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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 contains the active substance ibuprofen. Ibuprofen belongs to a group of medicines called NSAID (nonsteroidal anti- inflammatory drugs) which work by reducing pain, inflammation and fever. Ibuprofen is used for the symptomatic treatment of mild to moderate pain including migraine headache period pain and/or…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration. 4). During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor. The tablets should be swallowed with a drink of water or milk and should be taken preferably with or after food.
It is recommended that patients with sensitive stomachs take ibuprofen with food. If taken shortly after eating, the onset of action of ibuprofen may be delayed. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.
Adults and children over 12 years:
The usual dosage is 600 to 1800 mg spread throughout the day. Your doctor may choose to increase this depending on what you are being treated for; but no more than 2400 mg should be taken in one day. Children: 20 mg per kg of body weight daily, given in divided doses.
Not recommended for children weighing less than 7 kg. For young children, more suitable formulations are available. In cases of severe juvenile arthritis your doctor may increase the dosage up to 40 mg per kilogram.
Elderly:
The elderly are at an increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored for GI bleeding during NSAID therapy.
If renal or hepatic function is impaired, dosage should be assessed individually. 3 – Contraindications) Hepatic impairment: For patients with mild to moderate hepatic impairment (see section
The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency convention and system organ classification. g. 4) Cardiac disorders Not Known Kounis Syndrome Vascular disorders Very rare Hypertension *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.
, development of necrotising fasciitis) coinciding with the use of non-steroidal anti- inflammatory drugs has been described. This is possibly associated with the mechanism of action of the non-steroidal anti-inflammatory drugs. 4). If signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to go to a doctor without delay.
It is to be investigated whether there is an indication for anti-infective/antibiotic therapy.
Gastrointestinal disorders:
The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following ibuprofen administration. Less frequently, gastritis duodenal ulcer, gastric ulcer and gastrointestinal perforation has been observed.
Pancreatitis has been reported very rarely.
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders including rashes of various types, pruritis, urticaria, purpura, angiodema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiac disorders and vascular disorders:
3- Contraindications). 3 Contraindications Hypersensitivity to ibuprofen or to any of the excipients. This drug should not be given to patients with active, or history of re-current ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) in the stomach or small intestine (duodenum).
g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. 4). 6). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
Any active bleeding (including in the brain). This product should not be given to patients with conditions involving an increased tendency to bleeding. 4 Special warnings and precautions for use This drug contains lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the total lactose deficiency or glucose-galactose malabsorption should not take this medication. Additionally, this drug contains sucrose and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product also contains sodium benzoate which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). 12 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. As with other NSAIDs, ibuprofen may mask the signs of infection.
The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of analgesic medication. Patients with medication overuse headache should not be treated by increasing the dose of the analgesic.
In such cases the use of analgesics should be discontinued. The concomitant consumption of excessive alcohol with NSAIDs, including ibuprofen may increase the risk of adverse effects on the gastrointestinal tract, such as GI haemorrhage or the central nervous system, possibly due to an additive effect.
Hypersensitivity to ibuprofen or to any of the excipients. This drug should not be given to patients with active, or history of re-current ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) in the stomach or small intestine (duodenum).
g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. 4). 6). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
Any active bleeding (including in the brain). This product should not be given to patients with conditions involving an increased tendency to bleeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4).
Skin and subcutaneous tissue disorders:
In exceptional cases, severe skin infections and soft- tissue complications may occur during a varicella infection (see also "Infections and infestations").
Photosensitivity reactions:
Frequency unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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2, and GI and cardiovascular risks below). 5). 2).
Paediatric population:
There is a risk of renal impairment in dehydrated children and adolescents.
Respiratory disorders and hypersensitivity reactions:
Caution is required if ibuprofen is administered to patients suffering from, or with a previous history of, bronchial asthma. chronic rhinitis or allergic diseases since NSAIDs have been reported to precipitate bronchospasm, urticaria or angioedema in such patients Cardiac, renal and hepatic impairment: The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.
The habitual concomitant intake of various similar painkillers further increases this risk. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
3). Ibuprofen should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration. Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial data suggest that use of ibuprofen, particularly at a high dose (2400mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
g. ≤ 1200mg daily) 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.
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. […]