Ibuprofen (as arginine) 400 mg sachets
Sachets contain white granules
with a characteristic apricot odour.
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.
Pharmacotherapeutic group (ATC):
anti-inflammatory and anti-rheumatic products non steroids. 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.
in man showed that peak plasma levels are reached 15-30 minutes (tmax) post
In addition to the earlier t max, 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-arginine.
Excretion is virtually complete after 24 hours.
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
Rheumatic Inflammatory diseases: rheumatoid arthritis, ankylosing spondylitis,
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.
Adults: 400 mg sachets: 2-4/day according to medical advise The maximum
daily dose should not exceed 1800mg.
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. The content of each sachet must be dissolved in a glass of
water (50-100 ml) and immediately taken.
Mode Of Administration
Patients who have previously shown hypersensitivity to the drug. Patients
with active peptic ulceration or a history of peptic ulceration; active
gastro intestinal bleeding; ulcerative colitis; severe hepatic and/or renal
impairment. Since cross reactivity, between acetylsalilic acid and other
non-steroidal anti-inflammatory drugs has been reported, SPEDIFEN is
contraindicated in patients in whom aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) induced allergic reactions such us asthma,
urticaria, rhinitis, nasal polyps, angioedema. Patients with systemic lupus
erythematosus and with collagen diseases must consult the physician before
Warning and Precautions
PRECAUTIONS FOR USE
Gastrointestinal bleeding, which
is occasionally severe, and peptic ulceration have been reported in some
patients receiving ibuprofen. Even if these events are rare, SPEDIFEN should
be given under strict medical supervision to patients with a history of/or
with active gastrointestinal trod diseases. The same caution should be taken
for patients with a history of bronchospasm, particularly if it was followed
by drugs administration, and in patients with reduced renal and/or hepatic
or cardiac functions. In those patients, clinical and laboratory parameters
should be periodically monitored especially if prolonged treatment a
required. SPEDIFEN should be taken with caution in patients with a history
of heart failure or tension since cases of water retention with oedema have
been reported. As ibuprofen, like other NSAIDs, can prolong the bleeding
time, it should be used with caution in patients with intrinsic coagulation
defects and in patients on anticoagulant therapy. Patients who develop
ocular disturbances should discontinue the use of SPEDIFEN and undergo an
SPEDIFEN contains aspartame thus it is contraindicated in patients suffering
INSTRUCTIONS FOR USE/HANDING
The medicinal product has to be suspended in water before