Piracetam Reneval, 800 mg 30 pcs

In adults:

– Symptomatic treatment of psychorganic syndrome, particularly in elderly patients, accompanied by decreased memory, dizziness, decreased concentration and activity, mood changes, conduct disorder, and gait disturbances (these symptoms may be early signs of age-related diseases such as Alzheimer’s disease and senile Alzheimer-type dementia);

– Treatment of vertigo and related balance disorders, except for vascular and psychogenic vertigo;

– Comprehensive therapy and monotherapy of cortical myoclonias;

– Comprehensive therapy of sickle cell anemia (for prevention of sickle cell vaso-occlusive crisis).

In children:

– Treatment of dyslexia (in combination with other methods);

– Complex therapy of sickle cell anemia (for prevention of sickle cell vaso-occlusive crisis).

Indications

In adults:

– Symptomatic treatment of psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, dizziness, decreased concentration and decreased activity, mood changes, behavior disorder, gait disturbance (these symptoms may be early signs of age-related diseases such as Alzheimer’s disease and senile dementia of the Alzheimer’s type);

– Treatment of dizziness and associated imbalance, with the exception of vascular and psychogenic dizziness;

– Complex therapy and monotherapy for cortical myoclonus;

– Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

In children:

– Treatment of dyslexia (in combination with other methods);

– Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

Pharmacological effect

Pharmacotherapeutic group: Nootropic drug.

ATX code: N06BX03.

Special instructions

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.

Penetrates through the filter membranes of hemodialysis machines.

Impact on the ability to drive vehicles and operate machinery
During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Piracetam

Composition

For one tablet:

Active substance:

piracetam – 800.0 mg.

Excipients (core):

croscarmellose sodium – 12.0 mg,

pregelatinized starch – 12.0 mg,

povidone (polyvinylpyrrolidone) – 20.0 mg,

magnesium stearate – 8.0 mg.

Excipients (shell):

hypromellose – 15.2 mg,

macrogol-4000 – 4.0 mg,

titanium dioxide – 8.8 mg.

Pregnancy

There have been no controlled studies of the use of the drug during pregnancy.

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.

Piracetam should not be used during pregnancy.

During lactation, the issue of stopping breastfeeding should be decided.

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.

With caution: impaired hemostasis; extensive surgical interventions; heavy bleeding; chronic renal failure (with creatinine clearance 20-80 ml/min).

Side Effects

From the nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

Metabolism: weight gain.

On the part of the hearing organs: vertigo.

From the skin: dermatitis, itching, urticaria.

Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

Interaction

The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of piracetam is excreted unchanged by the kidneys.

When used concomitantly with thyroid hormones, there have been reports of confusion, irritability, and sleep disturbances.

According to a published study in patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g/day increases the effectiveness of indirect anticoagulants (there was a more pronounced decrease in platelet aggregation, fibrinogen levels, von Willebrand factors, blood and plasma viscosity compared with the use of indirect anticoagulants only).

In vitro, piracetam does not inhibit cytochrome P450 isoenzymes, such as CYP1A2, 2B6, 2C8, 2C9, 2C19, 2B6, 2E1 and 4A9/11 at concentrations of 142, 426 and 1422 μg/ml. At a concentration of 1422 mcg/ml, a slight inhibition of CYP2A6 (21%) and ZA4/5 (11%) was noted, however, the Ki level of these two isoenzymes is sufficient when exceeding 1422 mcg/ml, and therefore metabolic interaction with other drugs is unlikely.

Taking piracetam at a dose of 20 g/day for 4 weeks did not change the maximum serum concentration and the area under the concentration-time curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproic acid).

Co-administration with alcohol did not affect serum concentrations of piracetam; The concentration of ethanol in the blood serum did not change when taking 1.6 g of piracetam.

Overdose

Symptoms: diarrhea mixed with blood, abdominal pain.

Treatment: in case of significant overdose, rinse the stomach or induce vomiting. Symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

Storage conditions

In a place protected from light at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after expiration date.

Manufacturer

Update of PFC JSC, Russia