Skip to Content

NOOTROPIL 800MG FILM-COATED TABLETS

Active substance: PIRACETAM

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
In this leaflet:
1. What Nootropil Tablets are for
2. Before you take Nootropil Tablets
3. How to take Nootropil Tablets
4. Possible side effects
5. How to store Nootropil Tablets
6. Further information.

1. What Nootropil Tablets are 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. Before you take Nootropil Tablets
Do not take Nootropil Tablets if:
• You are allergic to the active ingredient piracetam
• You are allergic to any of the other ingredients of Nootropil
(these are listed in Section 6)
• You have ever had serious kidney problems
• You suffer from Huntington‘s Disease (also known as
Huntington‘s Chorea)
• 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.
Check with your doctor before taking Nootropil Tablets 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.
Tell your doctor if you are taking any of the following
medicines:
• Thyroid extract or thyroxine
• Anticoagulants such as warfarin or aceno-coumarol
• Low dose aspirin
• Any other medicines, including medicines obtained without
a prescription.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breastfeeding ask your doctor or pharmacist for advice before taking
Nootropil Tablets. If you are taking this medicine, use
contraception to avoid becoming pregnant. If you are taking
Nootropil Tablets and you think you may be pregnant, consult
your doctor immediately.
Driving and using machines
Nootropil Tablets may cause drowsiness and shakiness. If this
happens to you, do not drive or use machinery.
Warning about some of the ingredients in Nootropil
Tablets
This medicine contains 46 mg sodium per dose. To be taken
into consideration by patients on a controlled sodium diet.

3. How to take Nootropil Tablets
Always take Nootropil Tablets exactly as your doctor has told
you.
Important:
Your doctor will choose the dose that is right for you. Your
dose will be shown clearly on the label that your
pharmacist puts on your medicine. If it does not, or you
are not sure, ask your doctor or pharmacist.
Adults
How much medicine to take and when to take it
• The normal starting dose is 7.2 g each day (nine
tablets).
• It is best to split the dose so that the tablets are taken on
two or three separate occasions during the day (3 tablets
in the morning, 3 at midday and 3 in the evening).
• When you start taking this medicine your doctor may tell
you to gradually increase the dose to ensure that you
receive the best dose to treat your condition.
• Follow your doctor’s instructions carefully.
How to take your medicine
• Swallow the tablets whole with a glass of water.
• Do not break or chew the tablets as piracetam has a very
bitter taste.
• If you find it difficult to swallow the tablets tell your doctor
as soon as possible as they can prescribe piracetam in the
form of a solution.
Elderly and patients with kidney problems
If you are elderly or have kidney problems your doctor may
reduce your dose.
If you take more Nootropil Tablets than you should
If you accidentally take too much, immediately go to the
nearest hospital casualty department or your doctor.
If you forget to take Nootropil Tablets
Do not take a double dose to make up for a missed dose.
Simply take the next dose as planned.
Stopping Nootropil Tablets
Do not stop taking Nootropil Tablets without first talking to
your doctor. Abruptly stopping your medicine may cause
twitching and jerking.
If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Nootropil Tablets can cause side effects,
although not everybody gets them.
You may notice the following side effects:
• An allergic reaction and experience difficulty breathing,
swelling, fever
• Spontaneous bleeding caused by defects in your blood
clotting mechanism
• Worse fits
• Hallucinations
• Difficulty balancing and unsteadiness when standing
• Anxiety and agitation
• Confusion
• Restlessness
• Nervousness
• Sleepiness
• Depression
• Weakness
• Vertigo
• Weight increase
• Stomach pain
• Diarrhoea
• Feeling or being sick
• Headache
• Being unable to sleep
• Swelling of the skin, particularly around the face
• Skin rash and itching.

CIA72693C_MU1_GI_BRA_Nootropil_GB.indd 1

17.06.15 09:23

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Product Name

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Aesica Id.-No.
external Id.-No.

CIA72693C_MU1/PL

Dimensions

180 x 315 mm

Operator

Nagler

Creation Date

17.06.2015

Print Colours

Techn. Colours

Artwork Studio

black

Nootropil

techn. info

PT Approval

Date

Approver

GRA/Tonnellier

Dispatched to

Operator

Manufacturing Site

BRA

9 pt

Linespacing

10,8 pt

Artwork Information
Fontsize Bodytext
Technical remarks

Amended by

Modific. Date
Edition No.

01

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

R

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nootropil Tablets
Keep out of the reach and sight of children.
Do not use Nootropil Tablets after the expiry date on the
carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Return any medicine you no longer need to
your pharmacist.

6. Further information
What Nootropil Tablets contain
The active substance is piracetam. Each tablet contains
800 mg piracetam.
The other ingredients are Macrogol 6000, colloidal anhydrous
silica, magnesium stearate and croscarmellose sodium. The
film coating contains hypromellose (E464), titanium dioxide
(E171) and Macrogol 400.

V

What Nootropil Tablets look like
Nootropil 800 mg Tablets are white, film-coated tablets. The
tablets have the letters N/N marked on them to allow them
to be easily identified. They come in a blister pack of
90 tablets.
Marketing Authorisation Holder
UCB Pharma Ltd.,
208 Bath Road,
Slough,
SL1 3WE, UK
Manufacturer
UCB S.A. Pharma Sector,
B-1420 Braine-l’Alleud,
Belgium.
This leaflet was last updated June 2015.

If this leaflet is difficult to see or read
or you would like it in a different format,
please contact
UCB Pharma Ltd.,
208 Bath Road,
Slough,
SL1 3WE, UK.

© UCB (2015)

CIA72693C_MU1

CIA72693C_MU1_GI_BRA_Nootropil_GB.indd 2

17.06.15 09:23

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Product Name

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Aesica Id.-No.
external Id.-No.

CIA72693C_MU1/PL

Dimensions

180 x 315 mm

Operator

Nagler

Creation Date

17.06.2015

Print Colours

Techn. Colours

Artwork Studio

black

Nootropil

techn. info

PT Approval

Date

Approver

GRA/Tonnellier

Dispatched to

Operator

Manufacturing Site

BRA

9 pt

Linespacing

10,8 pt

Artwork Information
Fontsize Bodytext
Technical remarks

Amended by

Modific. Date
Edition No.

01

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide