Nootropil Tablet 800 mg

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

PIRACETAM

Disponible depuis:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

DCI (Dénomination commune internationale):

PIRACETAM

Unités en paquet:

90 Tablets; 90 Tablets

Fabriqué par:

UCB PHARMA SA

Notice patient

Consumer Medication Information Leaflet (RiMUP)
1
NOOTROPIL TABLET
Piracetam (800 mg, 1200 mg)
What is in this leaflet
1.
What NOOTROPIL is used for
2.
How NOOTROPIL works
3.
Before you use NOOTROPIL
4.
How to use NOOTROPIL
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
NOOTROPIL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
What NOOTROPIL is used for

Treatment of the elderly with some
degree of cerebral functional
impairment such as loss of memory,
a lack of concentration or alertness
and feeling of dizziness.

Nootropil is indicated for patients
suffering from myoclonus of
cortical origin, irrespective of
aetiology and should be used in
combination with other anti-
myoclonic therapies.
How NOOTROPIL works
Nootropil contains the active
ingredient Piracetam. It acts on the
brain and nervous system and is
thought to protect it against a
shortness of oxygen.
Nootropil is used in combination with
other medicines to treat myoclonus.
This is a condition in which the
nervous system causes muscles,
particularly in the arms and legs, to
start to jerk or twitch uncontrollably.
Before you use NOOTROPIL
-
When you must not use it
Do not take Nootropil if:

You are allergic (hypersensitive) to
piracetam, other pyrrolidone
derivatives or to any of the other
ingredients of Nootropil (see section
Product Description
).

You have ever had serious kidney
problems

You have ever experienced a brain
haemorrhage

You suffer from Huntington’s
Disease (also known as
Huntington’s Chorea)
If any of the above applies to you, do
not take Nootropil and talk to your
doctor or pharmacist.
-
Before you start to use it
Check with your doctor before taking
Nootropil if:

You think your kidneys may not be
working perfectly. (Your doctor
may need to start you on a lower
dose)

You have ever had any kind of
bleeding problem.
If you are pregnant, trying to become
pregnant or breast-feeding ask your
doctor or pharmacist for advice before
taking Nootropil

Résumé des caractéristiques du produit

NOOTROPIL
Piracetam
NAME OF THE MEDICINAL PRODUCT
_Nootropil Tablet 800mg _
_Nootropil Tablet 1200mg _
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Nootropil Tablet 800mg _
Each film-coated tablet contains 800mg of piracetam.
_Nootropil Tablet 1200mg _
Each film-coated tablet contains 1200mg of piracetam.
EXCIPIENTS
_Nootropil Tablet 800mg _
_Nootropil Tablet 1200mg _
Macrogol 6000, Opadry Y-1-7000 White, Opadry OY-S 29019 Clear, Sodium
Croscarmellose,
Colloidal anhydrous silica (Aerosil), Magnesium Stearate
PHARMACEUTICAL FORM
_Nootropil Tablet 800mg _
White oblong film-coated tablet imprinted with a bisect line and N/N
on one side and plain on
the other side.
_Nootropil Tablet 1200mg _
White oblong scored film-coated tablet marked N/N on one side and
plain on the other side.
_ _
CLINICAL INFORMATION
INDICATIONS
Treatment of the elderly with some degree of cerebral functional
impairment such as loss of
memory, a lack of concentration or alertness and vertigo.
NOOTROPIL is indicated for patients suffering from myoclonus of
cortical origin, irrespective
of aetiology and should be used in combination with other
anti-myoclonic therapies.
DOSAGE AND ADMINISTRATION
_ _
Piracetam may be taken with or without food. The film-coated tablets
should be swallowed
with liquid. It is recommended to take the daily dose in two to four
sub-doses.
ROUTE OF ADMINISTRATION
For oral use.
ADULTS
The daily dosage should begin at 7.2g, increasing by 4.8g every three
or four days up to a
maximum of 24g, in two or three divided doses. Treatment with other
anti-myoclonic
medicinal products should be maintained at the same dosage. Depending
on the clinical benefit
obtained, the dosage of other such medicinal products should be
reduced, if possible.
Once started, treatment with piracetam should be continued for as long
as the original cerebral
disease persists. In patients with an acute episode, spontaneous
evolution may occur over time
and an attempt should be made every 6 months to decrease or
discontinue the medicinal
treatment. This sho