COMPOSITION

Each film-coated tablet contains:

Active ingredient:

Piracetam ..................................................................... 800 mg.

Inactive ingredients:

Colloidal silicon dioxide, polyethylene glycol 6000, microcrystalline cellulose 102, magnesium stearate, Opadry II white.

Opadry II white ingredients: Polyvinyl alcohol-parted hydrolyzed, titanium dioxide, macrogol 4000, talc.

Piracetam 800 mg is indicated in adult patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies.

Posology

The daily dosage should begin at 7.2 g increasing by 4.8 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. This should be done by reducing the dose of piracetam by 1.2 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).

Special populations

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.

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. The Clcr in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula:

EN

Group Creatinine clearance (ml/min) Dosage and frequency
Normal > 80 Usual daily dose, divided in 2 to 3 doses
Mild 50 - 79 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

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).

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.

CONTRAINDICATIONS

Hypersensitivity to piracetam or to any of the excipients, 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.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Effects on platelet aggregation

Due to the effect of piracetam on platelet aggregation (see PHARMACODYNAMIC PROPERTIES), 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.

Renal insufficiency

Piracetam is eliminated via the kidneys and care should thus be taken in cases of renal insufficiency (see POSOLOGY AND ADMINISTRATION).

Elderly

For long-term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed (see POSOLOGY AND ADMINISTRATION).

Discontinuation

Abrupt discontinuation of treatment should be avoided as this may induce myoclonic or generalised seizures in some myoclonic patients.

PREGNANT AND BREAST-FEEDING WOMEN

Pregnancy

There are no adequate data from the use of piracetam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or post-natal development (see PRECLINICAL SAFETY DATA).

Piracetam crosses the placental barrier. Drug levels in the newborn are approximately 70% to 90% of maternal levels. Piracetam should not be used during pregnancy unless clearly necessary, when benefit exceeds the risks and the clinical condition of the pregnant mother requires treatment with piracetam.

Breast-feeding

Piracetam is excreted in human breast milk. Therefore, piracetam should not be used during breastfeeding or breastfeeding should be discontinued, while receiving treatment with piracetam. A decision must be made whether to discontinue breast-feeding or to discontinue piracetam therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no available clinical data on the effect of piracetam on fertility. Animal studies indicate that piracetam has no effect on fertility in male or female rats.

EFFECTS ON ABILITY TO DRIVE, USE MACHINES

In clinical studies, at dosages between 1.6 - 15 grams per day, hyperkinesia, somnolence, nervousness and depression were reported more frequently in patients on piracetam than on placebo. There is no experience on driving ability in dosages between 15 and 20 grams daily. Caution should therefore be exercised by patients intending to drive or use machinery whilst taking piracetam.

Box of 10 blisters of 10 film coated tablets (Alu - PVC/PVDC).

STORAGE CONDITIONON: Keep in dry place at a temperature not exceeding 30ºC.

SHELF LIFE: 36 months from manufacturing date.

SPECIFICATION: In-house.