INSTRUCTION

(patient information leaflet)

for the medical use of the drug product

PIRACETAM

Trade name: Piracetam.

International nonproprietary name: Piracetam.

Dosage form: 400 mg coated tablets.

Description: White biconvex coated tablets.

Composition: each tablet contains: active ingredient: piracetam - 400 mg;

excipients: povidone K-25; magnesium carbonate basic, light; calcium stearate; potato starch; Opadry II white (85G).

Composition of Opadry II white (85G): partially hydrolyzed polyvinyl alcohol; titanium dioxide; talc, polyethylene glycol 3350; lecithin (soya).

Pharmacotherapeutic group: Psychoanaleptics. Psychostimulants and nootropics.

АТX code: N06BX03.

Pharmacological effect

Has a positive effect on metabolic brain processes.Improves the brain integrative activity, promotes memory consolidation and facilitates learning process. Changes the speed of spread of excitation in the brain, improves microcirculation, without causing vasodilatory effect, and suppresses the aggregation of activated platelets. Exerts a protective effect in brain injuries caused by hypoxia, intoxication, electric shock. Enhances mental performance, improves cerebral blood flow. The effect develops gradually.

Therapeutic indications

Piracetam is indicated for the symptomatic treatment of memory disorders or intellectual disturbances in the absence of the diagnosis of dementia (symptomatic treatment of chronic psycho-organic syndrome). Piracetam can reduce the manifestations of cortical myoclonus. To determine the effect of piracetam in patients with cortical myoclonus it is necessary to conduct the test treatment course.

Posology and method of administration

In treatment of chronic conditions piracetam is used orally (before meal), drinking with plenty of water (100-200 ml), starting with 1,200 mg (400 mg three times a day), and adjusting the dose to 2,400 mg, sometimes up to 3,200 mg or more per day. Therapeutic effect in these cases is noticed usually 2-3 weeks after starting of the treatment. Later the dose is reduced to 1,200-1,600 mg (400 mg 3-4 times a day). The course of treatment with piracetam lasts from 2-3 weeks to 2-6 months. If necessary, it is repeated after 6-8 weeks.

In symptomatic treatment of chronic psycho-organic syndrome, depending on the severity of symptoms, a dose of 1,200-2,400 mg/day is prescribed, and for the first week – 4,800 mg/day.

In cortical myoclonus the treatment is started with 7,200 mg/day, every 3-4 days the dose is increased by 4800 mg/day until the maximum dose reaches 24,000 mg/day. Treatment is continued throughout the whole period of the disease. Every 6 months it should be attempted to reduce the dose or discontinue the administration, gradually reducing the dose by 1,200 mg every 2 days. At the absence of effect or a slight therapeutic effect the treatment is discontinued.

Since piracetam is excreted by the kidneys, the dose should be adjusted when prescribing the product for patients with renal insufficiency or elderly patients depending on the CLCR. CLCR for males is calculated from the serum creatinine content by the following formula:

CLCR (ml/min.) = (140 - age) хbody weight (kg)/72 хserum creatinine (mg/dl).

For females: calculation result should be multiplied by 0.85.

Patients with renal insufficiency require dose adjustment according to the following scheme.

In elderly patients thedose is adjusted in the presence of renal insufficiency; in prolonged therapy it is necessary to monitor renal function.

In patients with compromised hepatic function dose adjustment is not required. In patients with compromised renal and hepatic function the product is prescribed the same way as in patients with compromised renal function only.

This dosage form is not intended for use in children.

Adverse effects

Nervous system disorders: mental excitation, motor disinhibition, irritability, instability, reduced ability to concentrate, anxiety, insomnia or somnolence, depression, ataxia, dizziness, headache, extrapyramidal disorders (including hyperkinesia), convulsions, tremor .

Cardiovascular system disorders: possible arterial hypo-or hypertension, in elderly patients - aggravation of coronary insufficiency, worsening of angina.

Blood system disorders:coagulation disorders.

Gastrointestinal disorders:stomachalgia, nausea, vomiting, diarrhea.

Allergic reactions:dermatitis, itching, rash, edema.

Other:increased sexual activity, weight gain, fatigue.

Side effects are most often observed in elderly patients at doses above 2,400 mg/day.

Contraindications

Hypersensitivity, severe renal impairment (creatinine clearance less than 20 ml/min.), hemorrhagic stroke, psychomotor agitation, agitated depression, Huntington's disease, pregnancy, lactation period.

Cautiously: hemostatic disorders, massive surgery, severe bleeding, hyperthyroidism, epilepsy.

Overdose

Symptoms: strengthening of potential adverse effects.

Treatment: gastric lavage, activated charcoal, symptomatic therapy, hemodialysis is possible (efficiency - 50-60%). No specific antidote available.

Administration details

Continuous monitoring of renal function is recommended (especially in patients with chronic renal insufficiency) - residual nitrogen and creatinine, and in patients with liver disease - functional hepatic condition.

Treatment with piracetam, if necessary, may be combined with the administration of psychoactive, cardiovascular and other drug products.

When treating patients with cortical myoclonus the abrupt discontinuation of the product should be avoided (the risk of renewed attacks).

In case of sleep disorders occurrence it is recommended to cancel the evening administration, attaching this dose to the day administration.

Due to the effect of piracetam on platelet aggregation care should be taken when prescribing piracetam for patients with risk factors for bleeding: gastric ulcer and duodenal ulcer, previous intracerebral hemorrhage, a recent surgery (including dental), anticoagulation or antiplatelet therapy including low doses of aspirin.

The product penetrates through filter membranes of hemodialysis devices.

Use during pregnancy and lactation period. The product is contraindicated during pregnancy. If necessary to use during lactation, termination of breastfeeding should be considered.

Precautions for use

Effect on ability to drive and use machines. During treatment period care should be taken when driving and during other potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Interaction with other drug products

The drug increases the efficiency of antipsychotic drug products (neuroleptics), anticoagulants (on the background of high doses of piracetam). Simultaneous administration with drug products stimulating the central nervous system can cause excessive CNS stimulation. When prescribed with neuroleptics, it reduces the risk of extrapyramidal disorders. It reduces the efficiency of antiepileptic agents (reduces epileptic threshold, anticonvulsants dose adjustment is required). Simultaneous administration of piracetam and thyroid hormones confusion can lead to irritability and sleep disturbances.

Storage conditions

Store in a dark place at a temperature of or under 25 °С. Keep out of reach of children.

Shelf life

2 years. Do not use after the expiry date indicated on the package.

Prescription status

Over-the-counter.

Package

10 tablets in a blister.

2, 3 blisters together with the patient information leaflet are placed in a carton box.

Manufacturer:

Belmedpreparaty RUE

30 Fabritsius Str., 220007 Minsk, Republic of Belarus,

Tel./fax: (+375 17) 220 37 16,

e-mail: medic@belmedpreparaty.com,

http://www.belmedpreparaty.com