MYBULEN Capsule Ref.[51175] Active ingredients: Codeine Ibuprofen Paracetamol

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

Product name and form

MYBULEN CAPSULES 200 mg/10 mg/250 mg.

Pharmaceutical Form

Capsules.

MYBULEN CAPSULES is a white to off-white, compacted powder, encapsulated in a size “0” capsule with a blue cap and blue body.

Qualitative and quantitative composition

Each capsule of MYBULEN CAPSULES contains 200 mg ibuprofen, 10 mg codeine phosphate, 250 mg paracetamol.

Sugar free.

For 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

Brilliant blue (C.I. 42090)
Carmoisine (C.I. 14720)
Colloidal silicon dioxide
Gelatin
Magnesium stearate
Quinoline yellow (C.I. 47005)
Sodium starch glycollate
Titanium dioxide (C.I. 77891)

Pack sizes and marketing

10 capsules are packed in a clear polyvinylchloride, polyethylene, polyvinylidene chloride film sealed with an aluminium foil backing. The blister strips are packed into a unit cardboard carton together with a leaflet.

30 capsules are packed in a white polypropylene securitainer and sealed with a red or blue low-density polyethylene cap with a tamper evident seal together with a silica gel sachet or a white desiccant disc and a leaflet.

Not all packs and pack sizes are necessarily marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

A38/2.8/0527

Date of first authorisation: 29 July 2005

Drugs

Drug Countries
MYBULEN South Africa

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