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Logo NOOTROPIL CAPSULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form):

NOOTROPIL CAPSULES

COMPOSITION:
Each NOOTROPIL capsule contains 400 mg
piracetam.

PHARMACOLOGICAL CLASSIFICATION:
A.1.1 Central Analeptics.

PHARMACOLOGICAL ACTION:
An effect on metabolism has been shown in man indicating improved oxygen utilisation. Nootropil has a low toxicity and has no stimulating, sedative or neurovegitative activities.

INDICATIONS:
Nootropil has been used with varying effect in the following conditions and could influence them favourably, although no convincing proof of efficacy has been submitted.
1. Involutional syndromes related to ageing.
2. Chronic alcoholism.

CONTRA-INDICATIONS:
Nootropil has not been found to have any contra-indications to date.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
the average dosage shall be as follows:
2 x 400 mg capsules three times daily. This initial dosage should be carried on for 3 to 8 weeks before the dosage is gradually reduced to 1 capsule three times daily.
Children: half the adult dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
There are no metabolites and no accumulation and the LD/50 is above 10 g/kg.

IDENTIFICATION:
Opaque orange and white coloured capsule with 'NOOTROPIL' imprinted thereon.

PRESENTATION:
Containers of 60 and 240 capsules of 400 mg each.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from moisture.
Keep all medicines out of the reach of children.

REGISTRATION NUMBER:
F/1.1/184

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
UCB S.A. (Pty) Limited
3rd Floor, Park Terras,
33 Princess of Wales Terrace,
Parktown, Johannesburg.
Postal Address:
P.O. Box 31036, Braamfontein, 2071

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15.9.76                G228A

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