Biloba 40 mg. 60 capsules
Biloba 40 mg. 60 capsules
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains:
Ginkgo bilobae folii extractum sicc, (dry extract of ginkgo leaves) 40 mg (9.6 mg standardized ginkgo flavonoid glycosides and terpene lactones 2.4 mg (ginkgolidi and bilobalide))
3 PHARMACEUTICAL FORM
4 CLINICAL DATA
For the symptomatic treatment of age-related disorders of the circulatory system and brain function.
• loss of memory and intellectual abilities
• discomfort and anxiety
• sleep disorder.
Primary disorder of blood supply to the extremities.
4.2. Dosage in the method of administration
Those adults should take 1 capsule 3 times daily after meals. The capsules should be swallowed with water.
The first signs of improvement usually observed after 1 month of treatment. For long-acting effect caution should be taken for at least 3 months, especially in elderly patients.
Hypersensitivity to ginkgo extract or any of the ingredients of the drug.
4.4. Special precautions for use
If an allergic reaction the capsules should be preustanoveno.Upotrebata Bilobil capsules is not recommended in children
4.5. Is reacted with other medicinal products and other forms of interaction
Until now, there were no interactions with other drugs
4.6. Pregnancy and lactation
There are no clinical data on the use of the drug during pregnancy and lactation. Animal studies do not indicate any adverse effect on the fetus, but it is not recommended the use of the drug by pregnant and nursing mothers.
4.7. Effects on ability to drive and use machines
Not observed impact on the ability to drive or operate machinery.
4.8. side effects
Only in rare cases use the capsules can be observed gastrointestinal disorders, headaches and skin hypersensitivity reactions.
No reported cases of intoxicated extract of ginkgo.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Bilobil capsules contain a standardized extract from the leaves of dichotomous ginkgo (Ginkgo biloba L.). The main active ingredients of the extract are flavones, i.e. flavonoid glycosides, terpene ginkgolide and bilobalide. These substances dilate blood vessels, improve blood circulation, inhibit platelet aggregation and to regulate metabolism, protect cells and tissues from damage due to lack of oxygen. Various studies have established these pharmacological effects of ginkgo extract: improve blood circulation, especially microcirculation; improve tolerance to hypoxia; prevention of traumatic or toxic cerebral edema; prevention of age-related reduction holinoretseptorite and a2 -adrenotseptorite; better learning ability and memory; improve the flow of blood; inactivation of toxic oxygen radicals (flavonoids); suppression trombotsitoaktivirashtiya factor-PAF (ginkgolides); neuroprotective effect (partly bilobalide and ginkgolides).
Shown positive effects in experimental models of ischemia, hypoxia and edema is manifested by improvement after behavioral, and neurological disorders caused by damage to the brain cells.
Pharmacokinetics studies of extract of ginkgo is difficult because of its complex sastav.Pri study in rats with extract showed that 60% of the dose adopted by mouth, is absorbed first peak blood concentration is reached after 1.5 hours, and the second after 12 hours, indicating passage through the gut and liver. The biological half-life is about 4.5 hours was found that after 72 hours 38% of the orally administered extract of ginkgo is eliminated through the lungs, 22% in urine and 29% in faeces. It was found that Ginkgo flavonoid glycosides are absorbed in human intestine. It was also found that their maximum concentration is reached after 2 hours, the half-life of the glycoside is from 2 to 4 hours and the entire dose is eliminated within 24 hours
5.3 Predklinichin safety data
Toxicology studies revealed that the extract of ginkgo is practically non-toxic. Study on acute toxicity of our extract orally in mice showed that LD50 greater than 5 g / kg body weight. During the study there were no deaths sluchai.Pri study in mice with a similar extract, taken orally, the oral LD50 was 7725 mg / kg body weight in rats and it was impossible to determine LD5o, since the dose to 10 g / kg caused no death in experimental animals. Been traced chronic toxicity in rats and dogs for more than 6 months studies have not shown any biochemical, histological hemotologichni or damage, nor any signs of impaired hepatic or renal funktsiya.Pri conducted animal studies to date have not been established carcinogenicity, mutagenicity and reproductive toxicity of extract of ginkgo.
6 PHARMACEUTICAL PARTICULARS
6.1. List of ingredients
Excipients and their amounts
Lactose Monohydrate 66.0 mg
Maize Starch 30.0 mg
Talc 8.0 mg
Colloidal Anhydrous Silica 2.0 mg
Magnezium Stearate 2.0 mg
Titanium dioxide (E171) 2.000%
Sunset yellow (E110) 0.1314%
Ponceau 4 R (E 124) 0.2491%
Brilliant black (E 151) 0.0498%
Patent blue V (E 131) 0.0131%
Methyl hydrobenzoate 0.2945%
Propil hydrobenzoate 0.1241%
He is known.
6.3. Shelf life
6.4 Special precautions for storage
Store in a dry place at temperatures up to 25 C.
6.5. Packaging Data
Blister pack (aluminum foil / PVC foil): 20 capsules 60 capsules
6.6. Instructions for use
No special requirements.