IBUPAIN FORTE Capsule Ref.[108834] Active ingredients: Codeine Ibuprofen Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Magwa Crescent West, Waterfall City, Jukskei View, Midrand, 2090 1 Company Reg. No.: 1990/001979/07

Product name and form

Ibupain Forte (capsules).

Pharmaceutical Form

Capsules.

Size 0 capsule with red body and dark green cap containing a free flowing white powder.

Qualitative and quantitative composition

Each Ibupain Forte capsule contains 200 mg ibuprofen, 10 mg codeine phosphate and 250 mg paracetamol.

Ibupain Forte is sugar free.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Codeine

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. The anti-tussive activity of codeine is probably due to its depressant effect on the medullary cough centre in the brain.

Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Capsule fill:

Pregelatinised starch
Microcrystalline cellulose
Purified talc

Capsule shell:

Erythrosine
Red iron oxide
Titanium dioxide
Yellow iron oxide
Gelatine
Indigo carmine
Quinolone yellow

Pack sizes and marketing

White opaque polypropylene securitainers with clip-on, low density or medium density or high-density polyethylene pilfer proof seals with 10, 30, 60, 100 or 500 capsules.

Clear PVC or Tristar blisters sealed with aluminium foil with 10, 30, 60, 100 or 500 capsules packed into a cardboard carton.

Sealed aluminium layflat patient ready bags with LDPE ribbed zipper with 30, 60 or 100 capsules.

Amber glass containers with black, hard plastic (polypropylene) screw caps with expanded LDPC inner seals with 30, 60 or 100 capsules.

Marketing authorization holder

Sandoz SA (Pty) Ltd1, Magwa Crescent West, Waterfall City, Jukskei View, Midrand, 2090

1 Company Reg. No.: 1990/001979/07

Marketing authorization dates and numbers

37/2.8/0060

03 June 2005

Drugs

Drug Countries
IBUPAIN FORTE South Africa

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