PAINAMOL PLUS Tablet Ref.[50534] Active ingredients: Codeine Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext.1, Roodepoort, 1724, South Africa

Product name and form

PAINAMOL PLUS.

Pharmaceutical Form

Tablet.

Flat yellow and red mottled tablet, scored on the one side and a “b” embossed on the other side.

Qualitative and quantitative composition

Each tablet contains:

Paracetamol 500 mg.

Codeine Phosphate 8 mg.

Preservative:

Sodium metabisulphite 0,081% m/m

Contains TARTRAZINE.

Contains sugar: sucrose 20,0 mg per tablet.

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.

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

Alcohol 90% v/v
Be-Tabs Red C344/TF
Gelatin
Magnesium Stearate
Modified Starch
Povidone
Powdered Sucrose
Purified Water
Sodium Metabisulphite
Starch maize
Yellow Saffron LS2002/22

Pack sizes and marketing

Cartons with 2 X 10 tablets in push through blister packs.

Containers with 100, 500 and 1000 tablets.

Blue/green plastic buckets containing 5000 tablets.

Patient ready packs of different pack sizes.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext.1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

P/2.8/311 (S.A.)

27 February 1996

Drugs

Drug Countries
PAINAMOL PLUS South Africa

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