Ginkgo biloba-Astrafarm kaps. 80 mg No. 30

Translation of the instruction Mose

GINKGO of BILOBA-ASTRAFARM of the capsule of 40 mg, capsules of 80 mg

Instruction

On medical use of medicine

Ginkgo biloba-astrafarm

Ingredients:

Active ingredient:

1 capsule contains dry extract of a ginkgo of a biloba 40 mg or 80 mg (ginkgo biloba L.) (a ratio of starting material to the received extract 50:1; extractant ethanol 60%);

excipients: lactose, magnesium stearate;

structure of empty capsules: gelatin, titan dioxide, azoruby (E 122), ponso 4R (E 124).

Dosage form.

Capsule.

Main physical and chemical properties: solid gelatin capsules No. 1 of a cylindrical form with the hemispherical ends, the body — white color, a lid — red color. Contents of capsules — powder of yellowy-brown color with a specific smell.

Pharmacotherapeutic group.

Means, applied in dementia. code atkh n06d x02.

Pharmacological properties.

Pharmacodynamics.

.

Active ingredient – standardized extract of a ginkgo of a bilob: 24% of heterosites and 6% of di - and sequiterpenes (a ginkgolida of A, B and C and bilobalid).

At the person described only pharmacokinetic parameters of terpenic fraction.

Pharmacokinetics.

Bioavailability of ginkgolid of A and B and bilobalid at oral administration is 80 — 90%. The maximum concentration is reached within 1–2 hours; elimination half-life makes of 4 o'clock (bilobalid, ginkgolid A) till 10 o'clock (ginkgolid C).

These substances in an organism do not break up and are almost completely removed with urine, and the insignificant quantity is removed with a stake.

Clinical characteristics.

Indication.

• Symptomatic treatment of cognitive disorders at patients of advanced age, except for patients with the confirmed dementia, Parkinson's disease, cognitive disorders of iatrogenic origin or arisen owing to a complication of a depression, vascular disorders, disbolism. the accompanying treatment vertigo vestibular origin together with vestibular rehabilitation. symptomatic treatment of a ring in ears.

Contraindication.

Hypersensitivity to medicament components.

Interaction with other medicines and other types of interactions.

potentiation or inhibition of isoenzymes of cytochrome r450. level of concentration of midazolam changed after a concomitant use of a ginkgo of a bilob (egb 761) that allows to allow existence of interaction through cyp3a4. therefore medicines which are generally metabolized through cyp3a4 and have the narrow therapeutic index, it is necessary to apply with care.

Feature of use.

Is recommended to be watched patients who at the same time take the medicaments which are metabolized cytochrome r450 3a4 attentively. messages about abuse of a ginkgo of a bilob (egb 761) are absent. proceeding from pharmacological characteristics of drug, the ginkgo of a bilob (egb 761) has no potential for abuse.

Drug contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is not necessary to use drug.

Use during pregnancy or feeding by a breast.

Due to the lack of clinical data medicament is not recommended to be used during pregnancy or feeding by a breast.

Ability to influence speed of response at control of motor transport or other mechanisms.

Researches on assessment of the impact on speed of response at control of motor transport or other mechanisms was not carried out. however dizziness can worsen ability to run motor transport or other mechanisms.

Route of administration and doses.

For oral administration.

on 1 capsule 3 times a day at meal time. To wash down with a half of a glass of water.

Course of treatment is defined by the doctor individually.

Children.

to children.

Overdose.

Information concerning overdose of drug.

Side reactions.

Occasionally observe such side reactions:

from a digestive tract: digestive disturbance, dyspepsia, diarrhea, abdominal pain, nausea, vomiting;

from the immune system: reactions of hypersensitivity, including a Quincke's disease, a small tortoiseshell, an asthma;

from skin: inflammation of skin, reddening, hypostasis, rash, itching, eczema;

from nervous system: headache, dizziness, syncope (including vazovagalny).

Expiration date.

2 years.

Storage conditions.

in the dry, cool, protected from light place.

out of children's reach.

Packing.

On 10 capsules in the blister; on 3 or 6 blisters in a box.

Category of release.

Without prescription.

Producer.

LLC astrafarm.

Location of the producer and place of implementation of its activity.

Ukraine, 08132, Kiev Region, kiyevo-svyatoshinsky district, cherry, st. Kiev, 6.