Carrier tablets 10 mg N30

Release form: 10, 30, and 60 film-coated tablets along with instructions for use in a cardboard box.
Dosage form: Film-coated tablets 10 mg N10 (1×10), N30 (3×10), N60 (6×10) (blisters)

Composition: Each coated tablet contains:
Memantine hydrochloride 10.00 mg
Excipients: Cellactose 214.80 mg Lactose 12.20 mg Sodium croscarmellose 4.00 mg Talc 5.00 mg Magnesium stearate 1.60 mg Hydroxypropyl methyl cellulose 2.30 mg Povidone K30 0.35 mg Titanium dioxide 3.10 mg Sodium saccharin 0.15 mg Polyethylene glycol 6000 1.00 mg Propylene glycol 0.50 mg

Film-coated tablets 10 mg N10 (1×10), N30 (3×10), N60 (6×10) (blisters)

Glutamate is the main excitatory neurotransmitter in the brain. Glutamatergic overstimulation can cause neuronal damage (increased toxicity), which is a pathogenic mechanism in neurodegenerative diseases. Glutamate stimulates a number of postsynaptic receptors, including the N-methyl-O-aspartate (NMDA) receptor, which is particularly relevant to memory processes and the pathogenesis of dementia and Alzheimer's disease. Since memantine is a non-competitive NMDA receptor antagonist, it reduces glutamate hyperactivity, thereby exerting its therapeutic effect.

The drug is rapidly and completely absorbed after oral administration, reaching peak plasma levels in humans 6-8 hours after administration. These levels are not affected by food. The half-life of memantine ranges from 60 to 100 hours. It remains unchanged in elderly patients, even in those with impaired interneuronal impulse transmission. Only 45% of the drug binds to plasma proteins. Memantine is poorly metabolized, with 57%-82% of the administered dose excreted in the urine. The remaining 20%-40% is primarily converted into three polar metabolites with weak pharmacological activity, which are also excreted in the urine. Renal elimination involves active tubular secretion.

Cardiovascular system: Hypertension
Central and peripheral nervous system: Migraine, dizziness
Gastrointestinal tract: Vomiting, Constipation
Musculoskeletal system: Lumbago
Psychiatric disorders: Confusion, Drowsiness, Hallucinations
Respiratory system: Cough, Dyspnea

Other adverse reactions that occurred in less than 2% of patients included: agitation, fatigue, urinary incontinence, diarrhea, bronchitis, insomnia, urinary tract infection, flu-like symptoms, postural changes, depression, anxiety, peripheral edema, nausea, anorexia, and atralgia.

The following adverse reactions are not unique to memantine treatment; in most cases, adverse reactions were similar to those seen with placebo.
• General: Common: syncope. Rare: hypothermia, allergic reaction. • Cardiovascular system: Common: Heart failure.
Rare: Angina, bradycardia, myocardial infarction, thrombophlebitis, atrial fibrillation, hypertension, heart attack, hypotension, pulmonary embolism, pulmonary edema.
• Central and peripheral nervous system: Common: Transient ischemic attacks, cerebrovascular accidents, dizziness, ataxia, hypokinesia. Rare: Paresthesia, extrapyramidal disorders, hypertension, aphasia, hypoesthesia, impaired coordination, hemiplegia, hyperkinesia, involuntary muscle contractions, numbness, cerebral hemorrhage, neuralgia, ptosis, neuropathy.
• Gastrointestinal tract: Rare: gastroenteritis, diverticulitis, gastrointestinal hemorrhage, melena, esophageal ulcer.
• Hematopoiesis and lymphatic system disorders: Common: anemia.
Rare: leukopenia.
• ​​Metabolic and digestive disorders: Common: alkaline phosphatase increased, weight loss.
Rare: dehydration, hyponatremia, worsening of diabetes mellitus.
• Psychiatric disorders: Common: aggression.
Rare: delusion, personality disorder, emotional instability, nervousness, sleep disturbance, increased libido, psychosis, amnesia, apathy, paranoid reactions, abnormal thinking, abnormal crying, increased appetite, nightmares, delirium, depersonalization, neurosis, suicide attempts.
• Respiratory system: Common: pneumonia.
Rare: Dyspnea, asthma, hemoptysis.
• Skin and sensory organs: Common: Cataracts, conjunctivitis.
Rare: Macular degeneration, visual impairment, hearing impairment, tinnitus, blepharitis, blurred vision, corneal opacity, glaucoma, conjunctival hemorrhage, eye pain, retinal hemorrhage, ophthalmosclerosis, bifocal vision, myopathy, retinal detachment.
• Urinary system: Common: Increased urination.
Rare: Dysuria, hematuria, urinary retention.

This drug may impair alertness while driving or operating machinery. Given that only 20%-40% of the administered dose is metabolized by the liver, memantine's pharmacokinetics are likely to be slightly altered in patients with hepatic impairment. In patients with renal impairment, the dose should be reduced. Any condition (diet, treatment, clinical presentation, etc.) that causes urine alkalinization may promote accumulation of the drug. Therefore, memantine should be used with caution in these conditions.

Memantine may enhance the effect of neuroleptics, anticholinergics, L-dopa and dopaminergic agonists (L-antagonists, such as oromycin, and amantadine). The effect may be altered if the drug is used concomitantly with baclofen and dantrolene, and in those cases, the dose should be adjusted. The drug should be used with caution in combination with ISRS and IMAO antidepressants. Since memantine is partially eliminated through renal tubular secretion, co-administration of drugs that utilize the same renal cationic system, including hydrochlorothiazide, triamterene, cimetidine, ranitidine, quinidine, and nicotine, may potentially alter the levels of both drugs. However, co-administration of memantine and hydrochlorothiazide/triamterene does not affect the bioavailability of memantine and triamterene, while the bioavailability of hypochlorothiazide decreases by 20 %.

Store in a dry place at temperatures between 15°C and 30°C. Keep out of reach of children.
Shelf life: 24 months

Orally, with or without food intake (may be taken with meals). Dosage is individualized. It is recommended to begin therapy with the lowest effective dose.

Recommended regimen:
Week 1: 5 mg (1/2 tablet) once daily with breakfast
Week 2: 10 mg/day (5 mg with breakfast and 5 mg with an afternoon snack)
Week 3: 15 mg/day (10 mg with breakfast and 5 mg with an afternoon snack)
Week 4 and beyond: 20 mg/day (10 mg with breakfast and 10 mg with an afternoon snack)

There is evidence that, following an overdose of 400 mg of memantine, the patient experienced restless psychosis, visual hallucinations, drowsiness, stupor, and loss of consciousness. The patient's condition subsequently recovered. Treatment should be symptomatic. In case of a possible overdose, the patient should go to the nearest hospital or contact a poison control center.