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ALGIREX

ETORICOXIB INN


NAME STRENGTH PACK SIZE DOSAGE FORM
ALGIREX 120MG 120MG 20 S TABLET
ALGIREX 60MG 60MG 30 S TABLET
ALGIREX 90MG 90MG 20 S TABLET

Algirex 60 Tablet: Each film coated tablet contains Etoricoxib INN 60 mg. Algirex 90 Tablet: Each film coated tablet contains Etoricoxib INN 90 mg. Algirex 120 Tablet: Each film coated tablet contains Etoricoxib INN 120 mg.

Algirex (Etoricoxib) is a Non-Steroidal Anti-Inflammatory Drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. It is a potent, orally active, highly selective cyclooxygenase-2 (COX-2) inhibitor within and above the clinical dose range. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and fever. Selective inhibition of COX-2 by Etoricoxib decreases these clinical signs and symptoms with decreased GI toxicity and without effects on platelet function.

Pain and Inflammation in Osteoarthritis, Rheumatoid Arthritis, Acute Gout and Ankylosing Spondylitis.

• Osteoarthritis, ADULT and CHILD over 16 years, 30 mg once daily, increased if necessary to 60 mg once daily. • Rheumatoid arthritis and ankylosing spondylitis, ADULT and CHILD over 16 years, 90 mg once daily. • Acute gout, ADULT and CHILD over 16 years, 120 mg once daily for max. 8 days.

Patients with known hypersensitivity to Etoricoxib or to any of the excipients of this medicinal product, active peptic ulceration or gastro-intestinal bleeding, severe hepatic dysfunction, children under 16 years of age, inflammatory bowel disease, uncontrolled hypertension, breast feeding.

Decreased kidney function and liver function, dehydration, hypertension, history of heart failure, perforation and people over 65 years of age.

Dizziness, headache, gastro-intestinal disorders ( e.g. abdominal pain, flatulence, heart burn), palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

Not recommended.

Warfarin, ACE Inhibitor, Rifampicin, Lithium, Birth control pills, Methotrexate, Digoxin.

Administration at single doses up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. There have been reports of acute overdosage with etoricoxib, although adverse events were not reported in the majority of cases. The most frequently observed adverse events were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, renovascular events).

Store in a cool (below 30°C) and dry place protected from light and moisture. Keep out of the reach of children.

Algirex 60 Tablet: Each box contains 3×10 tablets in Alu-Alu blister strip. Algirex 90 Tablet: Each box contains 2×10 tablets in Alu-Alu blister strip. Algirex 120 Tablet: Each box contains 2×10 tablets in Alu-Alu blister strip.