Memoniq

Leaflet attached to the packaging: patient information

MemoniQ, 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, 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 only. 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 MemoniQ and what is it used for
• 2. Important information before taking MemoniQ
• 3. How to take MemoniQ
• 4. Possible side effects
• 5. How to store MemoniQ
• 6. Contents of the pack and other information

1. What is MemoniQ and what is it used for

MemoniQ is a nootropic medicine. MemoniQ reduces blood viscosity, improves blood flow through the brain vessels, without showing any vasodilating effect. The active substance of the medicine is piracetam, which increases oxygen utilization and glucose consumption in the brain tissue with impaired blood supply.

Indications for use

MemoniQ is indicated for:

• treatment of cortical myoclonus (short, sudden muscle contractions in one or more limbs or trunk),
• treatment of dyslexic disorders in children, in combination with speech therapy,
• treatment of dizziness of central and peripheral origin.

2. Important information before taking MemoniQ

When not to take MemoniQ:

• 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,
• if you have terminal renal failure,
• if you have Huntington's chorea.

Warnings and precautions

Before starting treatment with MemoniQ, discuss it with your doctor or pharmacist. Due to the effect of piracetam on platelet aggregation, caution should be exercised in patients:

• with coagulation disorders,
• undergoing major surgical procedures (including dental procedures),
• with severe bleeding,
• with a risk of bleeding, e.g., in gastric and intestinal ulcer disease,
• with a history of hemorrhagic stroke,
• taking anticoagulant medications or medications that inhibit platelet aggregation (e.g., low doses of acetylsalicylic acid).

Do not suddenly stop treatment in patients being treated for myoclonus, to avoid sudden recurrence of myoclonus or generalized seizures. The doctor may reduce the dose of piracetam in patients with impaired renal function. The doctor may reduce the dose of piracetam in patients with impaired liver function. In elderly patients treated for a longer period, the doctor will individually adjust the dose of the medicine after assessing kidney function.

Children and adolescents

See section 3.

MemoniQ and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. In particular, tell your doctor or pharmacist about taking any of the following medicines:

• thyroid hormones - cases of confusion, irritability, and insomnia have been reported during concomitant use of the medicine with thyroid hormones (T3 + T4),
• anticoagulant medications, e.g., acenocoumarol.

MemoniQ with food and drink

MemoniQ can be taken during or between meals.

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 There are no sufficient data on the use of piracetam in pregnant women. Piracetam crosses the placental barrier. Therefore, MemoniQ should not be used in pregnant women unless there are clear indications and benefits of using the medicine outweigh the risk to the fetus, and the health of the pregnant woman requires treatment with piracetam. Breastfeeding Piracetam passes into breast milk. Therefore, MemoniQ should be avoided during breastfeeding or breastfeeding should be discontinued during treatment with piracetam.

Driving and using machines

MemoniQ may affect your ability to drive or use machines. This effect should be taken into account.

MemoniQ contains sodium

The medicine contains a maximum of 3.22 mg of sodium (the main component of common salt) in each tablet. This corresponds to 0.16% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take MemoniQ

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Method of administration MemoniQ should be taken orally, during or between meals. The tablets should be swallowed with a small amount of water. The daily dose is recommended to be divided into 2-4 doses. The dividing line on the tablet is only intended to facilitate breaking the tablet if the patient has difficulty swallowing it whole. The dosing for different indications is presented below. 1 film-coated tablet of 1200 mg is equivalent to 1.2 g.

Treatment of cortical myoclonus

Treatment should start with a dose of 7.2 g of piracetam (i.e., 6 tablets of 1200 mg) per day, increasing every 3 or 4 days by 4.8 g of the medicine (i.e., 4 tablets of 1200 mg) per day to a maximum dose of 24 g per day. MemoniQ should be administered in divided doses 2 or 3 times a day. In combined treatment with other anti-myoclonic medicines, the doses of other medicines should be maintained at the recommended therapeutic doses. If clinical improvement is achieved and it is possible, the doses of other medicines should be reduced. In patients with myoclonus, the symptoms may evolve over time, and therefore the doctor may recommend attempting to reduce the dose or discontinue the medicine every 6 months. The dose of piracetam should then be reduced by 1.2 g (i.e., 1 tablet of 1200 mg) every 2 days to prevent sudden recurrence of the disease.

Treatment of dyslexic disorders in children (in combination with speech therapy)

In children from 8 years of age and adolescents, piracetam should be administered 3 times a day at a dose of 1.2 g (i.e., 1 tablet of 1200 mg). For easier swallowing by the child, the tablet can be broken.

Treatment of dizziness of central and peripheral origin

Usually, a dose of 1.2 g of piracetam (i.e., 1 tablet of 1200 mg) 2 or 3 times a day is recommended. In patients with impaired renal function, the doctor will reduce the dose.

Overdose of MemoniQ

Do not take a higher dose than recommended. If you have taken a higher dose than recommended, contact your doctor or pharmacist immediately.

Missed dose of MemoniQ

Do not take a double dose to make up for a missed dose. Continue taking the medicine at the recommended dose at the usual time.

Stopping treatment with MemoniQ

If your doctor has prescribed MemoniQ for you, do not stop taking the medicine without consulting your doctor or pharmacist. Do not suddenly stop treatment in patients being treated for myoclonus, to avoid sudden recurrence of myoclonus or generalized seizures. In the event of a need to stop treatment in the indication: cortical myoclonus, the dose of the medicine should be gradually reduced by the doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, MemoniQ can cause side effects, although not everybody gets them. The side effects reported in clinical trials and after the marketing of the medicine are listed below according to their frequency and in accordance with the classification of systems and organs. Common (occurring in 1 to 10 out of 100 patients)

• nervousness
• hyperkinesia (increased skeletal muscle activity)
• weight gain

Uncommon (occurring in 1 to 10 out of 1000 patients)

• depression
• drowsiness
• asthenia (a condition characterized by fatigue, weakness, exhaustion)

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

• bleeding disorders
• anaphylactoid reactions (a type of allergic reaction; if symptoms such as skin redness, swelling, urticaria, laryngeal edema, dyspnea, breathing difficulties occur, seek medical attention immediately)
• hypersensitivity (allergy)
• excitement
• anxiety
• confusion
• hallucinations
• ataxia (coordination disorder)
• balance disorders
• exacerbation of epilepsy
• headache
• insomnia
• dizziness
• abdominal pain
• epigastric pain

• diarrhea
• nausea
• vomiting
• angioedema
• skin inflammation
• itching
• urticaria

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 MemoniQ

Store in a temperature below 25°C, in the original packaging. The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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 MemoniQ contains

• The active substance of the medicine is piracetam. 1 film-coated tablet contains 1200 mg of piracetam.
• The other ingredients (excipients) are: Core:Macrogol 6000 Colloidal silica anhydrous Sodium croscarmellose Magnesium stearate

Coating Opadry II 85F18422 White:
Polyvinyl alcohol Titanium dioxide (E 171) Macrogol Talc

What MemoniQ looks like and contents of the pack

MemoniQ is a film-coated tablet, which is white, oblong, with a smooth surface, and has a dividing line on one side. The dividing line on the tablet is only intended to facilitate breaking the tablet if the patient has difficulty swallowing it whole. One pack of the medicine contains 10, 20, 30, or 60 film-coated tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A. 51-131 Wrocław, ul. Żmigrodzka 242 E Information about the medicine: Tel.: 22 742 00 22 e-mail: [email protected]

Date of last revision of the leaflet:

6/6