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NOOTROPIL 33% ORAL SOLUTION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - NOOTROPIL 33% ORAL SOLUTION

1. what nootropil solution is and what it is used 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.

2. what you need to know before you take nootropil solution

Do not take Nootropil Solution

  • 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 have ever experienced a brain haemorrhage
  • if 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.

Warnings and precautions

Talk to your doctor or pharmacist 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.)
  • if you have ever had any kind of bleeding problem

Other medicines and Nootropil Solution

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 acenocoumarol
  • 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 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.

3. how to take nootropil solution

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 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 forgotten dose. Simply take the next dose as planned.

If you stop taking 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 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.

5. how to store nootropil solution

Keep this medicine out of the sight and reach of children. Do not use Nootropil Solution 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 Solution contains

The active substance is piracetam. Each 5 ml of solution contains 1.666 g piracetam.

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

What Nootropil Solution looks like and contents of the pack

Nootropil Solution is a clear, colourless solution. It comes in bottle which contains 125ml or 300 ml of the solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer 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 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, Slough, Berkshire, SL1 3WE, UK.

© UCB (2015)

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N06 PSYCHOANALEPTICS

N06B PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS

N06BX Other psychostimulants and nootropics in ATC

N06BX03 piracetam

Frequently Asked Questions

What is Nootropil 33% Oral Solution used for?

Nootropil 33% Oral Solution, containing the active ingredient piracetam, is primarily used to improve cognitive function and memory in individuals experiencing cognitive decline or brain injuries.

How does Nootropil work in the brain?

Nootropil works by enhancing the communication between neurotransmitters in the brain, which can help improve memory, learning, and overall cognitive function.

Can I take Nootropil if I have a history of seizure disorders?

Yes, but you should consult your doctor first. Nootropil may be prescribed to prevent seizures in certain cases.

Is Nootropil safe for elderly patients?

Yes, Nootropil can be safe for elderly patients, however, it is crucial to follow your doctor’s dosage recommendations and monitor for any side effects.

What is the recommended dosage of Nootropil for adults?

The recommended dosage varies based on individual needs; typically, adults may start with 2.4 grams daily divided into two or three doses.

Can I take Nootropil with other medications?

Always consult your healthcare provider before combining Nootropil with other medications to avoid potential interactions.

Are there any common side effects of taking Nootropil?

Common side effects may include nausea, headache, and insomnia. If you experience severe reactions, contact your doctor immediately.

How long does it take for Nootropil to start working?

Patients often report improvements within a few weeks of starting treatment with Nootropil, but individual responses may vary.

Can I drink alcohol while taking Nootropil?

It is best to avoid alcohol while taking Nootropil, as it can interfere with how the medication works and increase side effects.

Is Nootropil effective for studying or enhancing academic performance?

Some people use Nootropil to enhance memory and learning capacity; however, its effectiveness can vary from person to person.

Can I use Nootropil during pregnancy or breastfeeding?

Consult your healthcare provider before using Nootropil if you are pregnant or breastfeeding; safety during these times hasn't been fully established.

What should I do if I miss a dose of Nootropil?

If you miss a dose of Nootropil, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose—never double up.

What should I avoid while taking Nootropil?

Avoid driving or operating heavy machinery until you know how Nootropil affects you. Also, limit caffeine intake since it may increase jitteriness.

How is Nootropil taken?

Nootropil 33% Oral Solution is taken orally. Measure the prescribed dose using the provided measuring spoon or syringe and swallow it directly.

What happens if I overdose on Nootropil?

In case of an overdose on Nootropil, seek emergency medical attention immediately. Symptoms may include agitation and confusion.

Are there any specific dietary recommendations while taking Nootropil?

There are no strict dietary restrictions; however, maintaining a balanced diet can support overall cognitive health while on this medication.

Can children take Nootropil?

Nootropil is primarily indicated for adults; consult a pediatrician if considering this medication for children.

How should I store my bottle of Nootropil 33% Oral Solution?

Store your bottle of Nootropil at room temperature away from direct sunlight and moisture. Keep out of reach of children.

Does insurance cover the cost of Nootropil?

Coverage for Nootropil varies by insurance plan; check with your provider regarding benefits related to this medication.