Nootropil - indications for use. Nootropil is an effective and safe replacement for Piracetam. What does Nootropil help with?

INSTRUCTIONS
on medical use of the drug

Registration number:

Tradename: Nootropil ®

International nonproprietary name:

Chemical rational name: 2-(2-oxopyrrolidin-1-yl)acetamide

Dosage form:

Compound
One ampoule contains:
active substance: piracetam - 1 g/5 ml or 3 g/15 ml;
Excipients: sodium acetate trihydrate, glacial acetic acid, water for injection.

Description
Transparent colorless solution.

Pharmacotherapeutic group:

ATX code: N06BX03.

Pharmacological properties

Pharmacodynamics. The active component is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA).
Piracetam is a nootropic that directly affects the brain, improving cognitive processes such as learning, memory, attention, and mental performance. Piracetam affects the central nervous system in various ways: by changing the speed of propagation of excitation in the brain, improving metabolic processes in nerve cells, improving microcirculation, affecting the rheological characteristics of the blood and without causing a vasodilator effect.
Improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures, increases mental performance, and improves cerebral blood flow.
Piracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. At a dose of 9.6 g, it reduces the level of fibrinogen and von Willebrand factors by 30-40% and prolongs bleeding time.
Piracetam has a protective and restorative effect in cases of impaired brain function due to hypoxia and intoxication.
Piracetam reduces the severity and duration of vestibular nystagmus.

Pharmacokinetics. The half-life of the drug from blood plasma is 4-5 hours and 8.5 hours from cerebrospinal fluid, which is prolonged in case of renal failure.
The pharmacokinetics of piracetam does not change in patients with liver failure.
Penetrates the blood-brain and placental barriers and membranes used in hemodialysis. In animal studies, piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. Does not bind to blood plasma proteins, is not metabolized in the body and is excreted unchanged by the kidneys through renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml/min.

Indications
Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, decreased concentration and decreased general activity, mood changes, behavior disorder, gait disturbance, as well as in patients with Alzheimer's disease and dementia of the Alzheimer's type.
Treatment of the consequences of acute cerebrovascular accident (ischemic stroke), such as speech disorders, emotional disturbances, decreased motor and mental activity.
Chronic alcoholism - for the treatment of psychoorganic and withdrawal syndromes.
Comatose states (and during the recovery period), including after injuries and intoxications of the brain.
Treatment of dizziness and related balance disorders, with the exception of dizziness of vascular origin and psychogenic dizziness.
For the treatment of cortical myoclonus as mono- or complex therapy.
As part of complex therapy for sickle cell anemia.
Treatment of dyslexia in children, in combination with other methods, including speech therapy.

Contraindications
Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
Psychomotor agitation at the time of drug administration.
Huntington's chorea.
Acute cerebrovascular accident (hemorrhagic stroke).
End-stage renal failure (with creatinine clearance less than 20 ml/min).
Children under 3 years of age.

Carefully:

Hello!

Today we will talk about the health of our babies, and in particular about medicines that are very necessary for the development and maintenance of the child.

Let's start with a little background...

It just so happened, but what is it? NOOTROPICS (and not only) We found out when our son was still just a baby. The reason for this was: premature placental abruption at 30 weeks, intrauterine hypoxia and, as a consequence, organic brain damage. It’s scary to imagine what it is and what consequences it has, it’s better to never know, but all the disorders caused imply a very difficult period of rehabilitation, constant drug treatment and a very long recovery period... for as long as possible.

In this case, nootropic drugs are also part of this long-term treatment. They serve as additional nutrition for brain cells, increasing blood circulation, thereby stimulating its work and activity. This helps very well with any developmental disorders and partial restoration of some functions.

In our case, organic brain damage affected psychomotor development to a greater extent, namely, it manifested itself in persistent motor disorders. Intellect and speech were least affected. For this reason, for recovery, we so need to take nootropic drugs, along with constant physical exercise and inpatient treatment.

For 4 years we have tried: Pantogam, Encephobol, Semax, Phenibut, Cerebrolysin, Cinnarizine, Cortexin and that’s not all...

Some drugs gave very good results, but there were others that after taking them I had to start all over again. And all for the reason that the effect of this or that drug is individual, and while in some children taking Phenibut gave a visible impetus to development, my son experienced a setback. The consequence of which was an even greater lag in the development of motor functions.

