The instruction for medical use
of Memantin-Tev Torgovoye medicine a name
the International unlicensed
name Memantin Lekarstvennaya
the Tablet form, film coated, 10 mg, 20 mg
One tablet contains
active agent: – a memantin a hydrochloride of 10 mg
(it is equivalent to a memantin of 8.31 mg)
– a memantin a hydrochloride of 20 mg
(it is equivalent to a memantin of 16.62 mg)
excipients: microcrystalline cellulose, silicon dioxide colloidal anhydrous, sodium of a kroskarmelloz, magnesium stearate
a film cover for a dosage of 10 mg: Opadray 03A28315 white (a gipromelloza 6 sr (HPMC 2910), the titan dioxide (E 171), talc)
a film cover for a dosage of 20 mg: Opadray 02G34586 pink (hypro-melloza 5 sr (HPMC 2910), the titan dioxide (E 171), a macrogoal (polyethyleneglycol 6000), a macrogoal (polyethyleneglycol 400), ferrous oxide red (E 172), indigotin (E 132, FD&C blue 2, indigo carmine), ferrous oxide black (E 172)
of the Tablet of an oval form, film coated from white till almost white color, with the M engraving on both sides risks on one party of a tablet and figure 1 on the left side risks and 0 C of the right side risks on other party of a tablet (for a dosage of 10 mg).
Tablets of an oval form, film coated from light pink till pink color, with the M engraving on one party of a tablet and figure 20 on other party (for a dosage of 20 mg).
Drugs for treatment of dementia. Other drugs for treatment of dementia.
ATH N06DX01 code
Pharmacokinetics Later properties of intake memantin is quickly and completely soaked up. Meal does not influence absorption of a memantin. The absolute bioavailability is about 100%. The maximum concentration in blood plasma is reached within 3-8 hours. Linking with proteins of plasma makes 45%. After oral administration of 80% of a dose is defined in blood in not changed look. The main metabolites of a memantin N-3.5-dimetil-Gludantanum, the mixed isomer of a 4- and 6-hydroksimemantin and 1-nitrozo 3.5-dimetiladamantan have no NMDA antagonistic activity. At normal function of kidneys of cumulation of a memantin it is noted. Elimination proceeds dvukhfazno. T1/2 averages in the first phase of 4-9 h, in the second phase – 40-65 h. It is removed mainly by kidneys (99%).
Memantin-Tev being a noncompetitive antagonist N-methyl-D-aspartate (NMDA) – receptors, has the modulating effect on a glutamatergichesky system. Has pathogenetic effect on degenerative processes in the central and peripheral nervous system. Regulates ionic transport – blocks calcium channels. Has neuroprotective effect. Normalizes membrane potential. Improves process of transfer of a nervous impulse. Improves cognitive processes, memory and ability to training, increases daily activity.
– treatment of dementia of Altsgeymerovsky type from moderated to heavy severity
the Route of administration and doses
Treatment has to be carried out under observation of the doctor having experience in diagnostics and treatment of dementia of Altsgeymerovsky type. Therapy can be begun on condition of presence of the responsible person who is taking care for the patient, and regularly controlling intake of medicines.
The diagnosis has to be established according to the modern managements.
Memantin-Tev it is necessary to accept once a day daily at the same time. Tablets can be applied together with food or irrespective of meal.
the Maximum daily dose makes 20 mg. For the purpose of reduction of risk of development of undesirable effects, the supporting dosage is reached by gradual increase in a dose on 5 mg a week within the first 3 weeks:
Week 1 (days 1-7):
The patient accepts a half of a tablet of 10 mg, i.e. 5 mg a day within 7 days.
Week 2 (days 8-14):
The patient takes one pill of 10 mg a day within 7 days.
Week 3 (days 15-21):
The patient takes one and a half pill of 10 mg, i.e. 15 mg a day within 7 days.
Since a week 4:
The patient takes two pill on 10 mg, i.e. 20 mg a day.
The recommended maintenance dose makes 20 mg a day.
Approximate value of a maintenance dose – 10-20 mg/days.
On the basis of clinical trials the recommended maximum daily dose for patients is more senior than 65 years makes 20 mg a day (two tablets on 10 mg once a day) as it is stated above.
The renal failure
with an insignificant renal failure (clearance of creatinine of 50-80 ml/min.) dose adjustment is not required From patients.
At patients with a moderately severe renal failure (30-49 ml/min.) the daily dose makes 10 mg. At good tolerance within at least 7 days of treatment the dose can be raised to 20 mg/days according to the standard scheme of titration.
At patients with a heavy renal failure (clearance of creatinine of 5-29 ml/min.) the dose has to be reduced to 10 mg a day.
The abnormal liver function
with abnormal liver functions easy or moderate severity (class A and class B on classification of Chayld-Pyyu) dose adjustment is not required From patients. There are no data after use of a memantin at patients with a heavy liver failure in this connection, drug use Memantin-Tev at such patients is not recommended.
