Lucetam

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is 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. 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 dilating them, and also increases oxygen and glucose utilization in the brain's ischemic 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:

and

Lucetam and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Remember to inform your doctor about taking thyroid hormones or anticoagulant medications. The simultaneous 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 child.
Breastfeeding
Piracetam is excreted into breast milk. Therefore, Lucetam should not be used during breastfeeding, or breastfeeding should be stopped 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.
Therefore, 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, ask 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, 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, 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, seek medical attention immediately.

Missed dose of Lucetam

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

Stopping Lucetam treatment

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

A severe allergic reaction to Lucetam may have 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, itching of the skin.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Lucetam

Store below 30°C.
Keep 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 month.
Medicines should 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.
The other ingredients are:
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 tablets with the inscription "E 243" embossed on one side.
Blister packs in a cardboard box, with an enclosed patient information leaflet, containing 60 coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 20040262
Parallel import authorization number: 302/19

Date of approval of the leaflet: 17.07.2024

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