Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Dosage and administration** Adults: 400 mg tablets: 2–4/day according to medical advice. The maximum daily dose should not exceed 1600 mg. In the treatment of elderly patients, the posology should be carefully established by the doctor, who has to consider a possible reduction in the above mentioned dosages. The tablet should be swallowed with some water.
ORAL
Medical Information
**Indication** For symptomatic relief of pain such as headache including migraine, toothache, and dysmenorrhoea.
**Contraindications** Patients who have previously shown hypersensitivity to the drug or to any of the excipients. Patients with active peptic ulceration or a history of peptic ulceration; active gastro intestinal bleeding; active cerebrovascular bleeding; ulcerative colitis, hemorrhagic diathesis; severe hepatic and/or renal impairment. Severe heart failure (NYHA III–IV). Third trimester of pregnancy. 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.
M01AE01
ibuprofen
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
Zambon S.p.A.
Active Ingredients
Documents
Package Inserts
Spedifen Film Coated Tablet PI.pdf
Approved: February 10, 2022