FLUANXOL Film-coated tablet Ref.[27514] Active ingredients: Flupentixol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK

Product name and form

Fluanxol 0.5 mg film-coated tablets.

Fluanxol 1 mg film-coated tablets.

Pharmaceutical Form

0.5 mg Film-coated tablet: Round, slightly biconvex, yellow, film-coated tablet marked FD.

1 mg Film-coated tablet: Oval, slightly biconvex, yellow, film-coated tablet marked FF.

Qualitative and quantitative composition

Each 0.5 mg film-coated tablet contains 0.5 mg flupentixol (as 0.5840 mg flupentixol dihydrochloride).

Each 1 mg film-coated tablet contains 1 mg flupentixol (as 1.168 mg flupentixol dihydrochloride).

Excipients with known effect: Lactose monohydrate.

For the full list of excipients, see section 6.1

Active Ingredient Description
Flupentixol
List of Excipients

Tablet core:

Betadex
Lactose monohydrate
Maize starch
Hydroxypropylcellulose
Microcrystalline cellulose
Croscarmellose sodium
Talc
Vegetable oil, hydrogenated
Magnesium stearate

Coating and colour:

Polyvinyl alcohol, partly hydrolyzed
Titanium dioxide (E171)
Macrogol/PEG 3350
Talc
Iron oxide yellow (E172)
Macrogol/PEG6000

Pack sizes and marketing

PVC/PE/PVdC/Aluminium blister, pack with an outer carton; 60 tablets.

Marketing authorization holder

Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK

Marketing authorization dates and numbers

Fluanxol 0.5 mg film-coated tablets: PL 00458/0011R
Fluanxol 1 mg film-coated tablets: PL 00458/0037

Date of First Authorisation in the UK:

Fluanxol 0.5 mg film-coated tablets: 25 November 1982
Fluanxol 1 mg film-coated tablets: 23 September 1982

Renewal of the Authorisation:

Fluanxol 0.5 mg film-coated tablets: 9 November 2010
Fluanxol 1 mg film-coated tablets: 9 November 2010

Drugs

Drug Countries
FLUANXOL Austria, Canada, Germany, Estonia, Finland, France, Lithuania, Malta, Mexico, Netherlands, Poland, Turkey, United Kingdom, South Africa
 
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