Memaralid (Tablets) Instructions for Use

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

ATC Code

N06DX01 (Memantine)

Active Substance

Memantine (Rec.INN WHO registered)

Dosage Forms

	Memaralid	Orally Disintegrating Tablets 10 mg
		Orally Disintegrating Tablets 20 mg

Dosage Form, Packaging, and Composition

Orally Disintegrating Tablets

	1 tab.
Memantine hydrochloride	10 mg

10 pcs. – bottles – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (11 pcs.) – cardboard packs (110 pcs.) – By prescription
10 pcs. – blister packs (12 pcs.) – cardboard packs (120 pcs.) – By prescription
10 pcs. – blister packs (13 pcs.) – cardboard packs (130 pcs.) – By prescription
10 pcs. – blister packs (14 pcs.) – cardboard packs (140 pcs.) – By prescription
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – blister packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
100 pcs. – bottles – cardboard packs (100 pcs.) – By prescription
105 pcs. – bottles – cardboard packs (105 pcs.) – By prescription
110 pcs. – bottles – cardboard packs (110 pcs.) – By prescription
112 pcs. – bottles – cardboard packs (112 pcs.) – By prescription
120 pcs. – bottles – cardboard packs (120 pcs.) – By prescription
14 pcs. – bottles – cardboard packs (14 pcs.) – By prescription
14 pcs. – blister packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – blister packs (10 pcs.) – cardboard packs (140 pcs.) – By prescription
14 pcs. – blister packs (11 pcs.) – cardboard packs (154 pcs.) – By prescription
14 pcs. – blister packs (12 pcs.) – cardboard packs (168 pcs.) – By prescription
14 pcs. – blister packs (13 pcs.) – cardboard packs (182 pcs.) – By prescription
14 pcs. – blister packs (14 pcs.) – cardboard packs (196 pcs.) – By prescription
14 pcs. – blister packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
14 pcs. – blister packs (3 pcs.) – cardboard packs (42 pcs.) – By prescription
14 pcs. – blister packs (4 pcs.) – cardboard packs (56 pcs.) – By prescription
14 pcs. – blister packs (5 pcs.) – cardboard packs (70 pcs.) – By prescription
14 pcs. – blister packs (6 pcs.) – cardboard packs (84 pcs.) – By prescription
14 pcs. – blister packs (7 pcs.) – cardboard packs (98 pcs.) – By prescription
14 pcs. – blister packs (8 pcs.) – cardboard packs (112 pcs.) – By prescription
14 pcs. – blister packs (9 pcs.) – cardboard packs (126 pcs.) – By prescription
20 pcs. – bottles – cardboard packs (20 pcs.) – By prescription
21 pcs. – bottles – cardboard packs (21 pcs.) – By prescription
28 pcs. – bottles – cardboard packs (28 pcs.) – By prescription
30 pcs. – bottles – cardboard packs (30 pcs.) – By prescription
35 pcs. – bottles – cardboard packs (35 pcs.) – By prescription
40 pcs. – bottles – cardboard packs (40 pcs.) – By prescription
42 pcs. – bottles – cardboard packs (42 pcs.) – By prescription
49 pcs. – bottles – cardboard packs (49 pcs.) – By prescription
50 pcs. – bottles – cardboard packs (50 pcs.) – By prescription
56 pcs. – bottles – cardboard packs (56 pcs.) – By prescription
60 pcs. – bottles – cardboard packs (60 pcs.) – By prescription
63 pcs. – bottles – cardboard packs (63 pcs.) – By prescription
7 pcs. – bottles – cardboard packs (7 pcs.) – By prescription
7 pcs. – blister packs – cardboard packs (7 pcs.) – By prescription
7 pcs. – blister packs (10 pcs.) – cardboard packs (70 pcs.) – By prescription
7 pcs. – blister packs (11 pcs.) – cardboard packs (77 pcs.) – By prescription
7 pcs. – blister packs (12 pcs.) – cardboard packs (84 pcs.) – By prescription
7 pcs. – blister packs (13 pcs.) – cardboard packs (91 pcs.) – By prescription
7 pcs. – blister packs (14 pcs.) – cardboard packs (98 pcs.) – By prescription
7 pcs. – blister packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – blister packs (3 pcs.) – cardboard packs (21 pcs.) – By prescription
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
7 pcs. – blister packs (5 pcs.) – cardboard packs (35 pcs.) – By prescription
7 pcs. – blister packs (6 pcs.) – cardboard packs (42 pcs.) – By prescription
7 pcs. – blister packs (7 pcs.) – cardboard packs (49 pcs.) – By prescription
7 pcs. – blister packs (8 pcs.) – cardboard packs (56 pcs.) – By prescription
7 pcs. – blister packs (9 pcs.) – cardboard packs (63 pcs.) – By prescription
70 pcs. – bottles – cardboard packs (70 pcs.) – By prescription
77 pcs. – bottles – cardboard packs (77 pcs.) – By prescription
80 pcs. – bottles – cardboard packs (80 pcs.) – By prescription
84 pcs. – bottles – cardboard packs (84 pcs.) – By prescription
90 pcs. – bottles – cardboard packs (90 pcs.) – By prescription
91 pcs. – bottles – cardboard packs (91 pcs.) – By prescription
98 pcs. – bottles – cardboard packs (98 pcs.) – By prescription

