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NUROFEN PLUS is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nurofen Plus (which contains codeine) is indicated in patients older than 12 years of age 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 considered to be relieved by other analgesics such as…
Verbatim from this product's MHRA label. Tap a section to expand.
4).
Posology:
Recommended dosage: Adults, the elderly and children over 12 years of age: One or two tablets every four to six hours.
Children aged 12-18 years:
One or two tablets every four to six hours. 4).
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. Leave at least four hours between doses and do not take more than 6 tablets (1200mg) in any 24 hour period.
The maximum recommended daily dose should not be exceeded 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. For short term use only.
Codeine should be used at the lowest effective dose for the shortest period of 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.
Method of administration For oral administration Treatment goals and discontinuation Before initiating treatment with Nurofen Plus, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment in case of prescription, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of treatment Nurofen Plus should not be used longer than necessary.
). 8). There is a risk of renal impairment in dehydrated children and adolescents. 8).
Cardiovascular and cerebrovascular effects:
Cases of Kounis syndrome have been reported in patients treated with ibuprofen containing products such as with Nurofen Plus Tablets. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
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).
g. £ 1200 mg daily) is associated with an increased risk of myocardial infarction. Nurofen Plus tablets should be used with caution in those with hypotension and/ or hypothyroidism. The tablets should be used with caution in patients with raised intracranial pressure or head injury.
8 Undesirable effects). Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
3), and in the elderly. These patients should commence treatment on the lowest dose available. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). 2).
Respiratory:
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8 Undesirable effects). 8). There is a risk of renal impairment in dehydrated children and adolescents.
8).
Cardiovascular and cerebrovascular effects:
Cases of Kounis syndrome have been reported in patients treated with ibuprofen containing products such as with Nurofen Plus Tablets. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
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).
g. £ 1200 mg daily) is associated with an increased risk of myocardial infarction. Nurofen Plus tablets should be used with caution in those with hypotension and/ or hypothyroidism. The tablets should be used with caution in patients with raised intracranial pressure or head injury.
8 Undesirable effects). Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
1. g. asthma, rhinitis, angioedema or urticaria) in response to Acetylsalicylic Acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 4, Special warnings and precautions for use). 6 Pregnancy and lactation). 6) Respiratory depression. 5). 4) In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 Interactions). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). Most of these reactions occured within the first month. If signs and suggestive of these reactions appear, ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate).
Sleeping disorder where your body stops and starts your breathing in a way that disrupts your sleep: Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion.
In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper Increased sensitivity to pain: Hyperalgesia has been reported with the use of opioids, particularly following long-term use and/or at high doses.
Hyperalgesia may resolve with opioid dose reduction, discontinuation, or switching to a different opioid Masking of symptoms of underlying infections This medicinal product can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection.
This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When this medicine is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Excipients • This medicine contains less than 1 mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’. Do not take concurrently with any other Codeine containing compounds. g. peptic ulcer), recent gastrointestinal surgery, gallstones, myasthenia gravis, a history of peptic ulcer or convulsions and also in patients with a history of drug abuse.
Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, codeine/ibuprofen has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
Elderly patients may metabolise or eliminate opioid analgesics more slowly than younger adults. Codeine should be used with caution in the elderly and debilitated patients as they may be more susceptible to the respiratory depressant effects.
Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of […]
3), and in the elderly. These patients should commence treatment on the lowest dose available. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity, ulceration or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti- platelet agents such as Acetylsalicylic Acid (aspirin) (see section