Nurofen for Children Suppositories

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For short term use only.
Do not use this product in children under 3 months of age without medical advice.
Do not use this product in children weighing less than 6 Kg.
Nurofen for children suppositories 125 mg are not suitable for infants weighing less than 12.5 kg (approximately 2 years of age), as suppositories containing less active substance are needed.
The maximum total daily dose of the product is 20 – 30 mg per kg of body weight, divided into 3-4 single doses. Please refer to doctor’s leaflet for dosage guidlines.
For infants aged 3-5 months, medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Method of administration: For rectal administration.

For the symptomatic treatment of mild to moderate pain, and for the symptomatic treatment of fever.

Hypersensitivity to the active substance or to any of the excipients.
Patients with severe hepatic failure, severe renal failure or severe heart failure.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/ haemorrhage (two or more distinct episodes of proven ulceration or bleeding or other gastrointestinal disorders).
Patients with a history of hypersensitivity reactions (e.g bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
During the last trimester of pregnancy.

The use of Nurofen for Children Suppositories with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any-time during treatment, with or without any warning symptoms or a previous 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, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.
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 ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (aspirin).
When GI bleeding or ulceration occurs in patients receiving Nurofen for Children
Suppositories, the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their conditions may be exacerbated.
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.
Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg 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.g. < 1200mg daily) is associated with an increased risk of myocardial infarction.
Caution is required in patients with renal impairment since renal function
may deteriorate. In patients with renal impairment, renal function should be monitored as it may deteriorate following the use of NSAIDs.
Caution is required in patients with hepatic impairment.
Elderly patients are particularly susceptible to the adverse effects of NSAIDs. Prolonged use of NSAIDs in the elderly is not recommended. Where prolonged therapy is required, patients should be reviewed regularly.
As NSAIDs can interfere with platelet function, they should be used with caution in patients with idiopathic thrombocytopenic purpura (ITP), intracranial haemorrhage and bleeding diathesis.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for 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. Nurofen for Children Suppositories should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue
infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Nurofen for Children Suppositories in case of varicella.
There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
Caution is advised in patients with systemic lupus erythematosus as well as those with connective tissue disease.
Caution is also required in patients with disorders of the anus or rectum.
There is a risk of renal impairment in dehydrated children.

See prescribing information for full details.

Ibuprofen should be avoided in combination with:
Acetylsalicylic acid (Aspirin): unless low-dose Acetylsalicylic Acid (Aspirin), (not above 75 mg daily), has been advised by a doctor, as this may increase the risk of adverse reactions. Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid (aspirin) on platelets aggregation when they are dosed concomitantly.
However, the limitations of these data and the uncertainties regarding the 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.
Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects.
It is considered unsafe to take NSAIDs in combination with warfarin or heparin unless under direct medical supervision.
Care should be taken in patients treated with any of the following drugs as interactions have been reported:
Anti-hypertensives (ACE inhibitors and Angiotensin II Antagonists) and diuretics: NSAIDs may reduce the effects of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, or angiotensin II antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking ibuprofen 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. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
Anti-coagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Lithium: decreased elimination of lithium.
Methotrexate: decreased elimination of methotrexate.
Cyclosporin: Increased risk of nephrotoxicity with NSAIDs.
Aminoglycosides: reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.
Probenecid: reduction in metabolism and elimination of NSAID and metabolites.
Oral hypoglycemic agents: inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.
Mifepristone: NSAIDs should not be used for 8-12 days after Mifepristone administration as NSAIDs can reduce the effect of Mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with Zidovudine.
There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with Quinolone antibiotics. Patients taking NSAIDs and Quinolones may have an increased risk of developing convulsions.

Pregnancy: There is insufficient experience about the safety of use of ibuprofen in humans during pregnancy.
As the influence of prostaglandin synthesis inhibition is unclear, it is recommended not to use ibuprofen during the first six months of pregnancy.
In the last trimester of pregnancy use of ibuprofen is contraindicated. Due to the mechanism of action, inhibition of uterine contractions, premature closure of ductus arteriosus and pulmonary hypertension of the neonate, an increased bleeding tendency in mother and child and increased formation of oedema in the mother could occur.
Breast-feeding: Ibuprofen and its metabolites can pass in very small concentrations (0.0008% of the maternal dose) into the breast milk. No harmful effects to infants are known, so it is not necessary to interrupt breast-feeding for short-term treatment with the recommended dose for mild to moderate pain and fever.

A dose in excess of 200 mg/kg carries a risk of causing toxicity.
Symptoms: Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, abdominal pain, or more rarely diarrhoea. Tinnitus, headache, nystagmus, blurred vision, hypotension and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as dizziness, drowsiness, loss of consciousness, 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.
Therapeutic Measure: Patients should be treated symptomatically as required. Use supportive care where appropriate. Management should include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma. No specific
antidote is available.