1. WHAT NOOTROPIL IS AND WHAT IT IS USES
Nootropil belongs to the group of nootropic drugs and does not have a calming or psychostimulant effect. Nootropil improves and restores cognitive abilities after various brain injuries such as hypoxia (lack of oxygen), intoxication (poisoning) and others. in case of vascular dementia (forgetfulness due to vascular damage).
Nootropil is used in:
Symptomatic treatment of psycho-organic syndrome with the following manifestations: impaired memory and attention, lack of motivation;
Treatment of cortical myoclonus (sudden involuntary muscle contractions), alone or in combination;
Treatment of vertigo (dizziness and tinnitus) and related imbalances, with the exception of dizziness of vasomotor or mental origin;
For prevention and remission of sickle cell vaso-occlusive crisis.
Treatment of dyslexia (reading disorders) in combination with appropriate measures, such as speech therapy;
For prevention and remission of sickle cell vaso-occlusive crisis.
2. BEFORE YOU TAKE NOOTROPIL
Do not take Nootropil:
If you are allergic (hypersensitive) to piracetam or any of the other ingredients of Nootropil;
In case of cerebral hemorrhage;
If you have severe kidney failure;
If you have Huntinggon's chorea.
Take special care with Nootropil:
If you have kidney problems, you may need to reduce the dose depending on their severity. Your doctor will decide if the dosage needs to be adjusted;
Abrupt discontinuation of treatment should be avoided in patients with myoclonus, as this may cause myoclonic or generalized seizures.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In a single case of concomitant treatment with thyroid extract (T 3 + T 4 ), confusion, irritability and sleep disturbances have been reported. No other interactions with other drugs are known at this time.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Nootropil should not be used during pregnancy unless clearly necessary. There are no adequate data from the use of piracetam in pregnant women.
Piracetam is excreted in human breast milk. Do not use piracetam during breast-feeding or breast-feeding should be discontinued while taking piracetam.
Driving and using machines
Nootropil may affect your ability to drive and use machines as a result of some of the side effects that should be taken into account.
Use in children
Nootropil is used in children in dosages and duration prescribed by your doctor. For children, it is appropriate to use the oral solution provided with a measuring cup.
Use in the elderly
It is recommended that elderly patients visit their doctor regularly to monitor the dose.
Important information about excipients
Nootropil 20% oral solution contains the excipients glycerol, methyl parahydroxybenzoate and propyl parahydroxybenzoate. Glycerol is harmful in high doses because it can cause headaches, upset stomach and diarrhea. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (probably of the delayed type);
Nootropil 2400 mg granules for oral solution contains the excipients mannitol (E421) and aspartame (E951). Mannitol may have a mild laxative effect at a dose of 6.5 g or more of piracetam daily. Aspartame contains a source of phenylalanine equivalent to 50 mg for a dose of 2.4 g piracetam. This may be harmful to patients with phenylketonuria.
3. HOW TO TAKE NOOTROPIL
Always take Nootropil exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. Nootropil can be taken with or without food.
The usual dose is:
Symptomatic treatment of psycho-organic syndromes (deterioration of mental activity):
Treatment begins with daily doses of 4.8 g piracetam for the first few weeks, then reduced to 2.4 g daily. These doses should be divided into 2-3 doses.
Treatment of myoclonus (sudden involuntary muscle contractions) of cortical origin:
The daily dose should be started at 7.2 g, and increased by 4.8 g every three or four days to a maximum of 24 g divided into two or three doses. Treatment with other antimyoclonic drugs should be maintained at the same dose. Depending on the clinical result achieved, if possible, the dosage of other similar drugs should be reduced.
Once started, piracetam treatment should be continued for as long as the initial cerebral disease continues.
However, every 6 months, attempts should be made to reduce the dose or stop treatment. Caution, patients with kidney problems should take lower doses (see Take special care with Nootropil). The duration of treatment depends on the nature of your illness and the response to your complaints. If you have the impression that the effect of Nootropil is too strong or too weak, talk to your doctor or pharmacist.
Treatment of vertigo: The
recommended daily dose varies from 2.4 g to 4.8 g, divided into two or three doses.
For the prevention and remission of sickle cell vaso-occlusive crisis: The
recommended daily prophylactic dose is 160 mg / kg orally, divided into four doses.
The recommended daily dose for remission is 300 mg / kg, intravenously, divided into four doses (injectable and infusion forms are used).
A dose lower than 160 mg / kg or irregular intake may lead to a resumption of the crisis.
