Description
Release form
Capsules
Packing
60 pcs.
Pharmacological action
Bilobil ® intens capsules contain a standardized extract of ginkgo biloba leaves, the effectiveness of which has been proven in randomized clinical trials involving patients with dementia, cerebrovascular insufficiency (vertigo, tinnitus), peripheral occlusion of the arteries.
The main active markers of dry extract of ginkgo biloba leaves are flavonglycosides and terpene lactones (ginkgolides and bilobalide).
In in vitro studies, the following pharmacological effects of ginkgo biloba extract were established: – prevention of the development of traumatic and toxic brain edema, inhibition of FAT (platelet activating factor), inactivation of toxic oxygen radicals
– increased hypoxic tolerance, prevention of age-related changes in cholinergic receptors and 2-adrenoreceptors , neuroprotective effect, improving blood perfusion, especially microcirculation, inactivation of toxic oxygen radicals, prevention the development of traumatic and toxic cerebral edema.
Mild or moderate dementia syndrome (primary degenerative dementia, vascular dementia or mixed form)
Numerous randomized, double-blind, placebo-controlled clinical trials of patients with dementia or cerebrovascular insufficiency after administration of 120-240 mg of dry extract of ginkgo biloba leaves per day showed an improvement in cognitive abilities, especially memory and attention. In a multicenter clinical study in 400 patients with Alzheimer’s disease, a statistically significant improvement in cognitive and non-cognitive symptoms of dementia was shown after 22 weeks of treatment with dry extract of ginkgo biloba leaves at a dose of 240 mg.In addition, compared with the placebo group, a significant improvement in the test series was observed SKT (Kurze syndrome test), neuropsychiatric symptoms of dementia, and improving the performance of basic self-care activities.
Peripheral occlusion of the artery
The effectiveness of the dry extract of ginkgo biloba leaves was confirmed in nine double-blind, placebo-controlled clinical trials in patients with peripheral occlusion of the arteries (Fontaine stage II).
Dry extract of ginkgo biloba leaves improves the symptomatology of intermittent claudication, which manifests itself as an increase in the distance of painless walking.
Indications
Symptomatic treatment for: cerebrovascular accidents and brain functions (dementia syndrome in primary degenerative dementia, vascular dementia or mixed form), manifested by decreased memory and mental performance, dizziness, tinnitus, apathy, headache and sleep disturbance
the initial stage of circulatory disturbance of the extremities, manifested by a feeling of cold, tingling, numbness, pain when walking.
Contraindications
Hypersensitivity to ginkgo biloba extract or other components of the drug.
Use during pregnancy and lactation
Data on the possibility and safety of the drug during pregnancy and during breastfeeding are not available.
Special instructions
Before taking Bilobil Intens capsules, you need to make sure that the symptoms presented in the indications section are not the result of another underlying disease that requires specific treatment.
In case of hypersensitivity reactions, stop taking the capsules.
Before surgery, the patient must inform the doctor that he is taking Bilobil Intens capsules.
Patients with a tendency to spontaneous bleeding (hemorrhagic diathesis) and patients taking drugs to prevent increased blood clotting should consult a doctor before treatment with Bilobil Intens capsules.
patients, taking hypoglycemic and antihypertensive drugs, before starting treatment with Bilobil Intens, they should consult a doctor.
The drug contains lactose and glucose. Patients with rare hereditary galactose intolerance, a deficiency of the lactase enzyme, or glucose / galactose malabsorption syndrome should not take this drug.
Pediatric use
Bilobil Intens is not recommended for children because of limited safety data for this category of patients.
Composition
1 capsule contains dry, purified and standardized extract of leaves of ginkgo biloba (35-67: 1) 120 mg, incl. flavonoids (in the form of flavonic glycosides) 26.4-32.4 mg, ginkgolides A, B, C 3.36-4.08 mg, bilobalide 3.12-3.84 mg,
Dosage and administration of
In cases of cerebrovascular accident and brain function (dementia syndrome in primary degenerative dementia, vascular dementia or mixed form), 1 capsule is prescribed. 2 times / day in the morning and in the evening.
At the initial stage of circulatory disturbance of the extremities – 1 caps. 1 time / day, preferably in the morning.
Capsules should be swallowed whole, washed down with water, regardless of food intake.
The first signs of improvement usually appear 1 month after the start of treatment. To achieve a long-term effect, especially recommended for elderly patients, the course of treatment should be carried out for at least 3 months. A second course is possible after consultation with a doctor.
If you miss the time for the next dose of Bilobil ® Intens, take the capsule as soon as possible. If the time has already come for the next dose of Bilobil ® Intens, you should not take the drug in a double dose, but you need to continue taking it in the usual way.
Side effects of the
Digestive system: very rare (
CNS side: very rare (
Allergic reactions: very rare (
Side effects that may be recovered during the course of the following groups, depending on the frequency of occurrence: very frequent (> 1/10), frequent (> 1/100 to 1/1000 to 1/10 000 to
Within each group, the side effects of the drug are presented in decreasing order of importance.
Drug Interactions
Drug interaction studies have been conducted in adult patients.
Concomitant use of Bilobil Intens is not recommended with the following drugs:
– drugs that reduce blood coagulation (coumarin anticoagulants, acetylsalicylic acid and other NSAIDs).
Concomitant treatment with these drugs may increase the risk of bleeding due to prolonged blood clotting times.
The simultaneous use of Bilobil Intens with the following drugs requires special care:
– anticonvulsants (eg, phenytoin).
Co-administration of these drugs can lower the seizure threshold and increase the likelihood of developing an epilepsy attack. In vitro dry extract of ginkgo biloba leaves significantly increased the metabolism of anticonvulsants, which proceeds with the participation of CYP2C enzymes.
– drugs metabolized by the cytochrome P450 enzyme system.
Based on the results of studies, the interaction of ginkgo biloba extract with drugs metabolized by the cytochrome P450 enzyme system cannot be completely ruled out.
Overdose
There have been no reports of overdose with Bilobil intensities at the moment. No reports of poisoning with standardized dry ginkgo biloba leaf extract have been obtained in humans.
Storage Conditions
The product should be stored out of the reach of children, protected from moisture, at a temperature not exceeding 25 ° C.
Shelf life
2 years.
Active ingredient
Ginkgo double bladed leaf extract
dosage form
capsules
Appointment
Appointment
Adult
KRKA d.d. Novo mesto AO, Slovenia
