Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Masking of symptoms of underlying infections:
Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Ibuprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms persist for more than 3 days, patients should be advised to consult their doctor.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).
Prolonged use of NSAIDs in the elderly is not recommended. Where prolonged therapy is required, patients should be reviewed regularly.

Other NSAIDs: The use of this product with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Respiratory: Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.

Renal: Caution is required in patients with renal impairment since renal function may deteriorate (see sections 4.3 and 4.8).
The dose should be as low as possible and renal function should be monitored.

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

Hepatic: Hepatic impairment (see section 4.8).
Gastrointestinal effects: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see section 4.8 – undesirable effects).

Gastrointestinal (GI) bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without any warning symptoms or a previous history of serious GI events.

When GI bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

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.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

Cardiovascular and cerebrovascular effects: Caution 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 (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200mg/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.
Careful consideration should also be exercised before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

Blood effects: As NSAIDs can interfere with platelet function, they should be used with caution in patients with idiopathic thrombocytopenic purpura (ITP), intracranial haemorrhage and bleeding diathesis.

Severe skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). 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. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue infectious complications. It is advisable to avoid use of ibuprofen in cases of varicella.

SLE and mixed connective tissue disease: Caution is advised in patients with systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis (see section 4.8).

Impaired female fertility: 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 upon withdrawal of treatment.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.
The diagnosis of “Medication Overuse Headache” should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Product specific special warnings:

Adex liqui-gels 200 / Ibupro liqui-gels 200/ Adex liqui-gels 400 contain Sorbitol.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Adex 200 / Adex forte 400 / Ibufen 400 / Ibupro 200 / Ibupro forte 400 contain less than 1 mmol sodium (23 mg) per caplet, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7 Effects on ability to drive and use machines
None expected at recommended dose and duration of therapy.