Spedifen Special Precautions





Zuellig Pharma


EP Plus Group
Full Prescribing Info
Special Precautions
Information applies to adult and paediatric patients: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
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.
Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and or mild to moderate congestive heart failure. Fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy.
Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at a high dose (2400 mg daily) and in a long term treatment may be associated with a small increased risk of arterial thrombotic event (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg daily) is associated with an increased risk of myocardial infarction.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be made before initiating longer term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking).
Skin reactions: 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. 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. SPEDIFEN should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Other effects: Caution is required in patients with coagulation disorders and liver, cardiac or kidney insufficiency.
Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration.
Risks of long-term habitual use of analgesic are headache and analgesic nephropathy. Ibuprofen may mask the objective and subjective signs of an infection. In isolated cases an exacerbation of infective inflammations (e.g. development of necrotizing fasciitis) has been described in temporal connection with the use of NSAIDs. Therapy with ibuprofen in patients with an infection should therefore be used with care.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Caution is required in patients with systemic lupus erythematosus or other collagen diseases.
There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Patients who experience visual disturbances during ibuprofen therapy should discontinue the treatment and have an ophthalmologic examination.
NSAIDs may produce an increase of liver function test results.
Use in children and adolescents (age range: ≥ 12 years to < 18 years): There is a risk of renal impairment in dehydrated children/adolescents.
SPEDIFEN contains 16.7 mg sucrose per dose unit, when taken according to the dosage recommendation tablet. Patient with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-is maltase insufficiency should not take this medicine. SPEDIFEN contains 82.7 mg sodium per dose unit. This should be taken into consideration for patients on a controlled sodium diet.
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