NOOTROPIL 200 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Nootropil 200mg/ml injectable solution

Piracetam

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 use Nootropil
4. Possible side effects
5. Storage of Nootropil
6. Package contents and further 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 states of 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 use Nootropil

• If you are allergic to piracetam or any of the components of this medicine (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 and signs of dementia and abnormal movements appear).

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 bleeding due to gastrointestinal ulcer, 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 (medicines that prevent blood clotting) or antiplatelet agents (medicines that act on the ability of platelets to aggregate), including low doses of aspirin (a pain-relieving medicine). Sudden withdrawal of treatment should be avoided in myoclonic patients (patients who present with a muscle contraction followed by relaxation), as it may cause a myoclonic crisis (sudden and involuntary jerks of a muscle or group of muscles) 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 medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine (low-dose aspirin, anticoagulants such as warfarin or acenocoumarol), even those medicines purchased without a prescription.

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

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

Pregnancy, breastfeeding, and fertility

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

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

Taking into account the possible side effects observed with this medicine, piracetam may affect the ability to drive and use machines.

Nootropil 200 mg/ml injectable solution contains

This medicine contains 20.28 mg (0.88 mmol) of sodium per maximum daily dose of piracetam (24 g); i.e., it is essentially "sodium-free".

3. How to use Nootropil

Nootropil is administered intravenously.

The recommended dose is:

For the symptomatic treatment of mental deterioration states:

Start treatment by administering 4.8 g (24 ml) of piracetam per day during the first weeks, and then 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 myoclonus:

Start treatment with 7.2 g (36 ml) of piracetam per day and gradually increase the dose by 4.8 g (24 ml) of piracetam per day every 3-4 days, until a satisfactory response is obtained or up to a maximum of 24 g (120 ml) of piracetam per day.

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

Once treatment with Nootropil has been 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 visit the doctor regularly so that they can indicate the correct dose (see "Warnings and precautions").

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

How Nootropil is administered

The injectable ampoules are administered intravenously over several minutes.

Piracetam is compatible with the following perfusion solutions:

Glucose 5%, 10%, and 20%

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

Sodium chloride 0.9%

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

Ringer's solution

Mannitol 20%

HES solution 6% and 10%

It has been shown that piracetam is stable in these solutions for at least 24 hours.

If you stop treatment with Nootropil

If your doctor decides to stop your treatment with Nootropil, the dose will be gradually decreased. This is to avoid your symptoms reappearing or worsening. The attempt to withdraw treatment should be made by reducing the dose by 1.2 g of piracetam every 2 days.

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

4. Possible side effects

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

Frequent 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: drowsiness, depression, and fatigue.

Rare side effects (may affect up to 1 in 1,000 patients) are: pain at the injection site, fever, thrombophlebitis (swelling of a vein caused by a blood clot), hypotension (decrease in blood pressure).

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, intestinal disorders (abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting), skin disorders: angioedema (sudden development of red rashes and hives), dermatitis, pruritus, and urticaria.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nootropil

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Package contents and further information

Nootropil 200mg/ml injectable solution composition

The active substance is piracetam. Each ml of injectable solution contains 200 mg/ml. One 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 package contents

• Nootropil 200 mg/ml injectable solution: clear and colorless solution.
• Package: the injectable solution is packaged in colorless glass ampoules and presented in a package of 50 ampoules of 15 ml injectable solution.

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:

Aesica Pharmaceutical, S.R.L.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Other presentations:

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

This package leaflet was approved in March 2020

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