Priadel 200mg Prolonged-release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lithium carbonate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N05AN; N05AN01

INN (International Name):

Lithium carbonate

Dosage:

200 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Lithium; lithium

Authorization status:

Marketed

Authorization date:

1988-04-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Priadel 200mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg lithium carbonate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White, scored, capsule-shaped tablets, engraved ‘P200’ on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
In the management of acute manic or hypomanic episodes.
2.
In the management of episodes of recurrent depressive disorders where
treatment with other antidepressants has
been unsuccessful.
3.
In the prophylaxis against bipolar affective disorders.
4.
Control of aggressive behaviour or intentional self harm.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage must
be individualized depending on serum lithium levels and clinical
response.
The dosage necessary to
maintain serum lithium levels within the therapeutic range varies from
patient to patient. The minimum effective dose
should be sought and maintained.
A simple treatment
schedule has been evolved which except
for some minor variations should be followed whether
using Priadel therapeutically or prophylactically.
The minor variations to this schedule depend on the elements of the
illness being treated and these are described later.
1.
In patients of average weight (70kg) an initial dose of 400-1,200mg of
Priadel may be given as a single daily
dose in the morning or on retiring. Alternatively, the dose may be
divided and given morning and evening. The
tablets should not be crushed or chewed.
When changing from other lithium preparations, serum lithium levels
should first be checked, then Priadel therapy started at a daily dose
as close as possible to the dose of the other
form of lithium.
As bioavailability varies from product to product (particularly with
regard to retard or slow
release preparations) a change of product should be regarded as
initiation of new treatment.
2.
Four to a maximum of seven days after starting treatment serum lithium
levels s