The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses and patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see Section 4.3 Contraindications) and in the elderly. These patients should commence treatment on the lowest dose available. Nurofen Plus should not be used for more than three days at a time unless on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. Diarrhoea caused by pseudomembranous colitis or poisoning (until the causative organism or toxin has been eliminated from the gastrointestinal tract, since codeine may slow down the elimination, thereby prolonging the diarrhoea). Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol. Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Nurofen Plus with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active antiemetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible. If a decision is made to prescribe Nurofen Plus concomitantly with any of the medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. Patients and their caregivers should be made aware of these symptoms. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Nurofen Plus. Therefore, Nurofen Plus is contraindicated for use during breastfeeding. However, in circumstances where a breastfeeding mother requires codeine therapy, breastfeeding should be suspended and alternative arrangement should be made for feeding the infant for any period during codeine treatment. Breastfeeding mothers should be told how to recognize signs of high morphine levels in themselves and their babies. For example, in a mother, symptoms include extreme sleepiness and trouble caring for the baby. In the baby, symptoms include signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Medical advice should be sought immediately.

If you're taking alendronic acid it's best to avoid taking Nurofen unless it's been recommended by your doctor, because ibuprofen may increase the risk of irritation to the foodpipe, stomach or intestines. Side effects from codeine are theoretical warnings based on drug class. No clinical data is available to determine frequency. During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects? Pregnancy and breastfeeding Women who are pregnant. Ibuprofen may increase the risk of miscarriage and malformations and should not be used during the first and second trimesters of pregnancy unless considered essential by your doctor. Ibuprofen must not be taken in the third trimester because it may delay labour, increase the length of labour and cause complications in the newborn baby.Oligohydramnios and neonatal renal impairment. Use of NSAIDs from about 20 weeks gestation may cause neonatal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Nurofen Plus, Contains ibuprofen and codeine, For the short-term treatment of acute, moderate pain which is not considered to be relieved by other analgesics such as paracetamol, ibuprofen or aspirin alone. For 3 days use only. May cause addiction. It's fine to take ibuprofen with paracetamol. You can also take it alongside opioid-type painkillers such as codeine, co-codamol, tramadol or morphine. However, don't take ibuprofen with painkilling doses of aspirin, or with other related anti-inflammatory painkillers (NSAIDs) like diclofenac and naproxen, as this increases the risk of side effects on the stomach and intestines. People taking selective inhibitors of COX-2 such as celecoxib or etoricoxib should not take ibuprofen for the same reason. Nurofen Plus given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn. Looking after your medicine

Anticoagulants. Concurrent use of NSAIDs and warfarin has been associated with severe, sometimes fatal haemorrhage. The mechanism of this interaction is not known but may involve increased bleeding from NSAID-induced gastrointestinal ulceration or an additive effect of NSAID inhibition of platelet function with the anticoagulant effect of warfarin. Nurofen Plus should only be used in patients taking warfarin if absolutely necessary. Patients taking this combination must be closely monitored. Nurofen Plus poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment.The list of the following adverse events relates to those experienced with ibuprofen and codeine (maximum of 1200 mg ibuprofen per day There may be an increased risk of side effects on the kidneys if ibuprofen is taken in combination with any of the following medicines:

The most commonly observed adverse events are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding which is dependent on the dosage range and duration of treatment.Nurofen Plus should be administered with caution in patients with mild to moderate hepatic impairment (see Section 4.3 Contraindications for severe hepatic impairment). Patients should be advised to remain alert for hepatotoxicity and be informed about the signs and/or symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms) and the steps to take should these signs and/or symptoms occur. There are a few differences between the different forms of Nurofen that are available for taking by mouth. The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Nurofen Plus. Care is advised in the administration of Nurofen Plus to patients with adrenocortical insufficiency. If you’re taking granules, the usual dose for adults is one sachet 2 or 3 times a day. Some people might need to take it 4 times a day.

Nurofen Plus is not recommended during the last 3 months of pregnancy. Your doctor will decide if you should take Nurofen Plus during the first 6 months of pregnancy. Active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). As with other non-steroidal anti-inflammatory agents, ibuprofen should not be used in active gastrointestinal bleeding or in the presence of peptic ulceration.Mifepristone. NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.