NOOTROPIL INJECTION 3 g/15 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PIRACETAM (injectable grade)

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

N06BX03

Dosage:

3 g/15 ml

Pharmaceutical form:

INJECTION

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

UCB Pharma S.p.A.

Authorization date:

1994-12-09

Patient Information leaflet

1
NOOTROPIL
®
Piracetam
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg or 1200 mg of piracetam.
Each ml of oral solution contains 200 mg of piracetam
EXCIPIENTS
NOOTROPIL 800 mg and 1200 mg film-coated tablet:
Core:
Macrogol 6000 - Colloidal anhydrous silica - Magnesium stearate -
Sodium
croscarmellose
Film-coating:
Hydroxypropylmethylcellulose - Titanium dioxide (E171) - Macrogol 400
- Macrogol
6000.
NOOTROPIL 200 mg/ml oral solution:
Glycerol (85%) - Saccharin sodium - Apricot flavour - Caramel flavour
- Methyl
parahydroxybenzoate - Propyl parahydroxybenzoate - Sodium acetate -
Glacial acetic
acid - Purified water.
PHARMACEUTICAL FORM
NOOTROPIL Tablet 800 and 1200 mg: white, oblong, film-coated tablet,
with a bisect
line, marked N/N on one side and plain on the other side
NOOTROPIL Oral Solution 20%: clear colourless solution
INDICATIONS
1. Studies carried out in the elderly suffering from loss of memory,
vertigo, a lack of
concentration or of alertness, changes of mood, a deterioration in
behaviour and
personal negligence, demonstrate an improvement in symptoms.
These symptoms can also provide an early warning of the onset of
pathological ageing
such as Alzheimer’s Disease, an Alzheimer type of senile dementia,
or the dementia
produced by multiple cerebral infarcts.
2. NOOTROPIL is advocated in the treatment of sickle-cell
vaso-occlusive crises.
3. 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.
DOSAGE AND ADMINISTRATION
_Oral formulations _
2
NOOTROPIL should be administered orally, and may be taken with or
without food.
The film-coated tablets should be swallowed with liquid.
_Parenteral formulations _
When parenteral adm

Summary of Product characteristics

PIRACETAM
NOOTROPIL
®
PRODUCT DESCRIPTION
Piracetam (_Nootropil_
_®_
)
800 mg Film-Coated Tablet: Each film-coated tablet contains 800 mg of
piracetam.
Piracetam (_Nootropil_
_®_
)
1.2 g Film Coated Tablet: Each film-coated tablet contains 1200 mg of
piracetam.
Piracetam (_Nootropil_
_®_
)
1 g/ 5 mL Solution for Injection: Each 5 mL solution for injection
contains 1 g of piracetam
Piracetam (_Nootropil_
_®_
)
3 g/ 15 mL Solution for Injection: Each 15 mL solution for injection
contains 3 g of piracetam
Piracetam (_Nootropil_
_®_
) 12 g/ 60 mL Solution for Infusion:
Each 60 mL solution for infusion contains 12 g of piracetam
PHARMACOLOGIC PROPERTIES
PHARMACODYNAMICS
MECHANISM OF ACTION
Available data suggest that piracetam basic mechanism of action is
neither cell-nor-organ-specific. Piracetam binds physically
in a dose-dependent manner to the polar head of phospholipids membrane
models, inducing the restoration of the membrane
lamellar structure characterised by the formation of mobile
drug-phospholipid complexes. This probably accounts for an
improved
membrane
stability,
allowing
the
membrane
and
transmembrane
proteins
to
maintain
or
recover
the
three-
dimensional structure or folding essential to exert their function.
Piracetam has neuronal and vascular effects.
PHARMACODYNAMIC EFFECTS
NEURONAL EFFECT
At the neuronal level, piracetam exerts its membrane activity in
various ways. In animals, piracetam enhances a variety of types
of neurotransmission, primarily through postsynaptic modulation of
receptor density and activity. In both animals and man, the
functions involved in cognitive processes such as learning, memory,
attention and consciousness were enhanced, in the
normal subject as well as in deficiency states, without the
development of sedative or psychostimulant effects. Piracetam
protects and restores cognitive abilities in animals and man after
various cerebral insults such as hypoxia, intoxications and
electroconvulsive therapy. It protects against hypoxia-induced changes
in brain function and p