SERENACE Tablet Ref.[50297] Active ingredients: Haloperidol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2017  Publisher: Norton Healthcare Ltd, T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Product name and form

Serenace 5 mg Tablets.

Pharmaceutical Form

Tablet.

Bright pink biconvex tablet coded ‘Norton 5’ on one face, ‘SERENACE’ on the other.

Qualitative and quantitative composition

Each tablet contains haloperidol 5 mg.

Excipients: Each tablet contains 120mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Haloperidol

Haloperidol is an antipsychotic belonging to the butyrophenones group. It is a potent central dopamine type 2 receptor antagonist, and at recommended doses, has low alpha-1 antiadrenergic activity and no antihistaminergic or anticholinergic activity.

List of Excipients

Lactose monohydrate
Maize starch
Pregelatinised starch
Magnesium stearate
Erythrosine Lake (E127)

Pack sizes and marketing

PVC/Aluminium blisters in packs of 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Norton Healthcare Ltd, T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Marketing authorization dates and numbers

PA 0282/063/006

Date of first authorisation: 17 February 1977
Date of last renewal: 17 December 2006

Drugs

Drug Countries
SERENACE Australia, Japan, New Zealand, South Africa

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