NOOTROPIL Tablet

Indicated for:

Adults

- symptomatic treatment of the psycho-organic syndrome whose features, improved by treatment, are memory loss, attention disorders and lack of drive,

- treatment of cortical myoclonus, alone or in combination,

- treatment of vertigo and associated disorders of balance, with the exception of dizziness of vasomotor or psychic origin,

- prophylaxis and remission of sickle cell vaso-occlusive crises.

Children

- treatment of dyslexia, in combination with appropriate measures such as speech therapy,

- prophylaxis and remission of sickle cell vaso-occlusive crises.

Dosage and Administration

Oral formulations

Piracetam may be taken with or without food. The film-coated tablets should be swallowed with liquid. It is recommended to take the daily dose in 2-4 sub doses.

Route of Administration

Oral formulations

For oral use.

Adults

Symptomatic treatment of psycho-organic syndromes

The recommended daily dose ranges from 2.4g up to 4.8g, in 2 or 3 sub-doses.

Treatment of myoclonus of cortical origin

The daily dosage should begin at 7.2g, increasing by 4.8g every 3-4 days up to a maximum of 24g, in 2-3 divided doses. Treatment with other antimyoclonic medicinal products should be maintained at the same dosage. Depending on the clinical benefit obtained, the dosage of other such medicinal products should be reduced, if possible. The dosage must be set individually for each patient by a therapeutic trial.

Once started, treatment with piracetam should be continued for as long as the original cerebral disease persists. In patients with an acute episode, spontaneous evolution may occur over time and an attempt should be made every 6 months to decrease or discontinue the medicinal treatment. This should be done by reducing the dose of piracetam by 1.2g every 2 days (every 3-4 days in the case of a Lance- Adams syndrome, in order to prevent the possibility of sudden relapse or withdrawal seizures).

Treatment of vertigo

The recommended daily dose ranges from 2.4g to 4.8g, in 2-3 divided doses.

Prophylaxis and remission of sickle cell vaso-occlusive crises

The recommended daily dose for prophylaxis is 160mg/kg, orally, in 4 divided doses. The recommended daily dose for remission is 300mg/kg intravenously, in 4 divided doses. For sickle cell anaemia the prophylactic dosage must be permanent. A dose lower than 160mg/kg/day or irregular intake may result in relapse of crises.

Children

Dyslexia in combination with appropriate measures such as speech therapy

The recommended dosage for school age children (from 8 years old) and adolescents is 3.2g per day, that means 8mL of 20% solution twice per day or 2 tablets of 800mg in the morning and in the evening, usually during the whole period of the school year.

Prophylaxis and remission of sickle cell vaso-occlusive crises

For children from 3 years old onwards the prophylactic dosage is 160mg/kg/day divided doses. In case of remission a dose of 300mg/kg/day is administered intravenously, divided into 4 divided doses. The prophylactic administration in sickle cell anaemia must be permanent.

A dose lower than 160mg/kg/day or an irregular intake may cause a relapse of the illness. Piracetam is administered to children with sickle cell anaemia indication in recommended daily doses (mg/kg-see above). Piracetam has been administered only to a limited number of children in the age range of 1-3 years.

Elderly

Adjustment of the dose is recommended in elderly patients with compromised renal function. For long term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed.

Renal Impairment

Hepatic Impairment

See the package insert about the details.

- hypersensitivity to piracetam, other pyrrolidone derivatives or any of the excipients,

- severe renal impairment (renal creatinine clearance of less than 20mL per minute),

- cerebral haemorrhage,

- patients suffering from Huntington’s Chorea.

Blood and lymphatic system disorders

Not known: anaphylactoid reaction, hypersensitivity

Psychiatric disorders

Common: nervousness

Uncommon: depression

Not known: agitation, anxiety, confusion, hallucination

Nervous system disorders

Common: hyperkinesia

Uncommon: somnolence

Not known: ataxia, balance disorder, epilepsy aggravated, headache, insomnia

Ear and labyrinth disorders

Not known: vertigo

Vascular disorders

Rare: thrombophlebitis (only for injectable form), hypotension (only for injectable form)

Gastrointestinal disorders

Not known: abdominal pain, abdominal pain upper, diarrhoea, nausea, vomiting

Skin and subcutaneous tissue disorders

Not known: angioneurotic oedema, dermatitis, pruritus, urticaria

General disorders and administration site conditions

Uncommon: asthenia

Rare: pyrexia (only for injectable form), injection site pain (only for injectable form)

Investigations

Common: weight increased

Please see the package insert about the details.

Pharmacokinetic interactions

In vitro, piracetam does not inhibit the human liver CYP450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2E1and 49/11.

Minor inhibitory effects on CYP2A6and 3A4/5 were observed.

Thyroid hormones

Acenocoumarol

Antiepileptic drugs

Alcohol

Fertility

There are no relevant data available.

Pregnancy

Piracetam should not be used during pregnancy unless clearly necessary, when benefit exceeds the risks and the clinical condition of the pregnant mother requires treatment with piracetam. Piracetam crosses the placental barrier. Drug levels in the newborn are approximately 70-90% of maternal levels.

There are no adequate data from the use of piracetam in pregnant women. Animal studies do not indicated direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-nasal development.

Lactation

Piracetam should not be used during breastfeeding or breastfeeding should be discontinued, while receiving treatment with piracetam. Piracetam is excreted in human breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue piracetam therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Please see the package insert about the details.

Effect son platelet aggregation

Renal insufficiency

Elderly

Discontinuation

Sickle cell vaso-occlusive crises.

Pharmacotherapeutic group: Psychostimulants, agents used for ADHD and nootropics

Available data suggest that piracetam basic mechanism of action is neither cell- not organ- specific. Piracetam binds physically in a dose-dependent manner to the polar head or phospholipids membrane models, inducing the restoration of the membrane lamellar structure characterized by the formation of mobile drug-phospholipid complexes. This probably accounts for an improved membrane stability, allowing the membrane and transmembrane proteins to maintain or recover the three-dimensional structure or folding essential to exert their function. Piracetam has neuronal and vascular effects.