Lucetam

Package Leaflet: Information for the Patient

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 Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 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:

• If you are allergic to piracetam, other pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6);
• If you have cerebral hemorrhage (hemorrhagic stroke);
• If you have end-stage renal disease;
• If you have Huntington's chorea.

Warnings and Precautions

Before taking Lucetam, tell your doctor or pharmacist:

• If you have 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 you have bleeding disorders, are bleeding heavily, or are at risk of bleeding, for example, due to stomach or intestinal ulcers; if you have had a hemorrhagic stroke in the past; or if you have had major surgery, including dental surgery, or are taking anticoagulant medications or platelet aggregation inhibitors (including low 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 you have 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

Tell your doctor about all medicines you are taking, or have recently taken, and any medicines you plan to take.
Remember to inform your doctor if you are taking thyroid hormones or anticoagulant medications. Concomitant use of these medicines with Lucetam requires close medical supervision or dose modification.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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 baby.
Breastfeeding
Piracetam is excreted in human 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 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.
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 on an empty stomach 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, 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 cases of renal impairment, dose adjustment may be necessary.

Use in Children and Adolescents

To Improve Learning Results 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

If you have taken more than the recommended dose of Lucetam, 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 of Lucetam 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, otherwise, there is a risk of overdose after taking 2 doses at once.

Stopping Lucetam Treatment

Do not stop taking Lucetam without first consulting your doctor.
If you have any further questions on the use of this medicine, ask 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 the hands, feet, lips, or throat, causing difficulty breathing or swallowing,
• Fainting or feeling faint
• Hives. It is possible that you have had a severe allergic reaction to Lucetam.

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, somnolence, 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, headache, insomnia, dizziness, abdominal pain, epigastric pain, diarrhea, nausea, and vomiting, skin inflammation, itching.

Reporting Side Effects

If you experience any side effects, including those 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, 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 that 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 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, ethylcellulose, 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) on one side.
The 800 mg tablets have a score line on both sides. The score line on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.
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
Hungary
For further information, please contact the representative of the marketing authorization holder:
EGIS 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