Nootropil

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nootropil

1200 mg, film-coated tablets

Piracetam
Read the leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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 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 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 trunk);
• 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 starting treatment with Nootropil, 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 surgery, 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 surgery, including dental surgery, 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.

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 impaired renal function, the doctor will adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice 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 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 discontinued during treatment with piracetam.

Driving and using machines

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

Nootropil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Especially tell them about:

• 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 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

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Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Nootropil is available in the following strengths: 800 mg and 1200 mg.
1000 mg is equivalent to 1 gram.
1200 mg film-coated tablets are equivalent to 1.2 grams.
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 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

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist immediately.
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

Do not take a double dose to make up for a forgotten 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 medicine was marketed are listed below by frequency of occurrence as follows:
Very common: more than 1 in 10 people;
Common: between 1 and 10 in 100 people;
Uncommon: between 1 and 10 in 1,000 people;
Rare: between 1 and 10 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 not listed in this leaflet, 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

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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: macrogol 6000, colloidal silica anhydrous, magnesium stearate, croscarmellose sodium,
coating: Opadry Y-1-7000 (macrogol 400, titanium dioxide (E 171), hypromellose), Opadry OY-S-29019 clear (macrogol 6000, hypromellose).

What Nootropil looks like and contents of the pack

White, elongated, scored tablets with N/N marking.
The pack 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, 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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian, country of export marketing authorization number: OGYI-T-1752/09
OGYI-T-1752/04

Parallel import authorization number: 1/23 Date of leaflet approval: 04.01.2023

[Information about the trademark]
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