Now we are again taking a course of nootropic drugs, last time, instead of the usual Pantogam, our attending physician suggested trying a new remedy, namely Nootropil in the form of an oral solution. In essence, this is the same piracetam, but after the second course of this drug I can say that the action ( child monitoring) I like him much more.

✦ Basic information:

Place of purchase : Pharmacy "Pharmacopeyka".

Price: 350 rub.

Volume: 125 ml.

Best before date: 4 years

Dosage form:

Oral solution.

I always prefer a solution to all tablets for a child. In this form, he is more inclined to take the drug.

Active substance:

Piracetam - 20.0 g.

✦ Description:

Medicinal pr eparat presented in the form of a solution in a dark glass bottle.

Myself the solution is completely homogeneous transparent liquid with a slight fruity odor.

Taste very similar to Pantogam, the same sickly sweet with bitterness and a slight aftertaste. As for me, it is very disgusting, I don’t even know how my son drinks it with such pleasure.

For ease of use, the kit includes small measuring cup with a maximum volume of 25 ml. and minimum 1.2 ml. But to be honest, measuring the norm using it is not so easy.

Indications for use:

I have already touched on most of this point above, but here I can only add:

For adults and seniors

• symptomatic treatment of psychoorganic syndrome, the symptoms of which can impair memory, reduce concentration and reduce overall activity

• treatment of cortical myoclonus, as mono- or complex therapy

• treatment of dizziness and related balance disorders, with the exception of dizziness of vascular and mental origin

For children

• treatment of dyslexia (in combination with other methods)

• prevention and treatment of sickle cell vascular-occlusive crises

Contraindications:

• hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug.

• psychomotor agitation at the time of drug prescription.

• acute cerebrovascular accident (hemorrhagic stroke).

• end-stage renal failure (with creatinine clearance less than 20 ml/min).

• children's age up to 1 year.

• Huntington's chorea.

• period of pregnancy and lactation.

Nootropil is prescribed to us as a complex treatment , which includes: physical exercise, massage, physiotherapy and other medications such as Mydocalm or Baclofen, Cerebrolysin or Cortexin.

The prescribed dosage is 2.5 ml. twice a day (morning and lunch).

Like all nootropic drugs, The best time to take it is from morning to 17:00 pm , for the reason that they are in stimulate the nervous system and negatively affect sleep . But, in the case of Nootropil, even in the first days of taking it, I did not notice any sleep disturbances or general excitability of the child.

A course of treatment We always use nootropics for at least 1.5 months, so during this period and after it is already possible to evaluate the results.

✦ Results after taking Nootropil ✦

As I wrote above, our main problem is movement disorders and a slight delay in intellectual and speech development.

Regarding movement disorders , then taking medications alone will not help here; in this case, you need constant proper physical exercise, which helps restore muscle function, relieve spasticity and normalize motor activity. Kinesitherapy helps us a lot in this matter, which we have been doing for a year now.

But with delayed intellectual and speech development, taking Nootropil has very good results.

To tell you what we have achieved, I will briefly describe our problems:

• My son’s intellect has suffered to a lesser extent, so at this stage we have practically no special problems in learning new things. Of course, there are lags, but mostly due to the fact that he cannot move completely independently. As for attention, attracting it to something requires effort - he is very absent-minded and inattentive.

• Speech. There is a delay in speech development. My son started babbling late, but at the age of one we already had several monosyllable words. A little later, words appeared, if one could say so, consisting of only one last syllable - “dog” - “ka”. Sometimes his sentences were something like “ka na ka and ka-ka.” The Cogitum technique had a very good effect on the development of speech, and then we definitely had full-fledged words and simple sentences, but my son still mostly named and showed everything with sounds.

✦ So, while taking Nootropil, my son has noticeable changes , which affected both the child’s attention and his speech. Now my son is showing great interest in everything around him, he is interested in “How is this?”, “What is this?”, “Why?” and so on, but these are not just questions, but he listens with interest and remembers. It's obvious that he likes it.

✦ We learn poems, which he then “reads” in books. Sings songs, repeating all intonations and melody.

✦ A very noticeable leap occurred in his speech; if in May he showed everything even more with sounds and individual words, now it is understandable childish speech with complex sentences.

Of course, there are problems in the pronunciation of some sounds, but I try very hard not to worry about this, since my daughter, with normal physical development, had much worse speech. Classes with a speech therapist, even without taking medications, corrected everything.

