Nootropil

Leaflet attached to the packaging: patient information

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

Nootropil (Νοотроп)

1200 mg, coated tablets
Piracetamum
Nootropil and Νοотроп 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 to a specific person. 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, pharmacist, or nurse. 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 vasodilating action, 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, violent muscle contractions in one or more limbs or torso);
• 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 to take 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 those 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 surgical procedures, including dental procedures, taking anticoagulant products or platelet aggregation inhibitors, including small doses of acetylsalicylic acid.
Do not suddenly stop treatment in patients being 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 degree 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 after assessing kidney function.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking 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, piracetam should be avoided during breastfeeding or breastfeeding should be stopped during treatment with piracetam.

Driving and operating machinery

The medicine may affect the ability to drive and operate machinery, 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

• 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 coated tablet contains less than 1 mmol (23 mg) of sodium.
The maximum daily dose (24 g of piracetam) contains about 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 directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Nootropil is available in the following strengths: 800 mg and 1200 mg.
1000 mg is equivalent to 1 g.
1200 mg 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 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 kidney function.

Taking a higher dose of Nootropil 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 was reported in a patient who overdosed on the medicine.
There is no specific antidote in case of piracetam overdose. Overdose treatment 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, Nootropil 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 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
• excitement
• 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 the leaflet, you should tell 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.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will allow for more information to be collected 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 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 coated tablet contains 1200 mg of piracetam.
The other ingredients are:
core: macrogol 6000, colloidal silica anhydrous (Aerosil), magnesium stearate, croscarmellose sodium;
coating: macrogol 6000, Opadry Y-1-7000 (hypromellose 2910 5 cp, titanium dioxide (E 171), macrogol 400), Opadry OY-S-29019 clear (hypromellose 2910 50 cp, macrogol 6000).

What Nootropil looks like and contents of the pack

1200 mg coated tablets are white, oblong, and scored with the marking N/N.
The pack contains: 20, 60, 100, or 120 coated tablets.
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.
Agiou Dimitriou 63
174 56 Alimos
Greece

Manufacturer:

UCB Pharma SA
Chemin du Foriest
B-1420 Braine l’Alleud
Belgium

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Greece, the country of export:42558/10/31-05-2011

Parallel import authorization number: 436/24

Date of approval of the leaflet: 13.12.2024

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