Nurofen for children chewable capsules 100mg

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For short term use only
The lowest effective dose should be used for the shortest duration necessary to relieve
symptoms and minimize undesirable effects.
For pain & fever: The daily dosage of Nurofen for children chewable capsules 100mg aged 7 years old and older is 5 to 10 mg/kg ORALLY every 6 to 8 hours as needed MAX 4 doses/day. Children with identical ages can have significantly different weights. Therefore, try to obtain the weight of the child and determine the dosage by weight. Only if you cannot find the child’s weight determine the dosage according to age. Doses should be given approximately every 6 to 8 hours, (or with a minimum of 6 hours between each dose if required).
Not suitable for children under 7 years of age. Adults and Children above 12 years old: Do not take more than 1200mg (12 chewable capsules) in any 24-hour period.

For the reduction of fever and the relief of mild to moderate pain, such as a sore throat, dental pain, earache, headache, minor aches and sprains.

* Hypersensitivity to the active substance (ibuprofen) or to any of the excipients.
* Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to 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 upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
* Severe hepatic failure, renal failure or heart failure.
* Last trimester of pregnancy

Respiratory:
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Other NSAIDs:
The use of Ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis.
Porphyrin metabolism:
Caution is required in patients with congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria).
Renal:
Renal impairment as renal function may further deteriorate, There is a risk of renal impairment in dehydrated paediatric patients.
Masking of symptoms of underlying infections:
This medical 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 Ibuprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised.
Cardiovascular and cerebrovascular effects:
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.
Kounis syndrome:
Cases of Kounis syndrome have been reported in patients treated with this medical product. 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.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.
Gastrointestinal:
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.
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without 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. 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 aspirin.
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Most of these reactions occurred within the first month. If signs and symptoms suggestive of thesereactionsappear ibuprofen should be withdrawn immediately.
Varicella:
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. It is advisable to avoid use of Ibuprofen in case of varicella.
Platelet function:
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.
Severe cutaneous adversereactions (SCARs):
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS) toxic epidermal necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be
life-threatening or fatal, have been reported in association with the use of ibuprofen.

See prescribing information for full details.

Ibuprofen should be avoided in combination with:
Aspirin: May increase the risk of adverse reactions.
Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects.
Ibuprofen should be used with caution in combination with:
Anticoagulants: NSAIDS may enhance the effects of anti-coagulants, such as warfarin.
Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs. In particular, concomitant use of potassium-sparing diuretics may increase the risk of hyperkalaemia.
Corticosteroids: as these may increase the risk of gastrointestinal ulceration or bleeding.
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 and phenytoin: There are evidence for potential increases in plasma levels of these medicinal products when co-administered with ibuprofen. If used correctly, monitoring of the plasma concentrations of lithium or phenytoin is usually not needed.
Probenecid and sulfinpyrazon: Medicinal products that contain probenecid or sulfinpyrazon may delay the excretion of ibuprofen.
Methotrexate: There is a potential for an increase in plasma methotrexate
Ciclosporin: Increased risk of nephrotoxicity.
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 haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Oral hypoglycemic agents: Inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia
See prescribing information for full details.

Pregnancy: During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Rarely, taking NSAIDs after the 20th week of pregnancy may cause impaired renal function of the fetus, which may cause low levels of amniotic fluid (oligohydramnios). Using NSAIDs after the 20th week of pregnancy should be limited. If it was decided that the benefit outweighs the risk for the fetus and the treatment with the medicine is essential after the 20th week of pregnancy, the lowest effective dose should be used for the shortest possible period. Referring the patient to ultrasound scan should be considered, in order to estimate the amount of amniotic fluid when the treatment with therapeutic dosage of these medicines exceeding 5 days and stopping the treatment if low levels of amniotic fluid is detected.
Lactation: Ibuprofen and its metabolites pass only in low concentrations into breast milk. Since harmful effects to infants have not become known to date, interruption of breast-feeding is usually not necessary during short-term treatment with the recommended dose.

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Symptoms
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 gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, 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.
Management
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. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.