My son and I also plan to soon start classes with a speech therapist-defectologist, but for now we are actively doing articulation gymnastics at home. We have a lot of different games for developing fine motor skills of the hands, and we also specially bought a Su-Jok massage ball for palms and fingers, which is actively used in speech therapy work.

In our case, this is already a necessity, without which it’s even scary to imagine what could have happened. Of course, constant drug treatment, along with its benefits, also brings harm, so if possible we try to alternate - in some places we injected the medicine, in others we took a break. And also, many thanks to our attending physician for always recommending the most optimal dosage and placing more emphasis on physical exercise.

As for Nootropil, I give it a solid 5 for our visible successes.

___________________________________________________________________________________

Other medicines for children:

____________________________________________________________________________________

Thank you for your attention.

Registration number
Capsules, 400 mg: P No. 014242/02-2003
Film-coated tablets, 800 mg, 1200 mg:
P N 011926/02 dated 06/25/2007

International nonproprietary name:

Chemical rational name: 2-(2-oxopyrrolidin-1-yl)acetamide

Dosage forms: capsules; film-coated tablets; solution for oral administration.

COMPOUND

Capsules
Active substance: piracetam - 400 mg
Excipients: Aerosil R972, magnesium stearate, Macrogol 6000, lactose.
Capsule shell: body: gelatin, water, titanium dioxide; cap: gelatin, water, titanium dioxide.

Film-coated tablets
Active substance: piracetam - 800 mg, 1200 mg
Excipients: silicon dioxide, magnesium stearate, Macrogol 6000, croscarmellose sodium.
Shell: Opadry Y-1-7000 - titanium dioxide (E171), Macrogol 400, hypromellose 2910 5cP (E464); Opadry OY-S-29019 - hypromellose 2910 50cP, Macrogol 6000.

Oral solution
Active substance: piracetam - 200 mg/ml.
Excipients: glycerol 85%, sodium saccharin, sodium acetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 52247/A apricot (flavor), 52939/A caramel (flavor), glacial acetic acid, purified water.

DESCRIPTION
Capsules, 400 mg: hard gelatin capsules No. 1 white with the inscription "N" and "ucb"; the contents of the capsules are white powder.
Film-coated tablets, 800 mg, 1200 mg: oblong tablets of white or almost white color, coated, with a dividing transverse score on both sides; On one side of the tablet to the right and left of the mark there is an engraving “N”.
Oral solution, 200 mg/ml: transparent colorless liquid.

Pharmacotherapeutic group:

ATX code: N06BX03.

Pharmacological properties

Pharmacodynamics. The active component of Nootropil is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA). Piracetam is a nootropic that directly affects the brain, improving cognitive processes such as learning, memory, attention, and mental performance. Nootropil influences the central nervous system in various ways: by changing the speed of propagation of excitation in the brain, improving metabolic processes in nerve cells; improving microcirculation, affecting the rheological characteristics of the blood and without causing a vasodilator effect. Improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures, increases mental performance, and improves cerebral blood flow.
Piracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. At a dose of 9.6 g, it reduces the level of fibrinogen and Willibrant factors by 30%-40% and prolongs bleeding time.
Piracetam has a protective effect, improves brain functions impaired due to hypoxia and intoxication.
Piracetam reduces the severity and duration of vestibular nystagmus.

Pharmacokinetics. When taking the drug orally, piracetam is quickly and almost completely absorbed, peak concentrations are reached 1 hour after administration. The bioavailability of the drug is approximately 100%. After taking a single dose of 2 g, the maximum concentration is 40-60 mcg/ml, which is achieved in the blood after 30 minutes and 5 hours in the cerebrospinal fluid after intravenous administration. The apparent volume of distribution of piracetam is about 0.6 l/kg. The half-life of the drug from blood plasma is 4-5 hours and 8.5 hours from cerebrospinal fluid, which is prolonged in case of renal failure. The pharmacokinetics of piracetam does not change in patients with liver failure. Penetrates the blood-brain and placental barrier and membranes used in hemodialysis. In animal studies, piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. Does not bind to blood plasma proteins, is not metabolized in the body and is excreted unchanged by the kidneys. 80-100% of piracetam is excreted unchanged by the kidneys by renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml/min.

