Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse reactions (see section 4.4). American Chronic Pain Association: “ACPA Consumer Guide to Pain Medication & Treatment, 2010 Edition.” Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Nurofen Cold & Flu should be discontinued and appropriate measures taken if needed. NUROFEN COLD AND FLU is only available from your pharmacist. Before you take/give NUROFEN® COLD AND FLU When you must not take it

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see Section 4.4).The safety of this medicine during pregnancy has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia.

When giving your child liquid medicine, make sure to use the appropriate measuring tool that came with the medication and not a spoon used for eating or cooking. Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. From the 20th week of pregnancy onward, ibuprofen use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If Ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to ibuprofen for several days from gestational week 20 onward. Ibuprofen should be discontinued if oligohydramnios or ductus arteriosus constriction are found. People who are at greater risk for liver damage from acetaminophen include people with liver disease and men who drink three or more alcoholic drinks a day (or two a day or more drinks for women).

After using NUROFEN® COLD AND FLU

As with other sympathomimetics, pseudoephedrine overdose may cause symptoms of central nervous system and cardiovascular stimulation, including: Adults and children from 12 years : 2 tablets, then 1 or 2 tablets every 4 hours as necessary (maximum 6 tablets in 24 hours).