Nootropil Tablets 1200 mg
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- Company information
- More information about this medicine
Adults:NOOTROPIL is indicated for patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies.
ElderlyAdjustment of the dose is recommended in elderly patients with compromised renal function (see 'Dosage adjustment in patients with renal impairment' below). For long term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed.
Patients with renal impairmentThe daily dose must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula:
|Group||Creatinine Clearance (ml/min)||Posology and frequency|
|Normal||> 80||usual daily dose, 2 to 4 sub-doses|
|Mild||50-79||2/3 usual daily dose, 2 or 3 sub-doses|
|Moderate||30-49||1/3 usual daily dose, 2 sub-doses|
|Severe||< 30||1/6 usual daily dose, 1 single intake|
|End-stage renal disease||--||contraindicated|
Patients with hepatic impairmentNo dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of dose is recommended (see 'Dosage adjustment in patients with renal impairment' above).
Method of administrationPiracetam should be administered orally, and may be taken with or without food. The tablet(s) should be swallowed with liquid. It is recommended to take the daily dose in two to four sub-doses.
Effects on platelet aggregationDue to the effect of piracetam on platelet aggregation (see section 5.1), caution is recommended in patients with severe haemorrhage, patients at risk of bleeding such as gastrointestinal ulcer, patients with underlying disorders of haemostasis, patients with history of haemorrhagic CVA, patients undergoing major surgery including dental surgery, and patients using anticoagulants or platelet antiaggregant drugs including low dose aspirin
Renal insufficiencyPiracetam is eliminated via the kidneys and care should thus be taken in cases of renal insufficiency (see section 4.2).
ElderlyFor long-term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed (see section 4.2).
DiscontinuationAbrupt discontinuation of treatment should be avoided as this may induce myoclonic or generalised seizures in some myoclonic patients.
Warnings related to the excipientsThis product contains about 2 mmol (or about 46 mg) sodium per 24 g piracetam. To be taken into consideration by patients on a controlled sodium diet.
Pharmacokinetics interactionsThe drug interaction potential resulting in changes of piracetam pharmacokinetics is expected to be low because approximately 90% of the dose of piracetam is excreted in the urine as unchanged drug. In vitro, piracetam does not inhibit the human liver cytochrome P450 isoforms CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations of 142, 426 and 1422 µg/ml. At 1422 µg/ml, minor inhibitory effects on CYP 2A6 (21%) and 3A4/5 (11%) were observed. However, the Ki values for inhibition of these two CYP isoforms are likely to be well in excess of 1422 µg/ml. Therefore, metabolic interaction of piracetam with other drugs is unlikely.
Thyroid hormonesConfusion, irritability and sleep disorder have been reported during concomitant treatment with thyroid extract (T3 + T4).
AcenocoumarolIn a published single-blind study on patients with severe recurrent venous thrombosis, piracetam 9.6 g/d did not modify the doses of acenocoumarol necessary to reach INR 2.5 to 3.5, but compared with the effects of acenocoumarol alone, the addition of piracetam 9.6 g/d significantly decreased platelet aggregation, β-thromboglobulin release, levels of fibrinogen and von Willebrand's factors (VIII : C; VIII : vW : Ag; VIII : vW : RCo) and whole blood and plasma viscosity.
Antiepileptic drugsA 20 g daily dose of piracetam over 4 weeks did not modify the peak and trough serum levels of antiepileptic drugs (carbamazepine, phenytoin, phenobarbitone, valproate) in epileptic patients who were receiving stable doses.
AlcoholConcomitant administration of alcohol had no effect on piracetam serum levels and alcohol levels were not modified by a 1.6 g oral dose of piracetam.
PregnancyThere are no adequate data from the use of piracetam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / foetal development, parturition or post-natal development (see section 5.3). Piracetam crosses the placental barrier. Drug levels in the newborn are approximately 70% to 90% of maternal levels. 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.
LactationPiracetam is excreted in human breast milk. Therefore, piracetam should not be used during breastfeeding or breastfeeding should be discontinued, while receiving treatment with piracetam. 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.
a. Summary of safety profileDouble-blind placebo-controlled clinical or pharmacoclinical trials, of which quantified safety data are available (extracted from the UCB Documentation Data Bank on June 1997), included more than 3000 subjects receiving piracetam, regardless of indication, dosage form, daily dosage or population characteristics.
b. Tabulated list of adverse reactionsUndesirable effects reported in clinical studies and from post-marketing experience are listed in the following table per System Organ Class and per frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.
Blood and Lymphatic disordersNot known: haemorrhagic disorder
Immune system disorders:Not known: anaphylactoid reaction, hypersensitivity
Psychiatric disorders:Common: nervousnessUncommon: depressionNot known: agitation, anxiety, confusion, hallucination
Nervous system disorders:Common: hyperkinesiaUncommon: somnolenceNot known: ataxia, balance impaired, epilepsy aggravated, headache, insomnia,
Ear and labyrinth disorders:Not known: vertigo
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
InvestigationsCommon: weight increased
SymptomsNo additional adverse events specifically related to overdose have been reported with piracetam. The highest reported overdose with piracetam was oral intake of 75 g. Bloody diarrhoea with abdominal pain, was most probably related to the extreme high dose of sorbitol contained in the used formulation.
Management of overdoseIn acute, significant overdosage, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specific antidote for overdose with piracetam. Treatment for an overdose will be symptomatic treatment and may include hemodialysis. The extraction efficiency of the dialyser is 50 to 60% for piracetam.
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