Nootropil 20%

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nootropil 20% (Νοοτροπ), 200 mg/ml (1 g/5 ml), oral solution

Piracetam
Nootropil 20% and Νοοτροπ are different trade names for the same medicine written in Polish and Greek.

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Nootropil 20% and what is it used for
• 2. Important information before using Nootropil 20%
• 3. How to use Nootropil 20%
• 4. Possible side effects
• 5. How to store Nootropil 20%
• 6. Contents of the packaging and other information

1. What is Nootropil 20% and what is it used for

Nootropil 20% is a medicine from the group of nootropic medicines. It reduces blood viscosity, increases blood flow through the vessels in the brain without vasodilating action, and also increases oxygen utilization and glucose consumption in ischemic brain tissue.

Indications for use of Nootropil 20%

Nootropil 20% is used in:

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

2. Important information before using Nootropil 20%

When not to use Nootropil 20%:

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

Warnings and precautions

Before starting to use Nootropil 20%, 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 people 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, using 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.

Using Nootropil 20% with food, drink, and alcohol

Nootropil 20% can be taken during or between meals.

Children and adolescents

See: "How to use Nootropil 20%".

Using Nootropil 20% 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 the renal impairment, dose adjustment may be required.

Using Nootropil 20% in elderly patients

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
There are 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 equal to about 70-90% of the concentration in the mother's blood.
Piracetam passes into human milk. Therefore, the use of piracetam should be avoided during breastfeeding or breastfeeding should be discontinued during treatment with piracetam.

Driving and using machines

The medicine may affect the ability to drive and use machines, and this effect should be taken into account.

Nootropil 20% and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
In particular, they 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 other medicines affecting the metabolism of piracetam 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 20% contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), glycerol 85%, 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.
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 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 using 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 using 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 use Nootropil 20%

This medicine should always be used in accordance with the recommendations of a doctor or pharmacist. In case of doubts, you should consult a 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.
Treatment of cortical myoclonus
Treatment should start with a dose of 7.2 g of Nootropil 20% 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 20% 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 every 6 months the doctor should attempt to reduce the dose or discontinue the medicine. To this end, 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 20% per day in 2 divided doses.
Treatment of dizziness
2.4 g of Nootropil 20% per day in 3 divided doses of 0.8 g for 8 weeks.
The doctor may reduce the dose of piracetam in patients with impaired renal function.

Use in elderly patients

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

Using a higher dose of Nootropil 20% than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.
Overdose symptoms: 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 20%

A double dose should not be taken 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 listed below according to their frequency of occurrence as follows:
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 the 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
• agitation
• anxiety
• confusion
• hallucinations
• dizziness
• abdominal pain
• epigastric pain
• diarrhea
• nausea
• vomiting
• angioedema
• skin inflammation
• itching
• hives
• coordination disorders (ataxia)
• balance disorders
• exacerbation of epilepsy
• headache
• insomnia

You should immediatelyinform your doctor if you experience symptoms such as skin redness, swelling, hives, shortness of breath, laryngeal edema, or breathing difficulties.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Nootropil 20%

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 packaging. The expiry date refers to the last day of the specified month.
After opening the bottle, it should not be used for more than 1 month.
There are no special precautions for storage.
After opening: Store in a temperature below 25°C.
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 does Nootropil 20% contain

The active substance of Nootropil 20% is piracetam. 1 ml of the oral solution contains 200 mg of piracetam.
The other ingredients are: glycerol 85%, sodium saccharin, sodium acetate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), apricot flavor 52247 A (contains benzyl alcohol, bergamot oil (debergaptenized), propylene glycol (E 1520), ethanol, linalol), caramel flavor 052929 A7 (contains benzyl alcohol, propylene glycol (E 1520), ethanol, anise oil), glacial acetic acid, purified water.

What Nootropil 20% looks like and what the packaging contains

Nootropil 20% oral solution is a clear liquid, colorless to very light brown.
The packaging contains a bottle (150 ml of solution) with a dosing device in the form of a scaled measuring cup, with a cap, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

UCB A.E., Agios Dimitriou 63, 17456 Alimos, Greece

Manufacturer:

NextPharma SAS, Route de Meulan 17, 78520 Limay, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 42560/10/31-05-2011

Parallel import authorization number: 105/24

Date of leaflet approval: 15.03.2024

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