Memotropil 20%

Package Leaflet: Information for the User

Memotropil 20%, 12 g/60 ml, Solution for Infusion

Piracetam

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Memotropil 20% and what is it used for
• 2. Important information before using Memotropil 20%
• 3. How to use Memotropil 20%
• 4. Possible side effects
• 5. How to store Memotropil 20%
• 6. Contents of the package and other information

1. What is Memotropil 20% and what is it used for

Memotropil 20% contains the active substance piracetam, which belongs to the group of psychostimulant drugs.
Piracetam works by affecting energy changes in the cells of the central nervous system (CNS), increasing the use of oxygen and glucose.
Memotropil 20% is indicated for the treatment of cortical myoclonus (short, sudden muscle contractions in one or more limbs or torso).

2. Important information before using Memotropil 20%

When not to use Memotropil 20%:

• if you are allergic to piracetam, pyrrolidine derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe renal impairment with creatinine clearance less than 20 ml/min;
• if you have cerebral hemorrhage. The most common symptom is severe headache, hemiparesis (e.g., facial muscle weakness with speech disturbances) and vomiting;
• if you have Huntington's chorea - a progressive and incurable genetic disorder affecting the nervous system, characterized by irritability, depression, memory disturbances, and involuntary movements.

Warnings and precautions

Before starting treatment with Memotropil 20%, discuss it with your doctor.
Particular caution should be exercised when using Memotropil 20%:

• in patients with renal impairment, as the drug is mainly excreted by the kidneys;
• in patients with severe bleeding, patients at risk of bleeding (such as patients with gastrointestinal ulcers), patients with hemostasis disorders (blood clotting), patients after cerebral vascular bleeding, patients undergoing major surgical procedures (including dental procedures), and patients taking anticoagulant medications or platelet aggregation inhibitors (including low-dose acetylsalicylic acid);

(in patients with bleeding disorders), in elderly patients, due to the longer elimination period of the drug from the body (in these patients, the doctor should modify the dosage).

• in elderly patients, due to the longer elimination period of the drug from the body (in these patients, the doctor should modify the dosage).

Memotropil 20% and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as the medicines you plan to take, especially:

• thyroid hormones
• anticoagulant medications, such as acenocoumarol
• antiepileptic medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Pregnancy
Piracetam crosses the placental barrier.
The medicine should not be used in pregnant women or women planning to become pregnant, unless it is absolutely necessary.
Breastfeeding
Piracetam passes into breast milk.
Due to the risk of side effects in breastfed infants, breastfeeding should be discontinued during treatment with Memotropil 20%.

Driving and using machines

Memotropil 20% may cause drowsiness and tremors. If they occur, do not drive or operate machinery.

Memotropil 20% contains sodium

The medicine contains 0.25 mg of sodium (the main component of common salt) per 1 ml of solution. A 60 ml container contains 15 mg of sodium, which corresponds to 0.75% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Memotropil 20%

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The infusion should be administered over 24 hours at the recommended daily dose. Treatment can be continued using piracetam in tablet form.
Detailed dosing and administration instructions are provided at the end of the package leaflet, in the section "Information intended for healthcare professionals only".

Use in elderly patients and patients with renal impairment

In these patients, the doctor may reduce the dose of the medicine.

Use in patients with liver function disorders

There is no need to modify the dosage in patients with liver function disorders only.

Using a higher than recommended dose of Memotropil 20%

If you think you have received too much of the medicine, inform your doctor.
Piracetam has low toxicity. During administration of very high doses of the medicine, side effects may worsen.

Missing a dose of Memotropil 20%

If you think you have missed a dose of the medicine, inform your doctor as soon as possible. Do not take a double dose to make up for the missed dose.

Stopping treatment with Memotropil 20%

Do not stop treatment with the medicine without consulting your doctor. After stopping treatment in patients with myoclonus, the disease may recur or seizures may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (in less than 1 in 10 patients)

• increased motor activity (hyperkinesia)
• weight gain
• nervousness.

Uncommon side effects (in less than 1 in 100 patients)

• drowsiness, depression
• weakness (asthenia).

Rare side effects (in less than 1 in 1000 patients)

• pain at the injection site
• phlebitis with thrombosis
• fever
• hypotension.

Side effects with unknown frequency

• dizziness
• bleeding disorders
• nausea, vomiting, diarrhea, abdominal pain, epigastric pain
• allergic reactions. You should immediatelyinform your doctor if you experience symptoms such as: skin redness, swelling, urticaria, dyspnea, laryngeal edema, breathing difficulties.
• hypersensitivity
• coordination disorders (ataxia), balance disorders, exacerbation of epilepsy, headache, insomnia
• agitation, anxiety, confusion (disorientation), hallucinations
• angioedema, skin inflammation, itching, urticaria.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memotropil 20%

Store in a dry place, at a temperature not exceeding 25°C, protected from light and the effects of chemically active vapors or gases with a strong odor.
Keep the medicine out of the 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 specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Memotropil 20% contains

• The active substance of the medicine is piracetam. 60 ml of the solution for infusion contains 12 g of piracetam. Each 1 ml of the solution for infusion contains 0.2 g of piracetam.
• The other ingredients of the medicine are: sodium acetate trihydrate, acetic acid, water for injections.

What Memotropil 20% looks like and what the package contains

Clear solution, odorless.
Polyethylene container formed with an Insocap adapter, containing 60 ml of solution.
The package contains 1 or 20 containers.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last revision of the package leaflet: -----------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
The medicine should be administered at the recommended dose in a continuous infusion over 24 hours. It should not be mixed with other medicines.

Treatment of cortical myoclonus

Initially, 7.2 g of piracetam is administered per day.
If necessary, the doctor will increase the dose every 3 or 4 days by 4.8 g of piracetam per day, up to a maximum dose of 24 g per day.
In combination therapy with other antiepileptic medications, the doses of other medications should be maintained at the recommended therapeutic doses. If clinical improvement is achieved, the doses of other medications should be reduced, if possible, as judged by the doctor.
Treatment with piracetam should be continued for as long as the underlying brain disease persists.
In patients with an acute episode, every 6 months the doctor will attempt to reduce the dose or discontinue the medicine. To do this, the dose of piracetam should be reduced by 1.2 g every 2 days (every 3 or 4 days in the case of Lance-Adams syndrome, to prevent sudden recurrence of the disease).

Dosing in patients with renal impairment

Piracetam is excreted by the kidneys, and therefore, particular caution should be exercised in patients with renal impairment. The following table shows the dose reduction based on creatinine clearance.

Method of administration

The polyethylene container, after checking the seal and breaking the protective foil, should be connected to a set with a double-lumen needle.
Do not use the solution remaining after infusion.
Do not use the medicine if visible changes in the solution are observed.