NUROFEN PLUS Film-coated tablet Ref.[50549] Active ingredients: Codeine Codeine and Ibuprofen Ibuprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg.

Pharmaceutical Form

Film-coated Tablet (Tablet).

Nurofen Plus is a white film-coated, biconvex capsule-shaped tablet embossed with the logo ‘N+’ on one side.

Qualitative and quantitative composition

Each tablet contains Ibuprofen 200.0 mg and Codeine Phosphate Hemihydrate 12.8 mg.

For a 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.

Codeine and Ibuprofen

Ibuprofen is an NSAID which acts peripherally, inhibiting prostaglandin synthesis and the action of chemical mediators of pain. In humans, ibuprofen reduces inflammatory pain, swellings and fever. 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. The combination of a well tolerated peripheral analgesic with a centrally acting analgesic provides optimum pain relief with a lower potential for producing side effects.

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.

List of Excipients

Tablet core:

Microcrystalline cellulose
Sodium starch glycolate Type A
Hypromellose
Pregelatinised maize starch

Film coating:

Hypromellose
Talc
Opaspray white M-1-7111B
(containing: Hypromellose and titanium dioxide (E171))

Pack sizes and marketing

Blister packs (250 micron PVC/40gsm PVDC heat sealed to aluminium foil) containing 6, 12 or 24 tablets (OTC pack sizes).

Blister packs (250 micron PVC/40gsm PVDC heat sealed to aluminum foil) containing 32 or 48 tablets (POM pack sizes).

Not all pack sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0979/034/001

Date of first authorisation: 21 March 1997
Date of last renewal: 21 March 2007

Drugs

Drug Countries
NUROFEN PLUS Ireland, Israel, Malta, New Zealand, Poland, Romania, Turkey, United Kingdom, South Africa

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