Spedifen

Spedifen

ibuprofen

Manufacturer:

Zambon

Distributor:

Zuellig Pharma

Marketer:

EP Plus Group
Full Prescribing Info
Contents
Ibuprofen (as L-arginine salt).
Description
Each film-coated tablet contains Ibuprofen (as L-arginine salt) 400 mg.
Excipients/Inactive Ingredients: l-arginine, sodium hydrogen carbonate, crospovidone, magnesium stearate, hypromellose (Methocel 5cP), sucrose, titanium dioxide, macrogol 4000.
Action
Pharmacotherapeutic group: anti-inflammatory and anti-rheumatic products non steroids.
Pharmacology: Pharmacodynamics and Pharmacokinetics:
SPEDIFEN contains ibuprofen as active ingredient. Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. Its analgesic activity is of non-narcotic type. Ibuprofen is a powerful inhibitor of prostaglandin synthesis and exhibits significant anti-inflammatory properties of doses within the usual therapeutic range.
The inclusion of the natural amino acid l-arginine in the formulation enhances the solubilisation of ibuprofen which results in a rapid absorption of the active ingredient after oral administration.
Pharmacokinetics studies in man showed that peak plasma levels are reached 15-30 minutes (tmax) post administration. In addition to the earlier tmax, the plasma concentrations during the first hour are also significantly higher than those observed with conventional tablet formulations. These pharmacokinetic properties are particularly favourable in conditions requiring rapid analgesic effect (e.g. moderate/severe pain). No accumulation of the active ingredient or its metabolites has been observed after administration of ibuprofen-argine.
Excretion is virtually complete after 24 hours.
Indications/Uses
Pain: headache including migraine, toothache, dysmenorrhoea, neuralgia, osteoarticular and muscular pain, episiotomy and post-partum pain, pain following tooth extraction, post-operative pain, soft tissues injuries and traumatisms.
Rheumatic Inflammatory diseases: rheumatoid arthritis, ankylosing spondylitis, Still's Disease.
Degenerative rheumatic disease: osteoarthritis (cervical, dorsal and lumbar arthritis, gonarthritis, coxarthritis, polyarthritis, etc).
Non-articular rheumatic conditions: tendonitis, fibrositis, bursitis, myalgia, lumbago, scapolohumeral periarthritis, sciatica, radiculoneuritis.
Dosage/Direction for Use
Adults: Initial dose: 1 tablet. 2-4/day according to medical advise. The maximum daily dose should not exceed 1600 mg.
The administration of the first daily dose on awakening (before food) patients can be advantageous to provide relief of the morning stiffness associated with arthritis.
The following daily doses should be taken during or after meals. In elderly the posology must be carefully assessed by the physician since a reduction of the above mentioned dosage may be needed.
Mode of Administration: Oral.
Overdosage
Gastric lavage and, if it is necessary, correction of serum electrolytes.
There is no specific antidote for ibuprofen.
Contraindications
Patients who have previously shown hypersensitivity to the drug. Patients with active peptic ulceration or a history of peptic ulceration; active gastrointestinal bleeding; ulcerative colitis, severe hepatic and/or renal impairment. Severe heart failure (NYHA III-IV). Since cross reactivity, between acetylsalicylic acid and other non-steroidal anti inflammatory drugs (NSAIDs) has been reported, SPEDIFEN is contraindicated in patients in whom aspirin and other NSAIDs induced allergic reactions such as asthma, urticaria, rhinitis, nasal polyps, angioedema. Patients with systemic lupus erythematosus and with collagen diseases must consult the physician before use SPEDIFEN.
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.
Use In Pregnancy & Lactation
The use of ibuprofen during pregnancy and lactation should be avoided.
Side Effects
Effects on the gastro-intestinal tract: The most frequent adverse effects occurring with ibuprofen are gastro-intestinal disturbances: heartburn, anorexia, nausea, vomiting, dyspepsia, gastric pyrosis, abdominal discomfort, diarrhea, ulcer activation and gastro-intestinal bleeding.
Effects on the central nervous system: Chefalea, confusion, tinnitus and somnolence have been reported less frequently than gastro-intestinal effects. Cases of psychotic and depressive reactions were experienced. Individual cases of severe headache, nausea, vomiting, fever, stiffness of neck muscles, sensorial disturbance (earlier sign of meningitis) were experienced.
Effects on sense organs: Reversible ocular reactions were observed: toxic amblyopia, blurred vision and changes in colour vision.
Effects on the skin/hypersensitivity reactions: Skin rashes, including urticaria, exanthema and purpura were reported. Those reactions may be accompanied with pruritus and Stevens Johnson's syndrome.
General reactions of hypersensitivity may be rarely experienced.
Symptoms may be fever with skin rashes, abdominal pain, headache, nausea and vomiting, abnormalities of function tests, meningism and anaphylactic reactions.
Systemic Lupus Erythematosus or other collagenous disease can increase the risk of general hypersensitivity reactions. Rarely Ibuprofen may induce bronchospasm in predisposed patients.
Effects on the blood: Doses higher than 1000 mg/day can prolong the bleeding time. Blood alterations have been reported with differences both in nature and in severity: thrombocytopenia, granulocytopenia, agranulocytosis, haemolitic anaemia and aplastic anaemia. Such blood dyscrasias have been observed particularly after prolonged administration of high doses.
Effects on the liver: Abnormalities of liver function tests (high levels of serum transaminases) and icterus have been reported. See also hypersensitivity reactions.
Effects on the kidneys: Sodium and water retention and oedema have been reported. Cases of dysuria and of acute intestinal nephritis have been experienced. Impaired renal functions may be experienced with different severity, particularly after prolonged administration of high doses. Acute renal failure may occur in case of general hypersensitivity reactions. Cases of renal injury (renal papillary necrosis) have been reported.
Other undesirable effects: Stomatitis, menstrual disorder, increased serum levels of urates has been occasionally experienced.
In case that adverse events occur, treatment must be immediately suspended and the physician must be consulted.
Drug Interactions
Diuretics: in some patients SPEDIFEN can reduce the natriuretic effect of thiazide or other diuretics, probably due to sodium retention associated to inhibition of renal prostaglandin synthesis by SPEDIFEN and other NSAIDs.
Anticoagulants: as Ibuprofen could increase the effect of oral anticoagulants, the prothrombin time must be carefully monitored during the first weeks of the concomitant treatment. Change in the anticoagulant dosage may be required.
Anti-hypertensive agents: antagonism of the anti-hypertensive effect of beta-adrenergic blocking agents by NSAIDs has been reported.
Corticosteroids: the concomitant use of corticosteroid drugs may increase the ulcerogenic effect.
Aspirin: concomitant administration of SPEDIFEN or other NSAIDs must be avoided.
Digoxin, phenytoin and lithium: individual cases of increased plasma levels of digoxin, phenytoin and lithium have been reported in literature following combined therapy with ibuprofen.
Storage
Store at temperature not exceeding 30°C.
Shelf-Life: 3 years.
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
FC tab 400 mg (white, capsule-shaped, scored on one side) x 30's.
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