Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

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

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

SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease, due to increased risk of aseptic meningitis (see section 4.8).

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 trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (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). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.
≤ 1200mg daily) is associated with an increased risk of myocardial infarction.

Renal:
Renal impairment as renal function may further deteriorate (See section 4.3 and Section 4.8).
There is a risk of renal impairment in dehydrated children (See section 4.3 and section 4.8).

Hepatic:
Hepatic dysfunction (See section 4.3 and 4.8).

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 upon withdrawal of treatment.

Gastrointestinal effects:
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their conditions may be exacerbated (see section 4.8).
Gastrointestinal 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.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, 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.

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 acetylsalicylic acid (aspirin) (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Severe skin reactions:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis, have been reported very 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 generalized exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.

Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Masking of symptoms of underlying infections:
Children's Advil 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 Children's Advil 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.

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. Thus, it is advisable to avoid use of Children’s Advil in case of varicella.

This medicine contains sucrose at a concentration of 2.5 g / 5 ml. This should be taken into account in patients with diabetes mellitus .
This medicine contains less than 1 mmol sodium (23 mg) per 15 ml, that is to say essentially ‘sodium-free’.
This medicine contains sorbitol. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicine contains 12.5 mg Sodium benzoate in each 5 ml.
Advil Children's Fruit Flavor contains a maximum of 0.4mg benzyl alcohol in each mL of suspension. Benzyl alcohol may cause allergic reactions.
Advil Children's Grape Flavor contains 1.9mg of propylene glycol in each mL of suspension.

Effects on Driving

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