Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Lucetam
1200 mg, film-coated tablets
Piracetam
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
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 or pharmacist. See section 4.

Table of contents:

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

1. What Lucetam is and what it is used for

Piracetam, the active substance in Lucetam, is a nootropic agent, i.e. it enhances brain metabolism. It reduces blood viscosity, increases blood flow through cerebral vessels without vasodilatory action, and enhances oxygen utilization and glucose consumption in ischemic brain tissue.
Lucetam is indicated for the treatment of:

Cortical myoclonus (brief, sudden muscle jerks affecting one or more limbs or the trunk);
Vertigo of various origins;
Dyslexic disorders in children (in combination with speech therapy).

2. Important information before using Lucetam

When not to use Lucetam:

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 bleeding in the brain (hemorrhagic stroke);
if the patient has end-stage renal disease;
if the patient suffers from Huntington's chorea.

Warnings and precautions
Before using Lucetam, inform your doctor or pharmacist:

if the patient has impaired kidney function, as in such cases elimination of the active substance of Lucetam may be reduced, resulting in a stronger effect of the medicine. Dose adjustment may be necessary. In elderly patients, the doctor will regularly monitor kidney function during treatment.
if the patient has coagulation disorders, severe bleeding or is at risk of bleeding, for example due to gastric or intestinal ulcer; if the patient has previously experienced a hemorrhagic stroke; or if the patient has recently undergone major surgery, including dental surgery, or is taking anticoagulant medicines or platelet aggregation inhibitors (including low-dose acetylsalicylic acid), because the active substance of Lucetam may affect blood coagulation and its use in such cases requires special caution (and careful medical supervision).
if the patient has central nervous system-originating muscle jerks (cortical myoclonus), as abrupt discontinuation of Lucetam may lead to recurrence of myoclonus and withdrawal seizures.

Lucetam and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Remember to inform the doctor about taking thyroid hormones or anticoagulant medicines. Concurrent use of these medicines with Lucetam requires careful medical supervision or adjustment of doses used.

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.

Pregnancy
Lucetam may be used during pregnancy only if clearly needed. The doctor will prescribe this medicine only when the benefits in the individual case outweigh the risks to the child.

Breastfeeding
Piracetam is excreted in breast milk. Therefore, Lucetam should not be used during breastfeeding, or breastfeeding should be discontinued for the duration of treatment with Lucetam.

Driving and operating machinery
Due to adverse events observed during treatment with this medicine, Lucetam may affect the ability to drive and operate machinery, which should be taken into account. Therefore, the doctor will determine appropriate restrictions.

3. How to use Lucetam

This medicine should always be taken as directed by the physician or pharmacist. In case of
doubt, consult your physician or pharmacist.
Recommended dose
The dose and duration of treatment should be individually determined by the physician according to the
type and severity of the disease, age, and other medical conditions.
Tablets should be taken with or without food and swallowed with 100–200 ml of liquid.
It is recommended to divide the daily dose into 2–4 equal parts.
Recommended daily doses depending on the indication:
Treatment of muscle jerks originating from the central nervous system (cortical myoclonus):
The recommended initial dose is 7.2 g per day. If necessary, this dose may be increased by 4.8 g
every 3–4 days, up to a maximum dose of 24 g, administered in 2 or 3 divided doses.
Treatment of dizziness:
The recommended daily dose ranges from 2.4 g to 4.8 g, in 2 or 3 divided doses.
In case of renal impairment, dosage adjustment may be necessary.
Use in children and adolescents
to improve learning outcomes in children with learning difficulties and dyslexic disorders (in
combination with other methods):
In adolescents and children from the age of 8, the recommended daily dose is approximately 3.2 g, in 2
divided doses. It should be used in combination with speech therapy.
Taking more Lucetam than recommended
If you take more Lucetam than recommended, contact your physician immediately.
Missing a dose of Lucetam
Do not take a double dose to make up for a missed dose. If you miss a dose at the scheduled time, take the
missed dose as soon as possible before the next dose. If it is already time for the next dose, skip the missed
dose. Otherwise, there is a risk of overdose when taking two doses at once.
Stopping Lucetam treatment
Do not stop taking this medicine without prior consultation with your physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur, stop taking Lucetam and seek urgent medical help:

swelling of the hands, feet, lips or throat causing difficulty in breathing or swallowing,
fainting or feeling faint,
urticaria (hives).

The following adverse effects have been reported:

Common adverse effects (may occur in 1 out of 10 patients):
Hyperkinesia (involuntary and excessive movement, usually of skeletal muscles), weight gain, nervousness.

Uncommon adverse effects (may occur in 1 out of 100 patients):
Weakness, somnolence, depression.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):
Coagulation disorders, agitation, anxiety, confusion, hallucinations, ataxia (impaired coordination of movement), balance disorders, exacerbation of epilepsy, headache, insomnia, dizziness, abdominal pain, epigastric pain, diarrhoea, nausea and vomiting, skin inflammation, skin pruritus (itching).

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also 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
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 this medicine.

5. How to store Lucetam

Do not store above 30°C.
Keep in a place inaccessible and out of sight of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
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 package and other information

What Lucetam contains
The active substance is piracetam.
Each coated tablet contains 1200 mg of piracetam. The other ingredients are: magnesium stearate,
povidone K 30, coating (macrogol 6000, dibutyl sebacate, titanium dioxide (E 171), talc,
ethylcellulose, hypromellose).

What Lucetam looks like and contents of the pack
White or almost white, oval, biconvex tablets with an imprint on one side: "E 243".
The pack consists of a brown glass bottle with a plastic closure and security ring, placed in a cardboard box containing 60 coated tablets.

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

Marketing Authorisation Holder in Hungary, country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
H-1106 Budapest, Hungary

Manufacturer:
Egis Gyógyszergyár Zrt.
Mátyás király utca 65.
H-9900 Körmend, Hungary

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

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

Hungary, country of export, marketing authorisation number: OGYI-T-7153/09
Parallel import authorisation number: 218/25