IBUPROFEN

For oral use. For short-term use only. 4).

Adults:

If the medicinal product is required for more than 4 days for pain or 3 days for fever and migraine headaches or if the symptoms worsen, the patient should consult a doctor.

Adolescents (12 years of age and above):

If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. If people experience mild indigestion it is recommended to take this medicine with food or milk to avoid gastrointestinal problems.

Adults and adolescents from ≥40 kg in weight (12 years of age and above): 400 mg (one capsule) with water. 400 mg (one capsule) to be repeated, if necessary, with intervals of at least 6 hours. Do not take more than 1200 mg ibuprofen (three capsules) in any 24 hour period.

Special patient groups The elderly and patients with renal and hepatic impairment should always start treatment with the lowest effective dose.

Paediatric population:

Ibuprofen 400 mg capsule, soft is contraindicated in adolescents under 40 kg body weight and in children, see section

The list of the following undesirable effects comprises all undesirable effects that have become known under treatment with Ibuprofen, also those under high-dose long-term therapy in rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1200 mg Ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.

With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary interindividually. The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration.

Less frequently, gastritis has been observed. Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Hypersensitivity reactions have been reported and these may consist of: a. Anaphylaxis and non-specific allergic reactions, b.

Respiratory tract reactivity comprising bronchospasm, asthma, aggravated asthma, or dyspnoea, c. g. rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme), angioedema, pruritus and urticaria.

Adverse reactions have been ranked under headings of frequency using the following convention: 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) ); not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. development of necrotizing fasciitis) coinciding with the use of nonsteroidal anti-inflammatory drugs has been described. This is possibly associated with the mechanism of action of the nonsteroidal anti- inflammatory drugs.

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 an anti- infective/antibiotic therapy.

8). g. acute intermittent porphyria). 8). 5). 8). 8). - directly after major surgery. 3). - in patients who suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk exists for them of allergic reactions occurring.

3). 8). 6). - There is some 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. 2 and gastrointestinal and cardiovascular risks below).

There is a risk of renal impairment in dehydrated adolescents. 5). 2).

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 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). 7). 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 high doses (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.

3.

Elderly:

No special dose adjustment is required. 4), it is recommended to monitor the elderly particularly carefully. 3). 3). 1. g. bronchospasms, asthma, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Bleeding diathesis or coagulation disorders. 4). Patients with cerebrovascular or other active bleeding. 5). Patients with unclarified blood-formation disturbances.

Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). We do not recommend taking Ibuprofen 400 mg Capsule, Soft if you are pregnant. Adolescents under 40 kg body weight and children.