Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PIRACETAM
UCB (Pharma) Ireland Limited
33.3 %w/v
Oral Solution
2002-05-03
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NOOTROPIL Oral Solution 33% w/v. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Piracetam – 33% w/v (1ml contains 0.333g of Piracetam). Excipients: contains 1.8 mg/ml methylparahydroxybenzoate and 0.2mg/ml propyl parahydroxybenzoate. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of cortical myoclonus, alone or in combination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nootropil Oral Solution 33% w/w will be administered orally and may be taken with or without food. Adults: The daily dosage should begin at 7.2 g/day, increasing by 4.8 g/day every 3 days up to a maximum of 24 g/day, given in either 2 or 3 divided doses. Treatment with other antimyoclonic drugs should remain unchanged at their optimal dosage. If possible, depending on clinical benefit, an attempt should be made to subsequently reduce the dosage of other antimyoclonic drugs. Once started treatment should be continued for as long as the condition persists. In patients with an acute episode, spontaneous evolution may occur over time and an attempt should be made at six month intervals to decrease or discontinue treatment. This may be accomplished by gradually reducing the daily piracetam dose by 1.2 g at two day intervals (or four days in the case of Lance or Adams syndrome) so as to prevent the possibility of sudden relapse or withdrawal seizures. Dosage adjustment in elderly Adjustment of the dose is recommended in elderly patients with compromised renal function (_refer to section 4.4,_ _Special warnings and precautions for use_). For long term treatment in the elderly, regular evaluation of the creatinine clearan Read the complete document