Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Nootropil 20% (Νοοτροπ), 200 mg/ml (1 g/5 ml), oral solution
Piracetamum
Nootropil 20% and Νοοτροπ are different brand names of the same medicine written in Polish and Greek.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

What is Nootropil 20% and what is it used for
Important information before using Nootropil 20%
How to use Nootropil 20%
Possible side effects
How to store Nootropil 20%
Contents of the pack and other information

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

Nootropil 20% is a nootropic agent. It reduces blood viscosity, increases blood flow through cerebral vessels without vasodilatory action, and enhances oxygen utilization and glucose consumption in ischemic brain tissue.
Indications for Nootropil 20%

Nootropil 20% is indicated for:

Treatment of cortical myoclonus (brief, sudden, "lightning-like" muscle jerks affecting one or more limbs or the trunk);
Treatment of dyslexic disorders in children, in conjunction with speech therapy;
Treatment of vertigo.

2. Important information before using Nootropil 20%

When not to use Nootropil 20%:

if the patient is allergic to piracetam, other pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has intracranial bleeding;
if the patient has end-stage renal failure;
if the patient has Huntington's chorea.

Warnings and precautions
Before starting treatment with Nootropil 20%, discuss this with your doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution is advised in patients with
coagulation disorders, those undergoing major surgical procedures, and individuals with severe
bleeding, or at risk of bleeding, e.g.: in peptic ulcer disease of the stomach and intestines, coagulation
disorders, history of haemorrhagic stroke, undergoing major surgical procedures, including dental
procedures, or taking anticoagulant products or platelet aggregation inhibitors, including low-dose
acetylsalicylic acid.
Do not abruptly discontinue treatment in patients treated for myoclonus, to avoid recurrence of
myoclonus or generalized seizures.
Taking Nootropil 20% with food, drink and alcohol
Nootropil 20% may be taken during or between meals.
Children and adolescents
See: "How to use Nootropil 20%".
Use of Nootropil 20% in patients with impaired kidney and/or liver function
Piracetam is excreted by the kidneys. Caution is required when administering the medicine to
patients with impaired renal function. Depending on the severity of renal impairment, dose
adjustment may be necessary.
Use of 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, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of piracetam in pregnant women. Piracetam crosses the placental
barrier. Drug concentrations in newborns' blood are approximately 70–90% of maternal blood
levels.
Piracetam passes into human milk. Therefore, the use of piracetam during breastfeeding should be
avoided or breastfeeding should be discontinued during treatment with piracetam.
Driving and operating machinery
This medicine may affect the ability to drive or operate machinery, and this should be taken into
account.
Nootropil 20% with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines planned for use.
In particular, inform about concomitant use of:

thyroid hormones. Cases of confusion (disorientation), irritability, and insomnia have been reported when the medicine is used concomitantly 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 serum concentrations of piracetam. A single oral
dose of 1.6 g piracetam did not affect alcohol concentrations. However, alcohol consumption is not
recommended during treatment with this medicine.
Nootropil 20% contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), glycerol 85% and sodium
The medicine contains methyl and propyl parahydroxybenzoates, which may cause allergic reactions
(including delayed-type reactions).
The medicine contains glycerol, which may cause headache, gastrointestinal disturbances and diarrhoea.
The maximum daily dose (24 g piracetam) contains 80.4 mg of sodium, a major component of table
salt. This corresponds to 4.02% of the maximum recommended daily dietary sodium intake for adults.
Nootropil 20% also contains benzyl alcohol
The maximum daily dose (24 g piracetam) contains 0.13 mg of benzyl alcohol, equivalent 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 large
amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called
metabolic acidosis).
Pregnant or breastfeeding women should consult their doctor before using the medicine, as large
amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called
metabolic acidosis).

3. How to use Nootropil 20%

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
1,000 mg converted into grams: 1 g.
1 ml of 200 mg/ml solution converted into grams: 0.2 g.
Treatment of cortical myoclonus
Treatment should begin at 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 up to a maximum dose of 24 g per day. Nootropil 20% should be
taken in divided doses 2 or 3 times daily.
When used in combination with other antimyoclonic medicines, the doses of other medicines should be
maintained at recommended therapeutic doses. If clinical improvement is achieved and it is feasible, the doses of other medicines should be reduced.
In patients with myoclonus, symptoms may evolve over time; therefore, every 6 months the doctor should attempt to reduce or discontinue the medicine. To achieve this, the dose of piracetam should be reduced by 1.2 g every two days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders in children in combination 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 vertigo
2.4 g of Nootropil 20% per day in 3 divided doses of 0.8 g each for 8 weeks.
The doctor may reduce the dose of piracetam in patients with renal function impairment.
Use in elderly patients
In elderly patients undergoing long-term treatment with piracetam, the doctor will individually adjust the dose after assessing kidney function.
Use of a higher than recommended dose of Nootropil 20%
If a higher than recommended dose of the medicine is taken, 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 include hemodialysis, gastric lavage, or induction of emesis.
Missed dose of Nootropil 20%
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported in clinical trials and after product marketing are listed below, classified by frequency of occurrence as follows:
Very common: more than 1 in 10 patients;
Common: 1 to 10 in 100 patients;
Uncommon: 1 to 10 in 1,000 patients;
Rare: 1 to 10 in 10,000 patients;
Very rare: less than 1 in 10,000 patients;
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 drug hypersensitivity reaction)
Hypersensitivity
Agitation
Anxiety
Confusion
Hallucinations
Dizziness
Abdominal pain
Epigastric pain
Diarrhoea
Nausea
Vomiting
Angioedema
Dermatitis
Itching
Urticaria
Motor coordination disturbances (ataxia)
Balance disorders
Worsening of epilepsy
Headache
Insomnia

Immediately inform a doctor if symptoms such as skin redness, swelling, urticaria, shortness of breath, laryngeal oedema, or breathing difficulties occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nootropil 20%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
After opening the bottle, do not use for longer than 1 month.
No special storage instructions apply.
After opening: Store below 25ºC.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Nootropil 20% contains
The active substance in Nootropil 20% is piracetam. 1 ml of 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 flavour 52247 A (containing benzyl alcohol, bergamot oil (debergaptenized), propylene glycol (E 1520), ethanol, linalool), caramel flavour 052929 A7 (containing benzyl alcohol, propylene glycol (E 1520), ethanol, anise alcohol), glacial acetic acid, purified water.

What Nootropil 20% looks like and contents of the pack
Nootropil 20% oral solution is a clear liquid, colourless to very light brown.
The pack contains a bottle (150 ml solution) with a dosing device in the form of a graduated measuring spoon, with a cap, in a cardboard box.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Greece, country of export: 42560/10/31-05-2011
Parallel Import Licence Number: 105/24