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 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.

Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors – increased risk of adverse reactions (see section "Interaction with other medicinal products and other forms of interaction).

Respiratory:
Bronchospasm may be precipitated in patients suffering from, or with a 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 "Interaction with other medicinal products and other forms of interaction).

SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section "undesirable effects").

Renal:
Renal impairment as renal function may further deteriorate (see sections "contraindications" and "undesirable effects").

Hepatic:
Hepatic dysfunction (see Sections "contraindications" and "undesirable effects") 
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 the use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.≤ 1200mg daily) is associated in an increased risk of myocardial infarction.

Impaired female fertility:
There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis NUROFEN® LIQUID CAPSULES 200mg                                                     April 2015 may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal:
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 "undesirable effects").
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 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 "contraindications"), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the 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 "Interaction with other medicinal products and other forms of interaction).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:
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 "undesirable effects"). 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. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Advice for patients with sugar-related disorders:
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.

Use in Pediatrics
Nurofen Tablets/Liquid Capsules and Nurofen Forte Tablets are not to be used in children under 12 years of age.

Nurofen Tablets 200 mg:
Advice for patients on a controlled sodium diet:
This medicinal product contains 1.1 mmol (or 25.3 mg) of sodium per 2 doses (2 tablets).
To be taken into consideration by patients on a controlled sodium diet.

Effects on Driving