Children’s and teenage age
Data on efficiency and safety of drug at children’s and teenage age are absent in this connection, drug use Memantin-Tev is not recommended at children up to 18 years.
Often (& ge, 1/100 to & lt, 1/10)
– reactions of hypersensitivity
– dizziness, balance disturbance, a headache, drowsiness
– arterial hypertension
– short wind
– increase in indicators of function of a liver
Infrequently (& ge, 1/1,000 to & lt, 1/100)
– confusion of consciousness, concern, hyperexcitability, insomnia, fatigue, hallucinations (hallucinations, were generally observed at patients with the heavy course of the disease of Alzheimer)
– fungal infections
– disturbance of gait
– increase in intraocular pressure
– heart failure, venous thromboses / a thrombembolia
– dysfunction of bodies of a respiratory system, a thorax and mediastinum
Very seldom (& lt, 1/1 0000)
– convulsive attacks
Frequency is unknown
– psychotic reactions of Alzheimer
– hypersensitivity to active ingredient and any components of drug
– the profound abnormal liver functions
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years
the Medicinal interactions
Due to the pharmacological effects and the mechanism of action of a memantin are possible the following interactions:
The mechanism of action indicates that effects of a levodopa, dopaminergic agonists and anticholinergic drugs can amplify at combined use with NMDA antagonists whom treats memantin. The efficiency of barbiturates and neuroleptics can decrease. Joint purpose of a memantin with anti-spastic means, dantroleny and Baclofenum, can change their effects and result in need of correction dosed
It is necessary to avoid combined use of a memantin and an amantadin in connection with risk of developing pharmakotoksichesky psychosis. Both drugs on the chemical building are to NMDA antagonists. Same treats ketamine and dextromethorphan.
The description of one clinical case of development of possible risk at a combination of a memantin and Phenytoinum is published.
Other active agents, such as Cimetidinum, ranitidine, novokainamid, the quinidine, quinine and nicotine using the same renal cationic transport system as amantadin, can also interact with memantiny, resulting in potential risk of increase in plasma concentration of drug.
Decrease in serumal level of Hydrochlorthiazidum (GHT) at joint purpose of a memantin with GHT or the combined drugs containing GHT is possible.
The patients receiving treatment by warfarin have separate messages about increase in the international normalized relation (INR). Though the causal relationship was not established, it is recommended to control a prothrombin time and MNO at the patients accepting oral anticoagulants.
instructions Memantin-Tev are recommended to be applied with care at patients with epilepsy, spasms in the anamnesis and the factors contributing to epilepsy.
It is necessary to avoid combined use of the drug Memantin-Tev with amantadiny, ketamine or dextromethorphan in connection with risk of increase in side effects from the central nervous system.
Some factors leading to increase in the pH level of urine demand attentive observation of patients (transition to a vegetarian diet, reception of high doses of buffer antacids). Increase in the pH level of urine is possible also in the renal canalicular acidosis or heavy urinary tract infections caused by Proteus bacteria.
In connection with limited clinical data at the patients who recently had a myocardial infarction, patients with dekompensirovanny heart failure (III IV degrees on classification of NYHA), uncontrollable hypertensia, careful constant observation of this category of patients at use of the drug Memantin-Tev is necessary.
Pregnancy and the period of a lactation
Are absent clinical data on influence of a memantin at its use during pregnancy. Use of the drug Memantin-Tev during pregnancy is not recommended.
There are no data on excretion of a memantin in breast milk, however, it perhaps, considering lyophilic property of this substance. The women accepting memantin should refrain from feeding by a breast.
The feature of influence on ability to run vehicles or potentially dangerous mechanisms
Sick with the medium-weight and heavy course of the disease of Alzheimer is not recommended to run vehicles and mechanisms. Drug can have insignificant negative impact on concentration of attention of the patient, nevertheless, patients have to be warned about possible side effects.
Symptoms: strengthening of expressiveness of side effects.
Treatment: gastric lavage, intake of activated carbon, artificial diuresis, symptomatic therapy. Specific antidote does not exist.
The form of release and packing
On 10 tablets place in blister strip packagings of Alu/Alu of type or in blister strip packagings from the transparent combined aluminum material PVC/PVDH/foil or aluminum PVC/PE/PVDH/foil.
On 3 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
In original packing at a temperature not higher than 25 of 0C.
To store out of children’s reach!
not to use a period of storage after expiry date.
According to the prescription
Teva Pharmaceutical Industries Limited Producer, Israel
18 Eli Hurvitz Str., Industrial Zone, Kfar Saba, Israel
Quality control of Pharmachemie B.V., the Netherlands
of RU Teva Pharmaceutical Industries Limited, Israel
of Teva Pharmaceutical Works Private Limited Company, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
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