Patient Information Leaflet

Piracetam Espefa, 800 mg, coated tablets
Piracetam
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Piracetam Espefa is and what it is used for
Important information before taking Piracetam Espefa
How to take Piracetam Espefa
Possible side effects
How to store Piracetam Espefa
Contents of the pack and other information

1. What Piracetam Espefa is and what it is used for

Piracetam Espefa is a medicine belonging to the group of nootropic drugs. This medicine reduces blood viscosity and increases blood flow through cerebral vessels without dilating them. It also enhances oxygen utilization and glucose consumption in ischemic brain tissue.

Indications

Treatment of cortical myoclonus (brief, sudden, "lightning-like" muscle jerks affecting one or more limbs or the trunk);
Treatment of dyslexic disorders in children, used concomitantly with speech therapy;
Treatment of vertigo (dizziness).

2. Important information before taking Piracetam Espefa

When not to take Piracetam Espefa:

if the patient is allergic to piracetam, other pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has end-stage renal failure;
if the patient has intracranial bleeding. The most common symptoms are severe headache, weakness of part of the body (e.g. facial muscles with speech disturbances), and vomiting;
if the patient has Huntington's chorea (characterized by involuntary movements, irritability, depression, memory disturbances).

Warnings and precautions
Before starting treatment with Piracetam Espefa, discuss this with your doctor:

if the patient has impaired kidney function (renal failure);
if the patient is elderly (over 65 years of age);
if the patient has blood coagulation disorders;
if the patient has severe hemorrhage.

Particular caution is required in patients:

at risk of bleeding (e.g. due to peptic ulcer disease of the stomach and intestines);
with hemostatic disorders (mechanisms preventing blood loss from blood vessels, both under normal conditions and after vascular injury);
with a history of hemorrhagic stroke;
taking anticoagulant medicines or drugs inhibiting platelet aggregation (clumping) (see section: "Piracetam Espefa and other medicines");
who are to undergo major surgical procedures, including dental surgery.

Treatment with piracetam should not be stopped abruptly in patients treated for myoclonus, to avoid recurrence of myoclonus or generalized seizures.
Piracetam Espefa and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The patient should inform the doctor if taking any of the following medicines:

thyroid hormones (e.g. thyroxine – used in the treatment of hypothyroidism) – due to the risk of irritability, insomnia, and confusion (disturbance in thought process, disorientation);
anticoagulant medicines, e.g. acenocoumarol (medicines that reduce the risk of blood clot formation).

The likelihood of piracetam causing disturbances in the metabolism of other medicines is low.
Taking Piracetam Espefa with food, drink, and alcohol
This medicine may be taken during or between meals.
Alcohol consumption is not recommended while taking this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy due to insufficient data on the use of piracetam in pregnant women.
This medicine should not be used during breastfeeding, as it passes into breast milk.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If drowsiness or dizziness occurs, the patient should not drive or operate machinery.
Piracetam Espefa contains Quinoline Yellow (azo dye)
This medicine may cause allergic reactions.
Piracetam Espefa contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Piracetam Espefa

Piracetam Espefa should always be taken according to the doctor's instructions. If you have any doubts,
you should consult your doctor or pharmacist.
To allow planning and application of an appropriate dosing regimen, Piracetam ESPEFA
is also available in a 1200 mg dose.
1000 mg converted to grams is: 1 g.
One 800 mg coated tablet converted to grams is: 0.8 g.
Recommended dose
Treatment of cortical myoclonus
The initial dose is 7.2 g of the drug per day.
If necessary, the doctor may recommend gradually increasing the dose by 4.8 g of the
drug every 3 or 4 days. The maximum daily dose is 30 tablets (24 g of the drug),
administered in divided doses, i.e. 2 or 3 times a day.
In combination therapy with other anticonvulsant (antimyoclonic) drugs, the doses of other
medications should be maintained at recommended therapeutic levels. If the patient's condition
improves, the doctor may reduce the doses of other drugs (when possible).
In patients with myoclonus, the doctor may attempt to reduce or discontinue the drug every 6 months.
To do this, the dose should be reduced by 1.2 g of the drug every 2 days to prevent sudden
recurrence of the disease.
Treatment of dyslexic disorders in children in combination with speech therapy
In combination with speech therapy in children and adolescents aged 8 to 13 years:
3.2 g of the drug per day in 2 divided doses (i.e. 2 tablets of 800 mg twice daily).
Treatment of vertigo
2.4 g of the drug per day in 3 divided doses (i.e. 1 tablet of 800 mg three times daily).
Treatment lasts 8 weeks.
Use of Piracetam Espefa in patients with renal function impairment
The doctor may reduce the dose of piracetam in patients with impaired renal function.
Use of Piracetam Espefa in elderly patients
In elderly patients undergoing long-term treatment with piracetam, the doctor will individually adjust
the dose after assessing kidney function.
Taking more than the recommended dose of Piracetam Espefa
If you have taken more than the recommended dose, you should contact your doctor immediately.
Missed dose of Piracetam Espefa
You should continue taking the medication as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Piracetam Espefa
Do not stop taking the medication without consulting your doctor.
Discontinuation of piracetam treatment in patients with myoclonus increases the risk of epileptic seizures.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if any of the following symptoms occur:
skin redness, swelling, urticaria, breathing difficulties, laryngeal oedema causing breathing problems. These are
symptoms of an allergic reaction.
The following adverse reactions may occur
Common (occur in 1 to 10 out of 100 people):

nervousness;
weight gain;
increased motor activity (hyperkinesia).

Uncommon (occur in 1 to 10 out of 1,000 people):

generalised weakness (asthenia);
depression;
drowsiness.

Frequency not known (cannot be estimated from available data):

haemorrhagic disorders;
allergic reactions;
hypersensitivity, restlessness, anxiety;
confusion (disturbances in thought processes, disturbances in orientation in time, place, situation or self);
hallucinations (perception of non-existent objects or people);
dizziness, headache;
abdominal or epigastric pain;
diarrhoea, nausea, vomiting;
angioedema (manifesting as sudden swelling of the face, limbs or joints without itching or pain);
skin inflammation;
itching, urticaria (bright pink, itchy blisters on the skin);
disturbances in body movement coordination (ataxia), difficulty maintaining balance, unsteady gait;
worsening of epilepsy symptoms;
insomnia.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Piracetam Espefa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Piracetam Espefa contains

The active substance is piracetam. One coated tablet contains 800 mg of piracetam.
Other ingredients are: core: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, talc, magnesium stearate; coating: hypromellose, stearic acid, talc, titanium dioxide (E 171), quinoline yellow, lac (E 104).

What Piracetam Espefa looks like and contents of the pack
Piracetam Espefa is in the form of yellow, coated, elongated tablets.
The pack contains 60 coated tablets.
Marketing Authorisation Holder and Manufacturer
Chemico-Pharmaceutical Workers' Cooperative ESPEFA,
J. Lea 208 Street,
30-133 Kraków,
Poland
Tel.: +48 12 639 27 27,
Fax: +48 12 639 96 45
Information for the blind and visually impaired: 800-007-777