Package leaflet: Information for the patient

Recodium, 800 mg, coated tablets
Piracetamum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Recodium is and what it is used for
Important information before taking Recodium
How to take Recodium
Possible side effects
How to store Recodium
Contents of the package and other information

1. What Recodium is and what it is used for

Recodium is a medicine belonging to the group of nootropic drugs (affecting cognitive functions).
This medicine reduces blood viscosity and increases blood flow in 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, in conjunction 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

When not to take Recodium

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, consult a doctor or pharmacist:

if the patient has coagulation disorders;
if the patient is scheduled for major surgery, including dental procedures;
if the patient has severe hemorrhage;
if the patient is at risk of bleeding, e.g. due to peptic ulcer disease of the stomach or intestines, or previous hemorrhagic stroke;
if the patient has impaired renal and/or hepatic 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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);
anticoagulants, 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 with food, drink, and alcohol
Recodium 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 a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless clearly indicated and when, in the doctor's opinion, the benefits outweigh the risks to the fetus, and the clinical condition of the pregnant patient requires treatment with piracetam.
This medicine should not be used during breastfeeding, as it passes into human milk.

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

Recodium contains sodium
This medicine contains approximately 3.3 mmol (or 75.9 mg) of sodium (the main component of table salt) per 24 g dose of piracetam. This corresponds to 3.8% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Recodium

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor 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 3 tablets three times daily (7 200 mg per day).
If necessary, your doctor may recommend gradually increasing the dose by 6 tablets (4 800 mg)
per day every 3 or 4 days. The maximum daily dose is 30 tablets (24 000 mg), administered in divided doses, 2 or 3 times daily.
Every 6 months, your doctor may attempt to reduce or discontinue the treatment.
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:
2 tablets (1 600 mg) twice daily.
Treatment of vertigo
Administer 3 tablets (2 400 mg) daily in three divided doses. Treatment lasts for 8 weeks.
Adjunctive treatment of age-related cognitive disorders (excluding Alzheimer's disease),
following thorough neurological/geriatric assessment by a specialist physician
Administer 3 to 6 tablets (2 400 mg to 4 800 mg) daily in 2 or 3 divided doses.
Use in patients with renal function impairment
The doctor 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 doctor will individually adjust the dose after evaluating kidney function.
Taking more Recodium than recommended
If you take more Recodium than recommended, contact your doctor immediately.
Symptoms of overdose include bloody diarrhoea and abdominal pain.
Missing a dose of Recodium
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
Do not stop treatment suddenly in patients being treated for myoclonus. Abrupt discontinuation
may cause a recurrence of symptoms or generalized seizures.
If you have any further questions about 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.
You should contact your doctor immediately if the following occur:
rash, severe swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing,
decreased blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness,
loss of consciousness, respiratory arrest or cardiac arrest. These are symptoms of an allergic reaction.
Other adverse reactions may include
Common (not more frequent than in 1 out of 10 people):

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

Uncommon (not more frequent than in 1 out of 100 people):

asthenia (generalized weakness);
depression;
somnolence. Frequency unknown:
haemorrhagic disorders;
hypersensitivity, agitation, anxiety;
confusion (disorders in thought process, disorientation regarding time, place, situation or self);
hallucinations (perception of non-existent objects or persons);
dizziness, headache;
abdominal pain or epigastric pain;
diarrhoea, nausea, vomiting;
angioedema (sudden swelling of the face, limbs or joints without itching or pain);
dermatitis;
pruritus, urticaria (bright pink, itchy wheals on the skin);
ataxia (difficulty maintaining balance, unsteady gait);
exacerbation of epilepsy symptoms;
insomnia.

If any of the above symptoms occur, the medicine should be discontinued
and you should contact your doctor.
Reporting of adverse reactions
If any adverse reactions 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,
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 Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Recodium

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 on the carton. The expiry date refers to the last day of the stated month.
Markings on the blister:
Lot: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Recodium contains

The active substance is piracetam. Each coated tablet contains 800 mg of piracetam.
The 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 looks like and contents of the pack
Recodium is a white, film-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 box.
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