XEFO Film-coated tablets Ref.[7304] Active ingredients: Lornoxicam

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS HP10 0DF, United Kingdom

Product name and form

Xefo 4 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to yellowish oblong film-coated tablet with imprint “L04”.

Qualitative and quantitative composition

One film-coated tablet contains 4 mg lornoxicam.

Excipients: 94 mg Lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Lornoxicam

Lornoxicam is a non-steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams. Lornoxicams mode of action is mainly related to the inhibition of the prostaglandin synthesis (inhibition of the cyclooxygenase enzyme) leading to desensitisation of peripheral nociceptors and consequently inhibition of inflammation. A central effect on nociception, which seems to be independent of anti-inflammatory effects has also been suggested.

List of Excipients

Core:

Lactose monohydrate
Cellulose, microcrystalline
Povidone K 30
Croscarmellose sodium
Magnesium stearate

Film:

Macrogol
Titanium dioxide (E171)
Talc
Hypromellose

Pack sizes and marketing

Blister: Opaque PVC/Aluminium. Each blister strip contains 10 film-coated tablets.

Pack sizes: 10, 20, 30, 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS HP10 0DF, United Kingdom

Marketing authorization dates and numbers

PA 1547/005/001

Date of First Authorisation: 22 May 2009

Date of last renewal: 17 January 2011

Drugs

Drug Countries
XEFO Austria, Brazil, Estonia, Israel, Lithuania, Poland, Romania, Turkey, South Africa

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