Nurofen Plus

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CODEINE PHOSPHATE, HEMIHYDRATE, IBUPROFEN

Available from:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC code:

M01AE51

INN (International Name):

CODEINE PHOSPHATE, HEMIHYDRATE, IBUPROFEN

Pharmaceutical form:

TABLET

Composition:

CODEINE PHOSPHATE HEMIHYDRATE 12.8 milligram(s) ; IBUPROFEN 200 milligram(s)

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-02-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Nurofen Plus 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active constituents: 
Ibuprofen Ph Eur 

200.0 mg 
Codeine phosphate Ph Eur 

12.8 mg 

3 
PHARMACEUTICAL FORM 

Tablet 

4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

For the short term treatment of acute, moderate pain (such
as rheumatic and muscular pain, 
backache, migraine, headache, neuralgia, period pain and
dental pain) which is not relieved 
by paracetamol, ibuprofen or aspirin alone. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral administration and short-term use only. 
RECOMMENDED DOSAGE: 
_ADULTS:_ 
One or two tablets every four to six hours. 
_CHILDREN UNDER 12 YEARS: _
Not recommended. 
Page 1 of 13 

_ELDERLY: _
No
special dosage modifications are required for elderly patients, unless renal or hepatic 
function is impaired, in which case dosage should be assessed
individually. 
Do not take more than 6 tablets in 24 hours. 
Leave at least four hours between doses and do
not take more than 1200mg in any 24 hour 
period. 
Do not take for more than 3
days continuously without medical review. 
The minimum effective dose should be used for the shortest time
necessary to relieve 
symptoms. The patient should
consult a doctor if symptoms persist or worsen, or if the 
product is required for more than 3 days. 

4.3 
CONTRAINDICATIONS 

Hypersensitivity to ibuprofen or any of the constituents in
the product. 
Patients who have previously shown
hypersensitivity reactions (e.g. asthma, rhinitis, 
angioedema or urticaria) in response to aspirin
or other non-steroidal anti-inflammatory 
drugs. 
Active or history of recurrent peptic ulcer/haemorrhage (two
or more distinct episodes of 
proven ulceration or bleeding). 
History of upper gastro