Nootropil (piracetam) 800 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIRACETAM

Available from:

UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium

ATC code:

N06BX03

INN (International Name):

PIRACETAM 800 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PIRACETAM 800 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2006-11-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOOTROPIL 800
MG FILM-COATED TABLETS
Piracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Nootropil is and what it is used for
2.
What you need to know before you take Nootropil
3.
How to take Nootropil
4.
Possible side effects
5.
How to store Nootropil
6.
Contents of the pack and other information
1.
WHAT NOOTROPIL IS AND WHAT IT IS USED FOR
Nootropil 800mg film-coated tablets is a medicine used to improve the
effectiveness of the functions of the
brain such as those that play a role in learning, memory, thought and
state of consciousness.
Nootropil is used:
-
for the symptomatic improvement of signs of memory or intellectual
impairment of a pathological nature
in the absence of a diagnosis of dementia.
-
to reduce myoclonus of cortical origin in some patients. In order to
test the sensitivity to piracetam, trial
treatment can therefore be instituted for a limited period.
-
for the treatment of dyslexia children concomitantly with other
measures also well adapted to correct
these learning difficulties, such as remedial teaching.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOOTROPIL
DO NOT TAKE NOOTROPIL
-
If you are allergic (hypersensitive) to piracetam or other pyrrolidone
derivates or any of the other
ingredients of Nootropil.
-
If you have cerebral haemorrhage or End Stage Renal Failure.
-
If you are suffering from Huntington’s chorea.
WARNINGS AND PRECAUTIONS
-
if you suffer from kidneys problems, follow your doctor’s
instructions. He/she may decide if your
dose should be adjusted.
-
if you suffer from bleeding p

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nootropil (piracetam) 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg piracetam
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, oblong, film-coated tablet, with a bisect line, marked N/N
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nootropil is suggested for the symptomatic improvement of memory
disorders and intellectual disorders that
can be regarded as pathological, in the absence of a diagnosis of
dementia.
Nootropil may diminish cortical myoclonus in some patients. To test
the sensitivity to piracetam, a trial
treatment may therefore be undertaken for a limited duration.
In children for the treatment of dyslexia, in combination with
appropriate measures such as speech therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Symptomatic treatment of memory and / or intellectual disorders
Starting treatment: 4.8 g per day in several doses for the first weeks
of the treatment; then a maintenance
treatment of 2.4 g per day in two or three doses, possibly reducing to
1.2 g per day.
Treatment of cortical myoclonus
The initial dosage is 24 g of piracetam per 24 hours for 3 days.
If there is no or little response by the 3rd day, continue
administering 24 g of piracetam until the 7th day. If
the response remains zero or insufficient, stop the treatment on the
7th day. From the day when the dose of
24 g is shown to be active, reduce it by 1.2 g every 2 days, until the
myoclonus symptoms reappear. This will
indicate the average active dose.
The dose daily of piracetam will be administered in 2 or 3 doses.
Treatment with other anti-myoclonic drugs
will be maintained at the same dosage.
Then, depending on the clinical benefit obtained, the doses of the
other anti-myoclonic drugs will be reduced
if possible.
Once started, piracetam treatment will have to be continued as long as
the pathology of cerebral origin
persists.
Nevertheless every 6 months red