ZARIVA

*Chronic hepatitis C in combination with direct acting antivirals, or interferon alfa 2a, or peginterferon alfa 2a:* Adult (body-weight up to 75 kg): 400 mg, dose to be taken in the morning and 600 mg, dose to be taken in the evening; (body-weight 75 kg and above): 600 mg twice daily. Children: 15-20 mg/kg body weight daily in three divided dose for 5-7 days. *Chronic hepatitis C genotype 2 or 3 (not previously treated), or patients infected with HIV and hepatitis C (in combination with peginterferon alfa):* Adult: Usual dose 400 mg twice daily.

Renal impairment, severe hepatic dysfunction or decompensated cirrhosis, autoimmune disease (including autoimmune hepatitis), history of severe psychiatric condition, severe cardiac disease, unstable or uncontrolled cardiac disease in previous 6 months, haemoglobinopathies, severe debilitating medical conditions.

Anaemia; haemoglobin concentration should be monitored during the treatment and corrective action taken, cardiac disease; assessment including ECG recommended before and during treatment; discontinue if deterioration), gout, haemolysis, patients with a transplant; risk of rejection, risk of growth retardation in children, there versibility of which is uncertain, consider starting treatment after pubertal growth spurt, severe dental disorders, severe ocular disorders, severe periodontal disorders, severe psychiatric effects. Exclude pregnancy before treatment; effective contraception essential during treatment and for 4 months after treatment in women and for 7 months after treatment in men; routine monthly pregnancy tests recommended; condoms must be used if partner of male patient is pregnant (ribavirin excreted in semen). Determine full blood count, platelets, electrolytes, serum creatinine, liver function tests and uric acid before starting treatment and then on weeks 2 and 4 of treatment, then as indicated clinically, adjust dose if adverse reactions or laboratory abnormalities develop (consult product literature).

GI disturbance, alopecia, angina, anorexia, anxiety, aplastic anaemia, arrhythmias, arthralgia, asthenia, ataxia, bipolar disorders, cardiomyopathy, cerebral haemorrhage, cerebral ischaemia, cheilitis, chest pain, colitis, dehydration, depression, diabetes, dizziness, dry eyes mouth, dyspepsia, dysphagia, dysphonia, dyspnea, earache, endocarditis, epistaxis, flushing, GI bleeding, gastroesophageal reflux, gingival bleeding, gingivitis, glossitis, growth retardation, haemolyticanaemia, hallucination, headache, hearing impairment or loss, hyperaesthesia, hyperglycaemia, hyperkinesia, hypertonia, hypertriglyceridaemia, hyperuricaemia, hypoaesthesia, hypocalcaemia, influenza-like symptoms, interstitial pneumonitis, leucopenia, lymphadenopathy, malaise, mania, menstrual disturbance, micturition disorders, musculoskeletal pain, myalgia, myocardial infarction, myositis, neutropenia, optic neuropathy, oral candidiasis, palpitation, pancreatitis, paraesthesia, mouth & peptic ulcer, pericarditis, peripheral ischaemia, peripheral neuropathy, peripheral oedema, photosensitivity, prostatitis, pruritus, psoriasis, psychotic disorders, pulmonary embolism, rash, renal failure, respiratory infections, retinal detachment, retinal haemorrhage, rhabdomyolysis, rheumatoid arthritis, sarcoidosis, seizures, skin discoloration, Stevens-Johnson syndrome, stomatitis, suicidal ideation, syncope, systemic lupus erythematosus, tachycardia, tachypnea, thrombocytopenia, thrombocytopenia purpura, thyroid disorders, tinnitus, tongue pigmentation, tooth disorder, toxic epidermal necrolysis, tremor, urinary tract infections, vaculitis, vertigo, virilism, visual disturbances, wheezing