1200 mg film-coated tablet
piracetam
What Nootropil is and what it is used for
Nootropil belongs to a group of medicines called GABA analogs.
Nootropil contains the active substance piracetam.
Nootropil tablets are used to treat muscle twitching (myoclonus) in adults.
The exact mechanism of action in the treatment of muscle twitching is not known.
The drug has several effects on the central nervous system.
Piracetam in Nootropil can be used to treat diseases other than those mentioned in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional and always follow their instructions.
What you need to know before you use Nootropil
Do not use Nootropil
- if you are allergic to piracetam, other pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6)
- if you have a history of cerebral haemorrhage
- if you have end-stage renal disease
- if you suffer from Huntington’s Korea
Take special care with Nootropil
Talk to your doctor or pharmacist before using Nootropil if you
- is older
- have a kidney disease
- have problems with blood coagulation or heavy bleeding
- stands on a low-salt diet
- will undergo surgical operations
If any of the above apply to you, talk to your doctor before starting treatment.
Nootropil with food and drink
You can use Nootropil with or without food. Concomitant consumption of alcohol has not shown any effect on the effect of Nootropil, but you should still avoid alcohol when using Nootropil.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience of use during pregnancy. As a precautionary measure, the use of Nootropil during pregnancy should be avoided.
The drug passes into breast milk. The doctor must decide whether it is best to stop breastfeeding or to refrain from treatment with Nootropil by evaluating the benefit of breastfeeding for the baby and the benefit of treatment for the woman.
Driving and using machines
Because the sensitivity is different for different individuals, some patients may experience slight drowsiness and other symptoms that may affect their ability to concentrate at the beginning of treatment or when increasing the dose. Therefore, caution is recommended in these patients when driving or handling machines, for example.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nootropil contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. When the dose exceeds 10 tablets per day, this medicine can not be considered “sodium-free”. This medicine contains 43.8 mg of sodium per maximum daily dose (20 tablets [24 g]). This corresponds to 2.19% of the highest recommended daily intake of sodium for adults.
How to use Nootropil
Always use Nootropil exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The doctor determines the dose individually for the patient. Follow the doctor’s instructions even when the dose is changed for any reason.
Does one usually starts with 7.2 grams of piracetam per day (6 tablets). The daily dose can be increased by 4.8 grams of piracetam every three days (4 tablets). The maximum daily dose is 24 grams (20 tablets). The daily dose is divided into 2-3 occasions.
The tablets are taken with a glass of water and should not be chewed or crushed. The tablets can be taken with or without food.
If you use more Nootropil than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital,for risk assessment and advice. Take the package with you.
The symptoms of an overdose are the same as the side effects but worse. The most common symptoms are diarrhea, insomnia, nervousness, and depression.
If you forget to use Nootropil
Do not take a double dose to make up for a forgotten tablet and continue treatment by taking the next tablet as usual.
If you stop using Nootropil
Sudden discontinuation of treatment should be avoided as this may cause seizures.
When treatment is to be stopped or dose one is reduced, dose one should be gradually reduced by 1.2 grams (1 tablet) every other day, to prevent the onset of seizures.
Always talk to your doctor before stopping taking the tablets or changing the dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions have been reported during controlled clinical trials and after approval:
- Common (may affect up to 1 in 10 people): Weight gain, abnormally large or unhealthy movement activity, nervousness
- Uncommon (may affect up to 1 in 100 people): Depression, drowsiness, weakness.
- Has been reported (occurs in an unknown number of users): Bleeding, abdominal pain, diarrhea, nausea, vomiting, allergic reactions and other hypersensitivity reactions , impaired coordination of movements, impaired balance, worsening of epilepsy , headache, insomnia, dizziness, agitation, anxiety, confusion, hallucinations, rash, itching , hives, swelling of the face, lips, tongue and throat possibly with difficulty breathing.
How to store Nootropil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is piracetam. Each tablet contains 1200 mg piracetam.
- The other ingredients are macrogol 6000 and 400, colloidal anhydrous silica, magnesium stearate, croscarmellose sodium, hypromellose and titanium dioxide (E171). For more information on some of the ingredients, see section 2 “Nootropil contains sodium”.
What the medicine looks like and contents of the pack
The film-coated tablets are white and oval, with a notch.
Print packs of 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
UCB Nordic A / S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Manufacturer
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium