P-Fen

Each 5 mL contains: Ibuprofen 100 mg.

Prescription only: For Symptomatic treatment of juvenile rheumatoid arthritis.
Prescription and OTC: For the fast and effective reduction of fever, including post immunization pyrexia and the fast and effective relief of the symptoms of colds and influenza and mild to moderate pain, such as a sore throat, teething pain, toothache, earache, headache, minor aches and sprains.

For oral administration preferably with or after food, the bottle should be thoroughly shaken before use. P-Fen Suspension should be used at the lowest effective dose for shortest possible time.
Infants: 3-6 months weighing more than 5 kg: 2.5 mL dose may be taken 3 times in 24 hours.
6-12 months: 2.5 mL dose may be taken 3 to 4 times in 24 hours.
Children: 1-3 years: 5 mL dose may be taken 3 times in 24 hours.
4-6 years: 7.5 mL dose may be taken 3 times in 24 hours.
7-9 years: 10 mL dose may be taken 3 times in 24 hours.
10-12 years: 15 mL (10 mL + 5 mL) dose may be taken 3 times in 24 hours.
Dose should be given approximately every 6 to 8 hours (or with a minimum of 4 hours between each dose if required).
For juvenile rheumatoid arthritis: The usual daily dosage is 30 to 40 mg/kg/day in three to four divided doses.
For post immunization pyrexia: One 2.5 mL dose followed by one further 2.5 mL dose 6 hours later if necessary. No more than two 2.5 mL dose in 24 hours. If the fever is not reduced, the patient must be advised to consult a doctor.

In children, ingestion of more than 400 mg/kg may cause symptoms. The half-life in overdose is 15-30 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 possible. In more serious poisoning, toxicity is seen in 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.
Treatment: 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 present 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.

P-FEN SUSPENSION is contraindicated in patients with severe heart failure and for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active or history of recurrent peptic ulcer/haemorrhage.
Hypersensitivity to ibuprofen or any ingredient of this drug.
The third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.

In rare cases, Ibuprofen has been associated with serious liver injury.
Oral ibuprofen at a daily dose of 2400 mg should be avoided in patients with ischemic heart disease, cerebrovascular disease, congestive heart failure or with risk factors for cardiovascular disease.
Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.

Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAIDs may cause a dose-dependent reduction in prostaglandin formation and, secondary, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAIDs therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of P-FEN SUSPENSION in patients with advanced renal disease. Therefore, treatment with P-FEN SUSPENSION is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects.
Use in Pregnancy: See USE IN PREGNANCY & LACTATION section for further information.

Pregnant Women: P-FEN SUSPENSION are contraindicated for use during the third trimester of pregnancy because of risks of premature closure of the ductus arteriosus and the potential to prolong parturition. Caution is recommended in prescribing P-FEN SUSPENSION during the first and second trimesters of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment or failure.
P-FEN SUSPENSION should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus.
Published studies and postmarketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDs were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from the middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if P-FEN SUSPENSION treatment extends beyond 48 hours and that NSAIDs treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow up.

Short-term use, adverse effects may occur are hypersensitivity reactions; non-specific allergic reactions and anaphylaxis, respiratory tract reactivity e.g., asthma, aggravated asthma, bronchospasm, dyspnea; various skin reactions e.g., pruritus, urticarial, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur such as hypersensitivity reactions with urticaria and pruritus, abdominal pain, nausea, dyspepsia, headache, acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema, various skin rashes.

NSAIDs may enhance the effects of anti-coagulants, such as warfarin.
Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Concomitant use with corticosteroids may increase the risk of gastrointestinal ulceration or bleeding.
Combination use with anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) increase risk of gastrointestinal bleeding.
Combination use with cardiac glycosides, NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Increase risk of nephrotoxicity when use with ciclosporin.
NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
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.

Store below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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