Priadel 200mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lithium carbonate

Available from:

Essential Pharma M

ATC code:

N05AN01

INN (International Name):

Lithium carbonate

Dosage:

200mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04020300; GTIN: 5000283642206

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
PRIADEL
200MG
AND
400MG
PROLONGED RELEASE TABLETS
lithium carbonate
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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 Tablets are and what they are used for
2.
What you need to know before you take Priadel
Tablets
3.
How to take Priadel Tablets
4.
Possible side effects
5.
How to store Priadel Tablets
6.
Contents of the pack and other information
1. WHAT PRIADEL TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Priadel 200mg or
Priadel 400mg Prolonged Release Tablets (called
Priadel Tablets in this leaflet). Priadel Tablets
contain a medicine called lithium. 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 Tablets 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 TABLETS
DO NOT TAKE PRIADEL TABLETS IF:
× You are allergic (hypersensitive) to lithium
carbonate or any of the other ingredients of
Priadel Tablets (see Section

Summary of Product characteristics

OBJECT 1
PRIADEL 200MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 01-Feb-2018 | SANOFI
1. Name of the medicinal product
Priadel 200mg prolonged release tablets.
2. Qualitative and quantitative composition
Each tablet contains 200mg of the active substance lithium carbonate.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablet
White, scored, capsule-shaped tablets engraved P200 on one side, in a
prolonged release formulation.
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 individualised 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.
As a general rule, the following dosing schedule is recommended.
Please refer also to the specific
recommendations for the different indications as listed below:
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
between 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
lithiu