KAPAKE Tablet Ref.[10431] Active ingredients: Codeine Paracetamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Product name and form

Kapake 30mg/500mg Tablets / Co-Codamol 30mg/500mg Tablets.

Pharmaceutical Form

Tablet.

Oblong, white uncoated tablets marked “Kapake” and bearing a scoreline on one side, the other side is plain and unmarked. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Per tablet:

Paracetamol 500mg
Codeine Phosphate 30mg

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.

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

Microcrystalline cellulose
Sodium starch glycolate (type A)
Magnesium stearate
Povidone

Pack sizes and marketing

High density polypropylene containers with low density polyethylene caps and/or cold-form aluminium blisters and/or PVC (250um)/aluminium (20um) blisters and/or PVC/child-resistant aluminium blisters.

Pack sizes: 2, 4, 6, 10, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 150, 200, 250 and 500 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Marketing authorization dates and numbers

PL 27827/0009

Date of first authorisation: 03 March 1993
Date of latest renewal: 23 February 2009

Drugs

Drug Countries
KAPAKE Ireland, United Kingdom

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