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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: For short term symptomatic treatment of mild to moderate pain such as headache, dysmenorrhea (period pain), dental pain, and fever and pain in the common cold.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration and short term use only. 4). Adults: 200mg – 400mg, up to three times a day as required. Leave at least four hours between doses of 200mg and six hours between doses of 400mg and do not take more than 1200mg in any 24 hour period.
If this medicinal product is required for more than 3 days in the case of fever or for more than 4 day for the treatment of pain, or if the symptoms do not improve or worsen a doctor should be consulted. Adolescents ≥ 40 kg (12 years of age and above): 200mg – 400mg, up to three times a day as required.
Leave at least four hours between doses of 200mg and six hours between doses of 400mg and do not take more than 1200mg in any 24 hour period. If this medicinal product is required for more than 3 days or if symptoms worsen a doctor should be consulted.
It is recommended that patients with a sensitive stomach take Ibuprofen 200 mg Coated Tablets with food.
Special patient groups Paediatric Population:
Not recommended for adolescents weighing under 40 kg or children under 12 years of age.
Elderly Population:
The elderly are at increased risk of 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 regularly for GI bleeding during NSAID therapy.
If renal or hepatic function is impaired, dosage should be assessed individually.
Renal impairment:
Caution should be taken with ibuprofen dosage in patients with renal impairment. The dosage should be assessed individually. 4).
Hepatic impairment:
Caution should be taken with dosage in patients with hepatic impairment. 3).
).
Renal:
Hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur. 8 Undesirable effects). As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other pathologic changes in the kidney.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependant reduction in prostaglandin formation and, in the second place, in renal blood flow, which may cause kidney failure.
Those who are at greatest risk of this are patients with renal impairment, heart failure, hepatic dysfunction, the elderly and patients on diuretics or ACE inhibitors. There is risk of renal impairment in dehydrated adolescents.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. 8) Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
3), and in the elderly. These patients should commence treatment on the lowest possible dose available. g. 5). 5). When gastrointestinal bleeding or ulceration occurs in patients receiving Ibuprofen 200 mg Coated Tablets, the treatment should be withdrawn.
8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen 200 mg Coated Tablets should be discontinued at the first appearance of skin rash mucosal lesions, or any other sign of hypersensitivity.
). Patients with cerebrovascular or other active bleeding. Patients with blood coagulation disorders. Patients with unclarified blood-formulation disturbances. Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
Last trimester of pregnancy (see section
1. g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). 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 hepatic failure, severe renal failure or severe heart failure (NYHA Class IV) (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Ibuprofen 200 mg Coated Tablets in case of varicella.
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.
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.
Information about some of the ingredients in this medicine:
Contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Other notes:
Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after taking/administering Ibuprofen 200 mg Coated Tablets therapy must be stopped. Medically required measures, in line with symptoms, much be initiated by specialist personnel.
In prolonged administration of Ibuprofen 200 mg Coated Tablets regular checking of the liver values, the kidney function, as well as of the blood count, is required. Ibuprofen, the active substance of Ibuprofen 200 mg […]