Indications
- Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients suffering from memory loss, dizziness, decreased concentration and general activity, mood changes, behavior disorder, gait disturbance, as well as in patients with Alzheimer's disease and senile dementia of the Alzheimer's type.
- Treatment of the consequences of stroke, such as speech disorders, emotional disturbances, to increase motor and mental activity.
- Chronic alcoholism - for the treatment of psychoorganic and withdrawal syndromes.
- The recovery period after comatose states, including after injuries and intoxications of the brain.
- Treatment of dizziness and related balance disorders, with the exception of dizziness of vascular and mental origin.
- As part of complex therapy for learning disabilities in children with psychoorganic syndrome.
- For the treatment of cortical myoclonus as mono- or complex therapy.
- In the complex therapy of sickle cell anemia.

Contraindications
- Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
- Acute cerebrovascular accident (hemorrhagic stroke).
- End-stage renal failure (with creatinine clearance less than 20 ml/min).
- Children's age up to 1 year (for oral solution, 200 mg/ml) and up to 3 years (for capsules and tablets).

Pregnancy and lactation
Animal studies did not reveal any damaging effects on the embryo and its development, including in the postnatal period, and did not change the course of pregnancy and childbirth.
No studies have been conducted in pregnant women. Piracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the mother's blood. Except in special circumstances, Nootropil should not be prescribed during pregnancy. You should refrain from breastfeeding when a woman is prescribed piracetam.

Directions for use and doses

Inside.
Daily dose - 30-160 mg/kg, frequency of administration - 2-4 times a day. Orally administered during meals or on an empty stomach; Tablets and capsules should be taken with liquid (water, juice).
- For symptomatic treatment of chronic psychoorganic syndrome, depending on the severity of symptoms, 1.2-2.4 g is prescribed, and during the first week - 4.8 g/day.
- When treating the consequences of a stroke, 4.8 g/day is prescribed.
- During the period of recovery from comatose states, as well as difficulties in perception in people with brain injuries, the initial dose is 9-12 g/day, maintenance - 2.4 g/day. Treatment continues for at least 3 weeks.
- For alcohol withdrawal syndrome during a crisis - 12 g/day in 2-3 doses. Maintenance dose - 2.4 g/day.
- Treatment of dizziness and related balance disorders 2.4-4.8 g per day.
- For children to correct learning disabilities, the dose is 3.3 g/day (approximately 8 ml of oral solution, twice a day). Treatment continues throughout the academic year.
- For cortical myoclonus, treatment begins with 7.2 g/day, every 3-4 days the dose is increased by 4.8 g/day until a maximum dose of 24 g/day is reached. Treatment continues throughout the entire period of the disease. Every 6 months, attempts are made to reduce the dose or discontinue the drug, to prevent an attack, gradually reducing the dose by 1.2 g every 2 days. If there is no effect or insignificant therapeutic effect, treatment is stopped.
- For sickle cell anemia, the daily prophylactic dose is 160 mg/kg body weight, divided into four equal doses. During a crisis, 300 mg/kg intravenously.

Dosing in patients with impaired renal function.
Since Nootropil is excreted from the body by the kidneys, caution should be exercised when treating patients with renal failure in accordance with this dosage regimen.

Dosing in patients with impaired liver function.
Patients with impaired liver function do not need dose adjustment. For patients with impaired renal and liver function, dosing is carried out according to the scheme (see Section "Dosing for patients with impaired renal function")

Side effect

Overdose
When taking 75 g of piracetam in dosage form, oral solution, dyspeptic symptoms were noted, such as diarrhea, blood and abdominal pain, which are most likely associated with a high sorbitol content. No other special symptoms of piracetam overdose were noted.
Immediately after a significant oral overdose, you can lavage the stomach or induce artificial vomiting. Treatment is symptomatic, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis is 50%-60% for piracetam.

