SPEDIFEN FILM COATED TABLET 400MG [SIN14169P]

Product Info

SPEDIFEN FILM COATED TABLET 400MG

[SIN14169P]

THERAPEUTIC INDICATIONS
For symptomatic relief of pain: such as headache including migraine, toothache, dysmenorrhoea, sign and symptom of rheumatoid arthritis.

DOSAGE AND ADMINISTRATION
Adults:
2–4 sachets/day according to medical advice
The maximum daily dose should not exceed 1600 mg.
The administration 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.

CONTRAINDICATIONS
Patients who have previously shown hypersensitivity to the components of the drug. Patients with active peptic ulceration or a history of peptic ulceration; active gastrointestinal bleeding; active cerebrovascular bleeding; ulcerative colitis; hemorrhagic diathesis; severe hepatic and/or renal impairment. Severe heart failure (NYHA IV). Since cross reactivity, between aspirin and other non- steroidal anti-inflammatory drugs have been reported, SPEDIFEN® is contraindicated in patients in whom aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) have induced allergic reactions such as asthma, rhinitis, nasal polyps, angioedema. Patients with systemic lupus erythematosus and with collagen diseases must consult the physician before using SPEDIFEN®. SPEDFEN® contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria. The use of ibuprofen during pregnancy and lactation should be avoided.