CLOPIXOL Film-coated tablet Ref.[8461] Active ingredients: Zuclopenthixol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Lundbeck Limited, Iveco House,, Station Road, Watford, Hertfordshire, WD17 1ET, United Kingdom

Product name and form

Clopixol 2 mg film-coated tablets.

Clopixol 10 mg film-coated tablets.

Clopixol 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

2 mg: Round, biconvex, pale red, film-coated tablet.

10 mg: Round, biconvex, light red-brown, film-coated tablet.

25 mg: Round, biconvex, red-brown, film-coated tablet.

Qualitative and quantitative composition

2 mg film-coated tablets: Each tablet contains 2 mg zuclopenthixol (as dihydrochloride).

10 mg film-coated tablets: Each tablet contains 10 mg zuclopenthixol (as dihydrochloride).

25 mg film-coated tablets: Each tablet contains 25 mg zuclopenthixol (as dihydrochloride).

Excipients with known effect:

Lactose monohydrate

Hydrogenated castor oil

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zuclopenthixol

Zuclopenthixol is a potent neuroleptic of the thioxanthene series with a piperazine side-chain. The antipsychotic effect of neuroleptics is related to their dopamine receptor blocking effect.

List of Excipients

Potato starch
Lactose
Microcrystalline cellulose
Copolyvidone
Glycerol
Talc
Castor oil hydrogenated
Magnesium stearate
Methylhydroxypropyl cellulose
Macrogol
Titanium dioxide (E171)
Red iron oxide (E172)

Pack sizes and marketing

Grey polypropylene container (with desiccant capsule for 2 mg strength)

or

Glass bottle

or

White HDPE container with LDPE twist-off cap including desiccant

Pack size: 100 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

2 mg tablets: PL 00458/0027
10 mg tablets: PL 00458/0028
25 mg tablets: PL 00458/0029

Date of First Authorisation in the UK: 17 March 1982
Renewal of the Authorisation: 3 July 2008

Drugs

Drug Countries
CLOPIXOL Australia, Brazil, Canada, Cyprus, Germany, Spain, France, Hong Kong, Ireland, Israel, Malta, Mexico, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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