Memantal pills 10mg, 30pcs

Composition

1 film-coated tablet contains: Active ingredient: memantine hydrochloride 10.00 mg; excipients: – core tablet – lactose monohydrate 149,75 mg, microcrystalline cellulose of 27.10 mg, talc 11,15 mg, silicon dioxide colloid 1.25 mg, magnesium stearate 0.75 mg;shell Opadry® white (lactose monohydrate of 2.16 mg,1.68 mg hypromellose, titanium dioxide 1,56 mg, macrogol-4000 0,60 mg) at 6.00 mg.

Pharmacological properties

Pharmacotherapeutic group: dementia means liceneced ATX: N06DX01 Pharmacological properties. Nootropic, cerebrovasculature, antihypoxic and psychoactive effect. A derivative of adamantane, the chemical structure and pharmacological properties are similar to amantadine. Blocks glutamate N-methyl-D-aspartate receptors (NMDA receptors) (including in the substantia nigra), thereby reducing the excessive stimulating effect of cortical glutamate neurons on the neostratum, which develops against the background of insufficient dopamine release. Reducing the flow of ionized calcium into neurons reduces the possibility of their destruction. To a greater extent, it affects stiffness (rigidity and bradykinesia). Improves impaired memory, concentration, reduces fatigue and symptoms of depression, reduces spasticity caused by diseases and brain damage. Pharmacokineticsafter oral use, memantine is rapidly and completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached within 2-6 hours. No accumulation of memantine was observed in normal renal function. Elimination proceeds in two phases. The elimination half-life is on average 4-9 hours in the first phase, and 40-65 hours in the second phase. About 80% of memantine is excreted unchanged. The metabolites do not have their own pharmacological activity. It is excreted in the urine. With an alkaline reaction of urine, excretion slows down.

Indications

Moderate to severe dementia in Alzheimer’s disease.

Contraindications

Individual hypersensitivity to the drug, severe renal impairment (creatinine clearance less than 5-29 ml / min), severe hepatic insufficiency, pregnancy, breastfeeding, children under 18 years of age (efficacy and safety have not been established); lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (the drug contains lactose monohydrate). Use with caution in patients with thyrotoxicosis, epilepsy, seizures (including in the anamnesis); simultaneous use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (sudden change of diet, heavy intake of alkaline gastric buffers), severe urinary tract infections, a history of myocardial infarction, heart failure (III-IV functional class). NYHA class), uncontrolled arterial hypertension, renal and hepatic insufficiency.

Side effects

The frequency of adverse reactions was classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (From the central nervous system: often-headache, drowsiness, dizziness; rarely-confusion, hallucinations (mainly in patients with Alzheimer’s disease at the stage of severe dementia), gait disorders; very rarely-convulsions; frequency not established-psychotic reactions. From the digestive system: often-constipation; rarely-nausea, vomiting; frequency is not established-pancreatitis. From the cardiovascular system: rarely-arterial hypertension, venous thrombosis/thromboembolism. Other: rarely-fatigue, fungal infections. There are isolated reports of these adverse reactions occurring with the use of memantine in clinical practice: Dizziness, drowsiness, increased excitability, increased fatigue, anxiety, increased intracranial pressure, nausea, hallucinations, headache, impaired consciousness, muscle hypertonicity, gait disorders, depression, convulsions, psychotic reactions, suicidal thoughts, constipation, nausea, pancreatitis, candidiasis, increased blood pressure, vomiting, cystitis increased libido, venous thrombosis, thromboembolism, allergic reactions.

Interaction

When used concomitantly with levodopa preparations, dopamine receptor antagonists, and m-holinoblockers, the effect of the latter may be enhanced. When used concomitantly with barbiturates and neuroleptics, the effect of the latter may decrease. When used together, it can change (increase or decrease) the effect of dantrolene or baclofen, so the dosage of drugs should be selected individually. Concomitant use with amantadine, ketamine, phenytoin, and dextromethorphan should be avoided because of the increased risk of psychosis. Plasma concentrations of cimetidine, ranitadine, procainamide, quinidine, quinine and nicotine may increase when co-administered with memantine. It is possible to reduce the level of hydrochlorothiazide when combined with memantine. Memantine can increase the excretion of hydrochlorothiazide. An increase in MHO (International normalized ratio) may occur in patients taking oral anticoagulants (warfarin). Concomitant use with antidepressants, selective serotonin reuptake inhibitors, and monoamine oxidase inhibitors requires careful monitoring of patients.

How to take, course of use and dosage

The drug is taken orally, once a day, always at the same time, regardless of food intake. The dosage regimen is set individually. It is recommended to start treatment with the minimum effective dose. Prescribe the drug during the 1st week of therapy (days 1-7) at a dose of 5 mg/day, during the 2nd week (days 8-14)-at a dose of 10 mg/day, during the 3rd week (days 15-21) – at a dose of 15 mg/day, during the 4th week (days 22-28)-at a dose of 20 mg/day. The maximum daily dose is 20 mg. In patients over 65 years of age, as well as patients with creatinine clearance of 50-80 ml/min, no dose adjustment is required. For patients with moderate renal insufficiency (creatinine clearance 30-49 ml / min), the daily dose is 10 mg. In the future, if the drug is well tolerated for 7 weeks, the dose can be increased to 20 mg according to the standard scheme. Instructions for dividing tabletsmest the tablet with the rounded side on a hard surface with the risk up. Press the index finger and thumb of one of the hands on opposite sides of the tablet, continue to apply pressure with your fingers until the tablet breaks into two parts.

Overdose

Symptoms: dizziness, tremor, agitation, drowsiness, confusion, agitation, stupor, convulsions, psychosis, aggressiveness, hallucinations, vomiting, unsteady gait, diarrhea. Treatment: gastric lavage, taking activated charcoal, symptomatic therapy. There is no specific antidote.

Description

Pills:  round, biconvex, film-coated in white, with a wide risk on one side and markings “M9MN” and “10” on the other.

Special instructions

Use with caution in patients with thyrotoxicosis, epilepsy, seizures (including in the anamnesis); concomitant use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (sudden change of diet, heavy intake of alkaline gastric buffers), severe urinary tract infections, a history of myocardial infarction, heart failure (III-IV functional class according to NYHA classification criteria), uncontrolled arterial hypertension, renal and hepatic insufficiency. Effects on motor vehicle driving and mechanism managementin patients with Alzheimer’s disease at the stage of moderate or severe dementia, the ability to drive motor vehicles and manage complex mechanisms is usually impaired. In addition, memantine can cause changes in the reaction rate, so patients should refrain from driving vehicles or working with complex mechanisms.

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children!

Shelf

life is 3 years.

Active ingredient

Memantine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Consequences of stroke, Concussion and other traumatic brain injuries, Alzheimer’s disease, Acquired dementia, Alcoholism