Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Lucetam
1200 mg, coated tablets
Piracetamum
Please read carefully the entire leaflet 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, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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:

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, improves blood flow in 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 suffered
a hemorrhagic stroke; or if the patient has recently undergone major surgery, including
dental surgery, or if the patient 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 cortical myoclonus (muscle jerks of central nervous system origin), as abrupt discontinuation of Lucetam may lead to recurrence of myoclonus and withdrawal seizures.

Lucetam with other medicines
You must 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.
It is important to inform the doctor about the use of thyroid hormones or anticoagulant medicines.
Concomitant use of these medicines with Lucetam requires careful
medical supervision or modification of the doses used.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to
have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Lucetam may be used during pregnancy only if clearly necessary. The doctor will prescribe this
medicine only when the benefits of treatment in an individual case outweigh the potential
risk to the unborn 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 Lucetam, the medicine 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 a doctor or pharmacist. In case of
doubt, consult a doctor or pharmacist.
Lucetam is available in the following strengths: 400 mg, 800 mg, 1200 mg.
Recommended dose
The dose and duration of treatment should be individually determined by the doctor depending on
the type and severity of the disease, age, and other medical conditions.
Tablets should be taken with food or independently of meals, 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, dose adjustment may be necessary.
Use in children and adolescents
to improve performance in children with learning difficulties and dyslexic disorders (in
combination with other methods):
In adolescents and children from 8 years of age, the recommended daily dose is approximately 3.2 g, in 2
divided doses. It should be used in combination with speech therapy.
Taking a higher than recommended dose of Lucetam
If a higher than recommended dose of Lucetam is taken, seek medical advice immediately.
Missed dose of Lucetam
Do not take a double dose to make up for a missed dose. If a dose is missed 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 if two doses are taken at once.
Stopping treatment with Lucetam
Do not stop taking this medicine without prior consultation with your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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,
hives. A severe allergic (hypersensitivity) reaction to Lucetam may have occurred.

The following adverse reactions have been reported:

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

Uncommon adverse reactions (may affect 1 in 100 patients):
Weakness, drowsiness, depression.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Bleeding disorders, restlessness, anxiety, confusion, hallucinations, ataxia (impaired coordination of movement), balance disorders, worsening of epilepsy, headache, insomnia, dizziness, abdominal pain, epigastric pain, diarrhoea, nausea and vomiting, skin inflammation, skin itching.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lucetam

Do not store above 30°C.
Keep the medicine out of the sight and reach 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 stated month.
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 Lucetam contains
The active substance is piracetam.
Each coated tablet contains 1200 mg of piracetam.
Other components: magnesium stearate, povidone, 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, embossed on one side with the code "E 243".
Packaged in brown glass bottles with a plastic closure and child-resistant cap, placed in a cardboard box with an enclosed patient information leaflet, containing 20 or 60 coated tablets.

For more detailed 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland

Marketing Authorisation Numbers in Hungary, country of export: OGYI-T-7153/08
OGYI-T-7153/09

Parallel Import Licence Number: 376/19