Interaction with other drugs
There was no interaction with clonazepam, phenytoin, phenobarbital, or sodium valproate.
High doses (9.6 g/day) of piracetam increased the effectiveness of acenocoumarol in patients with venous thrombosis: there was a greater decrease in platelet aggregation, fibrinogen levels, Willibrant factors, blood and plasma viscosity than when acenocoumarol was prescribed alone.
The possibility of changing the pharmacodynamics of piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in the urine.
In vitro piracetam does not inhibit cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19,2D6,2E1 and 4A9/11 at concentrations of 142, 426 and 1422 μg/ml. At a concentration of 1422 μg/ml, slight inhibition of CYP2A6 (21%) and 3A4/5 (11%) was noted. However, the Ki level of these two CYP isomers is sufficient when exceeding 1422 μg/ml. Therefore, metabolic interaction with other drugs is unlikely. Taking piracetam at a dose of 20 mg/day did not change the peak and curve of the concentration of antiepileptic drugs in the blood serum (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy receiving a constant dosage. Co-administration with alcohol did not affect the serum concentration of piracetam and the serum alcohol concentration did not change when taking 1.6 g of piracetam.

special instructions
Due to the effect of piracetam on platelet aggregation, caution is recommended when prescribing the drug to patients with impaired hemostasis, during major surgical operations, or to patients with symptoms of severe bleeding. When treating patients with cortical myoclonus, abrupt interruption of treatment should be avoided, which may cause resumption of attacks. During long-term therapy in elderly patients, regular monitoring of renal function indicators is recommended; if necessary, dose adjustment is carried out depending on the results of a creatinine clearance study.
Taking into account possible side effects, caution should be exercised when operating machinery or driving a vehicle. Penetrates through the filter membranes of hemodialysis machines.

Release form
Capsules, 400 mg: 15 capsules per blister made of PVC/aluminum foil. 4 blisters with instructions for use are placed in a cardboard box.
Film-coated tablets, 800 mg: 15 tablets in a PVC/aluminum foil blister. 2 blisters with instructions for use are placed in a cardboard box.
Film-coated tablets, 1200 mg: 10 tablets in a PVC/aluminum foil blister. 2 blisters with instructions for use are placed in a cardboard box.
Oral solution, 200 mg/ml: 125 ml each in a transparent dark glass bottle (type 3), sealed with a tamper-evident polypropylene stopper with a plastic measuring cup. The bottle is enclosed in a cardboard box along with instructions for use.

Storage conditions
Capsules, 400 mg:
In a dry place at a temperature not exceeding 25 ° C, out of the reach of children.
Oral solution, 200 mg/ml: At a temperature not exceeding 25 ° C, out of the reach of children.

Conditions for dispensing from pharmacies.
On prescription.

Best before date
Capsules, 400 mg: 5 years
Film-coated tablets, 800 mg, 1200 mg: 4 years.
Oral solution, 200 mg/ml: 4 years.
Do not use after expiration date.

Company manufacturer
Capsules, 400 mg; Film-coated tablets, 800 mg, 1200 mg:
"USB S.A. Pharma Sector", Belgium B-1420, Brain-L"Allue, Cheman du Foret
Oral solution, 200 mg/ml:
Manufacturer "Next-Pharma SAS, France F-78520 Limaye, Route de Molan, 17
Representative office in the Russian Federation / Organization receiving claims:
119048 Moscow, st. Shabolovka, building 10, building "(BC "CONCORD")

Instructions

Tradename

Nootropil®

International nonproprietary name

Piracetam

Dosage form

Film-coated tablets, 800 mg

Compound

One tablet contains

active substance - piracetam 800 mg,

Excipients: colloidal silicon dioxide anhydrous, magnesium stearate, polyethylene glycol 6000, croscarmellose sodium,

Shell composition: Opadry Y-1-7000-hydroxypropyl methylcellulose, titanium dioxide (E171), Opadry OY-S-29019-hydroxypropyl methylcellulose, polyethylene glycol 6000.

Description

The film-coated tablets are white, oblong, scored on both sides and engraved N on both sides of the score on one side.

Pharmacotherapeutic group

Psychostimulants and other nootropics. Piracetam.

ATX code N06BX03

Pharmacological properties

Pharmacokinetics

After oral administration, piracetam is rapidly and intensively absorbed, peak plasma concentrations are reached 1 hour after administration. The absolute bioavailability of the oral form of the drug is close to 100%. The volume of distribution of piracetam is about 0.6 l/kg. The half-life of the drug in plasma in adults is about 5 hours after oral administration. In cerebrospinal fluid, Tmax was reached 5 hours after dosing, with an elimination half-life of approximately 8.5 hours, which is prolonged in renal failure. The pharmacokinetics of piracetam does not change in patients with renal failure.

Penetrates the blood-brain and placental barriers and membranes used in hemodialysis. Piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital, in the cerebellum and basal ganglia. Piracetam does not bind to plasma proteins, is not metabolized in the body and is excreted unchanged by the kidneys. 80-100% of piracetam is excreted unchanged by the kidneys through glomerular filtration.

