The elderly have an increased frequency offrequency adverse adverse reactions toto NSAIDs especially gastrointestinal bleedingand andperforation perforationwhich whichmay maybe be fatal. Use Use with NSAIDs, including selective inhibitors, should Increased risk ofof aseptic meningitis with especially gastrointestinal bleeding with concomitant concomitant NSAIDs,inhibitors, includingcyclooxygenase-2 cyclooxygenase-2 inhibitors, shouldbe beavoided.
Increased risk of Increased asepticrisk meningitis with with Systemic lupus erythematosus and mixedconnective connectivetissue tissuedisease.
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GI bleeding, ulceration or perforation, which can be fatal, has been reported with NSAIDs anytime timeduring duringtreatment, treatment,with withororwithout withoutany anywarning warningsymptoms symptomsor oraaprevious previoushistory history of of serious GI GI events. The risk of GI bleeding, ulceration orserious perforation is higher with increasing NSAID doses, in patients withdoses, a history of with ulcer, particularly if complicated with haemorrhage perforation, andininthe theelderly.
These Thesepatients patientsshould shouldcommence commencetreatment treatmenton onthe thelowest lowestdose dose available. Combination Combination therapy with agents e. Combination therapy with protective agents e. Patients Patientswith withaahistory historyof ofGI GItoxicity, toxicity, particularly particularly when elderly, elderly, should report abdominal especially GIGIbleeding particularly ininthe initial When GIGI bleeding or concomitant low dose aspirin, oror other should report any any unusual unusual abdominalsymptoms symptoms especially bleeding initialstages stagesofoftreatment.
Caution Cautionshould shouldbe be advised advised in patients patients receiving receiving concomitant medications which increase ofofulceration or bleeding, anticoagulants such asas ulceration occurs in in patients receiving concomitant whichcould could increasethe therisk risk ulceration bleeding,such suchasasoral oralcorticosteroids, corticosteroids, anticoagulants such hdrawn. Caution should be advised in patients receiving concomitant medications whichincould increase the risk medications of ulceration or bleeding, such as oralorcorticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin.
Caution discussion with doctor or pharmacist is required prior to treatment in patients with a history of controlled or uncontrolled hypertension, congestive heart failure, cardiac oedema, established selective serotonin reuptakeor inhibitors or anti-platelet agents suchprior as aspirin. Similar Similarconsideration considerationshould shouldbe bemade made before before initiating longer-term longer-term treatment with factors for events hyperlipidaemia, diabetes mellitus and smoking.
Prolonged use any type painkillerforforheadaches headachescan canmake makethem themworse. IfIfthis thissituation situationisisexperienced experiencedor orsuspected, suspected, medical medical advice should should be be obtained and treatment be The ofof'Medication Overuse should suspected inin patients who have use ofof any ofof painkiller obtained treatment should should bediscontinued. Thediagnosis diagnosis 'Medication OveruseHeadache Headache shouldbebe suspected patients have n is Prolonged experienced ortype suspected, medical advice should be obtained and treatment should be advice discontinued.
The and diagnosis of 'Medication Overuse Headache should be suspected in patients who who have frequent or daily headaches despite or because of the regular use of headache medications. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses mg daily and in long term treatment may be associated with a small increased risk of of arterial frequent ortrial daily headaches despite or because of the regular use ofthat headache Clinical particularly trial and epidemiological data suggest mg that use of ibuprofen, particularly at high dosestreatment mg daily may and in be longassociated term treatment with may beaassociated with a small increased arterial ns.
Clinical and epidemiological data suggest usemedications. Overall, Overall,epidemiological epidemiologicalstudies studiesdo donot notsuggest suggestthat that low low dose dose ibuprofen ibuprofen e. Serious skin reactions, some ofofthem fatal, including Exfoliative thrombotic events for example myocardial daily is associated with an increased risk of myocardial infarction. Serious skin reactions, some them fatal, including Exfoliative tudies do not suggest that low dose ibuprofen e. Serious skin reactions, some of them fatal, including Exfoliative Dermatitis, Stevens-Johnson syndromeand andToxic ToxicEpidermal EpidermalNecrolysis, Necrolysis,have havebeen beenreported reported veryrarely rarelyin inassociation association with the the use of of NSAIDs.
Patients Patients appear to be at risk these reactions early ofoftherapy, the ofofthe occurring inin the majority of of cases Dermatitis, syndrome at highest highest riskof of reactionsthe earlyin inthe thecourse course therapy, theonset onset thereaction reaction occurring the majority cases very rarelyStevens-Johnson in association with the use of NSAIDs. Patients appearvery to be at highest with risk ofuse these reactions appear earlytoinbethe course ofthese therapy, onset of the reaction occurring in the majority of cases within the first month of treatment.
Nurofen Express Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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Renal impairment as renal function may deteriorate. Hepatic dysfunction.
