Priadel

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lithium carbonate 200mg

Available from:

W M Bamford & Co Ltd

INN (International Name):

Lithium carbonate 200 mg

Dosage:

200 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Lithium carbonate 200mg Excipient: Acacia Glyceryl palmito-stearate Magnesium stearate Maize starch Mannitol Sodium laurilsulfate Sodium starch glycolate

Units in package:

Bottle, plastic, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Chemetall GmbH

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1994-12-12

Patient Information leaflet

CONSUMER MEDICINE
INFORMATION
PRIADEL
®
400 MG PROLONGED RELEASE TABLETS
LITHIUM CARBONATE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PRIADEL. It does not
contain all the available
information. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking PRIADEL
against the benefits he/she expects it will have for you. If you have
any concerns about taking this
medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT PRIADEL IS USED FOR
PRIADEL is used for the treatment of mania and hypomania, recurrent
bipolar depression, and
prophylactic treatment of recurrent affective disorders. Lithium
carbonate provides a source of lithium,
which competes with sodium at various sites in the body.
BEFORE YOU TAKE PRIADEL
Do not take PRIADEL if:
•
you have an allergy to PRIADEL or any of the ingredients listed at the
end of this leaflet
•
you have problems passing urine or have an impairment of kidney
function
•
you have an impairment of heart function
•
you are on a low sodium diet or have a condition associated with low
sodium levels, such as
Addison’s disease
•
You are breastfeeding.
Tell your doctor if:
•
you have any other medical conditions
•
you are taking lithium in any other form
•
you are pregnant, or intend to become pregnant or to breastfeed.
Lithium may be harmful to the
foetus and newborn baby, so PRIADEL should not be used during
pregnancy unless considered
essential. Lithium is secreted into breast milk, so PRIADEL should not
be used during
breastfeeding.
Your doctor might arrange for blood tests and other health checks to
be carried out prior to and during
treatment with PRIADEL.
Treatment with PRIADEL tablets requires regular monitoring of serum
lithium levels. Your doctor will
arrange for the necessary blood tests to be carried out. Frequent
blood tests are required at the start
of treatment. The period between

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
PRIADEL PROLONGED RELEASE TABLETS 400 MG
Priadel prolonged release tablets 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg lithium carbonate.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release tablets.
White circular, bi-convex tablets engraved PRIADEL on one side, scored
on the other side. Each tablet
contains 400 mg Lithium Carbonate Ph Eur in a controlled release
dosage form.
PRIADEL tablets are scored; therefore they can be divided accurately
to provide dosage adjustments of 200
mg.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
Treatment of mania and hypomania.
2.
Lithium may also be tried in the treatment of some patients with
recurrent bipolar depression, for
which treatment with other antidepressants has been unsuccessful.
3.
Prophylactic treatment of recurrent affective disorders.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
_DOSE _
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 (70 kg) an initial dose of 1-3 tablets
(400-1,200 mg) 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. PRIADEL tablets should be taken with
food, as this causes less
nausea than on an empty stomach. The tablets should not be crushed,
chewed or swallowed with
hot liquids. When changing from other lithium preparations, serum
lithium levels should first be
checked, then PRIADEL therapy commenced 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 five day