Pharmacodynamics

The active substance of Nootropil® is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA).

Nootropil® is a nootropic that directly affects the brain, improving cognitive processes such as learning ability, memory, attention, and mental performance. Nootropil® affects the central nervous system in various ways: it changes the speed of spread of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation, affecting the rheological properties of the blood and without causing a vasodilator effect.

Improves synaptic conduction in neocortical structures, increases mental performance, and improves cerebral blood flow.

Nootropil® inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reduces the adhesion of erythrocytes. When taken at a dose of 9.6 g, adult volunteers observed a decrease in the level of fibrinogen and von Willibrand factors by 30%-40% and an increase in bleeding time.

Nootropil® has a protective and restorative effect in cases of impaired brain function due to hypoxia and intoxication. Nootropil® reduces the severity and duration of vestibular nystagmus.

Indications for use

For adults

Symptomatic treatment of psychoorganic syndrome, the symptoms of which include decreased memory, decreased concentration and decreased overall activity

Treatment of cortical myoclonus, as mono- or complex therapy

Treatment of dizziness and related balance disorders, with the exception of dizziness of vascular and mental origin

Prevention and treatment of sickle cell vascular-occlusive crises

For children

Prevention and treatment of sickle cell vascular-occlusive crises

Treatment of dyslexia (in complex therapy) - from 8 years

Directions for use and doses

Nootropil® should be taken orally during meals or on an empty stomach with liquid.

Attention! Take the last single dose no later than 17:00 to prevent sleep disturbances.

Symptomatic treatment of psychoorganic syndrome:

Treatment of dizziness and associated imbalance:

Treatment of cortical myoclonus:

Start with a dose of 7.2 g/day, every 3-4 days the dose is increased by 4.8 g per day until a maximum dose of 24 g/day is reached, in two or three doses. Treatment is continued throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g/day every 2 days.

Treatment of sickle cell vascular-occlusive crises:

The daily prophylactic dose is 160 mg/kg body weight, divided into 4 equal doses. A dose of less than 160 mg/kg or irregular use of the drug may cause exacerbations of the disease.

Treatment of dyslexia in children (in complex therapy):

Because the Nootropil® is excreted from the body by the kidneys, when prescribed drug for patients with renal failure and elderly patients the dose should be adjusted depending on the creatinine clearance (CC).

CC for men can be calculated based on serum creatinine concentration using the following formula:

× body weight (kg)

CC (ml/min)= ________________________________________

72 × CK serum (mg/dL)

Patients with impaired liver function no dose adjustment is required.

Patients with impaired renal and liver function dosing is carried out according to the table below.

Side effects

Not often (≥ 1/1 to ˂1/100)

Hyperkinesia

Weight gain

Nervousness

Drowsiness

Depression

Asthenia

Post-marketing experience

The following additional side effects have been identified from post-marketing experience (data are insufficient to estimate their frequency among patients):

Hemorrhagic disorders

Dizziness

Abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting

Anaphylactoid reactions, hypersensitivity

Ataxia, balance disorders, worsening epilepsy, headache, insomnia

Excitement, anxiety, confusion, hallucinations

Angioedema, dermatitis, itching, urticaria

Contraindications

Known hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug

Huntington's chorea

Acute cerebrovascular accident (hemorrhagic stroke)

End-stage renal failure (creatinine clearance ˂ 15 ml/min)

Pregnancy and lactation

Children under 8 years of age in complex treatment of dyslexia

Drug interactions

There was no interaction with clonazepam, phenytoin, phenobarbital, or sodium valproate. Confusion, irritability and sleep disturbance have been reported during concomitant thyroid treatment (T3+T4).

Nootropil® in high doses (9.6 g/day) increases the effectiveness of indirect anticoagulants in patients with venous thrombosis (a more pronounced decrease in the level of platelet aggregation, fibrinogen level, von Willibrand facts, blood and plasma viscosity was observed compared with the use of indirect coagulants only).

The possibility of changing the pharmacodynamics of the drug Nootropil® under the influence of other drugs is low, because 90% of the drug is excreted unchanged in the urine.

Nootropil® does not inhibit cytochrome P450 isoenzymes. Metabolic interaction with other drugs is unlikely.

