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Maxigesic should not be taken with other products containing ibuprofen, paracetamol, aspirin, salicylates or with any other anti-inflammatory medicines unless under a doctor's instruction. Refer to 'Interactions' for additional information.
Haematological Effects: Blood dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring.
Coagulation Defects: Like other NSAIDs, ibuprofen can inhibit platelet aggregation. Ibuprofen has been shown to prolong bleeding time (but within the normal range), in normal subjects. Because this prolonged bleeding effect may be exaggerated in patients with underlying haemostatic defects, ibuprofen should be used with caution in persons with intrinsic coagulation defects and those on anti-coagulation therapy.
Carcinogenicity/Mutagenicity: There is nothing in the available information on ibuprofen and paracetamol to suggest an increased or novel risk of genotoxicity or carcinogenicity with co-administration of ibuprofen and paracetamol.
Reproductive and Teratogenic Effects: No information was found about the potential effects of ibuprofen on mating behavior, or early embryonic development in animals. Paracetamol reportedly does not affect reproductive performance in mice.
When administered to pregnant rats and rabbits during the period of organogenesis, ibuprofen reportedly does not affect fetal development in either species. When administered to pregnant mice throughout gestation, paracetamol reportedly results in reduced birth weights.
No information was found about the potential effects of ibuprofen on peri-/post-natal development in animals. When administered to mice throughout gestation and lactation, paracetamol reportedly resulted in reduced pup growth.
Reversible infertility has been reported in women on long-term NSAIDs.
There is nothing in the available information on ibuprofen and paracetamol to suggest an increased or novel risk of reproductive or developmental toxicity with co-administration of the two drugs in the form of Maxigesic.
Potential Laboratory Test Interferences: Using current analytical systems, paracetamol does not cause interference with laboratory assays. However, there are certain methods with which the possibility of laboratory interference exists, as described as follows: Blood Tests: Paracetamol at recommended doses does not appear to interfere with glucose analysis using currently marketed blood glucose meters. For further detail, it may be advisable to contact the specific laboratory instrumentation manufacturer.
Urine Tests: Paracetamol in therapeutic doses may interfere with the determination of 5-hydroxyindoleacetic acid (5HIAA), causing false-positive results. False determinations may be eliminated by avoiding paracetamol ingestion several hours before and during the collection of the urine specimen.
Gastrointestinal Events: Upper gastro-intestinal ulcers, gross bleeding or perforation have been described with NSAIDs. The risks increase with dose and duration of treatment, and are more common in patients over the age of 65 years. Some patients will experience dyspepsia, heartburn, nausea, stomach pain or diarrhoea. These risks are minimal when this product is used at the prescribed dose for a few days.
Maxigesic should be used with caution, and at the lowest effective dose for the shortest duration, in patients with a history of gastrointestinal haemorrhage or a history of peptic ulcers since their condition may be exacerbated. It is contraindicated in patients with active gastrointestinal bleeding and in those with peptic ulcers or other stomach disorders.
This product should be discontinued if there is any evidence of gastrointestinal bleeding.
The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.
Cardiovascular Thrombotic Events: Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use. Maxigesic is contraindicated in patients with heart problems.
Hypertension: NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking antihypertensive medicines with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing Maxigesic to patients with hypertension. Blood pressure should be monitored closely during initiation of treatment with Maxigesic and at regular intervals thereafter.
Severe Skin Reactions: NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.
Pre-existing asthma: Products containing ibuprofen should not be administered to patients with aspirin sensitive asthma and should be used with caution in patients with pre-existing asthma.
Ophthalmological effects: Adverse ophthalmological effects have been observed with NSAIDs; accordingly, patients who develop visual disturbances during treatment with ibuprofen should have an ophthalmological examination.
Combination use of ACE inhibitors or angiotensin receptor antagonists, anti-inflammatory drugs and thiazide diuretics: The use of an ACE inhibiting drug (ACE-inhibitor or angiotensin receptor antagonist), an anti-inflammatory drug (NSAID or COX-2 inhibitor) and thiazide diuretic at the same time increases the risk of renal impairment. This includes use in fixed-combination products containing more than one class of drug. Combined use of these medications should be accompanied by increased monitoring of serum creatinine, particularly at the institution of the combination. The combination of drugs from these three classes should be used with caution particularly in elderly patients.
Aseptic Meningitis: For products containing ibuprofen aseptic meningitis has been reported only rarely, usually but not always in patients with systemic lupus erythematosus (SLE) or other connective tissue disorders.
Masking Signs of Infection: As with other drugs of this class containing ibuprofen, by reducing fever this may mask the usual signs of infection.
Special Precautions: In order to avoid exacerbation of disease or adrenal insufficiency, patients who have been on prolonged corticosteroid therapy should have their therapy tapered slowly rather than discontinued abruptly when ibuprofen is added to the treatment program.
Use in Pregnancy: Category C: drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible.
NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the foetal ductus arteriosus, foetal renal impairment, inhibition of platelet aggregation and delay labour and birth.
Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Further, there is inadequate information regarding the use of Maxigesic in pregnancy. Therefore Maxigesic should not be used during pregnancy or in patients planning to become pregnant.
Use in Lactation: Maxigesic is not recommended for nursing mothers.
Use in Elderly: No adjustment in labelled dosage is necessary for older patients who require paracetamol therapy. Those who require therapy for longer than a few days should consult their physician for condition monitoring; however, no reduction in recommended dosage is necessary. However, caution should be taken with regard to the use of ibuprofen as it should not be taken by adults over the age of 65 without consideration of co-morbidities and co-medications because of an increased risk of adverse effects, in particular heart failure, gastrointestinal ulceration and renal impairment.
