LODINE SR Tablet Ref.[9345] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Almirall, S.A., Ronda General Mitre 151, 08022, Barcelona, Spain

Product name and form

Lodine 600 mg SR Tablets.

Pharmaceutical Form

Lodine SR Tablets are for oral administration. Each tablet is capsular, oval shaped light grey film coated, impressed on one side with Lodine SR600 and contains etodolac 600mg in a sustained release formulation.

Qualitative and quantitative composition

Each tablet contains 600 mg of etodolac.

Excipients with known effect: Each tablet contains 109 mg lactose and 34 mg of sodium.

For the full list of excipients, see section 6.1.

List of Excipients

Hydroxypropyl methylcellulose
Dibasic sodium phosphate
Ethylcellulose
Lactose
Magnesium stearate
Hydroxypropyl cellulose
Macrogol 400
Macrogol 6000
Colourings – titanium dioxide (E171), iron oxide (E172)

Pack sizes and marketing

Vinyl Aclar or PVdC/PVC/Aluminium foil blister packs of 2, 28 or 30 tablets.

HDPE bottle with child resistant closures of 28 or 30 tablets.

Polypropylene securitainers with polyethylene caps of 28 or 30 tablets.

Marketing authorization holder

Almirall, S.A., Ronda General Mitre 151, 08022, Barcelona, Spain

Marketing authorization dates and numbers

PL 16973/0021

02/03/2009

Drugs

Drug Countries
LODINE France, Turkey, United Kingdom

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