Nootropil 200 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nootropil 200mg/ml oral solution

piracetam

Read the entire 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 should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 take 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, difficulties in daily activities and adaptation to the environment, which accompany 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 take Nootropil

• If you are allergic to piracetam or to any of the components 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 brain neurons wear out or degenerate, leading to signs of dementia and abnormal movements).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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-related 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 muscle contraction followed by relaxation), as it may trigger a myoclonic or generalized seizure.

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

Taking Nootropil with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines (such as low-dose aspirin, anticoagulants like warfarin or acenocoumarol).

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 identified.

Pregnancy and breastfeeding

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 using machines

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

Nootropil contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium.

• Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, allergic reactions (possibly delayed) may occur.
• This medicine contains 80.5 mg of sodium (the main component of table/cooking salt) in each 24 g of piracetam. This corresponds to 4.03% of the maximum daily sodium intake recommended for an adult.

3. How to take Nootropil

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

For symptomatic treatment of cognitive impairment states:

Begin treatment with 4.8 g of piracetam (6 doses of 4 ml of solution) per day during the first weeks, followed by maintenance treatment with a dose of 2.4 g of piracetam (3 doses of 4 ml of solution) per day. The daily dose should be divided into 2–3 doses.

For the treatment of cortical myoclonus:

Begin treatment with 7.2 g of piracetam (9 doses of 4 ml of solution) per day, increasing the dose by increments of 4.8 g of piracetam (6 doses of 4 ml of solution) every 3–4 days, until a satisfactory response is achieved or until the maximum daily dose of 24 g of piracetam is reached.

The daily dose should be divided into 2–3 doses, while maintaining other antimyoclonic treatments at their prescribed dosage. Subsequently, depending on the clinical response, it may be possible to reduce the dose of other antimyoclonic medications.

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

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

In elderly patients, it is recommended to visit your doctor regularly so that the appropriate dose can be determined (see "Warnings and precautions").

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

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

Administration of the oral solution

The doses of the solution may be taken undiluted or diluted with a small amount of water.

To administer, open the bottle. Insert the graduated syringe (marked in millilitres and milligrams) fully into the bottle and withdraw the prescribed dose according to the following table:

1 ml equals 200 mg of piracetam
2 ml equals 400 mg of piracetam
3 ml equals 600 mg of piracetam
4 ml equals 800 mg of piracetam
5 ml equals 1000 mg of piracetam

If you take more Nootropil than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses. Continue taking your next dose at the usual time.

If you stop taking Nootropil

Any attempt to discontinue treatment should be done gradually by reducing the dose by 1.2 g of piracetam (6 ml of solution) every 2 days, in order to avoid worsening of disease symptoms.

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 may 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.

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, gastrointestinal 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 listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://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 sight and reach of children.

No special storage conditions are required.

Do not use after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Empty containers and unused medicines should be returned to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nootropil

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.

Appearance of the product and contents of the pack

• Nootropil 200 mg/ml oral solution is a clear, colourless to very pale brown solution.
• The solution is supplied in a glass bottle with a 5 ml graduated plastic oral syringe (also graduated in milligrams) and is available in 100 ml packs.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Advanz Pharma Limited,

Unit 17, Northwood House,

Northwood Crescent,

Dublin 9, D09 V504,

Ireland

Manufacturer:

NextPharma, S.A.S.

17, Route de Meulan

Limay (France)

Local representative

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7th floor

28046 Madrid

Spain

Tel: +34 900 834 889

[email protected]

This leaflet was approved in June 2022

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