PRIADEL Prolonged-release tablet Ref.[27675] Active ingredients: Lithium

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Essential Pharma Limited, Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara, CBD 1070, Malta

Product name and form

Priadel 400mg Prolonged-release Tablets.

Pharmaceutical Form

Prolonged-release tablet.

White, circular, bi-convex tablets engraved PRIADEL on one side and a scoreline on the other.

The tablets can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 400 mg lithium carbonate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Lithium

Little is known about the way the lithium ion can modify neurotransmission within the CNS. Many of the proposed mechanisms have suggested an inhibitory effect on components of various neurotransmitter signalling pathways, such as cyclic AMP formation, cyclic GMP formation, G-proteins or inositol phosphate metabolism.
List of Excipients

Glycerol distearate
Mannitol (E421)
Acacia powder
Sodium laurilsulfate
Magnesium stearate
Maize starch
Sodium starch glycolate Type A

Pack sizes and marketing

Polypropylene tablet containers of 100 and 1000 tablets with a snap on low density polyethylene lid.

PVC/PVdC/aluminium blister strips, each strip containing 10 tablets. Ten strips are packed in a cardboard outer.

Hospital packs of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Essential Pharma Limited, Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara, CBD 1070, Malta

Marketing authorization dates and numbers

PA22587/001/002

Date of first authorisation: 01 April 1978
Date of last renewal: 01 August 2009

Drugs

Drug Countries
PRIADEL Ireland, Netherlands, New Zealand, United Kingdom
 
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