PIRACETAM 1200 MG FILM-COATED TABLETS
Active substance(s): PIRACETAM
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®
2357
26.05.15[5]
Nootropil 1200mg film-coated tablets
(piracetam)
PATIENT INFORMATION LEAFLET
Your medicine is available as the above, but will be referred to as
Nootropil Tablets throughout the following leaflet.
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 have ever experienced a brain haemorrhage
- You suffer from Huntington‘s Disease (also known as Huntington‘s
Chorea)
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 acenocoumarol
- Low dose aspirin
- Any other medicine, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding 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 (six tablets).
- It is best to split the dose so that the tablets are taken on two or three
separate occasions during the day (e.g. 2 tablets in the morning, 2 at
midday and 2 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Nootropil Tablets after the expiry date on the carton. The expiry
date refers to the last day of that month.
If the Nootropil Tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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. FURTHER INFORMATION
What Nootropil Tablets contain
The active substance is piracetam.
Each film-coated tablet contains 1200mg piracetam.
The other ingredients are macrogol 6000, colloidal silicon dioxide,
magnesium stearate, croscarmellose sodium, hypromellose, titanium
dioxide and macrogol 400.
What Nootropil Tablets look like and content of pack
Nootropil Tablets are white, capsule shaped film-coated tablets marked ‘N’
scoreline 'N' on one side and a scoreline on the other side.
Available in a blister pack of 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by UCB S.A., Pharma Sector, Belgium and procured from
within the EU by Product Licence holder: Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM
PL 20636/2357
Leaflet issue and Revision date (Ref): 26.05.15[5]
Nootropil is a trademark of UCB Pharma, S.A.
2357
26.05.15[5]
Nootropil 1200mg film-coated tablets
(piracetam)
PATIENT INFORMATION LEAFLET
Your medicine is available as the above, but will be referred to as
Nootropil Tablets throughout the following leaflet.
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 have ever experienced a brain haemorrhage
- You suffer from Huntington‘s Disease (also known as Huntington‘s
Chorea)
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 acenocoumarol
- Low dose aspirin
- Any other medicine, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding 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 (six tablets).
- It is best to split the dose so that the tablets are taken on two or three
separate occasions during the day (e.g. 2 tablets in the morning, 2 at
midday and 2 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Nootropil Tablets after the expiry date on the carton. The expiry
date refers to the last day of that month.
If the Nootropil Tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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. FURTHER INFORMATION
What Nootropil Tablets contain
The active substance is piracetam.
Each film-coated tablet contains 1200mg piracetam.
The other ingredients are macrogol 6000, colloidal silicon dioxide,
magnesium stearate, croscarmellose sodium, hypromellose, titanium
dioxide and macrogol 400.
What Nootropil Tablets look like and content of pack
Nootropil Tablets are white, capsule shaped film-coated tablets marked ‘N’
scoreline 'N' on one side and a scoreline on the other side.
Available in a blister pack of 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by UCB S.A., Pharma Sector, Belgium and procured from
within the EU by Product Licence holder: Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM
PL 20636/2357
Leaflet issue and Revision date (Ref): 26.05.15[5]
Nootropil is a trademark of UCB Pharma, S.A.
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.
