COGESIC Tablet Ref.[50555] Active ingredients: Codeine Paracetamol

Source: Marketing Authorisation Holder  Revision Year: 2022  Publisher: Oethmaan Biosims (PTY) Ltd, Office 207A, Sherwood House, Greenacres Office Park, c/o Victory and Rustenburg Roads, Victory Park, Johannesburg 2195

Product name and form

COGESIC (Tablets).

Pharmaceutical Form

Flat blue tablet, scored on the one side.

Qualitative and quantitative composition

Each tablet contains:

Codeine phosphate 8 mg
Paracetamol 500 mg

Preservative:

Sodium metabisulphite 0,081% m/m
Contains sugar (sucrose) 20 mg

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

Gelatin
Indigo carmine lake E132 IH (CI 73015:1)
Povidone
Magnesium stearate
Maize starch
Modified starch
Powdered sucrose

Pack sizes and marketing

Cartons containing 2 × 10 tablets in push through blister packs.

White plastic (LOPE) Ziploc bag (Patient Ready Pack) containing 56 tablets.

Amber plastic (PVC) bottles containing 100, 500, and 1000 tablets.

White plastic (HOPE) bottles containing 1000 tablets.

Blue/green plastic buckets containing 5000 tablets.

Marketing authorization holder

Oethmaan Biosims (PTY) Ltd, Office 207A, Sherwood House, Greenacres Office Park, c/o Victory and Rustenburg Roads, Victory Park, Johannesburg 2195

Marketing authorization dates and numbers

0/2.8/109

Date of registration: 23 August 1989

Drugs

Drug Countries
COGESIC South Africa

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