Nootropil

Piracetam.

Each film-coated tablet of NOOTROPIL 800 mg contains 800 mg of piracetam.
Excipients/Inactive Ingredients: Film-coated tablet: Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Sodium croscarmellose, Hydroxypropylmethylcellulose, Titanium dioxyde (E171), Macrogol 400.

1. NOOTROPIL is recommended for the symptomatic improvement of memory and intellectual impairment of a pathological nature in the absence of a diagnosis of dementia.
2. Studies have shown some improvement in children with learning difficulties associated with the written word, particularly with textual understanding which cannot be explained by intellectual backwardness, inadequate education or by the family environment. The administration of NOOTROPIL does not replace other measures also well adapted to correct these learning difficulties, such as remedial teaching.
3. NOOTROPIL can reduce myoclonus of cortical origin in some patients. In order to test the sensitivity to piracetam, trial treatment can therefore be instituted for a limited period.

Impairment of memory and/or intellectual functions: Initial treatment: 4.8 g per day in several intakes during the first weeks of the treatment; then maintenance treatment of 2.4 g per daily in two or three divided doses, eventually reducing 1.2 g daily.
In the treatment of myoclonus of cortical origin, the initial dose is 24 g of NOOTROPIL per 24 hours for 3 days. If the response on the third day is weak or absent, the administration of 24 g of NOOTROPIL should be continued up to the seventh day. If there is still no response or it is inadequate, treatment should be discontinued on the seventh day. From the day when the dose of 24 g has shown to be active, it should be decreased by 1.2 g every 2 days until myoclonus reappears.
This will enable to determine the mean active dose.
The daily dose of NOOTROPIL should be divided into 2 or 3 single doses. Treatment with other anti-myoclonic drugs should then be maintained using the same dosage. Depending on the clinical benefit obtained, the dose of the other anti-myoclonic drugs should then be reduced, if possible.
Once started, treatment with NOOTROPIL must be maintained as long as the original cerebral disorder persists.
Nevertheless, every 6 months it should be attempted to reduce or discontinue treatment with the drug. Treatment should be discontinued gradually, by reducing the dose of NOOTROPIL by 1.2 g every 2 days to prevent a sudden recrudescence of the disease.
Children with learning difficulties: In the treatment of 8 to 13 year-old children with learning difficulties, NOOTROPIL is given at a total dose of 3.3 g daily.
The medication may be more easily accepted if given in fruit juice, or in some other drink. Treatment should be continued throughout the school year. The efficacy of a longer period of treatment has not yet been investigated.
Adjustment of the dose is recommended in elderly patients with compromised renal function (see Renal impairment under Precautions).

Symptoms: One case of bloody diarrhea with abdominal pain, associated with the oral intake of 75 g piracetam daily, was most probably related to the extreme high dose of sorbitol contained in the used formulation.
No other case was reported that would point to additional adverse events specifically related to an overdose.
Treatment: In acute, significant overdose, the stomach may be emptied by induction of emesis. There is no specific antidote. Treatment for an overdose will be a symptomatic treatment and may include hemodialysis. The extraction efficiency of the dialyser is 50 to 60% for piracetam.

NOOTROPIL is contraindicated in: Hypersensitivity to piracetam or other pyrrolidone derivatives or any of the excipients.
Patients with cerebral haemorrhage.
Patients suffering from Huntington's Chorea.
End stage renal disease patients (renal creatinine clearance of less than 20ml per minute).

Effects on platelet aggregation: Due to the platelet antiaggregant effect of NOOTROPIL, 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 a history of haemorrhagic CVA, patients undergoing major surgery including dental surgery, and patients using anticoagulants or platelet antiaggregant drugs including low dose aspirin.
Renal insufficiency: NOOTROPIL is eliminated via kidneys and care should thus be taken in cases of renal insufficiency.
Discontinuation: Abrupt discontinuation of treatment should be avoided in myoclonic patients as this may induce myoclonic or generalised seizures.
Sickle cell vaso-occlusive crises: For sickle cell indication, a dose lower than 160 mg/kg/day or irregular intake may result in relapse of crises.
Huntington's Disease: When administering high doses of NOOTROPIL to patients with Huntington's Disease a slight deterioration of spontaneous movements was observed.
Warnings related to the excipients: Mannitol (E421): May have a mild laxative effect from an intake of 6.5 g piracetam or more, daily.
Aspartame (E951): Contains a source of phenylalanine equivalent to 50 mg for a dose of 2.4 g piracetam. May be harmful for people with phenylketonuria.
Methyl parahydroxybenzoate and propylparahydroxybenzoate: May cause allergic reactions (possibly delayed) (see Adverse Reactions).
Glycerol: May cause headache, stomach upset and diarrhea (see Adverse Reactions).
Sodium: NOOTROPIL 800 mg film-coated tablets: This product contains about 2 mmol (or about 46 mg) sodium per 24 g piracetam.
Renal impairment: The daily dose must be individualised 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: See equation.

Click on icon to see table/diagram/image

For this reason, the daily dose will be changed according to the table as follows: See table.

Click on icon to see table/diagram/image

Ability to perform tasks that require judgement, motor or cognitive skills: Given the adverse events observed with the drug, an influence on driving and using machines is possible and should be taken into account.
Use in Elderly: For long-term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / foetal development, parturition or post-natal development. There are no adequate data from the use of NOOTROPIL in pregnant women. Piracetam crosses the placental barrier.
Drug levels in the newborn are approximately 70% to 90% of maternal levels. NOOTROPIL 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 is excreted in human breast milk. Therefore, NOOTROPIL 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.

Clinical Studies: Double-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 NOOTROPIL, regardless of indication, dosage form, daily dosage or population characteristics.
Adverse reactions are ranked under headings of frequency using the following convention: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1000 to <1/100, Rare ≥1/10000 to <1/1000, Very rare <1/10000, Not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Not known: haemorrhagic disorder.
Immune 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.

Thyroid hormones: Confusion, irritability and sleep disorder have been reported during concomitant treatment with thyroid extract (T3 + T4).
Acenocoumarol: In a published single-blind study on patients with severe recurrent venous thrombosis, piracetam 9.6 g/d did not modify the dose 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.
Pharmacokinetic interactions: The 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 major human liver cytochrome P450 isoforms (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11) at concentrations of 142, 426 and 1422 mcg/ml. At 1422 mcg/ml, minor inhibitory effects on CYP 2A6 (21%) and 3A4/5 (11%) were observed. However, the K_i 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.
Antiepileptic drugs: A 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.
Alcohol: Concomitant 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.

Incompatibilities: None known.

Nootropics & Neurotonics/Neurotrophics

N06BX03 - piracetam ; Belongs to the class of other psychostimulants and nootropics.

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