Memotropil 20%

Package Leaflet: Information for the User

Memotropil 20%, 200 mg/ml (ampoules 1 g/5 ml), solution for injection

Memotropil 20%, 200 mg/ml (ampoules 3 g/15 ml), solution for injection

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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 pack and other information

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

Memotropil 20% is a medicine belonging to the subgroup of nootropic medicines. It reduces blood viscosity, increases blood flow through the brain vessels without vasodilating action, and also increases oxygen utilization and glucose consumption in ischemic brain tissue. Memotropil 20% is indicated for the treatment of myoclonus (short, sudden muscle contractions in one or more limbs or trunk) of cortical origin.

2. Important information before using Memotropil 20%

When not to use Memotropil 20%:

Warnings and precautions

Special caution should be exercised when using Memotropil 20%:

• in patients with renal impairment, as the medicine 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

in patients taking anticoagulant medications or medications that inhibit platelet aggregation (including acetylsalicylic acid used in low doses);

• in elderly patients, due to the longer elimination period of the medicine from the body (in these patients, the doctor should modify the dosage);
• in patients with very low blood pressure.

Memotropil 20% and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.

• Piracetam may enhance the effect of central nervous system stimulants.
• Piracetam may exhibit non-specific interactions with neuroleptics.
• The medicine may enhance the effect of thyroid hormones.
• The medicine should be used with caution with anticoagulant medications, such as acenocoumarol.

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 the medicine.

Driving and using machines

The occurrence of side effects after taking piracetam, such as drowsiness, nervousness, excessive restlessness, and depression, poses a risk associated with driving vehicles and operating machines. If they occur, do not drive vehicles or operate machines.

Memotropil 20% contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

3. How to use Memotropil 20%

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The medicine should be administered intravenously over a few minutes in the recommended dose or in 2 or 3 divided doses. It should not be mixed with other medicines. Treatment can be continued using piracetam in the form of film-coated tablets.
Detailed dosing and administration instructions are provided at the end of the leaflet, in the section "Information intended for healthcare professionals only".
Use in patients with renal impairment
Piracetam is excreted by the kidneys, and therefore, special caution should be exercised in patients with renal impairment. 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 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 be intensified.

Missing a dose of Memotropil 20%

If you think you have missed a dose of the medicine, tell your doctor as soon as possible. Do not take two doses of the medicine at the same time or at short intervals.

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 (less than 1 in 10 patients)

• excessive restlessness (hyperkinesia)
• weight gain
• nervousness.

Uncommon side effects (less than 1 in 100 patients)

• drowsiness
• depression
• general weakness (asthenia).

Rare side effects (less than 1 in 1000 patients)

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

Side effects of unknown frequency

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 the medicine.

5. How to store Memotropil 20%

Store the medicine out of sight and reach of children.
Do not store above 25°C. The solution should 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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Memotropil 20% contains

• The active substance of the medicine 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).
• The other ingredients of the medicine are: sodium acetate trihydrate, glacial acetic acid, water for injections.

What Memotropil 20% looks like and contents of the pack

Clear solution, odorless.
Packaging available:

• 12 ampoules of 5 ml
• 4 ampoules of 15 ml

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

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

Information intended for healthcare professionals only:
Memotropil 20% should be administered intravenously in the recommended dose over a few minutes or in a daily dose in 2-3 divided doses. It should not be mixed with other medicines.
Recommended dose of the medicine in cortical myoclonus
Initially, 7.2 g of piracetam per day is administered.
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 medicines, the doses of other medicines should be maintained at the recommended therapeutic doses. If clinical improvement is achieved, the doses of other medicines should be reduced, if possible, in the opinion of the doctor.
Treatment with piracetam should be continued 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 this end, the dose of piracetam 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 impairment

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

Do not use the medicine if visible changes are observed in the solution.