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Nootropil 33% Oral Solution

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Nootropil® 33 % Oral Solution

Piracetam

3U

Read all of this leaflet carefully before you start using

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 Solution is for

2. Before you take Nootropil Solution

3. How to take Nootropil Solution

4. Possible side effects

5. How to store Nootropil Solution

6. Further information.

1. What Nootropil solution is for

Nootropil Solution belongs to a group of medicines known as GABA analogues.

Nootropil Solution 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 Solution is 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.

Do not take Nootropil Solution 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 Solution and talk to your doctor or pharmacist.

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

Driving and using machines

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

Warnings about some of the ingredients in Nootropil Solution

Nootropil Solution contains parahydroxybenzoate which may cause allergic reactions (possibly delayed). Nootropil Solution contains 23 mg sodium per 24 g dose of piracetam. To be taken into consideration if you are on a controlled sodium diet.

Also contains glycerol which may cause headache, stomach upset and diarrhoea.

Always take Nootropil Solution 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 usual starting dose is 7.2 g which is approximately 4 teaspoons of solution per day (using a 5ml measuring teaspoon). This will be approximately 20ml.

• It is best to split the dose so that the solution is taken on two or three separate occasions during the day (e.g. Two spoons in the morning and two spoons in the evening. OR One spoon in the morning, one at midday and two spoons 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 undiluted solution

• Do not mix the solution with any other liquid

• As the medicine has a very bitter taste you may drink a glass of water or a soft drink afterwards.

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 Solution 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 Solution

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

Stopping Nootropil Solution

Do not stop taking Nootropil Solution 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.

Like all medicines Nootropil Solution 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.

Keep out of the reach and sight of children.

Do not use Nootropil Solution 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 Solution contains

The active substance is piracetam. There is 1g of piracetam in every 3 ml of the solution.

The other ingredients are glycerol, methyl arahydroxybenzoate (E 218), propyl parahydroxy-enzoate (E 216), sodium acetate, acetic acid and purified water.

What Nootropil Solution looks like

Nootropil Solution is a clear, colourless solution. It comes in bottle which contains 300 ml of the solution.

Marketing Authorisation Holder

UCB Pharma Ltd.,

208 Bath Road,

Slough, Berkshire,

SL1 3WE, UK.

Manufacturer

NextPharma SAS,

17, route de Meulan,

F-78520 Limay,

France

This leaflet was last updated September 2011.

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, Berkshire,

SL1 3WE, UK.