EMFLEX Capsule

Active ingredients: Acemetacin

Product name and form

Emflex Capsules.

Pharmaceutical Form

Gelatine capsule.

Qualitative and quantitative composition

Each capsule contains acemetacin 60mg.

Excipients: Each capsule contains 73.9mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Acemetacin is a glycolic acid ester of indomethacin and the pharmacological activity resulting from acemetacin administration in man is derived from the presence of both acemetacin and indomethacin. The precise pharmacological mode of action of acemetacin is not known. However, unlike other NSAIDs, acemetacin is only a relatively weak inhibitor of prostaglandin synthetase.

List of Excipients

Gelatine capsule (colourings: Ferric oxide red E172, Ferric oxide yellow E172 and titanium dioxide E171)
Lactose
Magnesium stearate
Silicon dioxide
Talc
sodium dodecylsulphate

Pack sizes and marketing

White polypropylene bottles with polypropylene screw caps.

Pack sizes: 90, 56, 60 and 30 capsules.

PVC/PVDC foil blister packs in cartons:

Pack sizes: 90, 60, 56, 30, 10, and 6 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK

Marketing authorization dates and numbers

PL 11648/0083

Date of first authorisation: 26 November 1990
Date of latest renewal: 25 March 1996