Lucetam

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Lucetam, 1200 mg

Coated tablets
Piracetamum

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 means it stimulates brain metabolism. It reduces blood viscosity, increases blood flow through brain vessels without vasodilating 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, the patient should inform their doctor or pharmacist:

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 close medical supervision or modification of the doses used.

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, the medicine may affect the ability to drive and use machines, which should be taken into account. In this regard, the doctor will establish appropriate restrictions.

3. How to take Lucetam

This medicine should always be taken exactly as directed 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.
The daily dose is recommended to be divided 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, given in 2 or 3 divided doses.

Treatment of dizziness:

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, a 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, given 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

A double dose should not be taken to make up for a missed dose. If a dose is missed, 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 missed dose should be skipped to avoid the risk of overdose after taking 2 doses at once.

Discontinuation of Lucetam

The patient should not stop taking Lucetam without prior consultation with their doctor. If they have any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lucetam can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they 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):
Bleeding 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 inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lucetam

Do not store above 30°C.
The medicine should be stored out of 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 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. 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 K 30, coating (macrogol 6000, dibutyl sebacate, titanium dioxide (E 171), talc, ethyl cellulose, hypromellose).

What Lucetam looks like and what the package contains

White or almost white, oval, biconvex tablets with the inscription "E 243" embossed on one side.
A brown glass bottle with a plastic closure and a guarantee ring, in a cardboard box, with an enclosed patient information leaflet, containing 60 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

Egis Gyógyszergyár Zrt., H-1106 Budapest, Keresztúri út 30-38., Hungary

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian, export country authorization number: OGYI-T-7153/09

Parallel import authorization number: 269/24

Date of leaflet approval:04.07.2024
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