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Package leaflet: Information for the patient

Nootropil ® 800  mg film-coated Tablets

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
• 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 kidneys may not be working perfectly.
(Your doctor may need to start you on a lower dose.)
• if you have ever had any kind of bleeding problem.
Other medicines and Nootropil Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. 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
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 this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you
are not sure.
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.
How much medicine to take and when to take it
• The recommended starting dose is 7.2 g each day (nine
• 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 forgotten dose.
Simply take the next dose as planned.
If you stop taking 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 on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.

Reporting of side effects
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
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nootropil Tablets
Keep this medicine out of the sight and reach of children.
Do not use Nootropil Tablets after the expiry date which is
stated on the carton after EXP. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Nootropil Tablets contains
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.
What Nootropil Tablets look like and contents of the pack
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 and Manufacturer
UCB Pharma Ltd.,
208 Bath Road,
UCB S.A. Pharma Sector,
B-1420 Braine-l’Alleud,
This leaflet was last revised in September 2016.

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,
SL1 3WE, UK.

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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.