Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Ibuprofen 400mg, 600mg.
Description: White, oval, biconvex film coated tablets scored on one side. Can be divided into equal halves.
Presentation: 400mg-100, €2.59; 600mg-100, €4.12.
Indications: 400mg: Mild to moderate pain such as headache (including migraine), dental pain. Primary dysmenorrhoea. Fever. All: Rheumatic conditions such as arthritic diseases, degenerative arthritic conditions, non-articular rheumatic conditions, other muscular and joint disorders, soft tissue injuries.
Pharmacology: Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity. It exerts an inhibitory effect on prostaglandin synthesis by inhibiting the activity of cyclo-oxygenase. In addition, ibuprofen has an inhibitory effect on ADP or collagen-stimulated platelet aggregation.
Dosage: Adult: Pain, fever: 200-400mg as single dose, or 3-4 times/day every 4-6 hours. Migraine headache: 400mg as single dose; if necessary 400mg every 4-6 hours. Maximum daily dose, 1200mg. Primary dysmenorrhoea: 200-400mg 1-3 times/day every 4-6 hours as needed. Maximum daily dose, 1200mg. Rheumatic diseases: Usually, 400-600mg 3 times/day. Maintenance, 600-1200mg daily. May increase to maximum 2400mg in 3 or 4 divided doses for acute and severe conditions. Children: Consider other ibuprofen preparations. Pain, fever: Over 12 years, as per adults. 6-9 years (20-29kg): 200mg 1-3 times/day every 4-6 hours as required. Maximum daily dose, 600mg. 10-12 years (30-40kg): 200mg 1-4 times/day every 4-6 hours as required. Maximum daily dose, 800mg. Primary dysmenorrhoea: Over 12 years, as per adults. Rheumatic diseases: Over 12 years, 20mg/kg to maximum 40mg/kg body weight daily in 3 to 4 divided doses.
Contraindications: Hypersensitivity to the active substance or any of the excipients. Previous hypersensitivity reactions (asthma, rhinitis, urticaria, angioedema) associated with aspirin or other NSAIDs. History of GI bleeding or perforation related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding). Severe hepatic/renal impairment. Severe heart failure or coronary heart disease. Significant dehydration. Cerebrovascular or other active bleeding. Dishaematopoiesis of unknown origin. Children under 6 years of age. Pregnancy.
Special precautions: Caution: Prolonged use, systemic lupus erythematosus or other autoimmune diseases, congenital disturbance of porphyrin metabolism, GI diseases including chronic inflammatory intestinal disease, uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, risk factors for cardiovascular events, renal/hepatic impairment, disturbed haematopoiesis, blood coagulation defects, allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease, bronchial asthma, directly after major surgery, elderly. May occur: GI bleeding, ulceration or perforation (discontinue); hypersensitivity reactions including skin rash or mucosal lesions (discontinue immediately). May mask symptoms of infection and fever. May impair female fertility. Driving/using machines. Lactation.
Drug interactions: Avoid: Acetylsalicylic acid, other NSAIDs, anticoagulants, ticlopidin, methotrexate. Caution: Moclobemide, phenytoin, lithium, cardiac glycosides, diuretics, antihypertensives, captopril, aminoglycosides, selective serotonin reuptake inhibitors, cyclosporine, cholestyramine, tacrolimus, zidovudine, ritonavir, mifepristone, probenecid, sulfinpyrazone, quinolone antibiotics, sulphonylureas, corticosteroids, anti-platelet aggregation agents, alcohol, bisphosphonates, oxpentifylline, baclofen.
Adverse drug reactions: GI disorders (including ulcers), headache, somnolence, vertigo, fatigue, agitation, dizziness, insomnia, irritability.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. E-mail: contact@actavis.ie