Patient Information Leaflet

MemoniQ, 1200 mg, coated tablets
Piracetam
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Table of contents

What MemoniQ is and what it is used for
What you need to know before taking MemoniQ
How to take MemoniQ
Possible side effects
How to store MemoniQ
Contents of the pack and other information

1. What MemoniQ is and what it is used for

MemoniQ is a nootropic medicine. MemoniQ reduces blood viscosity and improves blood flow through cerebral vessels, without exerting vasodilatory effects.
The active substance, piracetam, enhances oxygen utilization and glucose consumption in ischemic brain tissue.
Indications
MemoniQ is indicated for:

Treatment of cortical myoclonus (brief, sudden muscle jerks affecting one or more limbs or the trunk),
Treatment of dyslexic disorders in children, in combination with speech therapy,
Treatment of central and peripheral vertigo.

2. Important information before using MemoniQ

When not to use MemoniQ:

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 intracranial bleeding,
if the patient has end-stage renal failure,
if the patient has Huntington's chorea.

Warnings and precautions
Before starting treatment with MemoniQ, discuss this with your doctor or pharmacist.
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Due to the effect of piracetam on platelet aggregation (clumping), caution should be exercised in patients:

with coagulation disorders,
undergoing major surgical procedures (including dental procedures),
with severe bleeding,
at risk of bleeding, e.g. in peptic ulcer disease of the stomach and intestines,
with a history of haemorrhagic stroke,
taking anticoagulant medicines or medicines that inhibit platelet aggregation (e.g. low-dose acetylsalicylic acid).

Do not abruptly discontinue treatment in patients being treated for myoclonus, to avoid sudden recurrence of myoclonus or generalized seizures.
Use in patients with impaired kidney function
The doctor may reduce the dose of piracetam in patients with impaired kidney function.
Use in patients with impaired liver function
The doctor may reduce the dose of piracetam in patients with impaired liver function.
Use in elderly patients
In elderly patients undergoing long-term treatment, the doctor will individually adjust the dose after assessing kidney function.
Children and adolescents
See section 3.
Other medicines and MemoniQ
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or might take in the future.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

thyroid hormones – cases of confusion, irritability and insomnia have been reported when this medicine is taken concomitantly with thyroid hormones (T3 + T4),
anticoagulant medicines, e.g. acenocoumarol.

MemoniQ with food and drink
MemoniQ can be taken during or between meals.
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.
Pregnancy
There are insufficient data on the use of piracetam in pregnant women. Piracetam crosses the placental barrier. Therefore, MemoniQ should not be used during pregnancy unless there are clear medical indications, and the benefits of treatment outweigh the potential risks to the fetus, and the woman's health condition requires therapy with piracetam.
Breastfeeding
Piracetam passes into human milk. Therefore, the use of MemoniQ should be avoided during breastfeeding, or breastfeeding should be discontinued during treatment with piracetam.
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Driving and using machines
MemoniQ may affect the ability to drive and operate machinery. This effect should be taken into account.
MemoniQ contains sodium
This medicine contains up to 3.22 mg of sodium (the main component of table salt) per tablet.
This corresponds to 0.16% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use MemoniQ

This medicine should always be used according to the instructions given by the doctor or pharmacist. In case of doubt,
consult a doctor or pharmacist.
Method of administration
MemoniQ tablets should be taken orally, during or between meals.
Tablets should be swallowed with a small amount of water.
It is recommended to divide the daily dose into 2–4 doses.
The score line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty
swallowing it whole.
Dosage recommendations for various indications are provided below.
1 coated tablet of 1200 mg corresponds to 1.2 g.
Treatment of cortical myoclonus
Treatment should be initiated at 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 drug (i.e. 4 tablets of 1200 mg) per day up to a maximum dose of 24 g
per day. MemoniQ should be administered in divided doses, 2 or 3 times daily.
When used in combination with other antimyoclonic drugs, the doses of other medications should be
maintained at their recommended therapeutic levels. If clinical improvement is achieved and it is feasible,
the doses of other drugs should be reduced.
In patients with myoclonus, symptoms may evolve over time; therefore, every 6 months
the doctor may recommend attempting to reduce or discontinue the drug. The piracetam dose should then
be reduced by 1.2 g (i.e. 1 tablet of 1200 mg) every two days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders in children (in combination with speech therapy)
In children from the age of 8 and adolescents, piracetam should be administered 3 times daily at a dose of 1.2 g (i.e.
1 tablet of 1200 mg).
For easier swallowing by children, the tablet may be divided.
Treatment of central and peripheral vertigo
The usual recommended dose is 1.2 g of piracetam (i.e. 1 tablet of 1200 mg) 2 or 3 times daily.
In patients with impaired renal function, the doctor will reduce the dose.
Use of a higher than recommended dose of MemoniQ
Do not use a dose higher than recommended. If an overdose is taken,
seek immediate advice from a doctor or pharmacist.
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Missed dose of MemoniQ
Do not take a double dose to make up for a missed dose. Continue taking the medicine at the usual time
and in the recommended dose.
Stopping MemoniQ treatment
If your doctor has prescribed MemoniQ, do not stop taking it without consulting your doctor or pharmacist.
Do not abruptly discontinue treatment in patients being treated for myoclonus to avoid triggering
recurrence of myoclonus or generalized seizures.
If discontinuation of MemoniQ is necessary in the indication of cortical myoclonus,
the drug dose should be gradually tapered off under medical supervision.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported in clinical trials and after marketing of the medicine are listed below according to frequency of occurrence and by system organ classification.

Common (occur in 1 to 10 out of 100 patients)

Nervousness
Hyperkinesia (increased skeletal muscle activity)
Weight gain

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

Depression
Somnolence
Asthenia (a condition characterized by fatigue, weakness, exhaustion)

Frequency not known (cannot be estimated from available data)

Bleeding disorders
Anaphylactoid reactions (a type of allergic reaction; if symptoms such as skin redness, swelling, urticaria, laryngeal edema, shortness of breath, or breathing difficulties occur, contact a doctor immediately)
Hypersensitivity (allergy)
Agitation
Anxiety
Confusion
Hallucinations
Movement coordination disorder (ataxia)
Balance disorders
Exacerbation of epilepsy
Headache
Insomnia
Dizziness
Abdominal pain
Epigastric pain

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Diarrhea
Nausea
Vomiting
Angioedema
Dermatitis
Itching
Urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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:
Jerozolimskie Avenue 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store MemoniQ

Store below 25°C, in the original packaging.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What MemoniQ contains

The active substance is piracetam. One coated tablet contains 1200 mg of piracetam.
Other ingredients (excipients) are:
Core: Polyethylene glycol 6000
Colloidal anhydrous silica
Sodium croscarmellose
Magnesium stearate

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

What MemoniQ looks like and contents of the pack
MemoniQ is in the form of elongated, white, film-coated tablets with a smooth surface, biconvex on both sides and with a single-scored line. The break line is intended only to facilitate splitting the tablet if the patient has difficulty swallowing it whole.
One package contains 10, 20, 30 or 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medical information:
Tel.: 22 742 00 22
e-mail: [email protected]
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