Nootropil

Leaflet attached to the packaging: patient information

Nootropil, 800 mg, film-coated tablets

Nootropil, 1200 mg, film-coated tablets

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 you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this 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 nootropic medicine. It reduces blood viscosity, increases blood flow through the brain vessels without dilating them, and also increases oxygen and glucose utilization in the brain's ischemic 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 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 cerebral hemorrhage;
• if you have terminal renal failure;
• if you have Huntington's chorea.

Warnings and precautions

Before taking 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, those undergoing major surgery, and those with severe bleeding, bleeding risk, e.g., in gastric and intestinal ulcer disease, coagulation disorders, history of hemorrhagic stroke, undergoing major surgery, including dental procedures, taking anticoagulant products or platelet aggregation inhibitors, including low doses of acetylsalicylic acid.
Sudden discontinuation of treatment in patients treated for myoclonus should not be done to avoid recurrence of myoclonus or generalized seizures.

Taking Nootropil with food, 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 renal impairment, the doctor will adjust the dose of the medicine after assessing kidney function.

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 or have recently taken, as well as any 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 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 dose of sodium in the diet for adults.

3. How to take Nootropil

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
1000 mg is equivalent to 1 g.
800 mg film-coated tablets are equivalent to 0.8 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 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.

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 take more than the recommended dose of the medicine, 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

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 has been on the market 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 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:
Aleje Jerozolimskie 181C,
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.
Reporting side effects will help 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.
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. 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. One film-coated tablet contains 800 mg or 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 (E171), macrogol 400), Opadry OY-S-29019 clear (hypromellose, macrogol 6000).

What Nootropil looks like and contents of the pack

800 mg film-coated tablets are white, elongated, scored tablets with N/N marking.
The pack contains: 30, 90, or 150 film-coated tablets.
1200 mg film-coated tablets are white, elongated, scored tablets with N/N marking.
The pack contains: 20, 60, 100, or 120 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium
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
To obtain more detailed information, 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:April 2024