NOOTROPIL 333 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Nootropil 20%, 200 mg/ml, oral solution
3. Nootropil 33%, 333 mg/ml, oral solution
4. What is Nootropil and what is it used for
5. Important information before taking Nootropil
   1. When not to take Nootropil:
   2. Warnings and precautions
   3. Taking Nootropil with food, drink, and alcohol
   4. Children and adolescents
   5. Taking Nootropil in patients with renal and/or hepatic impairment
   6. Taking Nootropil in elderly patients
   7. Pregnancy and breastfeeding
   8. Driving and operating machinery
   9. Nootropil and other medicines
   10. Nootropil contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), glycerol, and sodium
   11. Nootropil 20% also contains benzyl alcohol
6. How to take Nootropil
   1. Taking Nootropil in elderly patients
   2. Taking a higher dose of Nootropil than recommended
   3. Missing a dose of Nootropil
7. POSSIBLE SIDE EFFECTS
   1. Reporting side effects
8. How to store Nootropil
9. Contents of the packaging and other information
   1. What Nootropil contains
   2. What Nootropil looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Nootropil 20%, 200 mg/ml, oral solution

Nootropil 33%, 333 mg/ml, oral solution

Piracetam
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Nootropil and what is it used for
• 2. Important information before taking Nootropil
• 3. How to take Nootropil
• 4. Possible side effects
• 5. How to store Nootropil
• 6. Contents of the packaging and other information

1. What is Nootropil and what is it used for

Nootropil is a medicine from the group of nootropic medicines. It reduces blood viscosity, increases blood flow through
vessels in the brain, without vasodilating action, also increases oxygen utilization and glucose consumption in
ischemic brain tissue.
Indications for use of Nootropil
Nootropil is used in:

• treatment of cortical myoclonus (short, violent ("lightning") muscle contractions in one or more limbs or trunk);
• treatment of dyslexic disorders in children simultaneously with speech therapy;
• treatment of dizziness.

2. Important information before taking Nootropil

When not to take Nootropil:

• if you are allergic to piracetam, other pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if you have intracerebral hemorrhage;
• if you have terminal renal failure;
• if you have Huntington's chorea.

Warnings and precautions

Before starting to take Nootropil, you should discuss it with your doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution should be exercised in people with coagulation disorders, undergoing major surgical procedures, and those with severe bleeding, bleeding risk, e.g., in gastric and intestinal ulcer disease, with coagulation disorders, with a history of hemorrhagic stroke, undergoing major surgical procedures, including dental procedures, taking anticoagulant products or platelet aggregation inhibitors, including small doses of acetylsalicylic acid.
Sudden discontinuation of treatment should not be performed in patients treated for myoclonus, to avoid recurrence of myoclonus or generalized seizures.

Taking Nootropil with food, drink, and alcohol

Nootropil can be taken during a meal or between meals.

Children and adolescents

See: "How to take Nootropil".

Taking Nootropil in patients with renal and/or hepatic impairment

Piracetam is excreted by the kidneys. Caution should be exercised when administering the medicine to patients with impaired renal function. Depending on the severity of renal impairment, dose adjustment may be required.

Taking Nootropil in elderly patients

In elderly patients with renal impairment, the doctor will adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
There is insufficient data on the use of piracetam in pregnant women. Piracetam crosses the placental barrier. The concentration of the medicine in the blood of newborns is approximately 70-90% of the concentration in the mother's blood.
Piracetam passes into human milk. Therefore, piracetam should be avoided during breastfeeding or breastfeeding should be discontinued during treatment with piracetam.

Driving and operating machinery

The medicine may affect your ability to drive and operate machinery, and this should be taken into account.

Nootropil and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
In particular, you should mention the use of:

• thyroid hormones. Cases of confusion (disorientation), irritability, and insomnia have been reported during concomitant use of the medicine with thyroid hormones (T + T).
• anticoagulant medicines, such as acenocoumarol.

The likelihood of piracetam affecting the metabolism of other medicines is low.
Concomitant administration of alcohol did not affect the concentration of piracetam in serum. Taking a dose of 1.6 g of piracetam orally did not affect the concentration of alcohol. However, it is not recommended to consume alcohol during treatment with the medicine.

Nootropil contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), glycerol, and sodium

The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
The medicine contains glycerol, which may cause headache, gastrointestinal disturbances, and diarrhea.
Nootropil 20%
The maximum daily dose (24 g of piracetam) contains 80.4 mg of sodium, the main component of table salt. This corresponds to 4.02% of the maximum recommended daily dose of sodium in the diet for adults.
Nootropil 33%
The maximum daily dose (24 g of piracetam) contains 24.35 mg of sodium, the main component of table salt. This corresponds to 1.22% of the maximum recommended daily dose of sodium in the diet for adults.

