Package leaflet: Information for the user

Recodium max, 1200 mg, coated tablets
Piracetamum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Leaflet contents

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

1. What Recodium max is and what it is used for

Recodium max is a nootropic medicine (affecting cognitive functions). This medicine reduces blood viscosity and increases blood flow through cerebral vessels without vasodilation. 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 concurrently with speech therapy;
Treatment of vertigo;
Adjunctive treatment of age-related cognitive impairment (excluding Alzheimer's disease), following thorough neurological/geriatric assessment by a specialist physician.

2. Important information before taking Recodium max

When not to take Recodium max

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. The most common symptoms include severe headache, partial paralysis (e.g. facial muscles with speech disturbances), and vomiting;
if the patient has end-stage renal failure;
if the patient has Huntington's chorea (characterized by involuntary movements, irritability, depression, and memory disturbances).

Warnings and precautions
Before starting treatment with Recodium max, consult your doctor or pharmacist if:

the patient has blood coagulation disorders;
the patient is scheduled for major surgery, including dental procedures;
the patient has severe hemorrhage;
the patient is at risk of bleeding, e.g. due to peptic ulcer disease of the stomach or intestines, or a history of hemorrhagic stroke;
the patient has impaired kidney and/or liver function and is elderly (over 65 years of age). In such patients, the doctor may reduce the dosage.

Children
Do not use in children under 8 years of age for the treatment of dyslexia-related disorders.

Recodium max and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
The patient should inform the doctor if they are taking any of the following medicines:

thyroxine (a hormone produced by the thyroid gland, used in the treatment of hypothyroidism) – due to the risk of irritability and confusion (disturbance in thought process, disorientation);
anticoagulant medicines, e.g. heparin, acenocoumarol, warfarin;
antiplatelet agents, including low-dose acetylsalicylic acid ("aspirin").

The likelihood of piracetam affecting the metabolism of other drugs is low.

Recodium max with food, drink, and alcohol
Recodium max may be taken during or between meals.
Alcohol consumption is not recommended during treatment with 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 unless there are clear medical indications, and only when the benefits of treatment outweigh the potential risks to the fetus, and the clinical condition of the pregnant patient requires therapy with piracetam.
This medicine should not be used during breastfeeding, as it passes into human milk.

Driving and operating machinery
Due to possible adverse effects, this medicine may affect the ability to drive and operate machinery. This should be taken into account.

Recodium max contains sodium
This medicine contains approximately 3.4 mmol (or 78.2 mg) of sodium (a main component of table salt) in a 24 g dose of piracetam. This corresponds to 3.9% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Recodium max

This medicine should always be taken as directed by a physician or pharmacist. If in
doubt, consult a physician or pharmacist.
This medicine is for oral use. It may be taken during or between meals. Tablets should be swallowed with water.
Recommended dose
Treatment of cortical myoclonus
The initial dose is 2 tablets three times a day (7 200 mg per day).
If necessary, the physician may recommend gradually increasing the dose by 4 tablets (4 800 mg) per
day every 3 or 4 days. The maximum daily dose is 20 tablets (24 000 mg), administered in divided doses, 2 or 3 times a day.
Every 6 months, the physician may attempt to reduce or discontinue the dose.
To achieve this, the dose should be reduced by one tablet every 2 days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders in combination with speech therapy
In combination with speech therapy in children and adolescents aged 8 to 13 years:
1.5 tablets (1800 mg) twice daily.
Treatment of vertigo
Administer 2 tablets (2 400 mg) per day in 3 or 2 divided doses. Treatment lasts
8 weeks.
Adjunctive treatment of age-related cognitive disorders (excluding Alzheimer's disease), following thorough neurological/geriatric assessment by a specialist physician
Administer 2 to 4 tablets (2 400 mg to 4 800 mg) per day in 2 or 3 divided doses.
Use in patients with renal function impairment
The physician may reduce the piracetam dose in patients with impaired renal function.
This medicine must not be used in patients with end-stage renal failure.
Use in elderly patients
In elderly patients undergoing long-term treatment with piracetam, the physician will individually adjust the dose following assessment of kidney function.
Taking more than the recommended dose of Recodium max
If more than the recommended dose has been taken, contact a physician.
Symptoms of overdose include bloody diarrhoea and abdominal pain.
Missing a dose of Recodium max
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Recodium max
Do not abruptly discontinue treatment in patients being treated for myoclonus. Sudden withdrawal
of the medicine may cause recurrence of symptoms or generalized seizures.
If you have any further questions concerning the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following occur:
rash, severe swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing,
decrease in blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness,
loss of consciousness, breathing difficulties, or cardiac arrest. These are symptoms of an allergic reaction.
Other possible adverse reactions include:
Common (occurring in no more than 1 in 10 people):

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

Uncommon (occurring in no more than 1 in 100 people):

asthenia (generalized weakness);
depression;
somnolence.

Frequency not known:

bleeding disorders;
hypersensitivity, restlessness, anxiety;
confusion (disorders in thought process, disorientation in time, place, situation or self);
hallucinations (perception of non-existent objects or people);
dizziness, headache;
abdominal or epigastric pain;
diarrhoea, nausea, vomiting;
angioedema (sudden swelling of the face, limbs or joints without itching or pain);
skin inflammation;
itching, urticaria (pinkish, itchy skin wheals);
ataxia (difficulty maintaining balance, unsteady gait);
exacerbation of epilepsy symptoms;
insomnia.

If any of the above symptoms occur, the medicine should be discontinued
and a doctor should be consulted.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions
not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Recodium max

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Markings on the blister
Lot: Batch number.
EXP: Expiry date.
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 packaging and other information

What Recodium max contains

The active substance is piracetam. Each coated tablet contains 1200 mg of piracetam.
Other ingredients are:
core: macrogol 6000, colloidal anhydrous silica, magnesium stearate, sodium croscarmellose;
coating: instacoat aqua (hypromellose, castor oil, talc), hypromellose, hydroxypropylcellulose, titanium dioxide (E171), Capol 1295 (white wax + carnauba wax).

What Recodium max looks like and contents of the pack
Recodium max is a white, coated, bean-shaped tablet with a division line.
The tablet can be divided into equal doses.
The pack contains 60 tablets. Blister packs are placed in a cardboard carton.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów