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NOOTROPIL 800MG TABLETS

Active substance(s): PIRACETAM

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NOOTROPIL® 800mg TABLETS / PIRACETAM 800mg TABLETS
(piracetam)
This product is available using any of the above names but will be referred to as Nootropil
Tablets throughout the remainder of this leaflet.
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 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 Tablets
This medicine contains 46 mg sodium per dose. To be taken into consideration by patients
on a controlled sodium diet.
This medicine contains the colouring agent sunset yellow (E110) which may cause allergic
reactions.
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.
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 recommended 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 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 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 sight and reach of children.
• Do not use after the expiry date shown on the end panel of the carton. The expiry date
refers to the last day of that month.
• If the tablets becomes discoloured or shows any other signs of deterioration, you should
seek the advice of your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nootropil Tablets contain
Each pack of Nootropil Tablets contains 60 orange capsule shaped tablets marked N
breakline N on one side and breakline on the reverse.
The tablets have the letters N breakline N on one side and breakline on the reverse marked
on them to allow them to be easily identified.
Each tablet contains 800mg of piracetam as the active ingredient. Each tablet also contains
macrogol 6000. macrogol 400, colloidal anhydrous silica, magnesium stearate,
hypromellose, titanium dioxide (E171), sunset yellow (E110), talc.
PL No: 15814/0572

POM

Manufactured by J. Uriach y Cia, S.A., Avda. Cami Reial 51-57, 08184 Palau-Solita i
Plegamans (Barcelona), Spain and is procured from within the EU and repackaged by the
Product Licence holder: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24
4PR.
Leaflet revision and issue date (Ref.) 10.04.2017.
Nootropil is a registered trademark of UCB, Belgium.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.