Solution for injection Ref.[7770] Active ingredients: Piracetam

Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: UCB Pharma S.A., 60, Allee de la Research, 1070 Brussels, Belgium

Product name and form

NOOTROPIL (piracetam) 800 mg film-coated tablet.

NOOTROPIL (piracetam) 1200 mg film-coated tablet.

NOOTROPIL (piracetam) 200 mg/ml oral solution.

NOOTROPIL (piracetam) 1 g/5 ml solution for injection.

NOOTROPIL (piracetam) 3 g/15 ml solution for injection.

Pharmaceutical Form
NOOTROPIL 800 and 1200 mg film-coated tablet: white, oblong, film-coated tablet, with a bisect line, marked N/N. NOOTROPIL 200 mg/ml oral solution: clear colourless solution. NOOTROPIL 1 g/5ml solution for injection and 3 g/15ml solution for injection: clear colourless solution.

Qualitative and quantitative composition

Each film-coated tablet of NOOTROPIL 800 mg contains 800 mg of piracetam.

Each film-coated tablet of NOOTROPIL 1200 mg contains 1200 mg of piracetam.

Each ml of NOOTROPIL oral solution contains 200 mg of piracetam.

Each ml of NOOTROPIL solution for injection contains 200 mg of piracetam.

5 ml solution for injection contains 1 g of piracetam
15 ml solution for injection contains 3 g of piracetam

For excipients, see 6.1.

Active Ingredient	Description
Piracetam	Piracetam’s mode of action in cortical myoclonus is as yet unknown. Piracetam exerts its haemorrheological effects on the platelets, red blood cells, and vessel walls by increasing erythrocyte deformability and by decreasing platelet aggregation, erythrocyte adhesion to vessel walls and capillary vasospasm.

List of Excipients
NOOTROPIL 800 mg and 1200 mg film-coated tablet: Core (current formulation): Macrogol 6000 Colloidal anhydrous silica Magnesium stearate Sodium croscarmellose White film-coating: Hydroxypropylmethylcellulose 2910 5cP (E464) Titanium dioxide (E171) Macrogol 400 Macrogol 6000 Hydroxypropylmethylcellulose 2910 50cP Purified water NOOTROPIL 20% oral solution: Glycerol (85 per cent) Saccharin sodium Apricot flavour Caramel flavour Methyl parahydroxybenzoate Propyl parahydroxybenzoate Glacial acetic acid Sodium acetate Purified water NOOTROPIL 1 g/5 ml, 3 g/15 ml solution for injection: Sodium acetate Glacial acetic acid Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

UCB Pharma S.A., 60, Allee de la Research, 1070 Brussels, Belgium

Marketing authorization dates and numbers

NOOTROPIL Tabs 1200mg: 17692

NOOTROPIL Tabs 800mg: 7086

NOOTROPIL Amps 1g/5ml: 4139

NOOTROPIL Amps 3g/15ml: 13874

NOOTROPIL Solution 20%: 7087

NOOTROPIL Tabs 1200mg: 22-04-98

NOOTROPIL Tabs 800mg: 14-8-79

NOOTROPIL Amps 1g/5ml: 8-5-73

NOOTROPIL Amps 3g/15ml: 29-10-92

NOOTROPIL Solution 20%: 14-8-79

Drugs

Drug	Countries
NOOTROPIL	Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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