Lucetam

Leaflet attached to the packaging: patient information

Lucetam, 400 mg, film-coated tablets

Lucetam, 800 mg, film-coated tablets

Lucetam, 1200 mg, film-coated tablets

Piracetam

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 means it 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:

Lucetam and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you 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 can be used during pregnancy only if clearly 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 discontinued during treatment with Lucetam.

Driving and using machines

Considering 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.
In case of doubts, consult your 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 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, 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 at the scheduled time, 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, as there is a risk of overdose if you take 2 doses at once.

Discontinuation of Lucetam

Do not stop taking Lucetam without consulting your doctor first.
In case of 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.
In case 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.

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 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 you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lucetam

Store in a temperature below 30°C.
Store in a place out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the given 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. Package contents and other information

What Lucetam contains

The active substance is piracetam.
Each film-coated tablet contains 400 mg, 800 mg, or 1200 mg of piracetam.
The other ingredients are: magnesium stearate, povidone K-30, coating (macrogol 6000, dibutyl sebacate, titanium dioxide (E171), talc, ethyl cellulose, hypromellose).

What Lucetam looks like and contents of the pack

White or almost white, oval, biconvex tablets with the inscription "E 241" (400 mg tablets), "E 242" (800 mg tablets), or "E 243" (1200 mg tablets) embossed on one side.
The 800 mg tablets have a score line on both sides. The score line on the tablet facilitates breaking, making it easier to swallow.
400 mg and 800 mg tablets: orange glass bottles with a plastic cap, equipped with a tablet retaining element, in a carton box, with an enclosed patient information leaflet, containing:
400 mg: 60 film-coated tablets;
800 mg: 30 or 60 film-coated tablets.
1200 mg tablets: orange glass bottle with a plastic child-resistant cap, in a carton box, with an enclosed patient information leaflet, containing 20 or 60 film-coated tablets.

Marketing authorization holder

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
HungaryEGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:07.10.2022