MYPRODOL Suspension Ref.[115246] Active ingredients: Codeine Ibuprofen Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Adcock lngram Limited Address: 1 New Road, Erand Gardens, Midrand, 1685 P.O. Box: Private Bag X69, Bryanston 2021

Product name and form

MYPRODOL SUSPENSION, 10 mg/200 mg/250 mg, suspension.

Pharmaceutical Form

Suspension.

An opaque pink suspension with a blackcurrant taste and odour.

Qualitative and quantitative composition

Each 10 mL contains codeine phosphate 10 mg, ibuprofen 200 mg and paracetamol 250 mg.

Excipient(s) with known effect:

Preservative (sodium benzoate): 0,1% m/v

Sugar free.

For full list of excipients, see section 6.1.

Active Ingredient

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 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 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

Blackcurrant NE 53984
Citric acid anhydrous
Disodium edetate
Glycerine
Kaolin light
Polyethylene glycol 4000
Polyvinylpyrrolidone (PVP) K25
Purified water
Raspberry red H 1277
Sodium benzoate
Sodium citrate
Sodium cyclamate
Sodium metabisulphite
Sodium saccharin 500
Sodium dihydrogen phosphate dehydrate
Xanthan gum TF

Pack sizes and marketing

100 mL amber round glass bottle, with a polypropylene lined (with an expanded polyethylene liner) white screw cap.

200 mL amber round glass bottle, with a polypropylene lined (with an expanded polyethylene liner) white screw cap.

200 mL amber round PVC bottle with a low-density polyethylene white snap-on cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Adcock lngram Limited

Address: 1 New Road, Erand Gardens, Midrand, 1685

P.O. Box: Private Bag X69, Bryanston 2021

Marketing authorization dates and numbers

South Africa (S3): Y/2.8/119
Botswana (S2): BOT0700928

22 June 1994

Drugs

Drug Countries
MYPRODOL South Africa

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