2357

06.04.13[4]

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

Leaflet issue and Revision date (Ref): 06.04.13[4] Nootropil is a trademark of UCB Pharma, S.A.

2357

06.04.13[4]

Piracetam 1200mg film-coated tablets

PATIENT INFORMATION LEAFLET

Your medicine is available as the above, but will be referred to as Piracetam 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 Piracetam Tablets are for

2.    Before you take Piracetam Tablets

3.    How to take Piracetam Tablets

4.    Possible side effects

5.    How to store Piracetam Tablets

6.    Further information.

1.    WHAT PIRACETAM TABLETS ARE FOR

Piracetam Tablets belongs to a group of medicines known as GABA analogues.

Piracetam 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.

Piracetam 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 PIRACETAM TABLETS Do not take Piracetam Tablets if:

-    You are allergic to the active ingredient piracetam

-    You are allergic to any of the other ingredients of Piracetam Tablets (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 Piracetam Tablets and talk to your doctor or pharmacist.

Check with your doctor before taking Piracetam 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 Piracetam Tablets. If you are taking this medicine, use contraception to avoid becoming pregnant. If you are taking Piracetam Tablets and you think you may be pregnant, consult your doctor immediately.

Driving and using machines

Piracetam Tablets may cause drowsiness and shakiness. If this happens to you, do not drive or use machinery.

Warning about some of the ingredients in Piracetam 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 PIRACETAM TABLETS

Always take Piracetam 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 Piracetam 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 Piracetam Tablets

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

Stopping Piracetam Tablets

Do not stop taking Piracetam 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 Piracetam 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE PIRACETAM TABLETS

Keep out of the sight and reach of children.

Do not use Piracetam Tablets after the expiry date on the carton. The expiry date refers to the last day of that month.

If the Piracetam 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 Piracetam 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 Piracetam Tablets look like and content of pack

Piracetam 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.

Leaflet issue and Revision date (Ref): 06.04.13[4]