SPC, UK: EMFLEX Capsule (2016)

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.

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
Authorization dates

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

Date of first authorisation: 26 November 1990

Date of latest renewal: 25 March 1996

Marketing authorization number:

PL 11648/0083