MYBUCOD Film-coated tablet Ref.[115234] Active ingredients: Codeine Ibuprofen Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

MYBUCOD 10 mg/200 mg/350 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

MYBUCOD is a blue, capsule-shaped, film-coated tablet with a break score on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet of MYBUCOD contains 10 mg Codeine phosphate, 200 mg Ibuprofen, 350 mg Paracetamol.

Sugar free.

For full list of excipients, see section 6.1.

Active Ingredient

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 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 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

Brilliant blue (C.I. 42090)
Magnesium stearate
Methocel
Microcrystalline cellulose
Polyvinylpyrrolidone povidone
Pregelatinised starch
Purified talc

Pack sizes and marketing

30 tablets are packed into a white, round, polypropylene container and sealed with a tamper evident, round, burnt-orange low density polyethylene cap, together with a leaflet and silica gel sachet.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

36/2.8/0379

25 November 2005

Drugs

Drug Countries
MYBUCOD South Africa

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