Nurofen Meltlets 200mg Orodispersible Tablets
- Revised
- August 2023
- Source updated
- 04 Sep 2023
- MA number
- PL 00327/0130
- ATC
- M01AE01
- Legal status
- Pharmacy General Sales List
Indications
Concepts (40)
+Angioedema (deep swelling)Contraindicated
Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous
Source SmPC ↗+Bleeding riskContraindicated
the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester
Source SmPC ↗+Heart conditionsContraindicated
ry of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6).
Source SmPC ↗+Stomach and gutContraindicated
the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester
Source SmPC ↗+Liver conditionsContraindicated
ry of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6).
Source SmPC ↗+Allergy to the medicineContraindicated
Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or hi
Source SmPC ↗+BlockageContraindicated
a) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6).
Source SmPC ↗+PregnancyContraindicated
or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6).
Source SmPC ↗+Kidney conditionsContraindicated
ry of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6).
Source SmPC ↗+Breathing conditionsContraindicated
Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous
Source SmPC ↗+Taken with other medicinesWarning
and perforation which may be fatal. Respiratory: Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease. Other NSAIDs: The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis (See section 4.8). Renal: Renal impairment as
Source SmPC ↗+Older peopleWarning
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Respiratory: Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease. Other NSAIDs: The use of ibuprofen with concomitan
Source SmPC ↗+Salt and mineral balanceWarning
is (See section 4.8). Renal: Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. Hepatic: Hepatic dysfunction (see sections 4.3 and 4.8). Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or pharmacist) is required prior to starting treatment in
Source SmPC ↗+Intolerance to an ingredientWarning
medicine is administered for pain or fever in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Caution is required in patients with phenylketonuria or who are intolerant to phenylalanine. The product contains aspartame which is a source of phenylalanine. Each orodispersible tablet contains a source equivalent to 14 mg of phenylalanine. This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains less than 1mmol sodium (23 mg) per dose that i
Source SmPC ↗+FertilityWarning
eatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. Impaired female fertility: There is limited evidence that drugs which inhibit cyclooxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of t
Source SmPC ↗+InfectionWarning
sease. Other NSAIDs: The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis (See section 4.8). Renal: Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosi
Source SmPC ↗+Acid build-up in the bloodWarning
is (See section 4.8). Renal: Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. Hepatic: Hepatic dysfunction (see sections 4.3 and 4.8). Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or pharmacist) is required prior to starting treatment in
Source SmPC ↗+Sodium and potassium contentWarning
rsible tablet contains a source equivalent to 14 mg of phenylalanine. This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains less than 1mmol sodium (23 mg) per dose that is to say essentially 'sodium-free'. The label will include: Read the enclosed leaflet before taking this product. Do not take if you: • have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding • are
Source SmPC ↗+ChildrenWarning
tosus and mixed connective tissue disease - increased risk of aseptic meningitis (See section 4.8). Renal: Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including dose
Source SmPC ↗+Sugar alcoholsWarning
tonuria or who are intolerant to phenylalanine. The product contains aspartame which is a source of phenylalanine. Each orodispersible tablet contains a source equivalent to 14 mg of phenylalanine. This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains less than 1mmol sodium (23 mg) per dose that is to say essentially 'sodium-free'. The label will include: Read the enclosed leaflet before taking this product. Do not tak
Source SmPC ↗+Serotonin effectsWarning
available. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Severe skin reactions Serious skin reactions, some of them fatal, including exfoliativ
Source SmPC ↗+Blood clotsWarning
equired prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treat
Source SmPC ↗+UnclassifiedWarning
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Respiratory: Bronchospasm may be precipitated in p
Source SmPC ↗+Blood vessel conditionsWarning
mple myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus,
Source SmPC ↗+BreastfeedingPregnancy
y occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, Nurofen is contraindicated during the third trimester of pregnancy. Lactation/Breastfeeding: In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely. See section 4.4 regarding female fertility.
Source SmPC ↗+AlcoholNot in scanned sections
+Benzyl alcoholNot in scanned sections
+Obstructed blood flow from the heartNot in scanned sections
+DehydrationNot in scanned sections
+Hormone disordersNot in scanned sections
+Enzyme deficiencyNot in scanned sections
+Heart rhythm blockNot in scanned sections
+LactoseNot in scanned sections
+Eye conditionsNot in scanned sections
+PorphyriaNot in scanned sections
+Propylene glycolNot in scanned sections
+Heart rhythm (QT interval)Not in scanned sections
+ShockNot in scanned sections
+ThyroidNot in scanned sections
+Gap needed after another medicineNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
3 years
§6.4 — Special precautions for storage
Do not store above 25°C.