Spedifen Special Precautions

General warning for the use of systemic non-steroidal anti-inflammatory drugs (NSAIDs).
Gastrointestinal effects: Gastrointestinal ulceration, haemorrhage or perforation may occur at any time during treatment with non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 selective or not, also without warning symptoms or history. To reduce risk, the lowest effective dose should be administered over the shortest possible duration of treatment.
Patients with a history of gastrointestinal toxicity, especially those of advanced age, should report any unusual abdominal symptoms (especially gastrointestinal haemorrhage).
If gastrointestinal haemorrhage or ulceration occur in patients taking ibuprofen, treatment has to be discontinued.
Caution is recommended when patients are simultaneously receiving medicines that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or platelet aggregation inhibitors such as acetylsalicylic acid (see also under Interactions).
Cardiovascular or cerebrovascular effects: Placebo-controlled studies have shown an increased risk of thrombotic cardiovascular and cerebrovascular complications for certain selective COX-2 inhibitors. It is not yet known if this risk correlates directly with the COX-1/COX-2 selectivity of individual NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2,400 mg daily), is associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction and stroke). Overall, according to epidemiological studies, there is no suggestion that low dose ibuprofen (e.g. ≤ 1,200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, heart failure (NYHA II), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful evaluation, and high doses (2,400 mg/day) should be avoided.
Careful consideration should also be taken, before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2,400 mg/day) are required.
Renal effects: The renal effects of NSAIDs include fluid retention with edema and/or arterial hypertension. Therefore, in patients with impaired cardiac function or other conditions predisposing them to fluid retention, ibuprofen should be used with caution.
Patients with severe dehydration or postoperative volume shifts should be rehydrated prior to treatment with ibuprofen and closely monitored thereafter. There is a risk of renal impairment, especially in dehydrated children and adolescents.
As with other NSAIDs, renal papillary necrosis and other kidney tissue damage may occur during long-term treatment.
Renal toxicity has also been observed in patients where renal prostaglandins have a supporting role in renal perfusion. In these patients, the administration of NSAIDs may result in a dose-dependent reduction in prostaglandin production in the kidneys, reduce kidney perfusion, and induce overt renal decompensation. These reactions are most common in patients with renal, cardiac, hepatic insufficiency, concomitant use of diuretics or ACE inhibitors, and in the elderly.
Respiratory disorders: Ibuprofen may cause bronchospasms, urticaria or angioedema in patients with or with a history of bronchial asthma, chronic rhinitis, or allergic disease.
Aseptic meningitis: In patients with systemic lupus erythematosus or collagenosis, due to increased risk of aseptic meningitis.
Other NSAIDs: The use of ibuprofen in combination with NSAIDs, including selective cyclo-oxygenase-2 inhibitors, should be avoided.
Severe skin reactions: During treatment with NSAIDs, cases of serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported very rarely (see Side Effects). The highest risk for such reactions seems to be at the beginning of treatment, as in the majority of cases they occurred in the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. At the first sign of rash, mucosal lesions or any other signs of hypersensitivity reactions, Spedifen should be discontinued.
Masking of symptoms of underlying infections: Ibuprofen may 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.
In isolated cases, an exacerbation of infective inflammations (e.g. development of necrotizing fasciitis) has been described in a temporal connection with the use of NSAIDs. When Ibuprofen 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.
Visual disturbances: Patients who experience impaired vision during treatment with ibuprofen should discontinue treatment and have an ophthalmic examination.
Liver function test: NSAIDs may produce an increase of liver function test results.
Excipients of particular interest: Spedifen film-coated tablets contain 83 mg of sodium per tablet, equivalent to 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product, as the pharmaceutical forms film-coated tablets contain sucrose.
Risk of GI Ulceration, Bleeding and Perforation with NSAID: Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk.
Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.
Effects on Ability to Drive and Use Machine: Spedifen may have an effect on the ability to drive and use machines due to potential undesirable effects.
Use in the Elderly: In older patients, there is increased incidence of adverse reactions after taking NSAIDs, especially gastrointestinal haemorrhage and perforation, with fatal outcomes.