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Qualitative and quantitative composition Active constituents:. Ibuprofen Ph Eur. Pharmaceutical form Tablet. 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 paracetamol, ibuprofen or aspirin alone.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms see section 4. Nurofen plus which contains Codeine 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. No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. 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. Patients who have ly shown hypersensitivity reactions e. Severe hepatic failure, renal failure or heart failure See section 4. 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.
The elderly are at increased frequency of adverse reactions to NSAIDS, especially gastrointestinal bleeding and perforation which may be fatal see section 4. Bronchospasm may be precipitated in patients suffering from or with a history of bronchial asthma or allergic disease. Systemic lupus erythematosus and mixed connective tissue disease due to increased risk of aseptic meningitis see section 4.
Renal impairment as renal function may further deteriorate See section 4. There is a risk of renal impairment in dehydrated children and adolescents. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses 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.
Overall, epidemiological studies do not suggest that low dose ibuprofen e. The tablets should be used with caution in patients with raised intracranial pressure or head injury. This is reversible upon withdrawal of treatment. NSAIDs should be given with care to patients with a history of gastrointestinal disease ulcerative colitis, Crohn's disease as these conditions may be exacerbated See section 4. 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 history of serious GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation see section 4. 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 4.
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs see section 4. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Acute generalised exanthematous pustulosis AGEP has been reported in relation to ibuprofen-containing products. Nurofen PLUS should be discontinued at the first appearance of s and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other of hypersensitivity. 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. Care is advised in the administration of Codeine to patients with hypotension, hypothyroidism, adrenocortical insufficiency, shock, obstructive bowel disorders, acute abdominal conditions e. 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. Prolonged regular use of Codeine, except under medical supervision, may lead to physical and psychological dependence addiction and result in withdrawal symptoms, such as restlessness and irritability once the drug is stopped. If you are pregnant or are being prescribed medicines by your doctor, seek this advice before taking this product.
Care is advised in the administration of this product in patients with severe renal or severe hepatic impairment hepatic disease. Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression which may be life-threatening and very rarely fatal.
Estimates of prevalence of ultra-rapid metabolisers in different populations are summarised below:. All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultrarapid or extensive metabolisers in their ability to metabolise codeine to morphine. Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. If you take this medicine for headaches for more than three days it can make them worse. If you need to take it for longer than three days you should see your doctor or pharmacist for advice. This can give you withdrawal symptoms from the medicine when you stop taking it. If the pain does not improve after 3 days, talk to your doctor for advice. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www. If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine.
However, if the following apply to you it is important that you talk to your doctor:. The following drug-drug interactions are known to occur in association with the Ibuprofen active substance in the product:. Acetylsalicylic Acid Aspirin : Unless low-dose acetylsalicylic acid aspirin not above 75mg daily has been advised by a doctor, as this may increase the risk of adverse reactions See section 4.
Experimental data suggest that ibuprofen may inhibit the effect of low dose Acetylsalicylic Acid aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use see section 5.
In some patients with compromised renal function e. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly.
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Corticosteroids : Increased risk of gastrointestinal ulceration or bleeding See section 4.
Anti-platelet agents and selective serotonin reuptake inhibitors SSRIs : increased risk of gastrointestinal bleeding see section 4. Quinolone antibiotics : Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. The following drug-drug interactions are known to occur in association with the Codeine active substance in the product:.
Naltrexone also blocks the therapeutic effect of opioids. Opioids may also interfere with gastric emptying studies as they delay gastric emptying and with hepatobiliary imaging using technetium Tc 99m disofenin as opioid treatment may cause constriction of the sphincter of Oddi and increase biliary tract pressure. Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen Plus should, if possible, be avoided during the first 6 months of pregnancy. During the last trimester, ibuprofen is contraindicated as there is there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension.
The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. See section 4. At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal. Rare side effects may include convulsions, hallucinations, blurred or double vision and orthostatic hypotension see section 4. If affected, patients should not drive or operate machinery. This medicine can impair cognitive function and can affect a patient's ability to drive safely.
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When taking this medicine, patients should be told:. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped. The following list of adverse effects relates to those experienced with ibuprofen at OTC doses maximum mg Ibuprofen per day , for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
Within each frequency grouping, adverse events are presented in order of decreasing seriousness. Clinical trial and epidemiological data suggest that use of ibuprofen particularly at high doses 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. Blood and Lymphatic System Disorders.
Immune System Disorders. Very rare. Severe hypersensitivity reactions.How long for nurofen plus to work
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