Nootropil 20%

Leaflet attached to the packaging: patient information

Nootropil 20%, 200 mg/ml, oral solution

Nootropil 33%, 333 mg/ml, oral solution

Piracetam
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Nootropil and what is it used for
• 2. Important information 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 is Nootropil and what is it used for

Nootropil is a nootropic medicine. It reduces blood viscosity, increases blood flow through the vessels in the brain without vasodilating action, and also increases oxygen and glucose utilization in ischemic brain tissue.
Indications for use of Nootropil
Nootropil is used in:

• treatment of cortical myoclonus (short, violent muscle contractions in one or more limbs or trunk);
• treatment of dyslexic disorders in children in combination with speech therapy;
• treatment of dizziness.

2. Important information before taking Nootropil

When not to take Nootropil:

• if the patient is allergic to piracetam, other pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has cerebral hemorrhage;
• if the patient has terminal renal failure;
• if the patient has Huntington's chorea.

Warnings and precautions

Before starting treatment with Nootropil, discuss it with your doctor or pharmacist.
Due to the effect of piracetam on platelet aggregation, caution should be exercised in patients with coagulation disorders, undergoing major surgical procedures, and in patients with severe bleeding, bleeding risk, e.g., in gastric and intestinal ulcer disease, with coagulation disorders, with a history of hemorrhagic stroke, undergoing major surgical procedures, including dental procedures, using anticoagulant products or platelet aggregation inhibitors, including small doses of acetylsalicylic acid.
Sudden discontinuation of treatment should not be performed in patients treated for myoclonus, to avoid recurrence of myoclonus or generalized seizures.

Taking Nootropil with food, drink, and alcohol

Nootropil can be taken during or between meals.

Children and adolescents

See: "How to take Nootropil".

Taking Nootropil in patients with renal and/or hepatic impairment

Piracetam is excreted by the kidneys. Caution should be exercised when administering the medicine to patients with impaired renal function. Depending on the severity of renal impairment, dose adjustment may be required.

Taking Nootropil in elderly patients

In elderly patients with impaired renal function, the doctor will adjust the dose of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
There are insufficient data on the use of piracetam in pregnant women. Piracetam crosses the placental barrier. The concentration of the medicine in the blood of newborns is approximately 70-90% of the concentration in the mother's blood.
Piracetam passes into human milk. Therefore, piracetam should be avoided during breastfeeding or breastfeeding should be discontinued during treatment with piracetam.

Driving and using machines

The medicine may affect the ability to drive and use machines, and this should be taken into account.

Nootropil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor or pharmacist about:

• thyroid hormones. Cases of confusion (disorientation), irritability, and insomnia have been reported during concomitant use of the medicine with thyroid hormones (T + T).
• anticoagulant medicines, such as acenocoumarol.

The likelihood of other medicines affecting the metabolism of piracetam is low.
Concomitant administration of alcohol did not affect the concentration of piracetam in serum. Taking a dose of 1.6 g of piracetam orally did not affect the concentration of alcohol. However, it is not recommended to consume alcohol during treatment with the medicine.

Nootropil contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), glycerol, and sodium

The medicine contains methyl and propyl parahydroxybenzoates, which may cause allergic reactions (possible late reactions).
The medicine contains glycerol, which may cause headache, gastrointestinal disturbances, and diarrhea.
Nootropil 20%
The maximum daily dose (24 g of piracetam) contains 80.4 mg of sodium, the main component of table salt. This corresponds to 4.02% of the maximum recommended daily dose of sodium in the diet for adults.
Nootropil 33%
The maximum daily dose (24 g of piracetam) contains 24.35 mg of sodium, the main component of table salt. This corresponds to 1.22% of the maximum recommended daily dose of sodium in the diet for adults.

Nootropil 20% also contains benzyl alcohol

The maximum daily dose (24 g of piracetam) contains 0.13 mg of benzyl alcohol, which corresponds to 0.001 mg/ml. Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse reactions (so-called metabolic acidosis).
Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse reactions (so-called metabolic acidosis).

