GEN-PAYNE Capsule, hard Ref.[50521] Active ingredients: Codeine Ibuprofen Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Private Bag X69, Bryanston 2021

Product name and form

GEN-PAYNE CAPSULES, 10 mg/200 mg/250 mg, capsules.

Pharmaceutical Form

Hard capsules.

The cap is opaque green, and the body is opaque red. “ADCO” is printed on both the cap and body. Contents of the capsule are fine white granular powder.

Qualitative and quantitative composition

Each capsule contains:

Codeine phosphate 10 mg
Ibuprofen 200 mg
Paracetamol 250 mg

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

Capsule fill:

Colloidal silica
Magnesium stearate
Maize starch
Potassium sorbate

Capsule shell:

Opaque Green Cap
Opaque Red Body
Printing ink

Capsule shell colourants:

Brilliant blue FCF
Erythrosine
Quinoline yellow
Sunset yellow
Titanium dioxide

Pack sizes and marketing

A white high density polypropylene (HDPP) securitainer with a low density polyethylene (LDPE) snap on lid or a white high density polyethylene container with a high density polyethylene (HDPE) screw cap containing 30 capsules.

Push through clear PVC and aluminium blister packs of 10 capsules in unit cartons of 10, 30, 60 or 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Private Bag X69, Bryanston 2021

Marketing authorization dates and numbers

South Africa (S2): 35/2.8/0046
Botswana (S3): BOT1001644A
Namibia (NS2): 04/2.8/1571
Zimbabwe (P): 2016/2.2/5239

21 May 2002

Drugs

Drug Countries
GEN-PAYNE South Africa

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