Priadel 200mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lithium carbonate

Available from:

Essential Pharma Limited

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:

2007-11-23

Patient Information leaflet

Pri200mg400mgTab-PL-IE-8
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIADEL 200 MG AND 400 MG PROLONGED-RELEASE TABLETS
lithium carbonate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Priadel is and what it is used for
2.
What you need to know before you take Priadel
3.
How to take Priadel
4.
Possible side effects
5.
How to store Priadel
6.
Contents of the pack and other information
1.
WHAT PRIADEL IS AND WHAT IT IS USED FOR
The name of your medicine is Priadel 200 mg or Priadel 400 mg
prolonged-release tablets (called
Priadel in this leaflet). Priadel contains a medicine called lithium
carbonate. This belongs to a group of
medicines called mood stabilisers. It works by stabilising the levels
of chemicals in your brain that
affect your mood.
Priadel can be used to manage or control:
-
Mania (feeling highly excited, being over-active and easily irritated
or distracted);
-
Hypo-mania (similar to mania, but less severe);
-
Repeated periods of depression, where treatment with other medicines
has not worked;
-
Aggressive or self-harming behaviour.
It is also used to help prevent bipolar depression - where the mood
changes between feeling very high
(mania) and very low (depression).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIADEL
DO NOT TAKE PRIADEL
-
if you are allergic to lithium carbonate or any of the other
ingredients of this medicine (listed in
section 6). Signs of an allergic reaction include: a rash, swallowing
or breathing problems,
swelling of your lips, face, throat or tongue;
-
if yo

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2022
CRN00D502
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Priadel 200mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 200 mg lithium carbonate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White, capsule-shaped, bi-convex tablets engraved ‘P200’ on one
side and a score line on the other 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 s