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.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. The elderly are at increased risk of the consequences of adverse reactions.

Caution is required 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) -       Congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria)
-       Gastrointestinal disorders and chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease) (see section 4.8)
-       A history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy (see Section 4.3 and Section 4.8)
-       Renal impairment as renal function may further deteriorate (see Section 4.3 and Section 4.8)
-       Hepatic dysfunction (see Section 4.3 and Section 4.8)
-       Directly after major surgery
-       Hay fever, nasal polyps or chronic obstructive respiratory disorders as an increased risk for them of allergic reactions occurring. These may be present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria.
-       In patients who have already reacted allergically to other substances, as an increased risk of hypersensitivity reactions occurring also exists for them on use of this product.


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

Other NSAIDs
Use with concomitant NSAIDs including cyclo-oxygenase-2 selective inhibitors should be avoided.

Gastrointestinal safety
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses and 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 medicinal products (eg Misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid, or other medicinal products likely to increase gastrointestinal risk (see below and 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 stage of treatment.
Caution should be advised in patients receiving concomitant medicinal products which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti- platelet medicinal products such as acetylsalicylic acid (See Section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, 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)

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 of 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. Nurofen for Children 200 mg/5 ml Orange 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.
Masking of symptoms of underlying infections :
This medicine 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 Nurofen Forte for Children Strawberry/Orange 40mg/1ml suspension 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 ibuprofen in case of varicella.

Cardiovascular and cerebrovascular effects
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/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. ≤ 1200 mg/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 long-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.

Other notes
Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction after taking/administering Nurofen for Children 200 mg/5 ml Orange therapy must be stopped. Medically required measures, in line with the symptoms, must be initiated by specialist personnel.
Ibuprofen may temporarily inhibit the blood-platelet function (thrombocyte aggregation). Patients with coagulation disturbances should therefore be monitored carefully.
In prolonged administration of Nurofen for Children 200 mg/5 ml Orange, regular checking of the liver values, the kidney function, as well as of the blood count is required.
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 (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Through concomitant consumption of alcohol, active substance-related undesirable effects, particularly those that concern the gastrointestinal tract or the central nervous system, may be increased on use of NSAIDs.


Renal:
In general the habitual use of analgesics, especially the combination of different analgesics, can lead to lasting renal lesions with the risk of renal failure (analgesic nephropathy).
There is a risk of renal impairment in dehydrated children.

Excipient warnings:
Nurofen Forte for Children Strawberry 40mg/1ml suspension
This medicinal product contains maltitol liquid and Propylene Glycol.

Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.

This medicinal product contains 1.87 mg sodium per 1 ml suspension. To be taken into consideration by patients on a controlled sodium diet.

Nurofen Forte for Children Orange 40mg/1ml suspension
This medicinal product contains maltitol liquid.

Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.

This medicinal product contains 1.87 mg sodium per 1 ml suspension. To be taken into consideration by patients on a controlled sodium diet.

Wheat starch in this medicine contains only very low levels of gluten, regarded as gluten-free, and is very unlikely to cause problems if you have coeliac disease.
One ml contains no more than 0.06 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
For short-term use this medicinal product, has no or negligible influence on the ability to drive and use machines.