Nootropil 200 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nootropil 200mg/ml solution for injection

Piracetam

Read the entire leaflet carefully before you start using 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.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Nootropil is and what it is used for
2. What you need to know before taking Nootropil
3. How to use Nootropil
4. Possible side effects
5. How to store Nootropil
6. Contents of the pack and other information

1. What Nootropil is and what it is used for

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

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 ingredients of this medicine (listed in section 6).
• If you have cerebral hemorrhage.
• If you have end-stage renal failure.
• If you have Huntington's chorea (an inherited disorder in which neurons in the brain wear out or degenerate, leading to signs of dementia and abnormal movements).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Nootropil.

• If you have kidney problems, a lower dose will be administered depending on the severity of the kidney impairment; your doctor will determine the appropriate dose.
• If you have severe bleeding, are at risk of gastrointestinal ulcer bleeding, have a hemostatic disorder (a disorder affecting the mechanism responsible for stopping bleeding), are at risk of cerebral hemorrhage, are about to undergo major surgery (including dental surgery), or are taking anticoagulants (medicines that prevent blood clotting) or antiplatelet agents (medicines that affect platelet aggregation), including low-dose aspirin (an analgesic drug). Abrupt discontinuation of treatment should be avoided in myoclonic patients (patients experiencing a muscle contraction followed by relaxation), as it may trigger a myoclonic crisis (sudden, involuntary jerks of a muscle or group of muscles) or generalized seizures.
• For long-term treatment in elderly patients, regular assessment of creatinine clearance is required in order to adjust the dose if necessary.

Use of Nootropil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines (including low-dose aspirin, anticoagulants such as warfarin or acenocumarol), even those obtained without a prescription.

Only one case has been reported in which concomitant use of piracetam and thyroid hormone extracts (T3 + T4) led to confusion, irritability, and sleep disturbances.

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 are planning 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 strictly necessary.

Breastfeeding

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

Driving and use of machines

Given the possible adverse effects observed with this medicine, piracetam may affect your ability to drive and operate machinery.

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); this is essentially "sodium-free".

3. How to use Nootropil

Nootropil is administered intravenously.

The recommended dose is:

For symptomatic treatment of mental impairment states:

Begin treatment with 4.8 g (24 ml) of piracetam per day for the first few weeks, followed by a maintenance dose of 2.4 g (12 ml) of piracetam per day. The daily dose should be divided into 2–3 administrations.

For the treatment of cortical myoclonus:

Begin treatment with 7.2 g (36 ml) of piracetam per day, increasing the dosage by 4.8 g (24 ml) of piracetam every 3–4 days until a satisfactory response is achieved or until the maximum dose of 24 g (120 ml) of piracetam per day is reached.

The daily dose should be divided into 2–3 administrations, while maintaining other antimioclonic treatments at their usual dosage. Subsequently, depending on the clinical response, the dose of other antimioclonic medications may be reduced if possible.

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

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

In elderly patients, regular visits to the physician are recommended to determine the appropriate dose (see "Warnings and precautions").

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

How Nootropil is administered

Injectable ampoules are administered intravenously over several minutes.

Piracetam is compatible with the following infusion solutions:

5%, 10%, and 20% Glucose
5%, 10%, and 20% Fructose (Levulose)
0.9% Sodium chloride
Dextran 40 (10% in 0.9% sodium chloride solution)
Ringer's solution
20% Mannitol
6% and 10% HES solution

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

If you interrupt treatment with Nootropil

If your doctor decides to discontinue your treatment with Nootropil, the dose will be reduced step by step. This is to prevent your symptoms from recurring or worsening. The attempt to withdraw treatment should be carried out 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 adverse effects

Like all medicines, Nootropil can cause adverse effects, although not everyone experiences them.

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

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

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

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of Nootropil 200 mg/ml injectable solution

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 contents of the pack

• Nootropil 200 mg/ml injectable solution: clear, colourless solution.
• Pack: the injectable solution is supplied in colourless glass vials and presented in a pack of 50 vials 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: Pack containing a 100 ml bottle of solution.

This leaflet was approved in March 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/