SULINDAC Tablets Ref.[8486] Active ingredients: Sulindac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Product name and form

Sulindac 100 mg Tablets.

Pharmaceutical Form

8mm flat bevel-edged orange yellow tablet marked “SD” breakline “100” on one side and “α” on the reverse.

Qualitative and quantitative composition

Each tablet contains 100 mg of sulindac.

Excipients with known effect: Each tablet contains 18 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sulindac

Sulindac is a fluorinated indene with a structural resemblance to indometacin. It has analgesic, anti-inflammatory and antipyretic actions.

List of Excipients

The tablets contain:

Lactose monohydrate
Cellulose, microcrystalline
Povidone
Sodium starch glycolate
Magnesium stearate
Talc
Quinolone yellow (E104)

Pack sizes and marketing

Sulindac tablets are available either in PVC/aluminium foil blisters or polypropylene containers with polyethylene caps. The pack sizes available in both pack types are 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112 120, 168 and 180. In the polypropylene containers pack sizes of 50, 200 and 500 are also available.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0187

Date of first authorisation: 17/11/1987

Date of latest renewal: 15/07/2005

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