Piracetam can be used in children over 3 years of age suffering from sickle cell anemia at the recommended daily dose (mg / kg). Piracetam is used in a limited number of children from 1 to 3 years.
Treatment of dyslexia in combination with speech therapy in children aged 8-13 years:
In children aged 8 years and adolescents, the recommended daily dose is about 3.2 g, divided into two doses.
tablets are swallowed with liquid. The granules are dissolved in liquid before use. It is recommended to take the daily dose in two to four doses.
Duration of treatment
You should take Nootropil for as long as your doctor advised. In the treatment of chronic diseases, the optimal effect is usually achieved after 6 to 12 weeks.
If you take more Nootropil than you should
Tell your doctor if you take more tablets than you need.
If you forget to take Nootropil
Do not take a double dose to make up for a forgotten dose. Continue to take Nootropil as your doctor has told you.
If you stop taking Nootropil
To prevent recurrence of symptoms, Nootropil should be stopped gradually - with 1.2 g of piracetam every 2 days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nootropil can cause side effects, although not everybody gets them.
Tell your doctor if you experience any of these reactions that are of concern to you:
Common (> 1% -10%) side effects reported with Nootropil are:
nervous system disorders: hyperkinesia (increased activity);
metabolic and eating disorders: weight gain;
mental disorders: nervousness.
Rare (> 0.1%,
mental disorders: somnolence (drowsiness), depression;
general disorders: asthenia (weakness);
In adult patients, adverse reactions in controlled trials were less than 2% and mainly occurred at a daily dose of more than 2.4 g piracetam. In most cases, these symptoms disappear when the dose is reduced.
Ear and labyrinth disorders: vertigo (feeling dizzy);
Gastrointestinal disorders: abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting;
Immune system disorders: anaphylactoid reaction, hypersensitivity;
Nervous system disorders: ataxia (lack of coordination of movements), balance disorders, worsening of epilepsy, headache, insomnia, drowsiness;
Mental disorders: agitation, anxiety, confusion, hallucinations;
Skin and subcutaneous tissue disorders: angioneurotic edema, dermatitis, pruritus, urticaria.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE NOOTROPIL
Keep out of the reach and sight of children.
No special storage conditions required.
Nootropil 20% oral solution has a shelf life after first opening: 1 month at room temperature.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
6. FURTHER INFORMATION
contains The active substance is piracetam.
The other ingredients are:
Nootropil 800 mg and Nootropil 1200 mg film-coated tablets:
Tablet core: Macrogol 6000, silica, colloidal anhydrous, magnesium stearate, croscarmellose sodium.
Film coating: hydroxypropylmethylcellulose, titanium dioxide (E171), macrogol 400 and macrogol 6000.
Nootropil 2400 mg granules for oral solution
Mannitol, aspartame, citric acid, anhydrous, orange and lemon flavors.
Nootropil 20% oral solution
Glycerol, saccharin sodium, methyl parahydroxybenzoate, propyl parahydroxybenzoate, flavors caramel and peach, glacial acetic acid, purified water.
What Nootropil looks like and contents of the pack
Nootropil 800 mg film-coated tabletsare white, oblong, film-coated tablets marked with N / N.
Nootropil 800 mg film-coated tablets are packed in PVC / aluminum blisters and placed in cartons of 30, 60 and 100 film-coated tablets.
Nootropil 1200 mg film-coated tablets are white, oblong, scored film-coated tablets marked with N / N.
Nootropil 1200 mg film-coated tablets are packed in PVC / aluminum blisters and placed in cartons of 20, 30, 60 and 100 film-coated tablets.
Nootropil 2400 mg granules for oral solution are cream-colored granules.
Nootropil 2400 mg granules for oral solution is packed in paper / polyethylene / aluminum / surlin sachets placed in cartons of 10, 20, 30, 50, 60 and 100 sachets.
Nootropil 20% oral solution is a clear, colorless solution.
Nootropil 20% oral solution is packaged in dark glass bottles, closed with a polyethylene seal-controlled cap and placed in cardboard boxes.
Each carton contains one bottle of 125 ml oral solution and a graduated measuring cup.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
UCB Pharma SA, Belgium.
Manufacturer of Nootropil 800 mg and Nootropil 1200 mg film-coated tablets:
UCB Pharma SA, Belgium.
Manufacturer of Nootropil 20% oral solution:
NextPharma SAS, France.
Manufacturer of Nootropil 2400 mg granules for oral solution:
UCB Pharma SA, Belgium;
Allphamed Pharbil Arzneimittel GmbH, Germany.