When taking Nootropil® at a dose of 20 mg/day, Cmax and the nature of the pharmacokinetic curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy receiving constant doses of these drugs do not change.

When piracetam was taken together at a dose of 1.6 g with alcohol, the concentrations in the blood serum of piracetam and ethanol did not change.

special instructions

Due to the platelet antiplatelet effect of priracetam (see Pharmacodynamics), caution is advised in patients with severe bleeding, patients at risk of bleeding such as gastrointestinal ulcers, patients with impaired underlying hemostasis, patients with a history of hemorrhagic stroke, patients who have had major operations, including dental surgery, and patients using anticoagulants or antiplatelet agents, including low-dose aspirin.

Treatment of sickle cell vascular-occlusive crises in children - piracetam can be used in children from 3 years of age suffering from sickle cell anemia at the recommended daily dosage (mg/ml) in a special dosage form, as an oral solution of 200 mg/ml.

Piracetam is excreted through the kidneys and special measures should be taken in cases of renal failure (see section Dosage and Administration).

With long-term use in the elderly, regular assessment of creatinine clearance is required to adapt the dose if necessary.

When treating cortical myoclonus, abrupt interruption of treatment should be avoided, as this may cause resumption of attacks.

When treating sickle cell anemia, a dose of less than 160 mg/kg or irregular use of the drug may cause an exacerbation of the disease.

When treating patients on a hyposodium diet, it is recommended to take into account that piracetam tablets at a dose of 24 g contain 46 mg of sodium.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Taking into account possible side effects, caution should be exercised when driving and operating machinery.

Overdose

Symptoms: dyspeptic symptoms such as bloody diarrhea and abdominal pain.

Treatment: Immediately after taking the drug orally, you can rinse the stomach or induce artificial vomiting. Symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

Release form and packaging

15 tablets per blister pack made of PVC/aluminum foil. 2 contour packages together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children!

Shelf life

Do not take the drug after the expiration date!

Conditions for dispensing from pharmacies

On prescription

Manufacturer

USB Pharma S.A., Belgium

Packer

USB Pharma S.A., Belgium

Chemean du Foret, B-1420 Brayne-l'Alleu

Registration Certificate Holder

GlaxoSmithKly Export Limited, UK

(980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom)

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Representative office of GlaxoSmithKline Export Ltd in Kazakhstan

050059, Almaty, Furmanov st., 273

Phone number: +7 727 258 28 92, +7 727 259 09 96

Fax number: + 7 727 258 28 90

E-mail address: [email protected]

The approved version of the instructions for medical use can also be found on the website www.dari.kz

Attached files

The product has four release forms. The drug is used to treat memory disorders and intellectual pathologies. Approved for use in children, but not prescribed for pregnant and lactating women.

Dosage form

The drug is available in four forms: tablets, capsules and solution for intravenous and intramuscular administration, as well as solution for oral administration.

Description and composition

The active component is represented by the substance.

Among the additional components included in the tablets are:

• propylene glycol 6000;
• silicon dioxide;
• lactose monohydrate;
• magnesium stearate.

Each capsule contains 400 mg of active substance. Among the auxiliary components:

• propylene glycol 6000;
• silicon dioxide;
• lactose monohydrate;
• magnesium stearate.

Per 1 ml of oral solution there are 200 or 330 mg of the main component. The list of auxiliary components includes:

• sodium saccharinate;
• purified water;
• glycerol;
• sodium acetate;
• acetic acid;
• methyl parahydroxybenzoate;
• flavorings;
• propyl parahydroxybenzoate.

The solution for parenteral administration contains 200 mg of the main substance. Additional elements are presented:

• sodium acetate trihydrate;
• water for injections;
• glacial acetic acid.

Pharmacological group

Nootropil increases the intensity of glucose utilization, the production of phospholipids and RNA, and when taking the drug, there is an increase in the level in brain cells, stimulation of glycolytic reactions, and a positive effect on the metabolic processes of the brain. As a result of the use of the drug, learning abilities and memory improve.

Nootropil exhibits the ability to inhibit the aggregation of activated platelets, as well as to have a positive effect on microcirculation and the speed of propagation of excitation impulses in brain tissue.

In case of brain lesions that were provoked by intoxication or electric shock, the drug produces a protective effect. The medication improves cerebral blood flow, increases the level of performance and conductivity between synapses in neocortical structures.

