NOOTROPIL 200 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Nootropil 200mg/ml Oral Solution

Piracetam

Read the entire package leaflet carefully before starting to takethis medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Nootropil and what is it used for
2. What you need to know before taking Nootropil
3. How to take Nootropil
4. Possible side effects
5. Storage of Nootropil
6. Package Contents and Additional Information

1. What is Nootropil and what is it used for

Nootropil contains piracetam, which is a nootropic active substance without sedative or psycho-stimulant effects, indicated for the treatment of attention and memory disorders, difficulties in daily activities and adaptation to the environment, which accompany mental deterioration due to a degenerative brain disease related to age.

It is also indicated for the treatment of cortical myoclonus.

2. What you need to know before taking Nootropil

Do not take Nootropil

• If you are allergic to piracetam or any of the components of this medication (listed in section 6). If you have a cerebral hemorrhage.
• If you have terminal renal insufficiency.
• If you have Huntington's disease (a hereditary disorder in which brain neurons deteriorate or degenerate, and signs of dementia and abnormal movements appear).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Nootropil.

• If you have kidney problems, a smaller dose will be administered according to the severity of the kidney problems; your doctor will indicate the dose to take.
• If you have severe bleeding, if you are at risk of bleeding from gastrointestinal ulcers, any hemostatic disorder (disorder of the mechanism responsible for stopping bleeding processes), patients at risk of cerebral bleeding, are going to undergo major surgery, including dental surgery, and patients using anticoagulants (medications that prevent blood clotting) or antiplatelet agents (medications that act on platelet aggregation), including low doses of aspirin (a pain-relieving medication). Sudden withdrawal of treatment should be avoided in myoclonic patients (patients who experience muscle contraction followed by relaxation), as it may cause a myoclonic or generalized crisis.

For long-term treatments in elderly patients, regular assessment of creatinine clearance is required to adjust the dose if necessary.

Using Nootropil with Other Medications

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication (low doses of aspirin, anticoagulants such as warfarin or acenocoumarol).

Only one case has been reported in which the use of piracetam and thyroid hormone extracts (T3 + T4) at the same time has resulted in confusion, irritability, and sleep disorders.

To date, no further interactions with other medications have been detected.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Although no adverse effects have been reported in animal studies, the use of Nootropil during pregnancy is not recommended unless it is strictly necessary.

Breastfeeding

Nootropil passes into breast milk, so its use should be avoided during breastfeeding or breastfeeding should be discontinued during treatment.

Driving and Using Machines

Given the possible side effects observed with this medication, piracetam may affect the ability to drive and use machines.

Nootropil contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium.

• As it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, it may cause allergic reactions (possibly delayed).
• This medication contains 80.5 mg of sodium (main component of table salt/cooking salt) per 24 g of piracetam. This is equivalent to 4.03% of the maximum recommended daily sodium intake for an adult.

3. How to Take Nootropil

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Nootropil is administered orally and can be taken with or without food. The recommended dose is:

For the symptomatic treatment of mental deterioration:

Start treatment by administering 4.8 g of piracetam (6 doses of 4 ml of solution) per day for the first few weeks, and then continue treatment with a dose of 2.4 g of piracetam (3 doses of 4 ml of solution) per day. The daily dose will be administered in 2-3 doses.

For the treatment of cortical myoclonus:

Start treatment with 7.2 g of piracetam (9 doses of 4 ml of solution) per day and gradually increase the dosage by 4.8 g of piracetam (6 doses of 4 ml of solution) per day every 3-4 days until a satisfactory response is obtained or a maximum of 24 g of piracetam per day.

The daily dose will be administered in 2-3 doses, maintaining the other antimioclonic treatments with their posology. Afterward, depending on the clinical response obtained, the dose of the other antimioclonic medications will be reduced, if possible.

Once treatment with Nootropil has started, it should be maintained for as long as the original brain pathology persists. However, every 6 months, an attempt should be made to decrease or discontinue treatment.

Note:Patients with kidney problems should take a lower dose (see "Warnings and Precautions").

In elderly patients, it is recommended to regularly visit the doctor to indicate the correct dose (see "Warnings and Precautions").

The duration of treatment depends on the type, duration, and course of the symptoms.

If you think the effect of Nootropil is too strong or too weak, consult your doctor or pharmacist.

Method of Administration of the Oral Solution

The doses of the solution can be administered alone or diluted with a little water.

For administration, open the bottle. Insert the graduated syringe in milliliters and milligrams to the bottom, and extract the dose prescribed according to the following table:

1 ml is equivalent to 200 mg of piracetam

2 ml is equivalent to 400 mg of piracetam

3 ml is equivalent to 600 mg of piracetam

4 ml is equivalent to 800 mg of piracetam

5 ml is equivalent to 1000 mg of piracetam

If You Take More Nootropil Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

If You Forget to Take Nootropil

Do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

If You Interrupt Treatment with Nootropil

The attempt to withdraw treatment should be done by reducing the dose by 1.2 g of piracetam (6 ml of solution) every 2 days to avoid exacerbating the symptoms of the disease.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Nootropil can cause side effects, although not everyone will experience them.

Common side effects (may affect up to 1 in 10 people) are: tremors, weight gain, nervousness.

Uncommon side effects (may affect up to 1 in 100 people) are: somnolence, depression, and fatigue.

Frequency not known (cannot be estimated from available data) are: hemorrhagic disorders, hypersensitivity reactions (allergies), anaphylactic reaction, agitation, anxiety, confusion, hallucinations, lack of coordination (ataxia), loss of balance, worsening of epilepsy, headache, insomnia, vertigo, intestinal disorders (abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting), skin alterations: angioneurotic edema (sudden development of red rashes and hives), dermatitis, pruritus, and urticaria.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that appears in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nootropil

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Nootropil Composition

The active substance is piracetam.

• The other components are: glycerol (E 422), sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), apricot flavor, caramel flavor, sodium acetate, acetic acid, and purified water.

Product Appearance and Package Contents

• Nootropil 200 mg/ml oral solution is a clear, colorless to very light brown solution.
• The solution is packaged in a glass bottle with a 5 ml graduated plastic syringe (also graduated in milligrams) and is presented in 100 ml packages.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n, Edificio Bronce, Planta 5, 28020 Madrid

Manufacturer:

NextPharma, S.A.S.

17, Route de Meulan

Limay (France)

Other Presentations:

Nootropil 200 mg/ml solution for injection: Clinical package with 50 ampoules of 15 ml.

This package leaflet was approved in June 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/