with arterial hypotension.

Contraindicated in persons under 18 years of age (efficacy and safety have not been studied)

Use with caution in patients with epilepsy and hypotension.

Do not exceed the recommended dose of Bilobil forte.

If a hypersensitivity reaction develops, the drug should be discontinued. Before surgery, you should inform your doctor about the use of Bilobil forte.

If you often experience 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 disorders (hemorrhagic diathesis) and patients receiving anticoagulant therapy should consult their doctor before starting treatment with Bilobil forte.

It is not recommended to use Bilobil forte together with ethanol.

Against the background of the use of Ginkgo bilobate preparations in patients suffering from epilepsy, epileptic seizures may occur.

Special information about excipients

1 capsule of Bilobil forte contains 196 mg of digestible carbohydrates (glucose, lactose, starch), which corresponds to 0.0163 bread units (XE), the maximum daily dose (3 capsules) corresponds to 0.049 XE.

Bilobil Forte contains the dye azorubin (E122), which can cause the development of allergic reactions.

While taking Bilobil forte, caution should be exercised when performing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms), and if undesirable reactions develop, including dizziness, it is necessary to refrain from driving vehicles.

Form of production

Capsules,80 mg.

During production at JSC “KRKA, D. D., Novo Mesto”, Slovenia:

10 capsules in a blister (contour cell package) made of combined PVC material/PVDC and aluminum foil.

2 or 6 blisters (contour cell packages) together with the instructions for use are placed in a cardboard pack.

During production at KRKA-RUS LLC, Russia:

10 capsules in a contour cell package (blister) made of combined PVC material/PVDC and aluminum foil.

2 or 6 contour cell packages (blisters) together with the instructions for use are placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date.

Active ingredient

Ginkgo Bilabial Leaf Extract

Dosage form

Capsules

Purpose

For adults

Indications

Prevention of thrombosis, Concussion and other traumatic brain injuries, Circulatory disorders, Stroke consequences