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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a 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 tell 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. Contents of the pack and other information

1. What is Lucetam and what is it used for

Piracetam, the active substance of Lucetam, is a nootropic agent, which means it stimulates brain metabolism. It reduces blood viscosity, increases blood flow through the brain vessels without vasodilating effects, and also increases oxygen utilization and glucose consumption in the brain tissue with impaired blood supply.

Lucetam is indicated for the treatment of:

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

2. Important information before taking Lucetam

When not to take Lucetam:

• if the patient is hypersensitive to piracetam, other pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has cerebral hemorrhage (hemorrhagic stroke);
• if the patient has end-stage renal disease;
• if the patient has Huntington's chorea.

Warnings and precautions

Before taking Lucetam, the patient should inform their doctor or pharmacist:

• if the patient has impaired renal function, as the elimination of the active substance of Lucetam may be reduced, and the effect of the medicine may be stronger. Dose adjustment may be necessary. In elderly patients, the doctor will regularly check renal function during treatment.
• if the patient has bleeding disorders, is bleeding heavily, or is at risk of bleeding, for example, due to stomach or intestinal ulcers; if the patient has had a hemorrhagic stroke in the past;

or if they have recently undergone major surgery, including dental surgery, or 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 careful medical supervision);

• if the patient has central nervous system-derived muscle tremors (cortical myoclonus), as sudden withdrawal of Lucetam may lead to recurrence of myoclonus and withdrawal seizures.

Lucetam and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should remember to inform their doctor about taking thyroid hormones or anticoagulant medications. Concomitant 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, thinks they may be pregnant, or plans to have a child, they should consult their 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 child.
Breastfeeding
Piracetam is excreted into breast milk. Therefore, Lucetam should not be used during breastfeeding, or breastfeeding should be discontinued during treatment with Lucetam.

Driving and using machines

Given the adverse events observed during the use of Lucetam, it is possible that the medicine may affect driving and operating machinery, which should be taken into account. In this regard, the doctor will determine the appropriate restrictions.

3. How to take Lucetam

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
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 central nervous system-derived muscle tremors (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 vertigo:
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, the patient should immediately consult their doctor.

Missed dose of Lucetam

The patient should not take a double dose to make up for a missed dose. In case of a missed dose, the patient should take the missed dose as soon as possible before the next dose. If it is already time for the next dose, the patient should skip the missed dose, as there is a risk of overdose if two doses are taken at the same time.

Discontinuation of Lucetam

The patient should not stop taking Lucetam without prior consultation with their doctor. In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lucetam can cause side effects, although not everybody gets them.
In case of the following symptoms, the patient should stop taking Lucetam and seek immediate medical attention:

• swelling of the 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.

The following side effects have been reported:
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 the 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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,
phone: +48 22 49 21 301, fax: +48 22 49 21 309;
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lucetam

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use Lucetam after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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: 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 the inscription "E 243" embossed on one side.
Pack sizes: 20 coated tablets (2 blisters of 10) and 60 coated tablets (6 blisters of 10), in a cardboard box with a patient information leaflet.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

EGIS PHARMACEUTICALS PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

Manufacturer:

EGIS Pharmaceuticals PLC
H-9900 Körmend
Mátyás király u. 65.
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
Marketing authorization number in Bulgaria, the country of export:20040262
Parallel import authorization number:182/12
Date of leaflet approval: 15.03.2022
[Information about the trademark]