ARTHREXIN Capsule Ref.[50339] Active ingredients: Indometacin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

Product name and form

ARTHREXIN 25 mg capsules.

ARTHREXIN-50 mg capsules.

Pharmaceutical Form

Capsules.

ARTHREXIN 25 is a yellow No. 3 opaque capsule imprinted in black ink with a Lennon logo and “LENNON” on one side of capsule and “ARTHREXIN 25” on the other side, containing a white powder.

ARTHREXIN-50 is a yellow No. 1 opaque capsule printed “ARTHREXIN 50” on the one part of the capsule and a mortar and pestle with “LENNON” on the other part.

Qualitative and quantitative composition

ARTHREXIN 25: Each capsule of ARTHREXIN 25 contains 25 mg indomethacin.

Contains sugar: Lactose 177,6 mg

For full list of excipients, see section 6.1.

ARTHREXIN-50: Each capsule of ARTHREXIN-50 contains 50 mg indomethacin.

Contains sugar: Lactose 429 mg

For full list of excipients, see section 6.1.

Active Ingredient Description
Indometacin

Indometacin has anti-inflammatory, antipyretic, and analgesic effects, it is an inhibitor of prostaglandin synthetase.

List of Excipients

ARTHREXIN 25: Gelatin, lactose, magnesium stearate, quinoline yellow (C.I. 47005), sodium lauryl sulphate, sodium starch glycollate, sunset yellow (C.I. 15985), titanium dioxide (C.I. 77891)

ARTHREXIN-50: Gelatin, lactose, magnesium stearate, quinoline yellow (C.I. 47005), sodium lauryl sulphate, sodium starch glycollate, sunset yellow (C.I. 15985), titanium dioxide (C.I. 77891)Not applicable

Pack sizes and marketing

ARTHREXIN 25

100 capsules are packed in a white cylindrical polypropylene container and sealed with a white round, flat topped linear low density polyethylene snap-on cap with a tamper evident seal.

500 capsules are packed in a white polypropylene container and sealed with a white low density polyethylene snap-on cap together with a silica gel sachet.

1000 capsules are packed in an amber polyvinylchloride container and sealed with a white round flat-topped, high-density polyethylene crab claw cap together with a silica gel sachet.

15 or 84 capsules are packed in a metallised polyester, laminant and opaque white linear low density polyethylene patient ready lay flat pack. The lay flat is then sealed with a clear zip and overwrapped with a clear, low density polyethylene bag.

ARTHREXIN-50

30 or 100 capsules are packed in a white cylindrical polypropylene container and sealed with a white linear low-density polyethylene cap together with a foam insert. 500 capsules are packed in an amber polyvinylchloride container and sealed with a white high-density polyethylene pilfer proof screw cap together with a silica gel sachet.

1000 capsules are packed in a clear polyethylene bag, inside a white round polypropylene bucket and sealed with a white high density polyethylene lid together with silica gel sachets.

Not all packs or pack sizes may be marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

Marketing authorization dates and numbers

ARTHREXIN 25: K/3.1/285
ARTHREXIN-50: K/3.1/286

ARTHREXIN 25: 01 May 1978
ARTHREXIN-50: 01 May 1978

Drugs

Drug Countries
ARTHREXIN Australia, Hong Kong, South Africa

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