Leaflet: information for the user

Nootropil 200mg/ml oral solution

Piracetam

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

1. What Nootropil is and what it is used for

2. What you need to know before you start taking Nootropil

3. How to take Nootropil

4. Possible side effects

5. Storage of Nootropil

6. Contents of the pack and additional information

Nootropil contains piracetam, an active non-nootropic principle, without sedative or psychostimulant effects, indicated for the treatment of attention and memory disorders, difficulties in daily activity 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 myoclonias.

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 (an inherited disorder in which neurons in the brain deteriorate or degenerate and symptoms 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; the dose to be taken will be indicated by your doctor.
• If you have severe bleeding, if you have a risk of gastrointestinal bleeding, some hemostatic alteration (alteration of the mechanism responsible for stopping bleeding processes), patients at risk of cerebral hemorrhage, are to undergo major surgery including dental surgery, and patients using anticoagulants (medications that prevent blood coagulation) or antiplatelet agents (medications that act on the ability of platelet aggregation), including low doses of aspirin (a pain-relieving medication). Abrupt withdrawal of treatment in myoclonic patients (patients who present a contraction followed by muscle relaxation) may cause a myoclonic or generalized crisis.

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

Use of 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 described in which the use of piracetam and thyroid hormone extracts (T3 + T4) together has led to confusion, irritability, and sleep disturbances.

No other interactions with other medications have been detected to date.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

Considering the possible adverse effects observed with this medication, it is possible that piracetam may affect the ability to drive and operate machinery.

Nootropil contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, and sodium.

-As it contains parahydroxybenzoic acid methyl ester and parahydroxybenzoic acid propyl ester, it may cause allergic reactions (possibly delayed).

-This medication contains 80.5 mg of sodium (main component of table salt/for cooking) in each 24 g of piracetam. This corresponds to 4.03% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

For symptomatic treatment of mental deterioration states:

Start treatment by administering 4.8 g of piracetam (6 doses of 4 ml of solution) per day during the first weeks, to 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 myoclonias:

Start treatment with 7.2 g of piracetam (9 doses of 4 ml of solution) per day and increase the dosage 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 until a maximum of 24 g of piracetam per day is reached.

The daily dose will be administered in 2-3 doses, maintaining other anticonvulsant treatments with their dosage. Then, based on the clinical response obtained, the dose of other anticonvulsant medications will be reduced, if possible.

Once treatment with Nootropil has been initiated, it should be continued as long as the original cerebral pathology persists. However, every 6 months, an attempt should be made to reduce or discontinue treatment.

Nota:Patients with kidney problems should take a lower dose (see “Advertencias y precauciones”).

In elderly patients, it is recommended to visit the doctor regularly to indicate the correct dose (see “Advertencias y precauciones”).

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

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

Forma de administración de la solución oral

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

To administer, 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 are equivalent to 400 mg of piracetam

3 ml are equivalent to 600 mg of piracetam

4 ml are equivalent to 800 mg of piracetam

5 ml are equivalent to 1000 mg of piracetam

Si toma más Nootropil del que debe

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

Si olvidó tomar Nootropil

Do not take a double dose to compensate for the missed doses. Continue taking your normal dose when it's time.

Si interrumpe el tratamiento con Nootropil

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

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

Like all medications, Nootropil may produce adverse effects, although not everyone will experience them.

Frequent adverse effects(may affect up to 1 in 10 people) are: tremor, weight gain, nervousness.

Infrequent (may affect up to 1 in 100 people) are: drowsiness, depression, and fatigue.

Unknown frequency (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, gastrointestinal disorders (abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting), skin alterations: angioneuritic edema (sudden development of red patches and hives), dermatitis, pruritus, and urticaria.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:http://www.notificaram.es

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

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of your usual pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Nootropil

The active principle is piracetam.

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

Appearance of the product and content of the container

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

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization:

UCB Pharma, S.A.

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

Responsible for Manufacturing:

NextPharma, S.A.S.

17, Route de Meulan

Limay (France)

Other presentations:

Nootropil 200 mg/mlg injectable solution: Clinical container with 50 ampoules of 15ml.

This prospectus was approved in June 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/