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IBUPROFEN is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ibuprofen is indicated for use in children, aged 3 months (weighing more than 5 kg) and upwards. Short term symptomatic treatment of mild to moderate pain and fever. Short-term symptomatic treatment of pain and feverishness associated with common cold and influenza.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Paediatric population For infants aged 3 - 6 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children aged from 6 months this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Doses should be given every 6-8 hours. Leave at least 4 hours between doses. Recommended daily dose is 20 mg/kg in divided doses. The respective dosing interval should be chosen in line with the symptomatology. The maximal daily dose should not be exceeded.
4). Method of administration For oral administration and short-term use only. To be taken preferably with or after food. A plastic syringe (5 ml) is provided with the bottle to aid correct dosing. Not to be given to children under 3 months of age.
The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis has been observed. Undesirable effects are mostly dose-dependent. Especially the risk for the occurrence of gastrointestinal bleedings depends on the dosage range and duration of the treatment.
4. g. g. pruritus, urticaria, purpura, angioedema and very rarely exfoliative and bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis). g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described.
If signs of an infection occur or get worse during use of IBUPROFEN, the patient is recommended to go to a doctor without delay. In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.
4). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Adverse events which have been associated with ibuprofen are given below, tabulated by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
System Organ Class Frequency Adverse Reaction Uncommon RhinitisInfections and infestations Very rare Aseptic meningitis Blood and lymphatic system disorders Very rare Leucopoenia, thrombocytopenia, neutropenia, agranulocytosis aplastic anaemia and haemolytic anaemia.
The first symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion unexplained bleeding and bruising. Uncommon Hypersensitivity reactions such as urticaria, pruritus, purpura and exanthema as well as asthma attacks (sometimes with hypotension) Rare Lupus erythematosus syndrome Immune system disorders Very rare Severe hypersensitivity reactions.
The use of Ibuprofen 100mg/5ml suspension with concomitant NSAIDs, including cyclooxygenase 2 selective inhibitors, should be avoided. Asthmatic patients are to seek their doctor’s advice before using ibuprofen (see below). 2, and GI and cardiovascular risks below).
Higher than recommended doses may cause serious risks. g. 6) Special care has to be taken in the following cases: - Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease) - Cardiac insufficiency and hypertension - Reduced renal function - Hepatic dysfunction - Disturbed haematopoiesis - Blood coagulation defects - Allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease or bronchial asthma as an increased risk of allergic reactions occurring in these patients.
These allergic reactions may present as asthma attacks (so-called analgesic asthma) Quincke’s oedema or urticaria - Immediately after major surgical interventions Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.
5). When GI bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn. 8). 2). Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required 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.
1. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs). Active or a 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. 4, Special warnings and precautions for use). Bleeding diathesis and coagulation disorders. Significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
Cerebrovascular or other active bleeding. Children under 3 months of age. 6 Pregnancy and lactation).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The symptoms may include: facial oedema, swelling of the tongue, internal laryngeal swelling with constriction of the airways, dyspnoea, tachycardia, fall of blood pressure to the point of life-threatening shock. Metabolism and nutrition disorders Not known Decreased appetite, hypokalaemia*.
Uncommon Anxiety Psychiatric disorders Rare Depression, confusional state, hallucinations Common Headache, somnolence, agitation, dizziness, insomnia, irritability Uncommon Paraesthesia, Nervous system disorders Rare Optic neuritis Eye disorders Uncommon Visual impairment Rare Toxic optic neuropathy Ear and labyrinth disorders Common Vertigo Uncommon Impaired hearing Very rare Tinnitus Cardiac disorders Very rare Palpitations, heart failure, myocardial infarction, acute pulmonary oedema, oedema Not known Kounis syndrome Vascular disorders Very rare Hypertension Respiratory, thoracic and mediastinal disorders Uncommon Asthma,bronchospasm, dyspnoea Gastrointestinal disorders Common Dyspepsia, diarrhoea, nausea, vomiting abdominal pain, flatulence, constipation Uncommon Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation Very rare Oesophagitis, pancreatitis,intestinal strictures, melena, haematemesis, gastrointestinal haemorrhage Not known Colitis and Crohn’s disease Hepatobiliary disorders Uncommon Hepatitis, jaundice, hepatic function abnormal Rare Liver injury Very rare Hepatic failure Skin and subcutaneous tissue disorders Uncommon Rash, urticaria, pruritus, purpura, photosensitivity reaction Very rare Severe cutaneous adverse reactions (SCARs) (including erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis) Alopecia Necrotising fasciitis Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Very rare Tubulointerstitial nephritis, nephrotic syndrome and renal failure, acute renal failure, papillary necrosis (especially in long-term use associated with increased serum urea ) Not known Ureteric colic, dysuria, renal tubular acidosis*.
General disorders and administration site conditions Common Fatigue Rare Oedema *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.
Reporting of suspected adverse reactions Reporting suspected adverse drug reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk-balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). 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.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications.
To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Ibuprofrn in case of varicella. Renal effects Ibuprofen may cause the retention of sodium, potassium and fluid in patients who have not previously suffered from renal disorders because of its effect on renal perfusion.
This may cause […]