DEPIXOL Film-coated tablet Ref.[8628] 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

Depixol 3 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Round, slightly biconvex, ochre, film-coated tablet marked FI.

Qualitative and quantitative composition

Each film-coated tablet contains 3 mg flupentixol (as 3.504 mg flupentixol dihydrochloride).

Excipients with known effect:

Lactose monohydrate

Sunset yellow (E110)

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
Macrogol/PEG 3350
Talc
Iron oxide yellow (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Sunset yellow (E110)
Macrogol/PEG 6000

Pack sizes and marketing

White, High Density Polyethylene (HDPE) tablet container with a child-resistant closure and tamper-evident seal; 100 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0458/0013R

Date of First Authorisation in the UK: 29 January 1987
Renewal of the Authorisation: 09 November 2010

Drugs

Drug Countries
DEPIXOL Ireland, Malta, New Zealand, United Kingdom

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