LUCETAM

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 this leaflet carefully before taking the medicine, because
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 person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Lucetam is and what it is used for
2. Important information before taking Lucetam
3. How to take Lucetam
4. Possible side effects
5. How to store Lucetam
6. 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 taking Lucetam, inform your doctor or pharmacist:

• if the patient has impaired kidney function, as in such cases elimination of the active substance of Lucetam is 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, experiences severe bleeding, or is at risk of bleeding, for example due to gastric or intestinal ulcer; if the patient previously suffered 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 muscle jerks originating from the central nervous system (cortical myoclonus), as abrupt discontinuation of Lucetam may lead to recurrence of myoclonic jerks 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.
Be sure to inform the doctor about taking thyroid hormones or anticoagulant medicines. Concurrent use of these medicines with Lucetam requires careful medical supervision or modification of the administered doses.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a 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 in an individual case outweigh the potential risks to the fetus.

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 your doctor or pharmacist. If in
doubt, consult your 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 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 vertigo:
The recommended daily dose ranges from 2.4 g to 4.8 g, given in 2 or 3 divided doses.
In case of renal impairment, dosage adjustment may be required.
Use in children and adolescents
For improving academic performance 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, given in 2 divided doses. It is used in combination with speech therapy.
Taking more than the recommended dose of Lucetam
If more than the recommended dose of Lucetam is taken, seek medical advice immediately.
Missing a 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 Lucetam treatment
Do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

If any of the following symptoms occur, stop taking Lucetam and seek immediate 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 occur in 1 out of 10 patients):
Hyperkinesia (involuntary and excessive movement, usually of skeletal muscles), weight gain, nervousness.

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

Adverse reactions with unknown frequency (frequency cannot be estimated from the 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 itching.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Lucetam

Store below 30°C.
Keep 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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.
The other ingredients are:
Tablet core: 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 coated tablets, embossed on one side with the code "E 243".
Blister packs contained in a cardboard box with an enclosed patient information leaflet, containing 60 coated tablets.
For further information, please contact the Marketing Authorisation Holder or the parallel importer.

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

Manufacturer:
EGIS Pharmaceuticals PLC
Mátyás király u. 65.
H-9900 Körmend
Hungary

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 number in Bulgaria, country of export: 20040262
Parallel import authorisation number: 302/19