Regulatory Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
Therapeutic
Prescription Only
Formulation Information
GRANULE, FOR SOLUTION
**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.
ORAL
Medical Information
**THERAPEUTIC INDICATIONS** For symptomatic relief of pain: such as headache including migraine, toothache, dysmenorrhoea, sign and symptom of rheumatoid arthritis.
**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 nonsteroidal 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.
M01AE01
ibuprofen
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
ZAMBON SWITZERLAND LTD
Active Ingredients
Documents
Package Inserts
Spedifen 400 Sachet PI.pdf
Approved: February 10, 2022