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Spedifen

Ibuprofen (as arginine) 400 mg sachets

 

Product Description

Sachets contain white granules with a characteristic apricot odour.

 

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.

 

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.

 

Pharmacokinetics studies in man showed that peak plasma levels are reached 15-30 minutes (tmax) post administration.


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.

Indication
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.

Recommended Dose
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

Oral

Contraindication
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 use SPEDIFEN.

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 ophthalmic examination.


SPEDIFEN contains aspartame thus it is contraindicated in patients suffering from phenylketonuria.

 

INSTRUCTIONS FOR USE/HANDING

The medicinal product has to be suspended in water before oral administration

 

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