NOOTROPIL ORAL SOLUTION 20%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PIRACETAM

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

N06BX03

Dosage:

20% w/v

Pharmaceutical form:

SOLUTION

Composition:

PIRACETAM 20g/100ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

NEXTPHARMA SAS

Authorization status:

ACTIVE

Authorization date:

1988-05-19

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

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