Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Nootropil
1200 mg, coated tablets
Piracetam
Please read the entire leaflet carefully before using 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Nootropil is and what it is used for
Important information before taking Nootropil
How to take Nootropil
Possible side effects
How to store Nootropil
Contents of the pack and other information

1. What Nootropil is and what it is used for

Nootropil is a nootropic medicine. 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.

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 should be exercised in patients with
coagulation disorders, those undergoing major surgical procedures, and individuals with severe
bleeding or risk of bleeding, e.g.: in peptic ulcer disease of the stomach and intestines, coagulation
disorders, history of haemorrhagic stroke, those undergoing major surgical procedures, including
dental procedures, and those taking anticoagulant products or platelet aggregation inhibitors,
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 degree of renal impairment, dose adjustment may
be required.
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 become
pregnant, she should consult her 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 newborn blood are approximately 70–90% of maternal
blood concentrations.
Piracetam passes 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 with other medicines
Inform your doctor or pharmacist about all medicines currently used or 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 the medicine is taken concomitantly with thyroid hormones (T* + T*).
anticoagulant medicines, such as acenocoumarol.

The likelihood of piracetam causing disturbances in the metabolism of other drugs is low.
Concomitant administration of alcohol did not affect serum concentrations of piracetam. Oral
administration of a 1.6 g dose of piracetam did 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 major
component of table salt. This corresponds to 2.3% of the maximum recommended daily sodium intake
in the diet of adults.

3. How to take Nootropil

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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.
The 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 per day up to a maximum dose of 24 g per day. Nootropil should be taken in divided doses,
2 or 3 times daily.
When used concomitantly with other antimyoclonic drugs, the doses of other medications should be
maintained at their recommended therapeutic doses. 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 attempt 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 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 physician may reduce the piracetam dose 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 based on assessment of kidney function.

Taking more Nootropil than recommended
If you take more Nootropil than recommended, seek immediate medical advice from your 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.

If you forget to take 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 everybody will experience them.
Adverse effects reported in clinical trials and after marketing of the medicine are listed below according to their frequency of occurrence 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;
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 drug hypersensitivity reaction)
Hypersensitivity
Restlessness
Anxiety
Confusion
Hallucinations
Dizziness
Abdominal pain
Epigastric pain
Diarrhea
Nausea
Vomiting
Angioedema
Dermatitis
Itching
Urticaria
Movement coordination disorders (ataxia)
Balance disorders
Exacerbation of epilepsy
Headache
Insomnia

Immediately inform a 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 any adverse effects not listed in this leaflet, tell a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring 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
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.
No special storage instructions apply.
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.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Nootropil contains
The active substance is piracetam. One coated tablet contains 1200 mg of piracetam.
The other ingredients are:
core: macrogol 6000, anhydrous colloidal silica, magnesium stearate, sodium croscarmellose,
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, divisible tablets marked with N/N.
Pack contents: 20, 60, 100 or 120 coated tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, country of export:
UCB Magyarország Kft., Árpád fejedelem útja 26-28., H-1023 Budapeszt, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian marketing authorisation number, country of export: OGYI-T-1752/09
OGYI-T-1752/04
Parallel import authorisation number: 1/23
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