Recodium max

Leaflet attached to the packaging: patient information

Recodium max, 1200 mg, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Recodium max and what is it used for
• 2. Important information before taking Recodium max
• 3. How to take Recodium max
• 4. Possible side effects
• 5. How to store Recodium max
• 6. Package contents and other information

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

Recodium max is a nootropic medicine (affecting cognitive functions). This medicine
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, violent muscle contractions in one or more limbs or torso);
• treatment of dyslexic disorders in children, simultaneously with speech therapy;
• treatment of dizziness;
• supportive treatment of age-related cognitive disorders (excluding Alzheimer's disease), after a thorough neurological/geriatric assessment by a specialist doctor.

2. Important information before taking Recodium max

When not to take Recodium max

• if the patient is allergic to piracetam, other pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has cerebral hemorrhage. The most common symptom is a severe headache, limb paresis (e.g., facial muscle weakness with speech disorders) and vomiting;
• if the patient has terminal renal failure;
• if the patient has Huntington's chorea (characterized by involuntary movements, irritability, depression, memory disorders).

Warnings and precautions

Before starting to take Recodium max, the patient should discuss it with their doctor or pharmacist:

• if the patient has blood coagulation disorders;
• if the patient is to undergo major surgery, including dental surgery;
• if the patient has severe bleeding;
• if the patient is at risk of bleeding, e.g., due to gastric and intestinal ulcer disease, a history of hemorrhagic stroke;
• if the patient has renal and/or hepatic impairment and is elderly (over 65 years). In these patients, the doctor may reduce the dose of the medicine.

Children

Do not use in children under 8 years of age for the treatment of dyslexic disorders.

Recodium max and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking
currently or recently, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking any of the following medicines:

• -thyroxine(a hormone produced by the thyroid gland, used to treat hypothyroidism) – due to the risk of irritability and confusion (disorder of thought process, disorientation);
• anticoagulant medicinese.g. heparin, acenocoumarol, warfarin;
• platelet aggregation inhibitors, including small doses of acetylsalicylic acid (aspirin).

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

Recodium max with food, drink, and alcohol

Recodium max can be taken during or between meals.
It is not recommended to drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have
a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy, unless the doctor considers that the benefits of taking the medicine 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 using machines

Due to side effects, the medicine may affect the ability to drive and use machines. This
should be taken into account.

Recodium max contains sodium

The medicine contains approximately 3.4 mmol (or 78.2 mg) of sodium (the main component of common salt) per 24 g dose of piracetam. This corresponds to 3.9% of the maximum recommended daily dose of sodium in the diet for adults.

3. How to take Recodium max

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case
of doubts, consult a doctor or pharmacist.
The medicine is for oral use. The medicine can be administered during or between meals. The tablets should be swallowed with water.

Recommended dose

Treatment of cortical myoclonus
The initial dose is 2 tablets 3 times a day (7,200 mg per day).
If necessary, the doctor 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 doctor may try to reduce the dose or discontinue the medicine.
To do this, the dose of the medicine should be reduced by one tablet every 2 days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders simultaneously with speech therapy
In combination with speech therapy in children and adolescents aged 8 to 13 years:
1.5 tablets (1,800 mg) 2 times a day.
Treatment of dizziness
2 tablets (2,400 mg) should be administered per day in 3 or 2 divided doses. The treatment lasts for 8 weeks.
Supportive treatment of age-related cognitive disorders (excluding Alzheimer's disease), after a thorough neurological/geriatric assessment by a specialist doctor
2 to 4 tablets (2,400 mg to 4,800 mg) should be administered per day in 2 or 3 divided doses.
Use in patients with renal impairment
The doctor may reduce the dose of piracetam in patients with renal impairment.
In patients with terminal renal failure, this medicine should not be used.
Use in elderly patients
In elderly patients treated with piracetam for a long time, the doctor will individually adjust the dose of the medicine after assessing kidney function.

Taking a higher dose of Recodium max than recommended

In case of taking a higher dose of the medicine than recommended, the patient should contact their doctor.
Symptoms of overdose are bloody diarrhea and abdominal pain.

Missing a dose of Recodium max

The patient should continue taking the medicine without increasing the next dose.
The patient should not take a double dose to make up for the missed dose.

Stopping Recodium max

The patient should not suddenly stop treatment if they are being treated for myoclonus. Sudden withdrawal of the medicine may cause a recurrence of the disease symptoms or the onset of generalized seizures.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience:

rash, severe swelling of the face, lips, or throat, making breathing, talking, or swallowing difficult,
decreased blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness,
loss of consciousness, respiratory and cardiac arrest. These are symptoms of an allergic reaction.

Other possible side effects

Frequent(not more than 1 in 10 people):

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

Not very frequent(not more than 1 in 100 people):

• asthenia (general weakness of the body);
• depression;
• drowsiness.

Frequency not known:

• bleeding disorders;
• hypersensitivity, agitation, anxiety;
• confusion (disorder of thought process, disorientation);
• hallucinations (perception of non-existent objects, people);
• dizziness, headache;
• abdominal pain or epigastric pain;
• diarrhea, nausea, vomiting;
• angioedema (characterized by sudden swelling of the face, limbs, or joints without itching and pain);
• skin inflammation;
• itching, urticaria (light red, itchy blisters on the skin);
• ataxia (difficulty maintaining balance, unsteady gait);
• exacerbation of epilepsy symptoms;
• insomnia.

If any of the above symptoms occur, the patient should stop taking the medicine and contact their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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, it is possible to gather more information on the safety of the medicine.

5. How to store Recodium max

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 month.
Blister markings
Lot: Batch number.
EXP: Expiry date.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Recodium max contains

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

What Recodium max looks like and what the pack contains

Recodium max is a white, coated, bean-shaped tablet, with a dividing line.
The tablet can be divided into equal doses.
The package contains 60 tablets. The blisters are packed in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: