NOOTROPIL

8 g every three to four days up to a maximum of 24 g, divided in two or three doses. Treatment with other anti- myoclonic medicinal products should be maintained at the same dosage. Depending on the clinical benefit obtained, the dosage of other such medicinal products should be reduced, if possible.

Once started, treatment with piracetam should be continued for as long as the original cerebral disease persists. In patients with an acute episode, spontaneous evolution may occur over time and an attempt should be made every 6 months to decrease or discontinue the medicinal treatment.

2 g every two days (every three or four days in the case of a Lance and Adams syndrome, in order to prevent the possibility of sudden relapse or withdrawal seizures). Elderly Adjustment of the dose is recommended in elderly patients with compromised renal function (see ’Dosage adjustment in patients with renal impairment’ below).

For long term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed. Patients with renal impairment The daily dose must be individualized according to renal function.

Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. 85 for women) 72 X serum creatinine (mg/dl) Group Creatinine Clearance (ml/min) Posology and frequency Normal > 80 usual daily dose, divided in 2 to 3 doses Mild 50-79 2/3 usual daily dose, divided in 2 or 3 doses Moderate 30-49 1/3 usual daily dose, divided in 2 doses Severe < 30 1/6 usual daily dose, 1 single intake End-stage renal disease -- contraindicated Patients with hepatic impairment No dose adjustment is needed in patients with solely hepatic impairment.

In patients with hepatic impairment and renal impairment, adjustment of dose is recommended (see ’Dosage adjustment in patients with renal impairment’ above). Method of administration Piracetam should be administered orally, and may be taken with or without food.

The tablet(s) should be swallowed with liquid. It is recommended to take the daily dose in two to three sub-doses.

a. Summary of safety profile Double-blind placebo-controlled clinical or pharmacoclinical trials, of which quantified safety data are available (extracted from the UCB Documentation Data Bank on June 1997), included more than 3000 subjects receiving piracetam, regardless of indication, dosage form, daily dosage or population characteristics.

b. Tabulated list of adverse reactions Undesirable effects reported in clinical studies and from post-marketing experience are listed in the following table per System Organ Class and per frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).

Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated. Blood and lymphatic system disorders Not known: haemorrhagic disorder Immune system disorders: Not known: anaphylactoid reaction, hypersensitivity Psychiatric disorders: Common: nervousness Uncommon: depression Not known: agitation, anxiety, confusion, hallucination Nervous system disorders: Common: hyperkinesia Uncommon: somnolence Not known: ataxia, balance impaired, epilepsy aggravated, headache, insomnia, Ear and labyrinth disorders: Not known: vertigo Gastrointestinal disorders: Not known: abdominal pain, abdominal pain upper, diarrhoea, nausea, vomiting Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, dermatitis, pruritus, urticaria General disorders and administration site conditions: Uncommon: asthenia Investigations Common: weight increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

1), caution is recommended in patients with severe haemorrhage, patients at risk of bleeding such as gastrointestinal ulcer, patients with underlying disorders of haemostasis, patients with history of haemorrhagic cerebro-vascular accident (CVA), patients undergoing major surgery including dental surgery, and patients using anticoagulants or platelet antiaggregant drugs including low dose acetylsalicylic acid.

2). 2). Discontinuation Abrupt discontinuation of treatment should be avoided as this may induce myoclonic or generalised seizures in some myoclonic patients. 6 g, that is to say essentially ‘sodium-free’. 6 g it cannot be considered ‘sodium-free’ and it should be taken into consideration by patients on a controlled sodium diet.

At maximum daily dose (24 g) this medicine contains 46 mg of sodium. 3% of the recommended maximum daily dietary intake of sodium for an adult.

1 or other pyrrolidone derivatives. Piracetam is contra-indicated in patients with severe renal impairment (renal creatinine clearance of less than 20 ml per minute). It is also contraindicated in patients with cerebral haemorrhage and in patients suffering from Huntington’s Chorea.