Advil Forte 400

/ Neopharm

For oral administration and short term use only.
Adults, the elderly and young persons over 12 years of age: The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, the patient should consult a doctor.
If in children or adolescents between 12 -18 years of age, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
1 capsule up to 3 times a day, as required.
The capsules should be taken with water.
Doses should be given approximately every 6-8 hours, with a minimum interval of 4 hours between each dose. Do not take more than 1200 mg (3 capsules) in any 24 hour period.
Not to be used for children under 12 years of age.

Relief of mild to moderate pain such as headache, pain associated with migraine, toothache, menstrual pain, backache, muscular pain, anti-inflammatory for rheumatic disease, reduction of fever.

Hypersensitivity to ibuprofen or any of the constituents in the product.
Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
Active or previous peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAID therapy.
Cerebrovascular bleeding, other active bleeding or haematological disease.
Severe hepatic failure, severe renal failure or severe heart failure.
Use in third trimester of pregnancy.

Caution is required in patients with certain conditions:
– systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis.
– gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn’s disease).
– Caution is required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate. The dose should be as low as possible and renal function should be monitored.
There is a risk of renal impairment in dehydrated children or adolescents between 12 -18 years of age.
See prescribing information for full details.

Hypersensitivity reactions have been reported and these may consist of:
a) Non-specific allergic reactions and anaphylaxis,
b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea,
c) Various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
See prescribing information for full details.

Ibuprofen should not be used in combination with:
Aspirin: unless low dose aspirin (not above 75mg 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 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.
Other NSAIDs including cyclooxygenase-2 selective inhibitors, as these may increase the risk of adverse effects.
Ibuprofen should be used with caution in combination with:
Corticosteroids: may increase the risk of adverse reactions, especially of the gastrointestinal tract.
Antihypertensives and diuretics: NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Anticoagulants: NSAIDS may enhance the effects of anticoagulants, such as warfarin.
When taking anticoagulants it should be taken into account that long-term use of ibuprofen may increase the risk of 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. Serum digitalis concentrations should therefore be monitored in patients with decreased renal function or congestive heart failure.
Lithium: There is evidence for potential increase in plasma levels of lithium which may be clinically significant.
Methotrexate: There is the potential for increased plasma levels of methotrexate. Concomitant administration of ibuprofen with moderate and high doses of methotrexate may lead to serious and fatal methotrexate toxicity. Patients with reduced renal function may be at additional risk of toxicity from the combination even when low doses of methotrexate (≤20 mg/week) are used.
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 of haemarthroses and haematoma in HIV positive 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.
Phenytoin: Ibuprofen may increase pharmacologically active free phenytoin. Patients taking ibuprofen for long-term use should be monitored.
Antacids: Certain antacids may increase the gastrointestinal absorption of ibuprofen. This is considered to be of clinical relevance particularly during long-term use of ibuprofen.

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.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
– cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
– renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
the mother and the neonate, at the end of pregnancy, to:
– possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
– inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Lactation: Ibuprofen appears in breast milk in very low concentrations, and is unlikely to affect the breast fed infant adversely.
See prescribing information for full details.

In children ingestion of more than 400mg/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 vertigo, headache, respiratory depression, dyspnoea, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, hypotension, hyperkalaemia, and 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: should be symptomatic and supportive and include 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  ronchodilators for asthma.

Storage: Store below 25°C.
Shelf life: 3 years.