Memorin® neo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEMORIN® NEO (MEMORINNEO)

Composition:

Active ingredient: 1 capsule contains 40 mg of dry extract of ginkgo biloba leaves (Ginkgo biloba L., folium) (35–67:1) (extraction solvent — ethanol-water (65:35)), containing:

– 8.8–10.8 mg flavonoids as flavonoid glycosides;

– 1.12–1.36 mg ginkgolides A, B, C;

– 1.04–1.28 mg bilobalides;

Excipients: lactose monohydrate; magnesium stearate;

Gelatin capsule: gelatin, titanium dioxide (E171), iron oxide (E172), azorubine (E122).

Pharmaceutical form. Capsules.

Main physicochemical characteristics: hard gelatin capsules with light yellow bodies and pink caps. The capsule contents consist of powder ranging from light brown to dark brown in color, containing small particles of light to dark color. Agglomeration of particles may be present.

Pharmacotherapeutic group.

Agents used in diseases of the nervous system. Other agents for the treatment of dementia. ATC code N06DX02.

Pharmacological Properties.

Pharmacodynamics.

The mechanism of action is unknown.

Pharmacological data indicate that Ginkgo biloba extract promotes increased alertness in elderly patients based on electroencephalography results, reduces blood viscosity, enhances vascularization in certain areas of the brain in healthy men (aged 60–70 years), and also causes a reduction in platelet aggregation. In addition, a vasodilatory effect on forearm blood vessels has been observed, leading to an increase in circulating blood volume.

Pharmacokinetics.

Following oral administration of 120 mg of Ginkgo biloba extract, maximum plasma concentrations of terpene lactones reached 16–22 ng/mL for ginkgolide A, 8–10 ng/mL for ginkgolide B, and 27–54 ng/mL for bilobalide. The corresponding elimination half-lives of ginkgolides A and B and bilobalide were 3–4, 4–6, and 2–3 hours, respectively. The elimination half-life of ginkgolide A was 5 hours, ginkgolide B — 9–11 hours, and bilobalide — 3–4 hours.

Clinical characteristics.

Indications.

Symptomatic treatment of cognitive disorders in elderly patients, excluding patients with confirmed dementia, Parkinson's disease, iatrogenic cognitive disorders, or those arising as a result of complications of depression or metabolic disturbances.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Pregnancy period.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with anticoagulants (e.g., phenprocoumon, warfarin) or antiplatelet agents (e.g., clopidogrel, acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs), the effect of the latter may be enhanced — increasing the risk of bleeding.

Results of studies on concomitant use with warfarin do not indicate the presence of interaction; however, appropriate monitoring is recommended at the beginning of therapy, when changing dosage, discontinuing treatment, 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 levels in the intestine of drugs metabolized by P-glycoprotein, such as dabigatran etexilate. Caution is recommended when combining medicinal products containing Ginkgo biloba leaf extract and dabigatran.

In one interaction study, the Cmax of nifedipine was increased when co-administered with Ginkgo biloba leaf extract. In some individuals, the increase reached 100%, leading to dizziness and worsening of flushing severity.

Concomitant use of medicinal products containing Ginkgo biloba leaf extract and efavirenz is not recommended; plasma concentrations of efavirenz may decrease due to induction of CYP3A4.

Ginkgo biloba leaf extract increases the metabolism of antiepileptic drugs metabolized via the CYP2C system. During concomitant therapy, antiepileptic agents (valproate, phenytoin) may reduce the seizure threshold, increasing the likelihood of epileptic seizures.

Interaction of Ginkgo biloba leaf extract with drugs metabolized by the cytochrome P450 enzyme system cannot be completely excluded (in individual cases, inhibition or induction of certain isoenzymes is possible).

Results of interaction studies with Ginkgo biloba products have demonstrated potentiation or inhibition of cytochrome P450 isoenzyme activity. Midazolam concentration changed after concomitant administration of Ginkgo biloba product, suggesting possible interaction via CYP3A4. Therefore, medicinal products that are primarily metabolized by CYP3A4 and have a narrow therapeutic index should be used with caution.

Special precautions for use.

Patients who are concurrently taking drugs metabolized by cytochrome P450 3A4 should be carefully monitored. There is no evidence of abuse potential with Ginkgo biloba preparations. Given the pharmacological profile of the drug, Ginkgo biloba has no potential for abuse.

ME morin® NEO contains lactose. Patients with intolerance to certain sugars should consult their physician.

ME morin® NEO capsules contain the azo dye azorubine (E 122), which may cause allergic reactions.

Patients with a predisposition to bleeding (hemorrhagic diathesis) who are receiving concomitant therapy with anticoagulants and antiplatelet agents should consult their physician before using this medicinal product.

Since Ginkgo biloba preparations may increase the risk of bleeding, their use should be discontinued 3–4 days prior to surgical intervention.

In patients with epilepsy, the possibility of seizures associated with the use of Ginkgo biloba medicinal products cannot be excluded.

Concomitant use of Ginkgo biloba preparations with efavirenz is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

Use during pregnancy or breastfeeding.

Pregnancy

Ginkgo biloba extract may reduce platelet aggregation. The tendency to bleeding may increase. Animal studies are insufficient to draw conclusions regarding reproductive toxicity.

The medicinal product is contraindicated during pregnancy.

Breastfeeding

There are no data on whether Ginkgo metabolites are excreted in breast milk. Risk to newborns and infants cannot be excluded.

Due to the lack of sufficient data, use of this medicinal product during breastfeeding is not recommended.

Fertility

No specific studies on the effect of Ginkgo biloba on human fertility have been conducted. However, certain effects were observed in female mice.

Ability to influence reaction speed when driving or operating machinery.

Studies on the effect on reaction speed when driving or operating machinery have not been conducted. However, dizziness may impair the ability to drive or operate machinery.

Dosage and Administration.

Take 1 capsule three times daily during meals. Swallow the capsules whole with ½ glass of water. The treatment course should last at least 8 weeks. If there is no improvement in condition after 3 months of treatment, or if the condition worsens, consult a physician regarding further management.

Children.

Do not use in children.

Overdose.

There is no information available regarding overdose. In case of overdose, adverse reactions may be intensified.

Adverse reactions.

The frequency of adverse reactions is categorized as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated based on available data). According to clinical trial data, the most common adverse reactions (≥ 5%) were abdominal pain, diarrhea, and dizziness.

If any adverse reactions occur, treatment must be discontinued and medical advice should be sought.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC. Keep out of reach of children.

Packaging.

10 capsules per blister pack, 3 blister packs per carton.

Supply category.

Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4 Korolova St., Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.