Label: information for the user

Nootropil 200mg/ml injectable solution

Piracetam

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

1. What is Nootropil and for what it is used

2. What you need to know before starting to take Nootropil

3. How to use Nootropil

4. Possible adverse effects

5. Storage of Nootropil

6. Contents of the package and additional information

Nootropil contains piracetam, an active 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 use 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 neurons in the brain degenerate and cause dementia and abnormal movements).

Warnings and precautions

Consult your doctor or pharmacist before starting to use 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, any hemostatic alteration (alteration of the mechanism responsible for stopping bleeding processes), patients at risk of cerebral hemorrhage, are to undergo a type of 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). The abrupt withdrawal of treatment in myoclonic patients (patients who exhibit a contraction followed by muscle relaxation) may cause a myoclonic crisis (sudden and involuntary contractions of a muscle or group of muscles) 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, have used recently, or may need to use any other medication, (low doses of aspirin, anticoagulants such as warfarin or acenocoumarol), even those medications obtained without a prescription.

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 disorders.

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you 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 it is strictly necessary.

Lactation

Nootropil passes into breast milk, so it should be avoided during lactation 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 200 mg/ml injectable solution contains

This medication contains 20.28 mg (0.88 mmol) of sodium per maximum daily dose of piracetam (24 g); this is essentially "sodium-free".

Nootropil is administered intravenously.

The recommended dose is:

For symptomatic treatment of mental deterioration states:

Initiate treatment by administering 4.8 g (24 ml) of piracetam per day during the first weeks, to continue treatment with a dose of 2.4 g (12 ml) of piracetam per day. The daily dose will be administered in 2-3 doses.

For the treatment of cortical myoclonias:

Initiate treatment with 7.2 g (36 ml) of piracetam per day and increase the dosage 4.8 g (24 ml) of piracetam per day, every 3-4 days, until a satisfactory response is obtained or until a maximum of 24 g (120 ml) of piracetam per day is reached.

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

Once treatment with Nootropil has been initiated, it should be continued for 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, regular visits to the doctor are recommended to indicate the correct dose (see “Advertencias y precauciones”).

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

How Nootropil is administered

The injectable ampoules are administered intravenously over several minutes.

Piracetam is compatible with the following infusion solutions:

Glucose 5%, 10%, and 20%

Fructose (Levulose) 5%, 10%, and 20%

Sodium chloride 0.9%

Dextran 40 (at 10% in a 0.9% sodium chloride solution)

Ringer

Manitol 20%

HES solution 6% and 10%

Piracetam has been found to be stable in these solutions for at least 24 hours.

If treatment with Nootropil is interrupted

If your doctor decides to interrupt your treatment with Nootropil, the dose will be gradually reduced. This is to prevent your symptoms from appearing again or worsening. The attempt to discontinue treatment should be made by reducing the dose 1.2 g of piracetam every 2 days.

If you have any other questions 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.

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

The less frequent adverse effects (may affect up to 1 in 100 people) are: drowsiness, depression, fatigue.

The rare adverse effects (may affect up to 1 in 1000 patients) are: pain at the injection site, fever, thrombophlebitis (swelling of a vein caused by a blood clot), hypotension (decreased blood pressure).

The frequency is unknown (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 rashes 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 not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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 this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.This will help protect the environment.

Composition of Nootropil 200mg/ml injectable solution

The active ingredient is piracetam. Each ml of injectable solution contains 200 mg/ml. A vial contains 15 ml of injectable solution, equivalent to 3 g of piracetam. The other components are sodium acetate trihydrate, acetic acid, and water for injectable preparations.

Appearance of the product and content of the container

• Nootropil 200mg/ml injectable solution: transparent and colorless solution.
• Container: the injectable solution is packaged in colorless glass ampoules and is presented in a container of 50 ampoules of 15ml injectable solution.

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:

Aesica Pharmaceutical, S.R.L.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Other presentations:

Nootropil 200 mg/ml oral solution: Container with a 100 ml solution bottle.

This leaflet was approved in March 2020

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/