IBUPROFEN 400mg Film-coated tablet Ref.[7559] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Ibuprofen 400 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Ibuprofen 400 mg film-coated tablets: pink coloured, round, approximately 13 mm in diameter, biconvex film coated tablets debossed with ‘DK’ on one side and plain on other side.

Qualitative and quantitative composition

Each film-coated tablet contains 400 mg ibuprofen.

Excipient with known effect: each tablet contains 47 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Tablet Core:

Lactose monohydrate
Maize starch
Croscarmellose sodium
Colloidal anhydrous Silica
Microcrystalline cellulose
Magnesium stearate

Tablet Coating:

Hypromellose
Triacetin
Titanium dioxide (E171)
Erythrosine aluminum lake (E127)

Pack sizes and marketing

PVC – Aluminium blisters or PVC/PVdC – Aluminium Blisters

Pack sizes: 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 48, 50, 60, 84, 100 or 500 film-coated tablets in carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0436

05/08/2016

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