Instructions for Bilobil Intense 120 mg capsules blister No. 60
Composition
active ingredients: 1 capsule contains dry extract of ginkgo biloba leaves (Ginkgo biloba L., folium) (35-67:1) containing:
– 26.4-32.4 mg of flavonoids in the form of flavone glycosides;
– 3.36-4.08 mg of ginkgolides A, B, C;
– 3.12-3.84 mg of bilobalide – 120 mg;
extractant - acetone;
excipients: lactose monohydrate, corn starch, talc, colloidal anhydrous silicon dioxide, magnesium stearate, glucose solution;
shell: gelatin, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172).
Dosage form
Capsules.
Main physicochemical properties: brown capsules. The capsules contain a light to dark brown powder with visible dark particles and possible small lumps.
Pharmacotherapeutic group
Means used for dementia. Ginkgo biloba. ATX code N06D X02.
Pharmacological properties
Pharmacodynamics
A herbal preparation that normalizes cell metabolism, blood rheological properties, and microcirculation.
Improves cerebral circulation and provides the brain with oxygen and glucose, prevents erythrocyte aggregation, inhibits platelet activation factor. Has a dose-dependent regulatory effect on the vascular system, stimulates the production of endothelium-dependent relaxing factor (nitric oxide–NO), dilates small arteries, increases venous tone, thereby regulating blood filling of vessels. Reduces the permeability of the vascular wall (anti-edema effect both at the level of the brain and on the periphery). Has an antithrombotic effect (due to stabilization of platelet and erythrocyte membranes, influence on prostaglandin synthesis, reduction of the action of biologically active substances and platelet-activating factor). Prevents the formation of free radicals and peroxidation of lipids of cell membranes. Normalizes the release, reabsorption and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors. Has an antihypoxic effect, improves metabolism in organs and tissues, promotes the accumulation of macroergs in cells, increases the utilization of oxygen and glucose, normalizes mediator processes in the central nervous system.
Pharmacokinetics
Active ingredient – standardized dry extract of ginkgo biloba: 24% heterosis and 6% ginkgolides-bilobalides (ginkgolide A, B and bilobalide C).
When administered orally, the bioavailability of ginkgolides A, B and bilobalide C is 80-90%. The maximum concentration is reached 1-2 hours after taking the drug. The half-lives are approximately 4 hours (bilobalide, ginkgolide A) and 10 hours (ginkgolide B).
These substances do not break down in the body, are almost completely excreted in the urine, and a small amount is excreted in the feces.
Indication
– Cognitive deficits of various genesis (dyscirculatory encephalopathy, due to stroke, traumatic brain injury, in old age, manifested by attention and/or memory disorders, decreased intellectual abilities, feelings of fear, sleep disturbances) and neurosensory deficits of various genesis (senile macular degeneration, diabetic retinopathy);
– intermittent claudication in chronic obliterating arteriopathy of the lower extremities (Fontaine stage II);
– visual impairment of vascular genesis, decreased visual acuity;
– hearing impairment, ringing in the ears, dizziness and impaired coordination, mainly of vascular origin;
– Raynaud's syndrome.
Contraindication
Hypersensitivity to ginkgo biloba extract or to any inactive component of the drug.
Interaction with other medicinal products and other types of interactions
Concomitant use with nonsteroidal anti-inflammatory drugs is not recommended.
The drug should not be taken if the patient is taking acetylsalicylic acid, warfarin, or thiazide diuretics for a long time.
When used simultaneously with drugs that inhibit blood coagulation (such as phenprocoumon and acetylsalicylic acid), the effect of the latter may be enhanced - the risk of bleeding increases.
The simultaneous use of ginkgo biloba extract with the following drugs requires special supervision:
– Ginkgo biloba increases the metabolism of antiepileptic drugs metabolized through the CYP2C enzyme system. With concomitant therapy, antiepileptic drugs (valproate, phenytoin) can reduce the seizure threshold, which increases the possibility of an epileptic seizure;
– drugs that are primarily metabolized by CYP34A and have a narrow therapeutic index should be used with caution;
– the interaction of ginkgo biloba extract with drugs metabolized through the cytochrome P450 enzyme system cannot be completely ruled out (in rare cases, there is a possibility of inhibition or induction of some isoenzymes).
Application features
The first signs of improvement appear 1 month after the start of treatment.
If an allergic reaction occurs, the patient should stop taking the drug.
Since there is evidence that drugs containing ginkgo biloba extract increase the tendency to bleed, taking this drug should be discontinued before surgery.
This medicine contains lactose and glucose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use during pregnancy or breastfeeding
Due to the lack of clinical data, the drug is not recommended for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, caution should be exercised when driving vehicles or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
Take 1 capsule 1-2 times a day with meals. Wash down with ½ glass of water. The average duration of the treatment course is 3 months.
Cognitive disorders: prescribe 1 capsule of 120 mg 1-2 times a day. The duration of treatment is at least 8 weeks. After 3 months of therapy, the doctor should check the need for further use of the drug.
Peripheral arterial occlusive disease, as well as dizziness of vascular and involutional origin: prescribe 1 capsule of 120 mg 1 time per day. The duration of treatment is at least 8 weeks.
For dizziness, the duration of therapy is no more than 6-8 weeks.
The duration of tinnitus treatment is at least 12 weeks.
Children
There is no sufficient experience with the use of the drug in children, therefore treatment of this category of patients is not recommended.
Overdose
In case of a single or repeated overdose of the drug, dyspeptic disorders, impaired consciousness and headache may occur. Treatment is symptomatic.
Adverse reactions
From the nervous system: headache, dizziness, syncope (including vasovagal).
On the part of the digestive tract: dyspeptic phenomena, nausea, vomiting, gastrointestinal disorders, diarrhea, abdominal pain.
Immune system disorders: hypersensitivity reactions or allergic reactions, including angioedema, urticaria, shortness of breath.
Skin: skin inflammation, redness, swelling, rash, itching, eczema.
In rare cases, the use of drugs containing ginkgo biloba extract can lead to hemorrhages (gastrointestinal, ocular, cerebral).
There is an increased likelihood of these side effects in the case of concomitant therapy with anticoagulants (e.g. phenprocoumon, acetylsalicylic acid, coumarin anticoagulants) and non-steroidal anti-inflammatory drugs.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging to protect from moisture. Keep out of the reach of children.
Packaging
10 capsules in a blister, 2 or 6 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto, Slovenia.
Location of the manufacturer and its business address
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
