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• MEDICAL NAME Spedifen®
• QUALITATIVE AND QUANTITATIVE COMPOSITION Spedifen® 400 mg: Per sachet: lbuprofen (INN), 400 mg.
• DOSAGE FORM Granulate containing sachets.
• CLINICAL DATA
• Therapeutical indications: Spedifen® is indicated in pain relief of different etiologies: Headache, dental extraction pain and postoperative pain, as well in primary dysmenorrhea treatment. Spedifen® is also indicated in the relief of signs and symptoms related to rheumatoid arthritis and osteoarthritis, as well as in skeletal muscle and traumatic impairment involving pain and inflammation.
• Dosage and administration form: Adult dosage: The mean recommended dosage is 1200 mg daily, in 2 to 4 intakes. If gastric discomfort is detected after drug intake, it will be administered with milk or with the meals. In rheumatoid arthritis, higher doses may be required, although a daily does of 2400 mg of lbuprofen should not be exceeded, bearing in mind that the least effective dose should be administered. Dosage should be established by the physician in elderly patients, since the usual dose might need to be reduced. In case of renal failure, doses should be adjusted since the drug is preferably eliminated by this route.
• Contraindications: Hypersensitivity to Ibuprofen. Active and recurrent peptic ulcer or risk of gastrointestinal bleeding. Ulcerative colitis. Severe hepatic and/or renal failure. Due to a possible cross allergic reaction with acetylsalicylic acid or other non steroidal anti inflammatory drugs, ibuprofen should not be administered in patients with a history of allergic reaction to these drugs, asthma, rhinitis, urticaria, nasal polypi and angioedema. The specialty Spedifen® contains aspartame as excipient. Importantly, each sachet of Spedifen® 400 mg contains the equivalent of approx. 14 mg of phenylalanine, for which they are contraindicated in patients with phenylketonuria.
• Warnings and special precautions of use: In patients at risk or with gastrointestinal impairment due to non steroidal anti inflammatory drugs, ibuprofen should be administered with caution and under medical supervision. It must also be administered with care in patients with history of bronchospasm related to other treatments, in elderly patients and in patients with impaired renal, hepatic and/or cardiac function, where clinical and laboratory parameters should be checked periodically, particularly with long term treatment. Hydrosaline retention has been sometimes observed after the administration of ibuprofen, which should therefore be administered with caution in heart failure or hypertensive patients. As other non steroidal anti inflammatory drugs, ibuprofen may extend the bleeding time, and should therefore be administered with caution in patients with blood clotting impairment or under anticoagulant treatment. In case of previous corticosteroid treatment, these should be gradually adjusted in case of combined treatment with ibuprofen. In rare cases, aseptic meningitis has been observed in ibuprofen treated patients. Although such effect is more likely in patients with systemic lupus erythematosus and other collagen related diseases, it has also been reported in some patients without chronic diseases, which should be considered at drug administration. Although very rarely, ophthalmologic impairment has been observed (see adverse reactions). As a preventive measure, treatment should be discontinued and ophthalmologic examination performed. As with other non steroidal anti inflammatory drugs, interstitial acute nephritis with hematuria, dysury and occasionally nephrotic syndrome have been observed in long term treatment with ibuprofen. Each sachet of Spedifen® 400 mg contains 1.835 g and 1.340 g of saccharose, which should be taken into account in diabetic patients.
• Drug interaction and other interactions: lbuprofen may reduce the efficacy of furosemide and thiazidic diuretics due to prostaglandin synthesis inhibition at renal level, which should be taken into account in combined therapy. Due to a possible enhancing effect of oral anticoagulants, prothrombin time should be monitored during the first week and anticoagulant dose adjustment should be foreseen in case of prolonged concomitant treatment. A lower hypotensive effect of β blockers could be observed, as well as an enhanced ulcerogenic effect after concomitant corticosteroid administration in case of combined therapy. In isolated cases, increased digoxin, phenytoin and lithium plasma levels have been observed after combined administration of ibuprofen. Ibuprofen administration may occasionally increase methotrexate toxicity, which should be considered in combined therapy. Ibuprofen should not be used with other non steroidal anti inflammatory drugs, such as acetylsalicylic acid and paracetamol. After combined administration of H2 antagonist drugs, no plasma level significant effect was observed.
• Pregnancy and lactation: Although no teratogenic action has been shown in animal studies, these sometimes fail to predict the response in cumulation has been shown after Spedifen® administration, with a plasma half-life of approx. 2 hours and practically complete drug excretion 24 hours after the last dose administration.
• Safety preclinical data: Some reproductive studies in animals have shown increased dystocia and delayed delivery, related to the typical prostaglandin synthesis inhibitory action of non-steroidal anti-inflammatory drugs.
• PHARMACEUTICAL DATA:
• List of excipients: Spedifen® 400 mg: L-Arginine, 370 mg; Sodium saccharin, 20 mg; Aspartame, 25 mg ; Saccharose, 1.835 g; Sodium bicarbonate; Apricot flavour.
• Incompatibilities: None observed.
• Shelf-life: 3 years in final confection.
• Special storage caution: None.
• Container nature and contents: Paper/aluminum/ polyethylene sachets with granulate. Spedifen® 400 mg: 30-sachet package.
• Use/handling instruction: Dissolve the contents of one sachet in a glass of water and ingest after solution preparation.