Nootropil 33% oral solution

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Piracetam

Tilgjengelig fra:

UCB Pharma Ltd

ATC-kode:

N06BX03

INN (International Name):

Piracetam

Dosering :

333.3mg/1ml

Legemiddelform:

Oral solution

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04090300; GTIN: 5024091300332

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NOOTROPIL
® 33% ORAL SOLUTION
PIRACETAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Nootropil Solution is and what it is used for
2.
What you need to know before you take Nootropil Solution
3.
How to take Nootropil Solution
4.
Possible side effects
5.
How to store Nootropil Solution
6.
Contents of the pack and other information.
1.
WHAT NOOTROPIL SOLUTION IS AND WHAT IT IS USED FOR
Nootropil Solution belongs to a group of medicines known as GABA
analogues.
Nootropil Solution 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 Solution 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOOTROPIL SOLUTION
DO NOT TAKE NOOTROPIL SOLUTION
•
if you are allergic to piracetam or any of the other ingredients of
this medicine (listed in section 6).
•
if you have ever had serious kidney problems
•
if you have ever experienced a brain haemorrhage
•
if you suffer from Huntington’s disease also known as Huntington’s
Chorea
IF ANY OF THE ABOVE APPLIES TO YOU, DO NOT TAKE NOOTROPIL SOLUTION AND
TALK TO YOUR DOCTOR OR
PHARMACIST.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nootropil Solution
•
if you think your kidneys

Preparatomtale

OBJECT 1
NOOTROPIL 33% SOLUTION
Summary of Product Characteristics Updated 15-Feb-2017 | UCB Pharma
Limited
1. Name of the medicinal product
Nootropil 33% Oral Solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 333.3 mg of piracetam
Excipients with known effect: Methylparahydroxybenzoates,
propylparahydroxybenzoates and Glycerol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for oral administration
4. Clinical particulars
4.1 Therapeutic indications
Nootropil is indicated in adults patients suffering from myoclonus of
cortical origin, irrespective of
aetiology, and should be used in combination with other anti-myoclonic
therapies.
4.2 Posology and method of administration
Posology
The daily dosage should begin at 7.2 g increasing by 4.8 g every three
to four days up to a maximum of
24 g, divided in two or three 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 should be done
by reducing the dose of piracetam by 1.2 g every two days (every three
or four days in the case of a Lance
and Adams syndrome, in order to prevent the possibility of sudden
relapse or withdrawal seizures).
Elderly
Adjustment of the dose is recommended in elderly patients with
compromised renal function (see 'Dosage
adjustment in patients with renal impairment' below). For long term
treatment in the elderly, regular
evaluation of the creatinine clearance is required to allow dosage
adaptation if needed.
Patients with renal impairment
The daily dose must be individualized according to renal function.
Refer to the fol