Nootropil, 800 mg 30 pcs

Stroke sequelae, Hangover, Alcoholism, Nausea, Dizziness, Headache, Impaired cerebral circulation, Tinnitus, Concussion and other brain injuries, Attention and memory disorders, Alzheimer’s disease, Learning disabilities, Acquired dementia, Disorientation in space For adults:

– Symptomatic treatment of psychorganic syndrome, symptoms of which include decreased memory, decreased concentration and decreased general activity

– Treatment of cortical myoclonias, as mono- or complex therapy

– Treatment of vertigo and related balance disorders, except vertigo of vascular and mental origin

– Prevention and treatment of sickle cell vasculo-occlusive crises

For children:

– prevention and treatment of sickle cell vascular occlusive crises

– treatment of dyslexia (in complex therapy) – from 8 years of age

Active ingredient

Composition

One tablet contains

the active ingredient:

piracetam 800 mg,

excipients: colloidal anhydrous silica, magnesium stearate, polyethylene glycol 6000, sodium croscarmellose,

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

How to take, the dosage

Daily doses range from 30-160 mg/kg body weight. The frequency of administration is 2-4 times a day.

In treatment of chronic psychoorganic syndrome the drug is prescribed at a dose of 4.8 g/day for the first week and then changed to a maintenance dose of 1.2-2.4 g/day.

In the treatment of ischemic stroke, Nootropil should be given in a dose of 4.8 g/day.

When treating comatose states as well as perceptual difficulties in persons with brain injuries the initial dose is 9-12 g/day, maintenance dose is 2.4 g/day. Treatment should be continued for at least 3 weeks.

In case of withdrawal in chronic alcoholism the dose of the drug reaches 12 g/day during the manifestation of alcohol withdrawal syndrome. Maintenance dose is 2.4 g/day.

In treatment of dizziness and associated balance disorders the dose is 2.4-4.8 g/day.

In the correction of learning disabilities Nootropil is prescribed in a daily dose of 3.3 g (about 8 ml of 20% solution for oral administration 2 times a day). The treatment must continue throughout the school year.

In case of cortical myoclonias treatment is started with a dose of 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 with Nootropil is continued for the entire period of the disease. Every 6 months an attempt should be made to reduce the dose or cancel the drug, gradually reducing the dose by 1.2 g/day every 2 days. If there is no effect or little therapeutic effect, treatment should be discontinued.

In sickle cell anemia, the daily prophylactic dose is 160 mg/kg body weight divided into 4 doses. During a crisis, up to 300 mg/kg v/v. This dose can be administered to children over the age of 1 year.

The drug is administered orally with meals or on an empty stomach; tablets and capsules should be washed down with liquids (water, juice). Parenterally if oral administration is not possible, in the same daily dose.

Interaction

No interaction with clonazepam, phenytoin, phenobarbital, sodium valproate has been reported. Confusion, irritability and sleep disturbances have been reported during concomitant thyroid treatment (T3+T4).

Nootropil® at high dose (9.6 g/day) improves the effectiveness of indirect anticoagulants in patients with venous thrombosis (greater reductions in platelet aggregation, fibrinogen levels, Willebrand factors, blood viscosity and plasma compared to indirect coagulants alone have been observed).

The possibility of changing pharmacodynamics of Nootropil® by 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.

The administration of the preparation Nootropil® in dose 20 mg/day does not change Cmax and character of pharmacokinetic curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy who receive constant doses of these drugs.

The serum concentrations of piracetam and ethanol were not altered when piracetam at a dose of 1.6 g was coadministered with alcohol.

Special Instructions

Caution should be exercised when prescribing the drug in patients with impaired hemostasis, during major surgery or in patients with symptoms of severe bleeding.

When treating patients with cortical myoclonias, abrupt withdrawal of current therapy should be avoided, as this may cause a recurrence of seizures.

In long-term therapy of elderly patients, regular monitoring of renal function parameters is recommended; if necessary, the dose should be adjusted depending on the results of creatinine clearance study.

Notropil passes through the filter membranes of hemodialysis machines.

Influence on driving and operating machinery

With due regard to possible adverse effects, the patient should exercise caution when operating machinery and driving.

Contraindications

– Huntington’s chorea

– acute cerebral circulation disorder (hemorrhagic stroke)

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– terminal renal failure (CK ˂ 15 ml/min)

– pregnancy and lactation

– children under 8 years of age in the complex treatment of dyslexia

Side effects

CNS side effects: hyperkinesia (1.72%), nervousness (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%). These side effects occur more frequently in elderly patients who received the drug in a dose greater than 2.4 g/day. In some cases – dizziness, headache, ataxia, loss of balance, worsening of the course of epilepsy, insomnia, confusion, agitation, anxiety, hallucinations, increased sexuality.

Metabolism: weight gain (1.29%).

Digestive system disorders: in some cases – nausea, vomiting, diarrhea, abdominal pain.

Dermatological reactions: dermatitis, itching, rash, edema.

Overdose

Symptoms: dyspeptic phenomena such as diarrhea with blood and abdominal pain.

Treatment: Gastric lavage or induced vomiting may be performed immediately after ingestion. Symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

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