Orally Disintegrating Tablets

	1 tab.
Memantine hydrochloride	20 mg

Clinical-Pharmacological Group

Glutamate NMDA-receptor blocker. Drug for the treatment of dementia

Pharmacotherapeutic Group

Psychoanaleptics; agents for the treatment of dementia; other agents for the treatment of dementia

Pharmacological Action

An agent for the treatment of dementia. It is a non-competitive antagonist of glutamate NMDA receptors (including in the substantia nigra), thereby reducing the excessive stimulatory influence of cortical glutamate neurons on the neostriatum, which develops against the background of insufficient dopamine release. By reducing the entry of Ca²⁺ into neurons, it reduces the possibility of their destruction.

It has nootropic, cerebrovasodilating, antihypoxic, and psychostimulating effects.

It improves weakened memory, increases the ability to concentrate, reduces fatigue and symptoms of depression, and reduces spasticity of skeletal muscles caused by brain diseases or injuries.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. C_max is reached in 3-8 hours. Plasma protein binding is 45%. When taken at a dose of 20 mg/day, C_ss of 70 to 150 ng/ml is achieved. V_d is 10 L/kg. Partially metabolized in the liver. Excreted by the kidneys. T_1/2 is 60-100 hours; clearance is 170 mL/min/1.73 m².

Indications

Moderate to severe dementia in Alzheimer’s disease.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F00	Dementia in Alzheimer's disease

ICD-11 code	Indication
6D80.Z	Dementia due to Alzheimer's disease, onset unknown or unspecified
6D8Z	Dementia, unknown or unspecified cause

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Initiate treatment with a 5 mg dose taken once daily.

Increase the dose in 5 mg increments each week.

Administer the maintenance dose as a single daily dose or in two divided doses.

The target therapeutic dose is 20 mg per day.

For improved tolerability, use a slower titration schedule if necessary.

Do not exceed the maximum daily dose of 20 mg.

For patients with moderate renal impairment, a maximum dose of 10 mg daily is recommended.

Take the tablets orally, with or without food.

Place the orally disintegrating tablet on the tongue; it will dissolve rapidly without water.

Do not split the orally disintegrating tablets.

Adhere strictly to the prescribed titration schedule to minimize adverse effects.

Adverse Reactions

From the immune system common – hypersensitivity reactions.

From the psyche common – drowsiness; uncommon – confusion, hallucinations (mainly observed in patients with Alzheimer’s disease at the severe dementia stage); frequency unknown – psychiatric reactions.

