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 possible 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 Nurofen Cold & Flu 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 – increased risk of aseptic meningitis (see section 4.8).

Renal:
Moderate to severe renal impairment as renal function may further deteriorate, especially in dehydrated children and adolescents. (see sections 4.3 and 4.8) Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

Hepatic:
Hepatic dysfunction (see sections 4.3 and 4.8)

Cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of occlusive vascular disease, hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in associated with NSAID therapy.

Clinical trial and epidemiological data suggest that the 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.

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:
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).

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time 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 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 aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Ischaemic colitis
Some cases of ischaemic colitis have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other systems or ischaemic colitis develop.

Severe cutaneous adverse reactions (SCARS) :
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), and 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 and pseudoepherine-containing products (see section 4.8).


This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, Most of these reactions occurred within the first month.
If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately, and an alternative treatment considered (as appropriate ).

Masking of symptoms of underlying infections:
This medicinal product 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 this medicine 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.

To be used with caution in patients with cardiovascular disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes,
phaeochromocytoma, closed angle glaucoma or elevated intraocular pressure, prostatic enlargement, hyperexcitability.

To be used with caution in combination with antihypertensives including adrenergic neurone blockers & Beta blockers (see section 4.5). The effects of a single dose on the blood pressure of these patients should be 
observed before         recommending repeated or unsupervised treatment.

To be used with caution with other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psycho-stimulants (see section 4.5).

If hallucinations, restlessness, or sleep disturbances are experienced whilst taking the product, use of the product should be discontinued.

Ischaemic optic neuropathy
Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
Cases of PRES and RCVS have been reported with the use of pseudoephedrine containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3).
Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.

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.


Excipients
 This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Speak to a pharmacist or your doctor before taking if you:
• Have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
• Are a smoker
• Are pregnant

If symptoms persist, consult your doctor.

Effects on Driving

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