Memotropil 20%

Patient Information Leaflet

Memotropil 20%, 12 g/60 ml, infusion solution
Piracetam
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. 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 adverse effects, including any adverse effects not listed in this leaflet, inform the doctor or nurse. See section 4.

Table of Contents

1. What Memotropil 20% is and what it is 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 pack and other information

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

Memotropil 20% contains the active substance piracetam, which belongs to a group of medicines
known as psychostimulants.
Piracetam acts by influencing energy metabolism in the cells of the central nervous system (CNS), enhancing oxygen and glucose utilization.
Memotropil 20% is indicated in the treatment of cortical myoclonus (brief, sudden muscle jerks affecting one or more limbs or the trunk).

2. Important information before using Memotropil 20%

When not to use Memotropil 20%:

• if the patient is allergic to piracetam, pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe renal insufficiency with creatinine clearance less than 20 ml/min;
• if the patient has intracerebral haemorrhage. The most common symptoms are severe headache, partial paralysis (e.g. facial muscles with speech disturbances) and vomiting;
• if the patient has Huntington's chorea – a progressive and incurable genetic disorder of the nervous system, manifested by irritability, depression, memory disturbances, and involuntary movements.

Warnings and precautions
Before starting treatment with Memotropil 20%, discuss this with your doctor.
Special caution is required when using Memotropil 20%:

• in patients with impaired kidney function, as the drug is mainly excreted via the kidneys;

• in patients with severe haemorrhage, in patients at risk of bleeding (such as those with gastrointestinal ulcers), in patients with coagulation disorders (blood clotting), in patients after cerebrovascular haemorrhage, in patients undergoing major surgical procedures (including dental procedures), and in patients taking anticoagulant medicines or platelet aggregation inhibitors (including acetylsalicylic acid used in low doses);

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

Memotropil 20% and other medicines
You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

• thyroid hormones
• anticoagulant medicines, such as e.g. acenocoumarol
• antiepileptic medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
Piracetam crosses the placental barrier.
This medicine should not be used in pregnant women or in women planning to become pregnant unless absolutely necessary.
Breastfeeding
Piracetam passes into breast milk.
Due to the risk of adverse effects in breastfed infants, breastfeeding should be discontinued during treatment with Memotropil 20%.
Driving and operating machinery
Memotropil 20% may cause drowsiness and tremor. If these occur, driving vehicles or operating machinery should be avoided.
Memotropil 20% contains sodium
The medicine contains 0.25 mg of sodium (main component of table salt) in 1 ml of solution. A 60 ml container contains 15 mg of sodium, equivalent to 0.75% of the maximum recommended daily intake of sodium in the diet of adults.

3. How to use Memotropil 20%

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The infusion should be administered over 24 hours according to the recommended daily dose. Treatment may
be continued using piracetam in tablet form.
Detailed dosage instructions, as well as directions for use and preparation of the medicine for administration,
are provided at the end of this leaflet under the section “Information intended exclusively for healthcare professionals”.
Use in elderly patients and patients with impaired renal function
The physician may reduce the dose in these patients.
Use in patients with impaired liver function
Dose adjustment is not necessary in patients with impaired liver function alone.
Use of a higher than recommended dose of Memotropil 20%
If the patient suspects that an excessive dose has been administered, inform the doctor immediately.
Piracetam has low toxicity. When very high doses are used, adverse reactions may become more pronounced.
Missed dose of Memotropil 20%
If the patient suspects that a dose has been missed, inform the doctor as soon as possible. Do not use a double dose to make up for the missed dose.
Discontinuation of Memotropil 20%
Do not discontinue use of this medicine without consulting your doctor. In patients with myoclonus, discontinuation of treatment may result in recurrence of the disease or seizure attacks.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Adverse reactions occurring frequently (in less than 1 out of 10 patients)

• Increased motor activity (hyperkinesia)
• Weight gain
• Nervousness

Adverse reactions occurring not frequently (in less than 1 out of 100 patients)

• Drowsiness, depression
• Weakness (asthenia)

Adverse reactions occurring rarely (in less than 1 out of 1000 patients)

• Pain at the injection site
• Thrombophlebitis
• Fever
• Hypotension

Adverse reactions occurring with unknown frequency

• Dizziness
• Bleeding disorders
• Nausea, vomiting, diarrhoea, abdominal pain, epigastric pain
• Allergic reactions. Immediately inform a doctor if symptoms such as skin redness, swelling, urticaria, shortness of breath, laryngeal oedema, or breathing difficulties occur.
• Hypersensitivity
• Impaired body movement coordination (ataxia), balance disorders, increased seizures, headache, insomnia
• Restlessness, anxiety, confusion (disorientation), hallucinations
• Angioedema, skin inflammation, itching, urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 from exposure
to vapours and chemically active gases or gases with strong odours.
The medicine should be stored out of 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the
abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Memotropil 20% contains

• The active substance is piracetam. 60 ml of infusion solution contains 12 g of piracetam. Each ml of infusion solution contains 0.2 g of piracetam.
• Other components of the medicinal product are: sodium acetate trihydrate, acetic acid, water for injections.

What Memotropil 20% looks like and contents of the pack
A clear, odourless solution.
Polyethylene container with an Insocap-type adapter, containing 60 ml of solution.
Pack contains 1 or 20 containers.

Marketing Authorisation Holder and Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Pelplinska Street 19, 83-200 Starogard Gdanski, Poland
Tel. +48 22 364 61 01

Information intended exclusively for medical professionals:

The medicinal product should be administered at the recommended dose as a continuous infusion over 24 hours. It must not be mixed with other medicinal products.
Treatment of cortical myoclonus
Initially, 7.2 g of piracetam per day is administered.
If necessary, the physician may increase the dose by 4.8 g of piracetam per day every 3 or 4 days, up to the maximum dose of 24 g per day.
When used in combination therapy with other anticonvulsant medicinal products, the doses of the other medicinal products should be maintained at the recommended therapeutic doses. If clinical improvement is achieved, doses of other medicinal products should be reduced, if in the physician's opinion this is possible.
Piracetam treatment should be continued as long as the underlying brain disorder persists.
In patients with acute episodes occurring every 6 months, the physician should attempt to reduce or discontinue the medicinal product. To achieve this, the piracetam dose should be reduced by 1.2 g every two days (every 3 or 4 days in the case of Lance–Adams syndrome, to prevent sudden recurrence of the disease).
Dosage in patients with renal function impairment
Piracetam is excreted by the kidneys and therefore particular caution is required in patients with renal insufficiency. The table below shows dose reductions according to creatinine clearance.

Administration method
After checking the integrity of the polyethylene container and removing the protective film,
connect it to an infusion set with a double-lumen needle.
Do not use any solution remaining after infusion.
Do not administer the medicinal product if visible changes in the solution occur.