Država: Malta
Jezik: angleščina
Source: Medicines Authority
PIRACETAM
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
N06BX03
PIRACETAM 800 mg
FILM-COATED TABLET
PIRACETAM 800 mg
POM
PSYCHOANALEPTICS
Authorised
2006-11-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NOOTROPIL 800 MG FILM-COATED TABLETS Piracetam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - 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. IN THIS LEAFLET : 1. What Nootropil is and what it is used for 2. What you need to know before you take 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 800mg film-coated tablets is a medicine used to improve the effectiveness of the functions of the brain such as those that play a role in learning, memory, thought and state of consciousness. Nootropil is used: - for the symptomatic improvement of signs of memory or intellectual impairment of a pathological nature in the absence of a diagnosis of dementia. - to reduce myoclonus of cortical origin in some patients. In order to test the sensitivity to piracetam, trial treatment can therefore be instituted for a limited period. - for the treatment of dyslexia children concomitantly with other measures also well adapted to correct these learning difficulties, such as remedial teaching. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOOTROPIL DO NOT TAKE NOOTROPIL - If you are allergic (hypersensitive) to piracetam or other pyrrolidone derivates or any of the other ingredients of Nootropil. - If you have cerebral haemorrhage or End Stage Renal Failure. - If you are suffering from Huntington’s chorea. WARNINGS AND PRECAUTIONS - if you suffer from kidneys problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted. - if you suffer from bleeding p Preberite celoten dokument
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nootropil (piracetam) 800 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 800 mg piracetam For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, oblong, film-coated tablet, with a bisect line, marked N/N 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nootropil is suggested for the symptomatic improvement of memory disorders and intellectual disorders that can be regarded as pathological, in the absence of a diagnosis of dementia. Nootropil may diminish cortical myoclonus in some patients. To test the sensitivity to piracetam, a trial treatment may therefore be undertaken for a limited duration. In children for the treatment of dyslexia, in combination with appropriate measures such as speech therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Symptomatic treatment of memory and / or intellectual disorders Starting treatment: 4.8 g per day in several doses for the first weeks of the treatment; then a maintenance treatment of 2.4 g per day in two or three doses, possibly reducing to 1.2 g per day. Treatment of cortical myoclonus The initial dosage is 24 g of piracetam per 24 hours for 3 days. If there is no or little response by the 3rd day, continue administering 24 g of piracetam until the 7th day. If the response remains zero or insufficient, stop the treatment on the 7th day. From the day when the dose of 24 g is shown to be active, reduce it by 1.2 g every 2 days, until the myoclonus symptoms reappear. This will indicate the average active dose. The dose daily of piracetam will be administered in 2 or 3 doses. Treatment with other anti-myoclonic drugs will be maintained at the same dosage. Then, depending on the clinical benefit obtained, the doses of the other anti-myoclonic drugs will be reduced if possible. Once started, piracetam treatment will have to be continued as long as the pathology of cerebral origin persists. Nevertheless every 6 months red Preberite celoten dokument