Bilobyl - instructions for use, dose, side effects, contraindications

Excipients: dextrose liquid [dextrose, oligo - and polysaccharides] 2.00 mg, lactose monohydrate 66.00 mg, corn starch 30.00 mg, talc 8.00 mg, silicon dioxide colloid 2.00 mg, magnesium stearate 2.00 mg

Composition of hard gelatin capsule (body and lid): dye iron black oxide (E172) 0.2450%,(E172) 0.3440%, titanium dioxide (E171) 0.7417%, indigocarmine (E132) 0.0181%, azorubin (E122) dye 0.0382%, gelatin to 100%

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

The ratio of the amount of medicinal plant raw material to the amount of the initial extract is 35-67: 1.

Extractant - acetone / water.

Description:

Hard gelatin capsules number 4, body and lid violet - brown. The contents of the capsules are powder from light brown to dark brown with particles of a darker color. Presence of lumps is allowed.

Pharmacotherapeutic group:Angioprotective agent of plant origin

ATX: & nbsp

N.06.D.X.02 Ginkgo Biloba Leaf Extract

Pharmacodynamics:

Preparation Bilobil® of vegetable origin. Increases the body's resistance to hypoxia, especially brain tissue. It inhibits the development of traumatic or toxic edema of the brain, improves cerebral and peripheral blood circulation, improves blood rheology.

Has a dose-dependent regulatory effect on the vascular wall, dilates the small arteries, increases the tone of the veins.Prevents formation of free radicals and peroxide oxidation of cell membrane lipids. Normalizes the release, reabsorption and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to combine with receptors. It improves the metabolism in organs and tissues, promotes the accumulation of macroerges in cells, increases utilization of oxygen and glucose, normalization of mediator processes in the central nervous system.

Pharmacokinetics:

flavone glycosides are absorbed in the small intestine. The maximum concentration in the blood plasma is reached after 2 hours, the half-life is 2-4 hours.

Indications:

Dyscirculatory encephalopathy of various etiologies (developing as a result of stroke, craniocerebral trauma, in old age), accompanied by: decreased attention, weakened memory, decreased intellectual abilities, sleep disturbance;
violation of peripheral circulation and microcirculation (including arteriopathy of the lower limbs), Raynaud's syndrome;
neurosensory disorders (dizziness, ringing in the ears, hypoacusia);
senile macular degeneration;
diabetic retinopathy.

Contraindications:

Hypersensitivity to the components of the drug, reduced coagulability blood, erosive gastritis, peptic ulcer of the stomach and duodenum in stages of exacerbation, acute disorders of cerebral circulation, acute myocardial infarction, children under 18 years of age (efficacy and safety not studied), galactosemia, lactase deficiency, glucose-galactose malabsorption syndrome, tk. the composition of the drug Bilobil® includes lactose.

Pregnancy and lactation:

Bilobyl® is not recommended for use during pregnancy and breastfeeding due to the lack of sufficient clinical data.

Dosing and Administration:

Inside. Capsules should be swallowed whole, squeezed with a small amount of liquid, regardless of food intake.

Dyscirculatory encephalopathy of various etiologies

Take 1-2 capsules 3 times a day.

Violation of peripheral circulation and microcirculation (including arteriopathy of the lower limbs), Raynaud's syndrome

Adults take 1 capsule 3 times a day.

Neurosensory disorders (dizziness, ringing in the ears, hypoacusia); senile macular degeneration; diabetic retinopathy

Adults take 1 capsule 3 times a day.

The first signs of improvement usually appear after 1 month. The course of treatment for at least 3 months (especially for elderly patients). Conducting a second course is possible after consulting a doctor.

Side effects:

Classification of the frequency of development of side effects of the World Organization

Health (WHO):

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 rarely from <1/10000, including individual messages.

the frequency of the unknown can not be estimated from the available data.

From the digestive system: very rarely - nausea, vomiting, diarrhea.

From the nervous system: very rarely - headache, dizziness, insomnia.

Allergic reactions: very rarely - redness of the skin, swelling, itching.

From the side of the hemostasis system: very rarely - a decrease in blood coagulability. There are reports of long-term use of ginkgo biloba preparations for bleeding in patients who simultaneously took funds that reduce blood coagulability.

From the sense organs: frequency unknown - hearing loss.

In case of occurrence of any undesirable phenomena reception of a preparation should be stopped and address to the attending physician.

Overdose:

At present, no cases of an overdose of Bilobil® have been reported.

Interaction:

It is not recommended to use the drug for patients who constantly take drugs that reduce blood clotting (for example, anticoagulants (direct and indirect action), acetylsalicylic acid and other non-steroidal anti-inflammatory drugs). Simultaneous use with these drugs may increase the risk of bleeding due to prolonged coagulation time.

Special instructions:

When developing a hypersensitivity reaction, the drug should be discontinued. Before surgery, you should inform your doctor about the use of Bilobil®.

When there is repeated dizziness and noise in the ears, you should see 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, it is necessary consult with your doctor before beginning of therapy with Bilobil®.

Against the background of the use of Ginkgo drugs bilobate, in patients suffering from epilepsy, there may be epileptic seizures.

Special information about auxiliary substances

A drug Bilobyl® contains a dye Azorubine (E122), which can cause development of allergic reactions and bronchospasm.

Effect on the ability to drive transp. cf. and fur:

During the period of taking the drug, care should be taken when carrying out potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms).

Form release / dosage:

Capsules, 40 mg.

Packaging:

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

For 2 or 6 blisters (contour mesh packages), together with instructions for use, put in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013517 / 01

Date of registration:12.11.2007 / 07.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, dd, Novo mesto, AO Slovenia

KRKA-RUS, LLC Russia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp25.01.2017

Illustrated instructions

Instructions

Bilobil® (Bilobil®)