Nootropil 20% also contains benzyl alcohol

The maximum daily dose (24 g of piracetam) contains 0.13 mg of benzyl alcohol, which corresponds to 0.001 mg/ml. Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to take Nootropil

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult your doctor or pharmacist.
1,000 mg is equivalent to 1 gram.
1 ml of the 200 mg/ml solution is equivalent to 0.2 grams
1 ml of the 333 mg/ml solution is equivalent to 0.333 grams
Treatment of cortical myoclonus
Treatment should start with a dose of 7.2 g of Nootropil per day, increasing every 3 or 4 days by 4.8 g of the medicine per day to a maximum dose of 24 g per day. Nootropil should be taken in divided doses 2 or 3 times a day.
In combination therapy with other anti-myoclonic medicines, the doses of other medicines should be maintained at the recommended therapeutic doses. If clinical improvement is achieved and it is possible, the doses of other medicines should be reduced.
In patients with myoclonus, the symptoms may evolve over time, and therefore the doctor should attempt to reduce the dose or discontinue the medicine every 6 months. To do this, the dose of piracetam should be reduced by 1.2 g every 2 days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders in children simultaneously with speech therapy
In combination with speech therapy in children aged 8 to 13 years: 3.2 g of Nootropil per day in 2 divided doses.
Treatment of dizziness
2.4 g of Nootropil per day in 3 divided doses of 0.8 g for 8 weeks.
The doctor may reduce the dose of piracetam in patients with renal impairment.

Taking Nootropil in elderly patients

In elderly patients treated with piracetam for a long time, the doctor will adjust the dose of the medicine individually after assessing kidney function.

Taking a higher dose of Nootropil than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
Symptoms of overdose: one case of bloody diarrhea and abdominal pain has been reported in a patient who overdosed on the medicine. There is no specific antidote in case of piracetam overdose.
Treatment of overdose is symptomatic and may involve hemodialysis, gastric lavage, or induction of vomiting .

Missing a dose of Nootropil

You should not take a double dose to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects reported in clinical trials and after the product was placed on the market
are presented below according to their frequency in the following way:
Very common:
more than 1 patient in 10;
Common:
from 1 to 10 patients in 100;
Uncommon:
from 1 to 10 patients in 1,000;
Rare:
from 1 to 10 patients in 10,000;
Very rare:
less than 1 patient in 10,000;
Frequency not known:
cannot be estimated from available data.
Common

• nervousness
• weight gain
• increased motor activity (hyperkinesia)

Uncommon

• weakness (asthenia)
• depression
• drowsiness

Frequency not known

• bleeding disorders
• anaphylactoid reactions (a type of hypersensitivity reaction to the medicine)
• hypersensitivity
• excitement
• anxiety
• confusion
• hallucinations
• dizziness
• abdominal pain
• epigastric pain
• diarrhea
• nausea
• vomiting
• angioedema
• skin inflammation
• itching
• hives
• coordination disorders (ataxia)
• balance disorders
• seizure exacerbation
• headache
• insomnia You should immediatelyinform your doctor if you experience symptoms such as: skin redness, swelling, hives, shortness of breath, throat swelling, breathing difficulties.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Nootropil

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special requirements for storage.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Nootropil contains

Nootropil 20%, 200 mg/ml, oral solution
The active substance of Nootropil is piracetam. 1 ml of the oral solution contains 200 mg of piracetam.
The other ingredients are: glycerol 85%, sodium saccharin, sodium acetate trihydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), apricot flavor 52247 A (contains benzyl alcohol, bergamot oil (debergaptenized), propylene glycol (E 1520), ethanol, linalool), caramel flavor 052929 A7 (contains benzyl alcohol, propylene glycol (E 1520), ethanol, anise oil), glacial acetic acid, purified water.
Nootropil 33%, 333 mg/ml, oral solution
The active substance of Nootropil is piracetam. 1 ml of the oral solution contains 333 mg of piracetam.
The other ingredients are: glycerol 85%, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate trihydrate, glacial acetic acid, purified water.

What Nootropil looks like and what the packaging contains

Nootropil 20% oral solution is a clear liquid, colorless to very light brown.
The packaging contains a 150 ml or 200 ml bottle of the solution.
Nootropil 33% oral solution is a clear, colorless liquid.
The packaging contains a 125 ml or 300 ml bottle of the solution.

Marketing authorization holder and manufacturer

Marketing authorization holder
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium
Manufacturer
NextPharma SAS
Route de Meulan 17
78520 Limay
France
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
UCB Pharma Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
phone: + 48 22 696 99 20

Date of last revision of the leaflet: