Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
For the relief of pain in such conditions as: rheumatic and muscular pain, backache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu.
This product is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone.
Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken up to 4 times daily at intervals of not less than 6 hours. The maximum daily dose should not exceed 6 tablets in 24 hours.
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
Initially two tablets, then if necessary one or two tablets every 6 hours.
Ibuprofen + Codeine combination solid dose strength products should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 & 4.4).
Nurofen Plus is contraindicated in children below the age of 12 years for the symptomatic treatment of cough and/or cold (see section 4.3).
Nurofen Plus is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough and or cold (see section 4.4).
No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. NSAIDs should not be used continuously over prolonged periods in the elderly for the management of arthroses without careful supervision.
For oral administration.
In children, ingestion of more than 400 mg/kg ibuprofen may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours. Ingestion of more than 350mg Codeine or for a child, more than 5mg Codeine per kg of bodyweight, should be considered potentially harmful. Fatalities due to codeine overdose have been reported with intakes above 500mg. Due to the relative concentrations of each active ingredient in the product and their respective toxicity thresholds, the toxic effects of codeine in overdose would be expected to occur before those of ibuprofen.
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 gastro-intestinal irritation or bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as dizziness, drowsiness, occasionally excitation and disorientation, respiratory depression, excitability, convulsions, loss of consciousness, or coma. Co-ingestion of other sedative agents, including alcohol, may exacerbate effects on the central nervous system. Occasionally patients develop convulsions. The pupils may be pin point in size. Hypotension and tachycardia are possible but unlikely. 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.
Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness (see section 4.4 and section 4.8).
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount, including more than 350mg Codeine or for a child, more than 5mg Codeine per kg of bodyweight. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodiliators for asthma.
If severe CNS depression has occurred, artificial respiration, oxygen and parenteral naloxone may be needed. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken. Any imbalance in electrolyte levels should be considered.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from light.
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.
No special requirements.
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