Nootropil

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language!
Nootropil (Nootropil 1200 mg)
1200 mg, coated tablets
Piracetamum
Nootropil and Nootropil 1200 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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, increases blood flow through cerebral vessels without vasodilatory effects, and enhances 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 (dizziness).

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, discuss this with your doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution is advised in patients with coagulation disorders, those undergoing major surgical procedures, and individuals with severe hemorrhage or risk of bleeding, e.g., in peptic ulcer disease of the stomach and intestines, coagulation disorders, history of hemorrhagic stroke, undergoing major surgical procedures, including dental procedures, and those taking anticoagulant products or platelet aggregation inhibitors, including low-dose acetylsalicylic acid.
Treatment should not be abruptly discontinued 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 impaired kidney and/or liver function
Piracetam is excreted by the kidneys. Caution is required when administering the drug to patients with impaired renal function. Depending on the severity of renal impairment, dose adjustment may be necessary.

Use of 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There is 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 blood concentrations.
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
This medicine may affect the ability to drive and operate machinery, and this effect should be taken into account.

Nootropil and other medicines
You must tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Particularly important are:

• thyroid hormones. Cases of confusion, irritability, and insomnia have been reported when taking the medicine concomitantly 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 has no effect on serum concentrations of piracetam. Oral administration of a 1.6 g dose of piracetam does not affect alcohol concentrations. However, alcohol consumption is not recommended during treatment with this 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 approximately 46 mg of sodium, a main component of table salt. This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Nootropil

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Nootropil is available in the following strengths: 800 mg, 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 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, the doses of other medications should be
maintained at their recommended therapeutic levels. If clinical improvement is achieved and it is feasible,
the doses of other drugs should be gradually reduced.

In patients with myoclonus, symptoms may evolve over time; therefore, every 6 months the physician
should consider attempting to reduce the dose or discontinue the drug. To prevent sudden recurrence
of the disease, the piracetam dose should be reduced by 1.2 g every two days.

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,
divided into 2 divided doses.

Treatment of vertigo (dizziness)
2.4 g of Nootropil per day in 3 divided doses of 0.8 g each, for 8 weeks.

The physician may reduce the dose of piracetam in patients with impaired renal function.

Use in elderly patients
In elderly patients undergoing long-term treatment with piracetam, the physician will individually
adjust the dose following assessment of kidney function.

Use of a higher than recommended dose of Nootropil
If a higher than recommended dose of Nootropil is taken, consult your doctor or pharmacist immediately.
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 hemodialysis, gastric lavage, or induction of vomiting.

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.
The adverse effects reported in clinical trials and after product marketing are listed below, classified according to 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 (vascular swelling)
• Dermatitis (skin inflammation)
• Itching
• Urticaria (hives)
• Motor coordination disturbances (ataxia)
• Balance disorders
• Exacerbation of epilepsy
• Headache
• Insomnia

Seek immediate medical attention if symptoms such as skin redness, swelling, hives, shortness of breath, laryngeal edema, or breathing difficulties occur.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects helps to provide more 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 packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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: magnesium stearate, colloidal anhydrous silica, 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, elongated, divisible tablets marked with N/N.
The pack contains 60 coated tablets.

For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in Hungary, country of export:
Advanz Pharma Limited
Unit 17 Northwood House, Northwood Crescent
Dublin 9, D09 V504
Ireland

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

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation numbers in Hungary, country of export: OGYI-T-1752/09
OGYI-T-1752/04
Parallel import authorisation number: 111/21