NOOTROPIL Film-coated tablet / Oral solution / Solution for injection Ref.[7770] Active ingredients: Piracetam

Method of Administration

Piracetam will 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 three sub-doses.

Parenteral Administration

When parenteral administration is needed (e.g. swallowing difficulties, unconsciousness) piracetam can be administered intravenously at the same recommended daily dose.

• The solution for injection will be administered intravenously over several minutes.
• The solution for infusion will be administered continuously at the recommended daily dose over a 24-hour period.

Treatment of myoclonus of cortical origin

The daily dosage should begin at 7.2 g, increasing by 4.8 g every three or four days up to a maximum of 20 g/day, in two or three sub-doses.

Treatment with other anti-myoclonic 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.

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 two days (every three or four days in the case of a Lance and Adams syndrome, in order to prevent the possibility of sudden relapse or withdrawal seizures).

Elderly

Adjustment 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 impairment

The 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:

Clcr = [140 – age (years)] X weight (kg) / 72 X serum creatinine (mg/dl) (X 0.85 for women)

Symptoms

No additional adverse events specifically related to overdose have been reported with piracetam.

The highest reported overdose with piracetam was oral intake of 75g. Bloody diarrhoea with abdominal pain, was most probably related to the extreme high dose of sorbital contained in the used formulation

Management of overdose

In 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.

NOOTROPIL 1 g/5 ml, 3 g/15 ml solution for injection: 5 years.

NOOTROPIL 800 mg and 1200 mg film-coated tablet: 4 years.

NOOTROPIL 20% oral solution: 3 years.

None.NOOTROPIL Tabs 1200mg: No special storage conditions.

NOOTROPIL Tabs 800mg: No special storage conditions.

NOOTROPIL Amps 1g/5ml: No special storage conditions.

NOOTROPIL Amps 3g/15ml: No special storage conditions.

NOOTROPIL Solution 20%: No special storage conditions.

Blister pack in an outer cardboard carton (60 tablets per carton).

NOOTROPIL Tabs 1200mg: Thermoformed PVC/aluminium blister strips. Pack size of 20 or 60 tablets.

NOOTROPIL Tabs 800mg: Thermoformed PVC/aluminium blister strips. Pack size of 30 tablets.

NOOTROPIL Amps 1g/5ml: Colourless glass ampoule. Pack size of 12 ampoules.

NOOTROPIL Amps 3g/15ml: Colourless glass ampoule. Pack size of 4 ampoules.

NOOTROPIL Solution 20%: Amber glass bottles, closed by a polypropylene tamper-proof cap equipped with a polyethylene inner joint. Pack size of 125 or 150 mL bottle.

Not all pack sizes may be marketed.

No special requirements.