COMPOSITION :

Each 5 ml syrup contains : Piracetam Eur.P. 1 gm

Each capsule contains : Piracetam Eur.P. 400 mg

Each tablet contains : Piracetam Eur.P. 800 mg.

DESCRIPTION :

Novacetam (Piracetam) is a nootropic agent which acts on the brain to improve the telencephalon which is involved in cognition

and plays a role in learning, memory and alertness. Piracetam acts by modifying neurotransmission within the brain by improving

the metabolic environment essential for good neuronal function and by improving the microcirculation. Piracetam is rapidly

absorbed from the GIT with almost 100% bioavailability. Peak blood levels of 40 - 60 mcg/ml are attained after 30 minutes

following a single oral dose of 2 gm. In the cerebrospinal fluid (CSF) the peak concentration is achieved 2 - 8 hrs post dosage.

Piracetam is concentrated in the cerebral cortex, in the frontal, parietal and occipital lobes. Piracetam is not metabolized and is

excreted unchanged. The plasma half life is achieved 4 - 5 hrs while the half life in CSF is 6 - 8 hrs.

INDICATIONS :

Novacetam is indicated in :

- Improvement of loss of memory, vertigo, lack of concentration or alertness. Changes of mood, deterioration in behavior and

personal negligence in elderly people.

- Treatment of sickle cell anaemia.

- Treatment of chronic alcoholism.

- Treatment of cognitive deficit as a result of head injury.

- Improvement of learning difficulties associated with written word in children.

DOSAGE & ADMINISTRATION :

Adults :

Psycho-organic syndrome : 1.2 - 2.4 gm daily with a loading dose as high as 4.8 gm/day for the first few weeks. The dose is

administered twice daily.

Sickle cell anaemia : 160 mg/kg/day divided in four equal doses.

Alcoholism : During the initial withdrawal period up to 12 gm daily : maintenance 2.4 gm daily. The dose is administered twice

daily.

Cognitive deficits : Initially 9 - 12 gm daily : maintenance 2 - 4 gm daily for not less than 3 weeks.

Children (8 - 13 years) :

Learning difficulties : 3.3 gm daily (8 ml of Novacetam syrup twice a day before breakfast and before evening meal).

RESTRICTIONS ON USE :

Contraindications

- Severe renal impairment.

Precautions

- Piracetam should not be prescribed to pregnant women and nursing mothers except under exceptional conditions.

- Administer with care in renal impairment.

DRUG INTERACTIONS :

Concomitant administration of Piracetam with thyroid extract may result in confusion, irritability and sleep disturbances.

ADVERSE EFFECTS :

- Nervousness, agitation, irritability, anxiety and sleep disturbances may occur at a rate of 5% or less especially in eldrly patients at

doses more than 2.4 gm daily. However, In the majority of cases these symptoms disappear with dose reducation.

- Nausea, vomiting, diarrhea and stomach ache may occur at a rate of 2% or less.

- Other symptoms may include vertigo, headache and sexual stimulation.

STORAGE INSTRUCTIONS :

- Store between 15 - 25°C. Protect from light.

PRESENTATIONS :

Novacetam Syrup : Bottle of 100 ml.

Novacetam Capsules : Blister pack of 60 capsules and hospital packs of different sizes.

Novacetam Tablets : Blister pack of 30 tablets and hospital packs of different sizes.

** Other presentations may be also available in some countries