From the nervous system: common – dizziness, balance disorders; uncommon – gait disturbance; very rare – seizures.

From the cardiovascular system common – increased blood pressure; uncommon – heart failure, venous thrombosis and/or thromboembolism.

From the digestive system: common – constipation; uncommon – vomiting, nausea; frequency unknown – pancreatitis.

From the liver and biliary tract common – elevated liver enzyme levels; frequency unknown – hepatitis.

From the hematopoietic system frequency unknown – agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombocytopenic purpura.

Other common – headache, shortness of breath; uncommon – fungal infections, fatigue; frequency unknown – acute renal failure, Stevens-Johnson syndrome.

Contraindications

Hypersensitivity to memantine; severe hepatic impairment; pregnancy; lactation (breastfeeding); children and adolescents under 18 years of age (efficacy and safety of the drug have not been established).

With caution: epilepsy, thyrotoxicosis, predisposition to seizures, concurrent use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), factors that increase urine pH (sudden change in diet, e.g., switching to a vegetarian diet, heavy intake of alkaline gastric buffers), renal tubular acidosis, severe urinary tract infections caused by Proteus spp., myocardial infarction (in history), heart failure, uncontrolled arterial hypertension, renal failure, mild or moderate hepatic impairment (class A and B according to Child-Pugh classification).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated for use in severe hepatic impairment (class C according to Child-Pugh scale). Use with caution in mild or moderate hepatic impairment (class A and B according to Child-Pugh scale).

Use in Renal Impairment

Contraindicated for use in renal failure. Use with caution in renal tubular acidosis, severe urinary tract infections caused by Proteus spp.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age (efficacy and safety have not been established).

Special Precautions

Use with caution in patients with epilepsy, renal failure, thyrotoxicosis, history of seizures, arterial hypertension, history of myocardial infarction, heart failure.

Concurrent use of memantine and NMDA receptor antagonists such as amantadine, ketamine, or dextromethorphan should be avoided. These compounds act on the same receptor system as Memantine, therefore, adverse reactions (mainly related to the CNS) may occur more frequently and be more pronounced.

The presence of factors in the patient that affect the increase in urine pH (sudden changes in diet, for example, switching from a diet including animal products to a vegetarian diet, or intensive consumption of alkaline gastric buffers), as well as renal tubular acidosis or severe urinary tract infections caused by Proteus spp., require careful monitoring of the patient’s condition.

Effect on ability to drive vehicles and machinery

Patients with Alzheimer’s disease at the stage of moderate or severe dementia usually have impaired ability to drive vehicles and operate complex machinery. In addition, Memantine may cause changes in reaction speed, so patients should refrain from driving vehicles or working with complex machinery.

Drug Interactions

With concurrent use, Memantine may reduce the effects of barbiturates and neuroleptics.

The action of baclofen and dantrolene may be altered under the influence of memantine (with this combination, dose adjustment may be required).

The effects of levodopa, dopamine receptor agonists, and anticholinergic agents are enhanced with the concurrent use of NMDA receptor antagonists.

Since Memantine and amantadine are NMDA receptor antagonists, concurrent use should be avoided due to the risk of toxic effects.

Combinations of memantine with ketamine, dextromethorphan, and phenytoin are also potentially toxic.

The same renal cationic system is used for the transport of amantadine, cimetidine, ranitidine, quinidine, quinine, and nicotine in the body, which may cause an interaction of these drugs with memantine, leading to an increase in its plasma concentration.

With concurrent use, Memantine may cause a decrease in the serum concentration of hydrochlorothiazide.

With concurrent use with warfarin and other indirect anticoagulants, careful monitoring of prothrombin time and INR is required.

Concurrent use with antidepressants, selective serotonin reuptake inhibitors, and MAO inhibitors requires careful monitoring of patients.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F).

Keep in original packaging, protected from light.

Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Medixlife (Author)

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