Piracetam Espefa
Ask a doctor about a prescription for Piracetam Espefa
How to use Piracetam Espefa
Package Leaflet: Information for the Patient
Piracetam Espefa, 1200 mg, Film-Coated Tablets
Piracetam
Read the package leaflet carefully before taking the medicine, 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 or pharmacist.
- 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 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. Contents of the pack and other information
1. What is Piracetam Espefa and what is it used for
Piracetam Espefa is a nootropic medicine. It 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 combination with speech therapy;
- treatment of dizziness.
2. Important information before taking Piracetam Espefa
When not to take Piracetam Espefa:
- 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 end-stage renal failure;
- if you have cerebral hemorrhage. The most common symptom is severe headache, limb weakness (e.g., facial muscle weakness with speech disorders) and vomiting;
- if you have 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 you have kidney function disorders (renal failure);
- if you are elderly (over 65 years old);
- if you have blood coagulation disorders;
- if you have severe bleeding.
Special caution should be exercised in patients:
- with a 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 or antiplatelet aggregation medications (see section: "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 now or have recently taken, as well as any medicines you 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy, due to the lack of sufficient data on the use of piracetam in pregnant women.
Do not take this medicine during breastfeeding, as it passes into breast milk.
Driving and Operating Machines
The medicine may affect your ability to drive and operate machines. If you experience drowsiness, dizziness, do not drive or operate machines.
Piracetam Espefa contains carmoisine(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".
However, in the maximum daily dose (24 g of piracetam), it contains approximately 1.7 to 3 mmol (or 40 to 70 mg) of sodium (maximum daily sodium intake for adults recommended by WHO = 2 g).
3. How to take Piracetam Espefa
Always take Piracetam Espefa exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
To plan and use the appropriate dosing regimen, Piracetam ESPEFA is also available in a dose of 800 mg.
1000 mg is equivalent to: 1 g.
One 1200 mg film-coated tablet is equivalent to: 1.2 g.
Recommended dose
Treatment of cortical myoclonus
The initial dose is 2 tablets 3 times a day (7.2 g of medicine per day).
If necessary, the doctor may recommend gradually increasing the dose by 4.8 g of medicine per day every 3 or 4 days. The maximum daily dose is 20 tablets (24 g of medicine) given in divided doses, i.e., 2 or 3 times a day.
In combination therapy with other antiepileptic (antimyoclonic) 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 of medicine 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 medicine per day in 2 divided doses.
Treatment of dizziness
2.4 g of medicine per day in 3 divided doses. The treatment lasts 8 weeks.
Use of Piracetam Espefa in patients with renal function disorders
The doctor may reduce the dose of piracetam in patients with renal function disorders.
Use of Piracetam Espefa in elderly patients
In elderly patients treated long-term with piracetam, the doctor will individually adjust the dose of the medicine after assessing kidney function.
Taking a higher dose of Piracetam Espefa than recommended
If you take more of the medicine than you should, 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 a missed dose.
Stopping treatment with Piracetam Espefa
Do not stop taking the medicine without consulting your doctor.
Stopping treatment with piracetam in patients with myoclonus increases the risk of seizures.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Piracetam Espefa can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience symptoms such as:
redness of the skin, swelling, hives, shortness of breath, swelling of the throat that makes breathing difficult. These are symptoms of an allergic reaction.
The following side effects may occur
Frequent(occurring in 1 to 10 people in 100):
- nervousness;
- weight gain;
- increased motor activity (hyperkinesia).
Uncommon(occurring in 1 to 10 people in 1000):
- general weakness (asthenia);
- depression;
- drowsiness.
Frequency not known(cannot be estimated 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 those 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Piracetam Espefa
Keep the medicine out of the 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 month.
Do not store above 25°C.
Store in the original package to protect from light and moisture.
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 Piracetam Espefa contains
- The active substance is piracetam. One film-coated tablet contains 1200 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), carmoisine, lake (E 122).
What Piracetam Espefa looks like and contents of the pack
Piracetam Espefa is a pink, film-coated, oblong tablet.
The pack 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 revision of the leaflet:
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterChemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
- 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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