Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration to control symptoms (see section 4.2 and further below gastrointestinal and cardiovascular risks).

Gastrointestinal safety

Concomitant administration of Ibufen 600 with NSAIDs, including cyclo-oxygenase-2 specific inhibitors, should be avoided.

Elderly patients:
With NSAID therapy, the elderly are at increased risk of adverse reactions, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2).

Gastrointestinal bleeding, ulceration and perforation:
Gastrointestinal bleeding, ulceration or perforation, also with fatal outcome, have been reported with all NSAIDs. They have occurred at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal effects.

The risk of gastrointestinal 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. 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 gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulcers or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When gastrointestinal bleeding or ulceration occurs in patients receiving Ibufen 600, the treatment should be withdrawn.

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

Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate decompensated heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trials suggest that use of ibuprofen, particularly at high doses (2,400 mg daily) 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 doses of ibuprofen (e.g. ≤ 1,200 mg daily) are 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 (2,400 mg daily) should be avoided.
Similar considerations should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2,400 mg daily) are required.

Cases of Kounis syndrome have been reported in patients treated with this medicine.
Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.

Severe cutaneous adverse reactions (SCARs)
Serious cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of Ibuprofen (see section 4.8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear, Ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

There have been exceptional cases of severe skin infections and soft tissue complications during varicella infection (see section 4.8). It is recommended to avoid Ibufen 600 therapy during varicella infection.

Masking of symptoms of underlying infections
Ibufen 600 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 Ibufen 600 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.

Also note:

Ibufen 600 must only be used after careful weighing of the benefit-risk-ratio
• With congenital impaired porphyrin metabolism (e.g. acute intermittent porphyria).
• With systemic lupus erythematosus (SLE) and mixed connective tissue disease (see section 4.8).

An especially careful medical supervision is necessary
• With a history of gastrointestinal disorders or with chronic inflammatory intestinal disorders (ulcerative colitis, Crohn's disease).
• With hypertension or congestive heart failure.
• With impaired renal function.
• With dehydration.
• With impaired hepatic function.
• Directly after major surgical procedures.


• With patients suffering from hay fever, nasal polyps or chronic obstructive respiratory diseases, as they are at increased risk of allergic reactions. These may be asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria.
• With patients with allergic reactions to other substances, as they are also at higher risk of hypersensitivity reactions when using Ibufen 600.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been reported very rarely. Ibufen 600 must be discontinued at the first appearance of hypersensitivity reactions after ingestion/use. Adequate therapeutic measures have to be taken by professionals.

Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Patients with coagulation disorders should therefore be monitored closely.

In long-term use of Ibufen 600, liver function, kidney function and blood count should be checked regularly.

During prolonged use of painkillers, headaches may occur, which must not be treated by increasing the medicine dose.

In general, habitual intake of painkillers, especially a combination of several analgesic active ingredients, may permanently harm the kidneys with the risk of renal failure (analgesic nephropathy).

Concomitant use of NSAIDs and alcohol may worsen undesirable effects related to the active ingredient, especially those affecting the gastrointestinal tract or the central nervous system (CNS).

Regarding female fertility, see section 4.6.

Adolescents
There is a risk of renal impairment in dehydrated adolescents.

Effects on Driving

4.7   Effects on ability to drive and use machines

Higher doses of Ibufen 600 may cause adverse reactions affecting the central nervous system such as fatigue and dizziness, and can thus influence the capacity of response in individual cases and impair the ability to drive and to use machines. This is especially true in combination with alcohol.