Instructions for Pramistar film-coated tablets 600 mg No. 20
Composition
active ingredient: pramiracetam;
1 film-coated tablet contains 818.4 mg of pramiracetam sulfate, equivalent to 600 mg of pramiracetam;
Excipients: microcrystalline cellulose, colloidal anhydrous silica, crospovidone, calcium stearate, hydroxypropylcellulose, titanium dioxide (E 171), hypromellose, polyethylene glycol 3350, polyethylene glycol 400.
Dosage form
Film-coated tablets.
Main physicochemical properties: white, elliptical, biconvex tablets, film-coated, with a score line on both sides.
Pharmacotherapeutic group
Psychostimulants and nootropics. ATX code N06B X16.
Pharmacological properties
Pharmacodynamics
Pramiracetam is a nootropic that improves memory and learning ability. Its mechanism of action is not fully understood. By acting on cholinergic receptors and choline metabolism, pramiracetam stimulates neuronal activity. The drug does not have a depressing effect on the central and has no effect on the autonomic nervous system. Pramiracetam also has an antidepressant effect. During clinical trials in patients with mild to moderate senile dementia, pramiracetam increased attention, improved learning ability, memory, orientation, and other mental activities.
Pharmacokinetics
Pharmacokinetic studies in humans have shown that the drug is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached after 2–3 hours. The drug has a half-life of 4–6 hours. The pharmacokinetics of the drug are similar in young and elderly patients. However, as creatinine clearance decreases, pramiracetam clearance decreases. The drug does not bind to plasma proteins. The drug is almost completely excreted unchanged in the urine.
Indication
Decreased ability to concentrate and memory disorders of a degenerative or vascular nature, especially in the elderly.
Contraindication
Hypersensitivity to the active substance or to any of the excipients listed in the "Composition" section. Cerebral hemorrhage. Severe renal failure. Hepatic failure.
Interaction with other medicinal products and other types of interactions
No interactions with cardiac glycosides, xanthines, anticoagulants, or ACE inhibitors have been observed in patients receiving 600 mg of pramiracetam every 12 hours. No other significant interactions have been reported.
Concomitant use of another active substance of the same pharmacological group (e.g. piracetam) with thyroid extract (T3+T4) caused confusion, irritability and sleep disturbances. According to a published single-blind study in patients with severe recurrent venous thrombosis, the administration of 9.6 g of piracetam per day did not lead to a change in the acenocoumarol dose required to achieve an INR (international normalized ratio) of 2.5–3.5. However, compared with the effect of acenocoumarol alone, the addition of 9.6 g of piracetam per day significantly reduced platelet aggregation, β-thromboglobulin release, fibrinogen and von Willebrand factor levels (VIII : C; VIII : vW : Ag; VIII : vW : RCo), blood and plasma viscosity.
Application features
In patients with mild to moderate renal impairment, pramiracetam excretion is slower. Therefore, caution should be exercised when using the drug in such patients. If any adverse reactions occur, the drug should be discontinued, as these reactions may be signs of accumulation of the active substance in the body (see section "Method of administration and dosage").
Piracetam, as a drug of the same pharmacological class, has an effect on platelet aggregation and function, as well as on other parameters of hemostasis. Therefore, caution should be exercised when used concomitantly with anticoagulants or platelet aggregation inhibitors (see section "Interaction with other medicinal products and other forms of interaction"), as well as when treating patients with blood coagulation disorders (see section "Interaction with other medicinal products and other forms of interaction").
Use during pregnancy or breastfeeding
Pramiracetam is contraindicated during pregnancy or breastfeeding; there are insufficient data on use during pregnancy or lactation.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect on the ability to drive or use machines has not been studied. However, adverse reactions such as dizziness, agitation, tremor and confusion have been reported in patients taking Pramistar (see section "Adverse reactions"). Therefore, patients should be warned about the possible effect on the ability to drive or use machines.
Method of administration and doses
The recommended dose is 600 mg every 12 hours.
Clinically significant effects are achieved within 4–8 weeks of treatment. In the case of long-term treatment in elderly patients, creatinine levels should be monitored regularly.
Patients with renal failure.
In patients with renal insufficiency, a delay in the excretion of pramiracetam is observed. The clinical significance of the delay in the excretion of pramiracetam in mild to moderate renal insufficiency is not determined. Therefore, caution should be exercised when treating patients with mild to moderate renal insufficiency, and Pramistar should be discontinued if undesirable effects occur, as this may be a sign of accumulation of the active substance in the body. Pramistar is contraindicated in severe renal insufficiency (see section "Contraindications").
Children
Studies in children have not been conducted, so the drug is not recommended for use in children.
Overdose
There are no reports of overdose.
Side effects
The following adverse reactions have been reported in clinical studies involving 1110 subjects. They are classified by organ system and by frequency. The frequency is defined as follows: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
| Organ system class | Frequency | Adverse reactions |
| Metabolic and nutritional disorders | Infrequently | Decreased appetite |
| Mental disorders | Often Infrequently Rarely | Excitement, insomnia Confusion of consciousness Dysphoria |
| Nervous system disorders | Often Infrequently | Dizziness Tremor |
| Gastrointestinal disorders | Often Infrequently Rarely | Nausea, upper abdominal pain Dry mouth, dyspepsia Fecal incontinence |
| Musculoskeletal and connective tissue disorders | Rarely | Muscle spasms |
| Kidney and urinary tract disorders | Rarely | Enuresis |
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicine has been authorised plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep the medicine out of the reach of children.
Packaging
10 tablets in a blister; 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
COSMO S.P.A.
Location of the manufacturer and address of its place of business
Via C. Colombo, 1, Lainate (MI), 20045, Italy.
Applicant
F.I.R.M.A. S.p.A.
Applicant's location
Via di Scandicci 37, 50143 Florence, Italy.
