Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1 Cape Town, 7460
Ibuprofen should not be given to patients with:
Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma.
Ibuprofen should not be given to patients in whom aspirin and other non-steroidal antiinflammatory agents induce the symptoms of asthma, rhinitis or urticaria. Due to the possibility of cross-sensitivity due to structural relationships which exist among nonsteroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
The safety of Ibuprofen in pregnancy has not been established. Regular use of NSAID’s during the 3rd trimester of pregnancy may result in closure of foetal ductus arteriosus in utero, and possibly in persistent pulmonary hypertension in the newborn. The onset of labour may be delayed and its duration increased.
Ibuprofen should be used with caution in patients with infections since symptoms such as fever and inflammation may be masked.
Asthma sufferers should only take ADVIL LIQUI-GELS 200 after consulting their doctor.
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with ADVIL LIQUI-GELS 200 therapy.
ADVIL LIQUI-GELS 200 should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
The elderly have an increased frequency of adverse reactions to NSAID’s, especially gastrointestinal bleeding and perforation (PUB’s) which may be fatal. When gastro-intestinal bleeding or ulcerations occurs in patients receiving ADVIL LIQUI-GELS 200, treatment should be stopped.
The risk of gastro-intestinal bleeding or perforation (PUB’s) is higher with increasing doses of ADVIL LIQUI-GELS 200, in patients with a history of ulcers, and the elderly.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Discontinue treatment at the first appearance of rash, mucosal lesions, or any other sign of hypersensitivity.
Use with care in patients using anticoagulant medicines, and in elderly patients. Acute reversible renal failure has been reported.
Use with care in patients with impaired hepatic, renal or cardiac function.
Use with care together with other protein-bound medicines (e.g. tolbutamide, coumarin and hydantoin).
Use with care in patients with asthma, if a history of hypersensitivity reactions to aspirin or other NSAID’s exists, patients with hypertension.
Ibuprofen should be discontinued in patients who experience blurred or diminished vision or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.
In view of the inherent potential of ibuprofen to cause fluid retention, heart failure may be precipitated in some compromised patients.
Interactions involving NSAIDs include possible enhancement of the effects of oral anticoagulants such as warfarin and increased plasma concentrations of lithium, methotrexate, and cardiac glycosides.
The risk of nephrotoxicity may be increased if given with angiotensin-converting enzyme inhibitors, cyclosporin tacrolimus or diuretics.
There may also be an increased risk of hyperkalaemia with angiotensin-converting enzyme inhibitors and potassium-sparing diuretics.
The antihypertensive effects of some antihypertensive agents including angiotensin-converting enzyme inhibitors, beta blockers, and diuretics may be reduced.
Convulsions may occur due to an interaction with quinolones. The effects of phenytoin and sulphonylurea antidiabetics may be enhanced.
The risk of gastro-intestinal bleeding and ulceration associated with NSAIDs is increased when used with corticosteroids, anti-platelet agents and selective serotonin reuptake inhibitors (SSRI’s) or possibly alcohol, bisphosphonates, or oxpentifylline.
The concomitant use of more than one NSAID should be avoided because of the increased risk of adverse effects. There may be an increased risk of haemotoxicity during concomitant use of zidovudine and NSAID; blood counts are recommended 1 to 2 weeks after starting simultaneous use.
Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ADVIL LIQUI-GELS 200 may decrease this benefit of aspirin.
The safety of Ibuprofen in pregnancy has not been established. Regular use of NSAID’s during the 3rd trimester of pregnancy may result in closure of foetal ductus arteriosus in utero, and possibly in persistent pulmonary hypertension in the newborn and also a risk of foetal renal impairment with subsequent oligohydramnios, see “4.3. Contraindications”. The onset of labour may be delayed and its duration increased.
No data available.
No data available.
No data available.
The most frequent side-effects occurring with ibuprofen are gastro-intestinal disturbances. Reactions range from abdominal discomfort, including abdominal distension, flatulence, dyspepsia, constipation, nausea, vomiting, abdominal pain and diarrhoea to serious gastrointestinal bleeding, perforation or activation of peptic ulcer, sometimes fatal. Melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease and gastritis.
Central nervous system related side-effects include headache, cerebrovascular accident, vertigo, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia.
Hypersensitivity reactions may occur less frequently and include anaphylactic reactions, fever, angioedema, bronchospasm and rashes.
Hepatotoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions. Some patients may experience visual disturbances.
Ibuprofen can provoke bronchospasm in patients with asthma.
Ibuprofen may cause cystitis and haematuria. They may also cause acute renal failure, interstitial nephritis, nephrotic syndrome proteinuria and renal papillary necrosis. Fluid retention may occur.
Other side-effects include anaemia, aplastic anaemia, hemolytic anaemia, leukopenia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, abnormalities in liver function tests, hepatitis, jaundice, meningitis, blurred vision, changes in visual colour perception, toxic amblyopia, asthma, bronchospasm, dyspnoea, wheezing, reversible inhibition of platelet aggregation, interstitial nephritis, nephrotic syndrome, haematuria, fluid retention, swelling, hypertension, cardiac failure, myocardial infarction, angina pectoris, photosensitivity, dermatitis bullous, erythema multiforme, face oedema, rash, maculo-papular rash, pruritis, purpura, urticaria, alveolitis, pulmonary eosinophilia, pancreatitis, angioneurotic oedema, StevensJohnson syndrome, toxic epidermal necrolysis. Induction or exacerbation of colitis has also been reported. Decreased haematocrit and haemoglobin.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8
No data available.
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