Bilobil forte, 80 mg capsules 20 pcs

Visual impairment, Concussion and other brain injuries, Attention and memory impairment, Stroke sequelae, Prevention of thrombosis, Impaired cerebral circulation, Visual impairment, Headache, Hearing impairment

– Symptomatic treatment for adult cognitive impairment.

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

– Symptomatic treatment for tinnitus (ringing or tinnitus).

Indications

· 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).

Pharmacological effect

angioprotective agent of plant origin

Special instructions

Use in patients with epilepsy and 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 arterial hypotension.

Do not exceed the recommended doses of Bilobil® forte.

If a hypersensitivity reaction develops, the use of the drug should 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 (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 ethanol.

When using Ginkgo biloba preparations in patients suffering from epilepsy, epileptic seizures may occur.

Special information on 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.

The drug Bilobil® forte contains the dye azorubine (E122), which can cause the development of allergic reactions.

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

Active ingredient

Ginkgo biloba leaf extract

Composition

1 capsule contains:

Active ingredient:

Ginkgo biloba leaf extract 80.00 mg (Ginkgo biloba leaf extract dry*)

Excipients:

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

Composition of hard gelatin capsule (body and cap):

Iron oxide dye black (E172), iron oxide red dye (E172), titanium dioxide (E171), azorubine dye (E122), gelatin

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

The ratio of the amount of medicinal plant raw materials to the amount of the original extract: 35 – 67:1. Extractant – acetone/water.

Pregnancy

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

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 period, children under 18 years of age (efficacy and safety have not been studied), lactose intolerance, lactase deficiency, glucose-galactose syndrome malabsorption, since the composition of the drug Bilobil® forte includes lactose.

Side Effects

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

very common ≥ 1/10

often ≥ 1/100 to < 1/10

uncommon ≥ 1/1000 to < 1/100

rarely from ≥ 1/10000 to < 1/1000

very rare from < 1/10000

frequency unknown cannot be estimated from available data.

Within each group, adverse effects are presented in order of decreasing severity.

From the digestive system:

very rarely: nausea, vomiting, diarrhea.

From the nervous system:

very rarely: headache, dizziness, insomnia.

Allergic reactions:

very rarely: hyperemia, swelling, itching.

From the hemostasis system:

very rarely: decreased blood clotting. There are reports of bleeding occurring during long-term use of Ginkgo biloba preparations in patients who were simultaneously taking anticoagulants.

From the senses:

frequency unknown: hearing impairment.

If any adverse events occur, you should stop taking the drug and consult your doctor.

Interaction

The use of Bilobil® forte is not recommended for patients constantly taking acetylsalicylic acid, anticoagulants (direct and indirect), 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 taking Ginkgo biloba preparations has not been confirmed.

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

The simultaneous use of Ginkgo biloba preparations 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 extract.

An interaction study with talinolol suggests that Ginkgo biloba 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.

Overdose

Currently, no cases of overdose of Bilobil® forte have been reported. In case of overdose, treatment is symptomatic.

Clinical pharmacology

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

Suction

After oral administration, the bioavailability of the terpene lactones (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 tablet administration. Plasma protein binding is 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide.

Removal

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

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.

Manufacturer

KRKA dd Novo Mesto, Slovenia