Instructions Memoplant forte film-coated tablets 80 mg No. 20
Composition
active ingredient: dry extract (EGb 761®) from Ginkgo biloba leaves;
1 film-coated tablet contains 80 mg of dry extract (EGb 761®) from Ginkgo biloba leaves (35-67:1), standardized to 17.6-21.6 mg of ginkgo flavone glycosides and to 4.32-5.28 mg of terpene lactones, of which 2.24-2.72 mg are ginkgolides A, B, C and 2.08-2.56 mg are bilobalide and not more than 0.4 μg of ginkgolic acids [extractant: acetone 60% (m/m)];
excipients: lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 1500, titanium dioxide (E 171), red iron oxide (E 172), brown iron oxide (E 172), antifoam emulsion SE 2 (dimethicone, colloidal anhydrous silica, macrogol stearic ester, sorbic acid), talc.
Dosage form
Film-coated tablets.
Main physicochemical properties: red, smooth, round tablets, film-coated.
Pharmacotherapeutic group
Drugs used in dementia. ATX code N06D X02.
Pharmacological properties
Pharmacodynamics
A herbal preparation that normalizes cellular metabolism, blood rheological properties, and microcirculation. Improves cerebral blood flow and oxygen and glucose supply to the brain, 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 vascular wall permeability (anti-edema effect both at the brain and peripheral levels). 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 lipid peroxidation of cell membranes. Normalizes the release, reabsorption and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to combine with 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 (EGb 761®): 24% heterosides 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 deficit of various genesis (dyscirculatory encephalopathy (dementia), due to stroke, traumatic brain injury, in old age, manifested by attention and/or memory disorders, decreased intellectual abilities, feelings of fear, sleep disturbances);
intermittent claudication in chronic obliterating arteriopathy of the lower extremities (Fontaine stage II);
Hearing impairment, tinnitus, dizziness and coordination disorders, mainly of vascular origin.
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
When used simultaneously with anticoagulants (e.g. phenprocoumon, warfarin) or antiplatelet agents (e.g. clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs), the effect of the latter may be enhanced.
The results of studies on concomitant use with warfarin do not indicate the presence of an interaction, however, appropriate monitoring is recommended at the beginning of therapy, when changing the dosage, discontinuing use or replacing the drug.
Interaction studies with talinolol have shown that Ginkgo biloba leaf extract may inhibit the activity of P-glycoprotein in the gastrointestinal tract. This may lead to increased intestinal levels of drugs that are metabolized by P-glycoprotein, such as dabigatran etexilate. Caution is advised when combining drugs containing Ginkgo biloba leaf extract with dabigatran.
In one interaction study, it was found that the Cmax of nifedipine was increased when co-administered with the extract. In some individuals, the increase reached 100%, leading to dizziness and increased severity of hot flashes.
Interactions with anticoagulants cannot be excluded. In a placebo-controlled, double-blind study conducted in 50 subjects over 7 days, no interaction was found between EGb 761® (daily dose 240 mg) and acetylsalicylic acid (daily dose 500 mg).
Application features
The first signs of improvement appear 1 month after the start of treatment.
Before starting treatment with Memoplant Forte, it is necessary to determine whether the pathological symptoms observed are a consequence of an underlying disease that requires specific treatment.
If dizziness and tinnitus occur frequently, you should always consult a doctor. In case of sudden hearing loss or hearing impairment, you should consult a doctor immediately.
In case of pathologically increased bleeding tendency (hemorrhagic diathesis), as well as in case of simultaneous use of anticoagulants, the drug should be taken only after consulting a doctor.
Preparations containing ginkgo biloba extract may increase the tendency to bleed, so their use should be discontinued 3-4 days before surgery.
In patients with epilepsy, an increase in epileptic seizures caused by taking medications containing Ginkgo biloba leaf extract cannot be ruled out.
The concomitant use of drugs containing ginkgo biloba extract and efavirenz is not recommended.
Since this medicinal product contains lactose, it is contraindicated in patients with congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency.
Use during pregnancy and 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 or operating other machinery.
Method of administration and doses
Take 1 tablet 2 times a day with meals. Wash down with ½ glass of water. The average duration of the treatment course is 3 months.
Children.
There is insufficient experience with the use of the drug in children.
Overdose
There is no information on overdose of the drug. Overdose may increase side effects.
Side effects
Possible side effects:
Blood and lymphatic system: bleeding in individual organs (eyes, nose, cerebral and gastrointestinal bleeding) has been reported;
– from the digestive tract, including dyspeptic phenomena, nausea, vomiting;
– from the nervous system: headache, dizziness;
Immune system disorders: hypersensitivity reactions, including angioedema, urticaria, dyspnoea.
Skin: skin inflammation, redness, swelling, itching, rash, eczema.
If any adverse reactions occur, you should stop taking the drug and consult a doctor.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C in a place inaccessible to children.
Packaging
10 film-coated tablets in a blister; 2 or 3 blisters in a cardboard box.
20 film-coated tablets in a blister; 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Wilmar Schwabe GmbH & Co. KG.
Address
Wilmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.
