Memoplant

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEMOPLANT MEMOPLANTÒ

Composition:

Active substance: dry extract (EGb 761®) from leaves of Ginkgo biloba (35−67:1), standardized to 8.8−10.8 mg of ginkgo flavonoid glycosides and 2.0−2.8 mg of terpene lactones, of which 1.12−1.36 mg are ginkgolides A, B, and C and 1.04−1.28 mg is bilobalide, and not more than 0.2 μg of ginkgolic acids, extraction solvent: acetone 60% (m/m);

One film-coated tablet contains 40 mg of dry extract (EGb 761®) from leaves of Ginkgo biloba (35−67:1), standardized to 8.8−10.8 mg of ginkgo flavonoid glycosides and 2.0−2.8 mg of terpene lactones, of which 1.12−1.36 mg are ginkgolides A, B, and C and 1.04−1.28 mg is bilobalide, and not more than 0.2 μg of ginkgolic acids, extraction solvent: acetone 60% (m/m);

Excipients: sodium croscarmellose, anti-adherent agent SE 2, colloidal anhydrous silicon dioxide, hypromellose, lactose monohydrate, macrogol 1500, magnesium stearate, corn starch, microcrystalline cellulose, talc, titanium dioxide (E 171), yellow iron oxide (E 172), and yellow iron hydroxide (E 172).

Pharmaceutical form.

Film-coated tablets.

Main physicochemical properties: yellow, smooth, round film-coated tablets.

Pharmacotherapeutic group.

Drugs used in dementia. ATC code N06DX02.

Pharmacological Properties

Pharmacodynamics

A plant-derived medication that normalizes cellular metabolism, blood rheological properties, and microcirculation. It improves cerebral blood flow and enhances oxygen and glucose supply to the brain, prevents erythrocyte aggregation, and inhibits platelet-activating factor. It exerts a dose-dependent regulatory effect on the vascular system by stimulating the production of endothelium-derived relaxing factor (nitric oxide – NO), dilates small arteries, increases venous tone, thereby regulating vascular blood filling. Reduces vascular wall permeability (exerts anti-edematous effect both in the brain and peripherally). Exerts antithrombotic action by stabilizing platelet and erythrocyte membranes, influencing prostaglandin synthesis, and reducing the effects of biologically active substances and platelet-activating factor. Prevents the formation of free radicals and lipid peroxidation of cellular membranes. Normalizes the release, reuptake, and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors. Exerts an anti-hypoxic effect, improves metabolism in organs and tissues, promotes accumulation of macroergic compounds in cells, enhances utilization of oxygen and glucose, and normalizes neurotransmitter processes in the central nervous system.

Pharmacokinetics

Active substance: standardized dry extract of Ginkgo biloba (EGb 761®) containing 24% flavone glycosides and 6% terpene lactones (ginkgolides A, B, and bilobalide).

Pharmacokinetic parameters of terpene fractions only have been studied in clinical trials involving volunteers. After oral administration, the bioavailability of ginkgolides A, B, and bilobalide C ranges between 80–90%. Maximum plasma concentration is reached within 1–2 hours after drug intake. Elimination half-lives are approximately 4 hours (bilobalide, ginkgolide A) and 10 hours (ginkgolide B).

These substances are not metabolized in the body and are almost completely excreted in urine; a small amount is excreted in feces.

Clinical characteristics.

Indications.

• Cognitive deficits of various etiologies (due to dyscirculatory encephalopathy, stroke, traumatic brain injury, in elderly patients), manifested by disturbances of attention and/or memory, decline in intellectual abilities, feelings of fear, and sleep disturbances; and neurosensorial deficits of various etiologies (age-related macular degeneration, diabetic retinopathy);
• Intermittent claudication in chronic occlusive arteriopathies of the lower limbs (Fontaine stage II);
• Hearing disorders, tinnitus, dizziness, and coordination disorders, predominantly of vascular origin.

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

Interactions with medicinal products that inhibit blood coagulation cannot be excluded. In a placebo-controlled, double-blind study lasting 7 days involving 50 volunteers, no interaction was detected between EGb 761® (daily dose 240 mg) and acetylsalicylic acid (daily dose 500 mg).

Special precautions for use.

The first signs of improvement appear after 1 month from the beginning of treatment.

Since this medicinal product contains lactose, it is contraindicated in patients with congenital galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency.

Seizure episodes may possibly be provoked by taking medicinal products containing Ginkgo biloba extract in patients suffering from epilepsy. However, a causal relationship between the occurrence of seizures and administration of the drug has not been established.

Use during pregnancy and lactation.

Due to the lack of clinical data, the drug is not recommended for use during pregnancy or breastfeeding.

Ability to affect reaction speed while driving or operating machinery.

During treatment, caution should be exercised when driving or operating other machinery.

Method of administration and dosage.

Administer 1 tablet 3 times daily during meals. Swallow with ½ glass of water. The average duration of treatment is 3 months.

Children.

There is insufficient experience regarding the use of the drug in children.

Overdose.

There is no information available regarding overdose of the drug.

Side effects.

Possible side effects:

• Gastrointestinal disorders, including dyspeptic symptoms, nausea, vomiting;
• Nervous system disorders: headache, dizziness;
• Immune system disorders: hypersensitivity reactions, including angioneurotic edema, urticaria, dyspnea;
• Skin disorders: dermatitis, redness, swelling, itching, rash, eczema.

After prolonged treatment with Memoplant, bleeding has been observed in individual cases.

Shelf life. 5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in places inaccessible to children.

Packaging.

Blister packs of 10 tablets; 2 blisters per cardboard box. Blister packs of 20 tablets; 3 blisters per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Dr. Willmar Schwabe GmbH & Co. KG.

Manufacturer's address and location of business operations:

Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.