|The adverse reactions which may occur at doses used in the prophylaxis or treatment of malaria are generally not of a serious nature. Where prolonged high dosage is required, i.e. in the treatment of rheumatoid arthritis, adverse reactions can be of a more serious nature.Cardiovascular: hypotension and ECG changes (at high doses) cardiomyopathy.Central nervous system: convulsions and psychotic reactions including hallucinations (rare), anxiety, personality changes.Eye disorders: retinal degeneration, macular defects of colour vision, pigmentation, optic atrophy scotomas, field defects, blindness, corneal opacities and pigmented deposits, blurring of vision, difficulty in accommodation, diplopia.Gastro-intestinal: gastro-intestinal disturbances, nausea, vomiting, diarrhoea, abdominal cramps.General: headache.Haematological: bone marrow depression, aplastic anaemia, agranulocytosis, thrombocytopenia, neutropenia.Hepatic: Changes in liver function, including hepatitis and abnormal liver function tests, have been reported rarely.Hypersensitivity: allergic and anaphylactic reactions, including urticaria, angioedema and vasculitis.Hearing disorders: tinnitus, reduced hearing, nerve deafness.Metabolism and nutrition disorders: hypoglycaemia (see section 4.4). Frequency: unknown.Muscular: neuromyopathy and myopathy.Respiratory: diffuse parenchymal lung disease.Skin: macular, urticarial and purpuric skin eruptions, occasional depigmentation or loss of hair, erythema multiforme, Drug rash with eosinophilia and systemic symptoms syndrome (DRESS), Stevens-Johnson syndrome, toxic epidermal necrolysis, precipitation of psoriasis, pruritus, photosensitivity, lichen-planus type reaction, pigmentation of the skin and mucous membranes (long term use).|
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.