Lucetam

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lucetam

1200 mg, coated tablets

Piracetamum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Lucetam and what is it used for
• 2. Important information before taking Lucetam
• 3. How to take Lucetam
• 4. Possible side effects
• 5. How to store Lucetam
• 6. Package contents and other information

1. What is Lucetam and what is it used for

Piracetam, the active substance of Lucetam, is a nootropic agent, which stimulates brain metabolism. It reduces blood viscosity, increases blood flow through brain vessels without vasodilatory effects, and also increases oxygen utilization and glucose consumption in ischemic brain tissue.
Lucetam is indicated for the treatment of:

• cortical myoclonus (short, sudden muscle contractions of one or more limbs or trunk);
• dizziness of various origins;
• dyslexic disorders in children (in combination with speech therapy).

2. Important information before taking Lucetam

When not to take Lucetam:

Warnings and precautions

Before taking Lucetam, inform your doctor or pharmacist:

for example, due to stomach or intestinal ulcers; if the patient has had a hemorrhagic stroke in the past; or if they have undergone major surgery, including dental surgery, or if they are taking anticoagulant medications or antiplatelet agents (including small doses of acetylsalicylic acid), as the active substance of Lucetam may affect blood coagulation, and its use in such cases requires special caution (and close medical supervision);

Lucetam and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take.
Remember to inform your doctor about taking thyroid hormones or anticoagulant medications. Concomitant use of these medicines with Lucetam requires close medical supervision or modification of the administered doses.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Lucetam should only be used during pregnancy if clearly necessary. The doctor will only prescribe this medicine if the benefits of its use in individual cases outweigh the risk to the fetus.
Breastfeeding
Piracetam is excreted into breast milk. Therefore, Lucetam should not be used during breastfeeding, or breastfeeding should be interrupted during treatment with Lucetam.

Driving and using machines

Given the adverse events observed during the use of Lucetam, the medicine may affect the ability to drive and use machines, which should be taken into account. In this regard, the doctor will determine the appropriate restrictions.

3. How to take Lucetam

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 determined individually by the doctor, depending on the type and severity of the disease, age, and other diseases.
Tablets should be taken with food or independently of food and washed down 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 tremors of central nervous system origin (cortical myoclonus):
The recommended initial dose is 7.2 g per day. If necessary, this dose can 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 learning outcomes in children with learning problems 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 is used in combination with speech therapy.

Overdose of Lucetam

In case of overdose, consult your doctor immediately.

Missed dose of Lucetam

Do not take a double dose to make up for a missed dose. If you miss a dose, take it 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 after taking 2 doses at once.

Withdrawal of Lucetam

Do not stop taking Lucetam without consulting your doctor first.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lucetam can cause side effects, although not everybody gets them .
If you experience any of the following symptoms, stop taking Lucetam and seek immediate medical attention:

• swelling of hands, feet, lips, or throat, causing difficulty breathing or swallowing,
• fainting or feeling faint,
• hives. It is possible that a severe allergic reaction to Lucetam has occurred.

Reported side effects:

Common side effects(may affect up to 1 in 10 people):
Hyperkinesia (involuntary and excessive movement, usually of skeletal muscles), weight gain, nervousness.
Uncommon side effects(may affect up to 1 in 100 people):
Weakness, drowsiness, depression.
Side effects of unknown frequency(frequency cannot be estimated from available data):
Coagulation disorders, excitement, anxiety, confusion, hallucinations, ataxia (coordination disorders), balance disorders, exacerbation of epilepsy, headaches, insomnia, dizziness, abdominal pain, epigastric pain, diarrhea, nausea, and vomiting, skin inflammation, skin itching.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects will help gather more information on the safety of the 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 expiration date stated on the packaging. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents 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, 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 the inscription "E 243" embossed on one side.
Brown glass bottle with a plastic closure and a safety feature, in a cardboard box, with an enclosed patient information leaflet, containing 20 or 60 coated tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, the country of export:

Egis Gyόgyszergyár 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Authorization number in Hungary, the country of export:OGYI-T-7153/08
OGYI-T-7153/09
Parallel import authorization number:376/19

Date of leaflet approval: 27.09.2024

[Information about the trademark]