Memotropil 20%

Package leaflet: Information for the user

Memotropil 20%, 200 mg/ml (1 g/5 ml ampoules, 3 g/15 ml ampoules), solution for injection
Piracetamum
Please read all of this leaflet carefully before you are given this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Memotropil 20% is and what it is used for
2. What you need to know before you are given 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% is a medicine belonging to the group of nootropic drugs. It reduces blood viscosity,
increases blood flow in cerebral vessels without vasodilatory action, and enhances oxygen utilization and glucose consumption in ischemic brain tissue.
Memotropil 20% is indicated for 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, other 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 intracranial hemorrhage. 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
Special caution is required when using Memotropil 20%:

• in patients with impaired kidney function, as the drug is primarily excreted by the kidneys;
• in patients with severe bleeding, in patients at risk of bleeding (such as those with gastrointestinal ulcers), in patients with coagulation disorders (blood clotting disorders), in patients after cerebrovascular hemorrhage, in patients undergoing major surgical procedures (including dental procedures), and

in patients taking anticoagulant drugs 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 physician should adjust the dosage);
• in patients with very low arterial blood pressure.

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

• Piracetam may enhance the effects of central nervous system stimulants.
• Piracetam may exhibit non-specific interactions with neuroleptics.
• The drug may enhance the effects of thyroid hormones.
• The drug should be used cautiously with anticoagulant medicines, such as acenocoumarol.

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.
The drug should not be used in pregnant women or in women planning pregnancy 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 this medicine.
Driving and operating machinery
Adverse effects such as drowsiness, nervousness, hyperactivity, and depression may occur after taking piracetam, which may impair the ability to drive or operate machinery. If these effects occur, the patient should not drive or operate machinery.
Memotropil 20% contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

3. How to use Memotropil 20%

This medicine should always be used exactly as directed by the doctor or nurse. If in doubt,
consult the doctor or pharmacist.
The medicine should be administered intravenously over several minutes in the recommended dose,
or divided into 2 or 3 doses. It should not be mixed with other medicines. Treatment may be continued
using piracetam in the form of coated tablets.
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 medical professionals”.
Use in patients with impaired kidney function
Piracetam is excreted by the kidneys, and therefore particular caution should be exercised in patients
with renal insufficiency. The doctor may recommend reducing the dose of the medicine.
Use in elderly patients
The doctor may recommend reducing the dose of the medicine.
Use in patients with impaired liver function
There is no need to adjust the dosage 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, the doctor should be informed 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, the doctor should be informed as soon as possible.
Do not take two doses at the same time or within a short interval.
Stopping treatment with Memotropil 20%
Do not discontinue treatment without consulting the doctor. After stopping treatment, patients with myoclonus
may experience a recurrence of the disease or seizures.
If there are any further doubts regarding the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions (in less than 1 in 10 patients)

• Excessive movement (hyperkinesia)
• Weight gain
• Nervousness

Uncommon adverse reactions (in less than 1 in 100 patients)

• Drowsiness
• Depression
• Generalized weakness (asthenia)

Rare adverse reactions (in less than 1 in 1,000 patients)

• Pain at injection site
• Thrombophlebitis
• Fever
• Hypotension

Adverse reactions with unknown frequency

• Dizziness
• Bleeding disorders
• Nausea, vomiting, diarrhoea
• Abdominal pain, epigastric pain (especially during long-term treatment)
• Allergic reactions. Immediately inform a doctor if symptoms occur such as: skin redness, swelling, urticaria, shortness of breath, laryngeal oedema, breathing difficulties
• Hypersensitivity
• Ataxia (movement coordination disorders), balance disorders, worsening of epilepsy symptoms
• Headache, insomnia, agitation, anxiety, confusion, hallucinations
• Angioedema, dermatitis, pruritus, urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Memotropil 20%

Keep the medicine out of sight and reach of children.
Do not store at temperatures above 25°C. The solution must not be frozen.
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 label on the packaging: EXP indicates the expiry date, and Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the pack and other information

What Memotropil 20% contains

• The active substance is piracetam. Each 5 ml ampoule contains 1 g of piracetam (200 mg/ml). Each 15 ml ampoule contains 3 g of piracetam (200 mg/ml).
• Other components of the medicine are: sodium acetate trihydrate, glacial acetic acid, water for injections.

What Memotropil 20% looks like and contents of the pack
A clear, odourless solution.
Available pack sizes:

• 12 ampoules with a capacity of 5 ml
• 4 ampoules with a capacity of 15 ml

Marketing Authorisation Holder and Manufacturer
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Information intended exclusively for medical professionals:

Memotropil 20% should be administered intravenously at the recommended dose as an injection lasting several minutes or as a daily dose divided into 2–3 doses. It should not be mixed with other drugs.

Recommended dosage in 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 a maximum dose of 24 g per day.
When used concomitantly with other anticonvulsant drugs, the doses of other medications should be maintained within their recommended therapeutic ranges. If clinical improvement is achieved, doses of other drugs should be reduced, as deemed possible by the physician.
Treatment with piracetam should be continued as long as the underlying brain disorder persists.
In patients experiencing acute episodes every 6 months, the physician will attempt dose reduction or discontinuation of the drug. 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).

Use in patients with renal function impairment
Piracetam is eliminated via the kidneys; therefore, particular caution is required in patients with renal insufficiency. The table below shows dose adjustments according to creatinine clearance.

The medicinal product should not be used if visible changes in the solution occur.