The therapeutic effect appears gradually. The product does not produce sedative or psychostimulating effects.

Indications for use

The drug is used for the treatment of memory disorders and intellectual disabilities in the absence of dementia in the patient.

for adults

Adult patients are prescribed Nootropil for:

• psychoorganic syndrome, accompanied by decreased memory and cognitive abilities, dizziness, mood swings, behavioral disorders;
• therapy for dizziness and imbalance (exceptions are vasomotor and psychogenic dizziness);
• cortical myoclonus;
• sickle cell vaso-occlusive crisis.

for children

Nootropil is used in children over 3 years of age (for tablets) and 1 year of age (for solution) if present, as well as for the prevention of sickle cell vaso-occlusive crisis.

A sufficient number of studies regarding use in pregnant women and during lactation have not been conducted. It is better for the above categories of patients to stop taking Nootropil.

Contraindications

There are the following contraindications to the use of the drug Nootropil:

• Huntington's syndrome;
• children under 1 year of age (for oral solution);
• child's age up to 3 years (for use in tablet form);
• chronic renal failure at the last stage;
• cerebrovascular accident;
• intolerance to pyrrolidone derivatives;
• individual intolerance to the components included in the medication.

The drug is used under the supervision of a physician for hemostasis, extensive surgical interventions, severe bleeding, as well as for chronic renal failure.

Applications and dosages

Due to the extensive list of indications for use, it is recommended to contact your healthcare provider to establish an individual dosage regimen. He will be able to select a specific dosage regimen that corresponds to age, course of the disease and other factors.

for adults

The initial dosage for parenteral administration is 10 g. The duration of the infusion is from 20 minutes to half an hour. After the therapeutic effect appears, the amount of the drug is reduced and a switch is made to taking Nootropil orally.

Tablets and capsules are taken twice a day, at a dose of 30 to 160 mg per 1 kg of patient body weight. The course of treatment ranges from 2 to 6 months.

for children

The product can be used in children over 1 year of age (for oral solutions) and three years of age (for taking tablets). To calculate dosages, you must consult your doctor.

for pregnant women and during lactation

There is not a sufficient number of high-quality studies on the impact on the fetus and child when taking the drug by pregnant women and women during the lactation period. The above determines the fact that Nootropil is not prescribed to these categories of patients.

Side effects

The following reactions may occur:

• irritability;
• nausea;
• drowsiness;
• diarrhea;
• depression;
• anaphylactic reactions;
• dizziness;
• ataxia;
• headache;
• anxiety;
• Quincke's edema;
• hallucinations;
• dermatitis;
• increased libido;
• asthenia;
• abdominal pain;
• insomnia;
• thrombophlebitis (rarely, when administered intravenously);
• imbalance;
• hyperthermia;
• confusion;
• low blood pressure (rarely, when administered intravenously);
• vertigo.

Interaction with other drugs

When Nootropil was combined with hormones, confusion, sleep problems and irritability were noted. There is no inhibition of cytochrome P450 isoenzymes.

special instructions

When treating cortical myoclonus, it is necessary to avoid sudden interruptions in treatment, as this can cause recurrence of attacks.

When treating sickle cell anemia, doses of less than 160 mg/kg, as well as irregular use of the drug, can provoke an exacerbation of the pathology.

The active substance Nootropil has the ability to penetrate the filter membranes of hemodialysis machines.

Overdose

Among the manifestations that occur against the background of an overdose of the drug: pain in the abdomen and bloody diarrhea. Therapy is carried out by induction or gastric lavage, and hemodialysis is also possible.

Storage conditions

Keep away from children. Store at room temperature.

The shelf life is four years.

Analogs

On the pharmaceutical market you can find many structural analogues of the drug Nootropil; they will coincide in the active component and the method of action on the patient’s body.

But there are also medications that have a similar effect, but have some differences from Nootropil.

Dendrix

Dendrix tablets are a psychostimulant with the active substance citicoline sodium. Used for attention deficit disorder and hyperactivity disorder. The medication is not prescribed for pregnant women, lactating women, or children.

Capsules contain as the main component. Refers to psychostimulants and nootropic drugs. Indications for use are asthenic and anxious-neurotic conditions, restlessness, fear, anxiety, in childhood: stuttering, enuresis, tics.

Price

The cost of Nootropil is on average 262 rubles. Prices range from 206 to 391 rubles.