ROFEN, IBUPROFEN

4).

Posology:

Adults and children over 12 years of age: The recommended dosage of Ibuprofen Tablets is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided doses.

Paediatric population:

The daily dosage of Ibuprofen Tablets is 20 mg/kg of body weight in divided doses. For young children, more suitable formulations are available. In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.

Not recommended for children weighing less than 7 kg.

Elderly:

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. Method of administration For oral administration. It is recommended that patients with sensitive stomachs take Ibuprofen Tablets with food. If taken shortly after eating, the onset of action of Ibuprofen Tablets may be delayed.

To be taken preferably with or after food, with plenty of fluid. Ibuprofen Tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.

Gastrointestinal disorders: the most commonly observed adverse events are gastro- intestinal in nature. 4). 4) have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.

Immune system disorders: hypersensitivity reactions have been reported following treatment with NSAIDs. ).

Cardiac disorders and vascular disorders:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. 4). 4). Exacerbation of infection-related inflammations 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 therefore recommended to go to a doctor without delay.

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"). The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency convention and system organ classification.

Frequency groupings are classified according to the subsequent conventions: very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

g. Tubulointerstitial nephritis, nephrotic syndrome and renal failure Common FatigueGeneral disorders and administration Rare Oedema 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2, and GI and cardiovascular risks below). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medication. As with other NSAIDs, ibuprofen may mask the signs of infection.

5). 2).

Paediatric population:

There is a risk of renal impairment in dehydrated children and adolescents.

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 GI events. 3), and in the elderly. These patients should commence treatment on the lowest dose available.

g. 5). Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal 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). 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.

1. g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer, or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. 4). 6).