Lucetam
Ask a doctor about a prescription for Lucetam
How to use Lucetam
Leaflet attached to the packaging: patient information
Warning!
The leaflet should be kept. Information on the immediate packaging in a foreign language.
Lucetam, 1200 mg
coated tablets
Piracetamum
It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
- The leaflet should be kept so that it can be re-read if necessary.
- In case of any doubts, you should consult a doctor, pharmacist, or nurse.
- This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
- If the patient experiences any adverse reactions, including any adverse reactions 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, i.e., it stimulates metabolism in the brain. It reduces blood viscosity, increases blood flow through the brain vessels without vasodilating action, 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 torso);
- 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 allergic 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 suffers from 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. A dose adjustment may be necessary. In elderly patients, the doctor will regularly check renal function during treatment;
- if the patient has coagulation disorders, severe bleeding, 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 undergone major surgery, including dental surgery, or are taking anticoagulant 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);
- 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 medicines. Concurrent use of these medicines with Lucetam requires close 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 can be used during pregnancy only if necessary. The doctor will prescribe this medicine only 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 reactions 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 according to the doctor's or pharmacist's recommendations. 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, 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, in 2 divided doses. It is used in combination with speech therapy.
Overdose of Lucetam
In case of taking a higher dose of Lucetam than recommended, 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. If a dose of Lucetam is missed at the scheduled time, 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 after taking 2 doses at once.
Withdrawal of Lucetam
The patient should not stop taking Lucetam without prior consultation with their doctor. If the patient has 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 following symptoms occur, 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 adverse reactions have been reported:
Common adverse reactions(may occur in 1 in 10 patients):
Hyperkinesia (involuntary and excessive movement, usually of skeletal muscles), weight gain, nervousness.
Uncommon adverse reactions(may occur in 1 in 100 patients):
Weakness, drowsiness, depression.
Adverse reactions with 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 any side effects occur, including any side effects not listed in this leaflet, the patient 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
Store at a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiration date stated on the packaging.
The expiration date indicates the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.
6. Package contents and other information
What Lucetam contains
The active substance of Lucetam 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 what the package contains
White or almost white, oval, biconvex tablets with the inscription "E 243" embossed on one side.
Blisters in a cardboard box, with an attached patient information leaflet, containing 20 or 60 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or 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
Mátyás király u. 65.
H-9900 Körmend
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
Marketing authorization number in Bulgaria, the country of export: 20040262
Parallel import authorization number: 475/12
Date of leaflet approval:21.07.2022
[Information about the trademark]
- Country of registration
- Active substance
- Prescription requiredYes
- Marketing authorisation holder (MAH)Egis Pharmaceuticals PLC
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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