Nootropil

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nootropil, 1200 mg, film-coated tablets

Piracetam

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 you need to.
• 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 symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 using Nootropil
• 3. How to use 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 belonging to the group of nootropic medicines. It reduces blood viscosity, increases blood flow through the brain vessels without dilating them, and also increases oxygen and glucose utilization in ischemic brain tissue.

Indications for use of Nootropil

Nootropil is used in:

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

2. Important information before using Nootropil

When not to use Nootropil:

• 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, you should discuss it with your doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution should be exercised in patients with coagulation disorders, undergoing major surgical procedures, and in patients 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, in order to avoid recurrence of myoclonus or generalized seizures.

Using Nootropil with food, drink, and alcohol

Nootropil can be taken during or between meals.

Children and adolescents

See: "How to use Nootropil".

Using 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 degree of renal impairment, dose adjustment may be required.

Using Nootropil in elderly patients

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 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 using machines

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

Nootropil 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 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 sodium

1 film-coated tablet contains less than 1 mmol (23 mg) of sodium.
The maximum daily dose (24 g of piracetam) contains approximately 46 mg of sodium, the main component of common salt. This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Nootropil

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
1000 mg is equivalent to 1 g.
1200 mg film-coated tablets are equivalent to 1.2 g.
Nootropil is available in the following strengths: 800 mg and 1200 mg.
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, in combination 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.

Use 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.

Using a higher dose of Nootropil than recommended

If a higher dose of the medicine than recommended is taken, 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

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 has been on the market are listed below according to their frequency:
Very common: more than 1 in 10 people;
Common: between 1 in 10 and 1 in 100 people;
Uncommon: between 1 in 100 and 1 in 1,000 people;
Rare: between 1 in 1,000 and 1 in 10,000 people;
Very rare: less than 1 in 10,000 people;
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,
• 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, or breathing difficulties.

Reporting side effects

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

5. How to store Nootropil

The medicine should be stored 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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nootropil contains

The active substance of Nootropil is piracetam. 1 film-coated tablet contains 1200 mg of piracetam.
The other ingredients are:
core: macrogol 6000, colloidal silica anhydrous, magnesium stearate, croscarmellose sodium;
coating: Opadry Y-1-7000 white (hypromellose, titanium dioxide (E 171), macrogol 400), Opadry OY-S-29019 clear (hypromellose, macrogol 6000).

What Nootropil looks like and contents of the packaging

1200 mg film-coated tablets are white, elongated, scored tablets with the marking N/N.
The packaging contains: 20, 60, 100, or 120 film-coated tablets.

For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, the country of export:

UCB Magyarország Kft.
Árpád fejedelem útja 26-28
H-1023 Budapest
Hungary

Manufacturer:

UCB Pharma SA
Chemin du Foriest
B-1420 Braine-l’Alleud
Belgium
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Hungary, the country of export:OGYI-T-1752/09
OGYI-T-1752/04
Parallel import authorization number:80/13

Date of leaflet approval: 17.03.2025

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