Patients with bronchospasm or SLE within the first monthof ofskin treatment. Nurofen Expresslesions, Tablets should be discontinued at the appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Renal impairment as renal functiondysfunction. Patients with bronchospasm or SLE first appearance rash, mucosal or any other sign offirst hypersensitivity.
Hepatic Patients with bronchospasm or SLE should consult their doctor before taking this medicine. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. Bronchospasm may precipitated in patients suffering from ordisease. This is reversible on withdrawal of treatment. As NSAIDs can interfere with platelet function, they should be used with caution in patients with intracranial haemorrhage and bleeding diathesis.
If you are pregnant, elderly or have impairmentAs of female fertility by an effect on ovulation. NSAIDswith can interfere with in platelet function,with they should be used with caution in patientsand with intracranial haemorrhage andIfbleeding diathesis. If you areelderly pregnant, or elderly or have reatment. NSAIDs can interfere with platelet function, they should beAsused caution patients intracranial haemorrhage bleeding diathesis.
Each tablet contains an average of This should be considered in patients whose overall intake of sodium must be markedly restricted. This should be considered in patients overall intake of sodium must be markedly restricted. There is a risk of renal impairment in dehydrated adolescents. Interaction with other medicinal products and other forms of interaction: known to interact with the following please see SPC for full details : Corticosteroids, Anti-coagulants, Anti-platelet agents and SSRIs , Anti-hypertensive is a risk ofand renalother impairment in dehydrated adolescents.
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Fertility, Pregnancy and Lactation: Ibuprofen is not recommended during the first six months of pregnancy and is contraindicated in the last trimester of pregnancy. Ibuprofen and its metabolites can pass in very small concentrations into the breast milk. No mended during months of pregnancy and is contraindicated in the last of pregnancy. Ibuprofen its metabolites pass initsvery small concentrations into the breast milk.
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No antibiotics and lowthe dose first aspirin. No harmful effects to infants are known, so it is not necessary to interrupt breast-feeding for short-term treatment with the recommended dose for mild to moderate pain and fever. Side Effects: Haematopoietic disorders anaemia, leucopenia, thrombocytopenia, pancytopenia, ort-term treatment the so recommended for mild to moderate and fever. Side Effects: Haematopoietic anaemia, leucopenia, thrombocytopenia, pancytopenia, harmful effects to infantswith are known, it is not necessary to dose interrupt breast-feeding for short-term pain treatment with the recommended dose for mild to moderate paindisorders and fever.
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Side Effects: Haematopoietic disorders anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis are very rare - first signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding, and bruising. Hypersensitivity reactions consisting of urticaria and pruritus uncommon , severe hypersensitivity reactions including likeagranulocytosis symptoms,are severe nose bleeding, andflu-like bruising.
Hypersensitivity reactions consisting of urticaria and reactions pruritus uncommon , severe reactions reactions including very rareexhaustion, - first signs are fever, soreand throat,skin superficial mouth ulcers, symptoms, severe exhaustion, nose and skin bleeding, and bruising. Hypersensitivity consisting of urticaria and pruritus hypersensitivity uncommon , severe hypersensitivity including tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension anaphylaxis, angioedema or severe shock are very rare.
Aggravated asthma, bronchospasm. Respiratory tract reactivity comprising asthma or dyspnoea. Headache, dizziness. Aseptic meningitis very rare. Impaired matongue or severe shock are very rare. Aseptic very rare. Impaired and laryngeal swelling, dyspnoea, tachycardia, hypotension anaphylaxis, angioedema or severe shock are very rare. Headache,meningitis dizziness. Impaired hearing uncommon. Cardiac failure, oedema, hypertension very rare. Abdominal pain, nausea and dyspepsia uncommon Diarrhoea, flatulence, constipation and vomiting rare. Peptic ulcers, perforation or gastrointestinal haemorrhage, malaena, haematemesis, sometimes fatal, ausea and dyspepsia uncommon flatulence, constipation and vomiting rare.
Pepticflatulence, ulcers,constipation perforation or gastrointestinal malaena, haematemesis, sometimes fatal,fatal, hearing uncommon. Cardiac failure, oedema,Diarrhoea, hypertension very rare. Abdominal pain, nausea and dyspepsia uncommon Diarrhoea, and vomiting rare. Liver disorders, especially in long-term treatment very rare. Severe forms of skin reactions such as bullous reactions including Stevens-Johnson Syndrome, erythema multiforme disease very rare. Liver disorders, especially long-term treatment very rare.
Severe forms of skin reactions such as bullous reactions including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur very rare. Acute renal failure, papillary necrosis, especially in long-term use associated with increased serum urea and oedema very rare , decreased haemoglobin levels and decreased urea clearance very rare. Name and Address of Marketing specially long-term use associated with increased serum urea especially and oedema very rare , decreased levels and urea clearance very rare.
Name and Address Marketing and toxicin epidermal necrolysis occur very rare. For product queries, please call 01 or contact the MAH above.