NOOTROPIL

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nootropil (Nootrop)
1200 mg, coated tablets
Piracetam
Nootropil and Nootrop are different trade names of the same medicine written in Polish and Greek respectively.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Nootropil is and what it is 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 Nootropil is and what it is used for

Nootropil is a nootropic agent. It reduces blood viscosity, enhances blood flow through cerebral vessels without vasodilatory effects, and increases oxygen utilization and glucose consumption in ischemic brain tissue.
Indications for Nootropil

Nootropil is indicated for:

• Treatment of cortical myoclonus (brief, sudden, "lightning-like" muscle jerks affecting one or more limbs or the trunk);
• Treatment of dyslexic disorders in children, in combination with speech therapy;
• Treatment of vertigo.

2. Important information before using Nootropil

When not to use Nootropil:

• if the patient is allergic to piracetam, other pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has intracranial bleeding;
• if the patient has end-stage renal failure;
• if the patient has Huntington's chorea.

Warnings and precautions
Before starting treatment with Nootropil, consult a doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution should be exercised in patients with coagulation disorders, those undergoing major surgical procedures, and individuals with severe bleeding or at risk of bleeding, e.g., in peptic ulcer disease of the stomach and intestines, coagulation disorders, history of hemorrhagic stroke, those undergoing major surgical procedures including dental procedures, and those taking anticoagulant agents or antiplatelet drugs, including low-dose acetylsalicylic acid.
Do not abruptly discontinue treatment in patients treated for myoclonus to avoid recurrence of myoclonus or generalized seizures.

Taking Nootropil with food, drink and alcohol
Nootropil may be taken during or between meals.

Children and adolescents
See: "How to take Nootropil".

Use of Nootropil in patients with renal and/or hepatic impairment
Piracetam is excreted by the kidneys. Caution is advised when administering the drug to patients with impaired renal function. Depending on the severity of renal impairment, dose adjustment may be required.

Use of Nootropil in elderly patients
In elderly patients with impaired renal function, the physician will adjust the dose.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are insufficient data on the use of piracetam in pregnant women. Piracetam crosses the placental barrier. Drug concentrations in newborns' blood are approximately 70–90% of maternal concentrations.
Piracetam is excreted into human milk. Therefore, the use of piracetam should be avoided during breastfeeding or breastfeeding should be discontinued during treatment with piracetam.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery, and this effect should be taken into account.

Nootropil and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
In particular, inform about concomitant use of:

• thyroid hormones. Cases of confusion, irritability, and insomnia have been reported when Nootropil was used concomitantly with thyroid hormones (T$_4$ + T$_3$).
• anticoagulant medicines such as acenocoumarol.

The likelihood of piracetam affecting the metabolism of other drugs is low.
Concomitant administration of alcohol did not affect serum concentrations of piracetam. A 1.6 g oral dose of piracetam did not affect alcohol concentrations. However, alcohol consumption is not recommended during treatment with this medicine.

Nootropil contains sodium
One 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, a major component of table salt. This corresponds to 2.3% of the maximum recommended daily dietary intake of sodium in adults.

3. How to take Nootropil

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Nootropil is available in the following strengths: 800 mg and 1200 mg.
1000 mg is equivalent to grams: 1 g.
1200 mg coated tablets are equivalent to grams: 1.2 g.
Treatment of cortical myoclonus
Treatment should be initiated at a dose of 7.2 g of Nootropil per day, increasing every 3 or 4 days
by 4.8 g of Nootropil per day up to a maximum dose of 24 g per day. Nootropil should be taken in
divided doses 2 or 3 times daily.
In combination therapy with other antimyoclonic drugs, doses of other medications should be
maintained at recommended therapeutic levels. If clinical improvement is achieved and it is feasible,
the doses of other drugs should be reduced.
In patients with myoclonus, symptoms may evolve over time; therefore, every 6 months the doctor
should attempt to reduce or discontinue the drug. To achieve this, the dose of piracetam should be
reduced by 1.2 g every two 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
two divided doses.
Treatment of vertigo
2.4 g of Nootropil per day in three divided doses of 0.8 g each for 8 weeks. The doctor may reduce
the dose of piracetam in patients with renal function impairment.
Use in elderly patients
In elderly patients undergoing long-term treatment with piracetam, the doctor will individually
adjust the dose after assessing kidney function.
Use of a higher than recommended dose of Nootropil
If a higher than recommended dose is taken, seek immediate advice from a doctor or pharmacist.
Symptoms of overdose: one case of bloody diarrhoea 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 include haemodialysis, gastric lavage, or induction of emesis.
Missed dose of Nootropil
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects reported in clinical trials and after product marketing are listed below, classified by frequency as follows:
Very common: more than 1 in 10 patients;
Common: 1 to 10 in 100 patients;
Uncommon: 1 to 10 in 1,000 patients;
Rare: 1 to 10 in 10,000 patients;
Very rare: less than 1 in 10,000 patients;
Frequency not known: cannot be estimated from available data.

Common

• Nervousness
• Weight gain
• Increased motor activity (hyperkinesia)

Uncommon

• Weakness (asthenia)
• Depression
• Somnolence (drowsiness)

Frequency not known

• Bleeding disorders
• Anaphylactoid reactions (a type of drug hypersensitivity reaction)
• Hypersensitivity
• Agitation
• Anxiety
• Confusion
• Hallucinations
• Dizziness
• Abdominal pain
• Epigastric pain
• Diarrhea
• Nausea
• Vomiting
• Angioedema
• Dermatitis
• Itching
• Urticaria
• Motor coordination disorders (ataxia)
• Balance disorders
• Worsening of epilepsy
• Headache
• Insomnia

Immediately inform your doctor if symptoms such as skin redness, swelling, urticaria, shortness of breath, laryngeal edema, or breathing difficulties occur.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse effects can also be reported to the responsible entity or parallel importer.
Reporting adverse effects helps to collect further information on the safety of the medicine.

5. How to store Nootropil

Keep this medicine 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 stated month.
No special storage instructions apply.
Medicines must 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 in Nootropil is piracetam. One coated tablet contains 1200 mg of piracetam.
The other ingredients are:
core: macrogol 6000, colloidal anhydrous silica (Aerosil), magnesium stearate,
sodium croscarmellose;
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
Coated tablets 1200 mg are white, elongated, divisible tablets marked with N/N.
The pack contains: 20, 60, 100 or 120 coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Greece, 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 in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing authorization number in Greece, country of export: 42558/10/31-05-2011
Parallel import authorization number: 436/24