Recodium

Package Leaflet: Information for the Patient

Recodium, 800 mg, Film-Coated Tablets

Piracetam

Read the Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed specifically for you. 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, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Recodium and what is it used for

Recodium is a medication from the group of nootropic drugs (affecting cognitive functions).
This medication 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, sudden muscle contractions in one or more limbs or torso);
• treatment of dyslexic disorders in children, in combination 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

When Not to Take Recodium

• if you are allergic to piracetam, other pyrrolidone derivatives, or any of the other ingredients of this medication (listed in section 6);
• if you have intracerebral hemorrhage. The most common symptoms are severe headache, hemiparesis (weakness on one side of the body), and vomiting;
• if you have end-stage renal failure;
• if you have Huntington's chorea (characterized by involuntary movements, irritability, depression, memory disorders).

Warnings and Precautions

Before starting to take Recodium, discuss it with your doctor or pharmacist:

• if you have blood coagulation disorders;
• if you are going to have a major surgical procedure, including dental surgery;
• if you have a severe hemorrhage;
• if you are at risk of bleeding, e.g., due to gastric or intestinal ulcer disease, or a history of hemorrhagic stroke;
• if you have kidney or liver function disorders and are elderly (over 65 years old). Your doctor may reduce the dose of the medication.

Children

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

Recodium and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
Inform your doctor if you are taking any of the following medications:

• 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 medications, e.g., heparin, acenocoumarol, warfarin;
• platelet aggregation inhibitors, including low doses of acetylsalicylic acid (aspirin).

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

Recodium with Food, Drink, and Alcohol

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Do not use this medication during pregnancy, unless your doctor considers it necessary and the benefits of taking the medication outweigh the risk to the fetus, and the clinical condition of the pregnant patient requires treatment with piracetam.
Do not use this medication during breastfeeding, as it passes into human milk.

Driving and Operating Machines

Due to side effects, the medication may affect your ability to drive or operate machines. This should be taken into account.

Recodium Contains Sodium

The medication contains approximately 3.3 mmol (or 75.9 mg) of sodium (the main component of common salt) per 24 g dose of piracetam.
This corresponds to 3.8% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Take Recodium

Always take this medication exactly as your doctor or pharmacist has told you.
In case of doubts, consult your doctor or pharmacist.
The medication is for oral use. It can be taken during or between meals. Swallow the tablets with water.

Recommended Dose

Treatment of cortical myoclonus
The initial dose is 3 tablets 3 times a day (7,200 mg per day).
If necessary, your doctor may gradually increase 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) taken in divided doses, 2 or 3 times a day.
Every 6 months, your doctor may try to reduce the dose or discontinue the medication.
To do this, the dose of the medication 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) 2 times a day.
Treatment of dizziness
Take 3 tablets (2,400 mg) per day in 3 divided doses. The treatment lasts 8 weeks.
Supportive treatment of age-related cognitive disorders (excluding Alzheimer's disease), after a thorough neurological/geriatric assessment by a specialist doctor
Take 3 to 6 tablets (2,400 mg to 4,800 mg) per day in 2 or 3 divided doses.
Use in patients with renal function disorders
Your doctor may reduce the dose of piracetam in patients with renal function disorders.
Do not use this medication in patients with end-stage renal failure.
Use in elderly patients
In elderly patients treated with piracetam for a long time, the doctor will adjust the dose individually after assessing kidney function.

Taking More Than the Recommended Dose of Recodium

In case of taking more than the recommended dose, contact your doctor.
Symptoms of overdose are bloody diarrhea and abdominal pain.

Missing a Dose of Recodium

Continue taking the medication without increasing the next dose.
Do not take a double dose to make up for the missed dose.

Stopping Recodium Treatment

Do not suddenly stop treatment in patients being treated for myoclonus. Sudden withdrawal of the medication may cause recurrence of the disease or generalized seizures.
In case of any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Recodium can cause side effects, although not everybody gets them.

Seek Immediate Medical Attention if You Experience:

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

Other Possible Side Effects

Frequent(less than 1 in 10 people):

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

Uncommon(less 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 or people);
• dizziness, headache;
• abdominal pain or epigastric pain;
• diarrhea, nausea, vomiting;
• angioedema (characterized by sudden swelling of the face, limbs, or joints without itching or pain);
• skin inflammation;
• itching, urticaria (pink, itchy blisters on the skin);
• ataxia (difficulty maintaining balance, unsteady gait);
• exacerbation of epilepsy symptoms;
• insomnia.

If you experience any of the above symptoms, stop taking the medication and consult your doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
al. Jerozolimskie 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Recodium

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medication after the expiration date stated on the blister pack and carton. The expiration date is the last day of the specified month.
Blister pack markings
Lot: Batch number.
EXP: Expiration date.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Recodium Contains

• The active substance of the medication is piracetam. Each film-coated tablet contains 800 mg of piracetam.
• Other ingredients are:
• core: macrogol 6000, colloidal silica anhydrous, 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 Looks Like and What the Pack Contains

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

Marketing Authorization Holder

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

Manufacturer

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

Date of Last Update of the Leaflet: