Nootropil

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Nootropil(Nootropil 1200 mg)

1200 mg, film-coated tablets

Piracetam
Nootropil and Nootropil 1200 mg are different trade names for the same medicine.
It is essential to carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 taking Nootropil
• 3. How to take Nootropil
• 4. Possible side effects
• 5. How to store Nootropil
• 6. Contents of the pack and other information

1. What is Nootropil and what is it used for

Nootropil is a nootropic medicine. It reduces blood viscosity, increases blood flow through the brain vessels without vasodilating action, and 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, sudden muscle contractions in one or more limbs or trunk);
• treatment of dyslexic disorders in children in conjunction with speech therapy;
• treatment of dizziness.

2. Important information before taking Nootropil

When not to take 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 treatment with Nootropil, the patient should discuss it with their doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution should be exercised in patients with coagulation disorders, undergoing major surgery, and in patients with severe bleeding, risk of bleeding, e.g., in gastric and intestinal ulcer disease, with coagulation disorders, with a history of hemorrhagic stroke, undergoing major surgery, including dental surgery, using anticoagulant products or platelet aggregation inhibitors, including low 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 and drink and alcohol

Nootropil can be taken during 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 impaired renal function, 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 taking this medicine.
There are no sufficient 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 is excreted in 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 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 take.
In particular, they should mention the use of

• thyroid hormones. Cases of confusion, 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 interactions with other medicines under the influence 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 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 take Nootropil

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Nootropil is available in the following strengths: 800 mg, 1200 mg.
1000 mg is equivalent to 1 g.
1200 mg film-coated tablets are equivalent to 1.2 g.
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 conjunction 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 impaired renal function.

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 renal function.

Taking a higher dose of Nootropil than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
Overdose symptoms: one case of bloody diarrhea and abdominal pain was 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 marketing of the product are listed below according to their frequency of occurrence as follows:
Very common:
more than 1 in 10 patients;
Common:
from 1 to 10 in 100 patients;
Uncommon:
from 1 to 10 in 1,000 patients;
Rare:
from 1 to 10 in 10,000 patients;
Very rare:
less than 1 in 10,000 patients;
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 The patient should immediatelyinform their doctor if they experience symptoms such as: skin redness, swelling, hives, shortness of breath, throat swelling, breathing difficulties.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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 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, it is possible to gather more information on the safety of the medicine.

5. How to store Nootropil

The medicine should be stored out of sight and reach of children.
The medicine should not be used 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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: magnesium stearate, colloidal silica anhydrous, sodium croscarmellose, macrogol 6000;
coating:macrogol 6000, Opadry OY-S-29019 Clear (hypromellose, macrogol 6000), Opadry Y-I-7000 (hypromellose, titanium dioxide (E 171), macrogol 400).

What Nootropil looks like and contents of the pack

Nootropil tablets are white, oblong, and scored, with the marking N/N.
The pack contains 60 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

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

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Hungary, the country of export: OGYI-T-1752/09
OGYI-T-1752/04
Parallel import authorization number: 111/21

Date of leaflet approval: 23.12.2024

[Information about the trademark]