Spedifen

Spedifen

ibuprofen

Manufacturer:

Zambon

Distributor:

Zuellig Pharma

Marketer:

EP Plus Group
Concise Prescribing Info
Contents
Ibuprofen (as l-arginine salt)
Indications/Uses
Headache including migraine, toothache, dysmenorrhoea, neuralgia, osteoarticular & muscular pain, episiotomy & post-partum pain, pain following tooth extraction, post-op pain, soft tissues injuries & traumatisms. RA, ankylosing spondylitis, Still's disease. OA (cervical, dorsal & lumbar arthritis, gonarthritis, coxarthritis, polyarthritis, etc). Tendonitis, fibrositis, bursitis, myalgia, lumbago, scapolohumeral periarthritis, sciatica, radiculoneuritis.
Dosage/Direction for Use
Adult Initially 1 tab bd-qds. Max daily dose: Not to exceed 1,600 mg.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Active peptic ulceration or a history of peptic ulceration; active GI bleeding; ulcerative colitis; severe heart failure (NYHA III-IV). Aspirin- & other NSAIDs-induced allergic reactions eg, asthma, urticaria, rhinitis, nasal polyps, angioedema. SLE; collagen disesases. Severe hepatic &/or renal impairment.
Special Precautions
Discontinue use once skin rash, mucosal lesions or signs of hypersensitivity appears. Prior history of serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking & corticosteroid therapy. History of HTN &/or mild to moderate CHF; established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease; risk factors for CV events eg, hyperlipidaemia, DM. Coagulation disorders; dehydration; infection. Previous history of bronchial asthma or allergic disease. SLE; collagen diseases. Visual disturbances. Controlled Na diet. Long-term use. Fructose intolerance, glucose-galactose malabsorption or sucrose-maltase insufficiency. Avoid use during pregnancy & lactation. Adolescents ≥12 to <18 yr. Elderly or debilitated patients.
Adverse Reactions
GI bleeding & disturbances, heartburn, anorexia, nausea, vomiting, dyspepsia, gastric pyrosis, abdominal discomfort, diarrhea, ulcer activation; toxic amblyopia, blurred vision, changes in colour vision. Stevens-Johnson syndrome.
Drug Interactions
Reduced natriuretic effect of thiazide or other diuretics. Increased effect of oral anticoagulants. Anti-hypertensive effect antagonism of β-adrenergic blocking agents. Increased ulcerogenic effect w/ corticosteroids. Increased plasma levels of digoxin, phenytoin & lithium. Avoid use w/ aspirin.
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Spedifen FC tab 400 mg
Packing/Price
30's
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