3. How to take Nootropil

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
1,000 mg is equivalent to 1 gram.
1 ml of the 200 mg/ml solution is equivalent to 0.2 grams.
1 ml of the 333 mg/ml solution is equivalent to 0.333 grams.
Treatment of cortical myoclonus
Treatment should start with a dose of 7.2 g of Nootropil per day, increasing every 3 or 4 days by 4.8 g of the medicine per day to a maximum dose of 24 g per day. Nootropil should be taken in divided doses 2 or 3 times a day.
In combination therapy with other anti-myoclonic medicines, the doses of other medicines should be maintained at the recommended therapeutic doses. If clinical improvement is achieved and possible, the doses of other medicines should be reduced.
In patients with myoclonus, the symptoms may evolve over time, and therefore the doctor should attempt to reduce the dose or discontinue the medicine every 6 months. To do this, the dose of piracetam should be reduced by 1.2 g every 2 days to prevent sudden recurrence of the disease.
Treatment of dyslexic disorders in children in combination with speech therapy
In combination with speech therapy in children aged 8 to 13 years: 3.2 g of Nootropil per day in 2 divided doses.
Treatment of dizziness
2.4 g of Nootropil per day in 3 divided doses of 0.8 g for 8 weeks.
The doctor may reduce the dose of piracetam in patients with impaired renal function.

Taking Nootropil in elderly patients

In elderly patients treated with piracetam for a long time, the doctor will individually adjust the dose of the medicine after assessing kidney function.

Taking a higher dose of Nootropil than recommended

If a higher dose of the medicine than recommended is taken, consult your doctor or pharmacist immediately.
Overdose symptoms: one case of bloody diarrhea and abdominal pain has been reported in a patient who overdosed on the medicine. There is no specific antidote in case of piracetam overdose.
Treatment of overdose is symptomatic and may involve hemodialysis, gastric lavage, or induction of vomiting .

Missing a dose of Nootropil

Do not take a double dose to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects reported in clinical trials and after the product was marketed are listed below by frequency of occurrence as follows:
Very common:
more than 1 in 10 people;
Common:
between 1 and 10 in 100 people;
Uncommon:
between 1 and 10 in 1,000 people;
Rare:
between 1 and 10 in 10,000 people;
Very rare:
less than 1 in 10,000 people;
Frequency not known:
cannot be estimated from the available data.
Common

• nervousness
• weight gain
• increased motor activity (hyperkinesia)

Uncommon

• weakness (asthenia)
• depression
• drowsiness

Frequency not known

• bleeding disorders
• anaphylactoid reactions (a type of hypersensitivity reaction to the medicine)
• hypersensitivity
• excitement
• anxiety
• confusion
• hallucinations
• dizziness
• abdominal pain
• epigastric pain
• diarrhea
• nausea
• vomiting
• angioedema
• skin inflammation
• itching
• hives
• coordination disorders (ataxia)
• balance disorders
• seizure exacerbation
• headache
• insomnia You should immediatelyinform your doctor if you experience symptoms such as: skin redness, swelling, hives, shortness of breath, throat swelling, breathing difficulties.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Nootropil

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nootropil contains

Nootropil 20%, 200 mg/ml, oral solution
The active substance of Nootropil is piracetam. 1 ml of the oral solution contains 200 mg of piracetam.
The other ingredients are: glycerol 85%, sodium saccharin, sodium acetate trihydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), apricot flavor 52247 A (contains benzyl alcohol, bergamot oil (debergaptenized), propylene glycol (E 1520), ethanol, linalol), caramel flavor 052929 A7 (contains benzyl alcohol, propylene glycol (E 1520), ethanol, anise oil), glacial acetic acid, purified water.
Nootropil 33%, 333 mg/ml, oral solution
The active substance of Nootropil is piracetam. 1 ml of the oral solution contains 333 mg of piracetam.
The other ingredients are: glycerol 85%, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate trihydrate, glacial acetic acid, purified water.

What Nootropil looks like and contents of the pack

Nootropil 20% oral solution is a clear, colorless to very light brown liquid.
The pack contains a 150 ml or 200 ml bottle of the solution.
Nootropil 33% oral solution is a clear, colorless liquid.
The pack contains a 125 ml or 300 ml bottle of the solution.

Marketing authorization holder and manufacturer

Marketing authorization holder
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium
Manufacturer
NextPharma SAS
Route de Meulan 17
78520 Limay
France
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
UCB Pharma Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
phone: + 48 22 696 99 20

Date of last revision of the leaflet: