Piracetam Espefa

Leaflet attached to the packaging: patient information

Piracetam Espefa, 800 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 or pharmacist.
• 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Piracetam Espefa and what is it used for
• 2. Important information before taking Piracetam Espefa
• 3. How to take Piracetam Espefa
• 4. Possible side effects
• 5. How to store Piracetam Espefa
• 6. Package contents and other information

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

Piracetam Espefa is a nootropic medicine. This medicine reduces blood viscosity, increases blood flow through brain vessels without dilating them. It also increases oxygen utilization and glucose consumption in ischemic brain tissue.

Indications for use

• treatment of cortical myoclonus (short-term, violent - "lightning" muscle contractions in one or more limbs or torso);
• treatment of dyslexic disorders in children in conjunction with speech therapy;
• treatment of 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 any of the other ingredients of this medicine (listed in section 6);
• if the patient has end-stage renal failure;
• if the patient has cerebral hemorrhage. The most common symptom is severe headache, limb weakness (e.g., facial muscle weakness with speech disorders) and vomiting;
• if the patient has Huntington's chorea (characterized by involuntary movements, irritability, depression, memory disorders).

Warnings and precautions

Before starting to take Piracetam Espefa, discuss it with your doctor:

• if the patient has kidney function disorders (renal failure);
• if the patient is elderly (over 65 years old);
• if the patient has blood coagulation disorders;
• if the patient has severe bleeding.

Special caution should be exercised in patients:

• at risk of bleeding (e.g., due to gastric and intestinal ulcer disease);
• with hemostasis disorders (mechanism preventing blood flow from blood vessels, both under normal conditions and after blood vessel damage);
• with a history of hemorrhagic stroke;
• taking anticoagulant medications or medications that inhibit platelet aggregation (see "Piracetam Espefa and other medicines");
• who will undergo major surgery, including dental surgery.

Do not suddenly stop taking piracetam in patients being treated for myoclonus, to avoid recurrence of myoclonus or generalized seizures.

Piracetam Espefa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The patient should inform the doctor if they are taking any of the following medicines:

• thyroid hormones(e.g., thyroxine - used to treat hypothyroidism) - due to the risk of irritability, insomnia, and confusion (disorder of thought process, disorientation);
• anticoagulant medications, e.g., acenocoumarol (medicines that reduce the risk of blood clot formation).

The likelihood of piracetam affecting the metabolism of other medicines is low.
Taking Piracetam Espefa with food, drink, and alcohol
The medicine can be taken during or between meals.
It is not recommended to drink alcohol while taking this medicine.

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.
This medicine should not be used during pregnancy, due to the lack of sufficient 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

The medicine may affect the ability to drive and operate machinery. If drowsiness or dizziness occurs, do not drive or operate machinery.
Piracetam Espefa contains tartrazine(azo dye)
The medicine may cause allergic reactions.

Piracetam Espefa contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Piracetam Espefa

Piracetam Espefa should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
To plan and use the appropriate dosing regimen, Piracetam ESPEFA is also available in a dose of 1200 mg.
1000 mg is equivalent to: 1 g.
One 800 mg film-coated tablet is equivalent to: 0.8 g.

Recommended dose

Treatment of cortical myoclonus
The initial dose is 7.2 g of the medicine per day.
If necessary, the doctor may recommend gradually increasing the dose by 4.8 g of the medicine per day every 3 or 4 days. The maximum daily dose is 30 tablets (24 g of the medicine) taken in divided doses, i.e., 2 or 3 times a day.
In combination therapy with other antiepileptic medicines, the doses of other medicines should be maintained at the recommended therapeutic doses. If the patient's condition improves, the doctor may reduce the doses of other medicines (if possible).
In patients with myoclonus, the doctor may try to reduce the dose or discontinue the medicine every 6 months. To do this, the dose of the medicine should be reduced by 1.2 g every 2 days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders in children in conjunction with speech therapy
In combination with speech therapy in children and adolescents aged 8 to 13 years:
3.2 g of the medicine per day in 2 divided doses (i.e., 2 tablets of 800 mg 2 times a day).
Treatment of dizziness
2.4 g of the medicine per day in 3 divided doses (i.e., 1 tablet of 800 mg 3 times a day).
Treatment lasts 8 weeks.
Using Piracetam Espefa in patients with kidney function disorders
The doctor may reduce the dose of piracetam in patients with kidney function disorders.
Using Piracetam Espefa in elderly patients
In elderly patients treated with piracetam for a long time, the doctor will individually adjust the dose of the medicine after assessing kidney function.

Taking a higher dose of Piracetam Espefa than recommended

In case of taking a higher dose of the medicine than recommended, contact your doctor immediately.

Missing a dose of Piracetam Espefa

Continue taking the medicine without increasing the next dose.
Do not take a double dose to make up for the missed dose.

Stopping Piracetam Espefa

Do not stop taking the medicine without consulting your doctor.
Stopping piracetam treatment in patients with myoclonus increases the risk of seizures.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical attention immediately if you experience symptoms such as:

skin redness, swelling, hives, shortness of breath, throat swelling that makes breathing difficult. These are symptoms of an allergic reaction.

The following side effects may occur

Frequent(occurring in 1 to 10 people out of 100):

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

Uncommon(occurring in 1 to 10 people out of 1000):

• general weakness (asthenia);
• depression;
• drowsiness.

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

• bleeding disorders;
• allergic reactions;
• hypersensitivity, agitation, anxiety;
• confusion (disorder of thought process, disorientation);
• hallucinations (perception of non-existent objects or people);
• dizziness, headache;
• abdominal pain or epigastric pain;
• diarrhea, nausea, vomiting;
• angioedema (characterized by sudden swelling of the face, limbs, or joints without itching or pain);
• skin inflammation;
• itching, hives (light red, itchy blisters on the skin);
• coordination disorders (ataxia), difficulty maintaining balance, unsteady gait;
• exacerbation of epilepsy symptoms;
• insomnia.

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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw, Tel.: +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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Piracetam Espefa

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton. The expiration date is the last day of the specified month.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Piracetam Espefa contains

• The active substance of the medicine is piracetam. One film-coated tablet contains 800 mg of piracetam.
• The other ingredients are: core: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, magnesium stearate; coating: hypromellose, stearic acid, talc, titanium dioxide (E 171), tartrazine, lake (E 104).

What Piracetam Espefa looks like and what the package contains

Piracetam Espefa is a yellow, film-coated, oblong tablet.
The package contains 60 film-coated tablets.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA,
ul. J. Lea 208,
30-133 Kraków
Tel.: +48 12 639 27 27,
Fax: +48 12 639 96 45
Information for the blind and visually impaired:800-007-777

Date of last update of the leaflet: