Nootropil 800mg tablets

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 :

800mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04090300; GTIN: 5024091800900

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NOOTROPIL
®
800 MG FILM-COATED TABLETS
PIRACETAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Tablets are and what they are used for
2.
What you need to know before you take Nootropil Tablets
3.
How to take Nootropil Tablets
4.
Possible side effects
5.
How to store Nootropil Tablets
6.
Contents of the pack and other information.
1.
WHAT NOOTROPIL TABLETS ARE AND WHAT THEY ARE USED FOR
Nootropil Tablets belongs to a group of medicines known as GABA
analogues.
Nootropil Tablets 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 Tablets are 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 TABLETS
DO NOT TAKE NOOTROPIL TABLETS
•
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 suffer from Huntington‘s Disease (also known as
Huntington‘s Chorea)
•
if you have ever experienced a brain haemorrhage
IF ANY OF THE ABOVE APPLIES TO YOU, DO NOT TAKE NOOTROPIL TABLETS AND
TALK TO YOUR DOCTOR OR
PHARMACIST.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nootropil Tablets
•
if you think your

Preparatomtale

OBJECT 1
NOOTROPIL TABLETS 800 MG
Summary of Product Characteristics Updated 26-May-2022 | UCB Pharma
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Nootropil 800 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 800mg of piracetam
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
Nootropil is indicated in adult 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
dosag