Psychiatric: Severe psychiatric adverse reactions may manifest in patients receiving therapy with interferons, including Roferon-A. Depression, suicidal ideation, suicidal attempt, and suicide may occur in patients with and without previous psychiatric illness. Physicians should monitor all patients treated with Roferon-A for evidence of depression. Physicians should inform patients of the possible development of depression prior to initiation of therapy, and patients should report any sign or symptom of depression immediately. Psychiatric intervention and/or drug discontinuation should be considered in such cases.

Ophthalmologic: As with other interferons, retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, retinal artery or vein thrombosis and optic neuropathy which may result in loss of vision, have been reported after treatment with Roferon-A. Any patient complaining of decrease or loss of vision must have an eye examination. Because these ocular events may occur in conjunction with other disease states, a visual examination prior to initiation of Roferon-A monotherapy or in the combination therapy with ribavirin is recommended in patients with diabetes mellitus or hypertension. Roferon-A monotherapy or the combination therapy with ribavirin should be discontinued in patients who develop new or worsening ophthalmologic disorders.

Endocrine: Hyperglycaemia has been observed rarely in patients treated with Roferon-A. All patients who develop symptoms of hyperglycaemia should have their blood glucose measured and followed-up accordingly. Patients with diabetes mellitus may require adjustment of their antidiabetic regimen.

When mild to moderate renal, hepatic or myeloid dysfunction is present, close monitoring of these functions is required.

Hepatic function: In rare cases interferon alpha has been suspected of causing an exacerbation of an underlying autoimmune disease in hepatitis patients. Therefore, when treating hepatitis patients with a history of autoimmune disease caution is recommended. If a deterioration in liver function in these patients develops a determination of autoimmune antibodies should be considered. If necessary treatment should be discontinued.

Bone marrow suppression: Extreme caution should be exercised when administering Roferon-A to patients with severe myelosuppression as it has a suppressive effect on the bone marrow, leading to a fall in the white blood count, particularly granulocytes, platelet count and, less commonly, haemoglobin concentration. This can lead to an increased risk of infection or of haemorrhage. It is important to monitor closely these events in patients and periodic complete blood counts should be performed during the course of Roferon-A treatment, both prior to therapy and at appropriate periods during therapy.

Autoimmune: The development of different auto-antibodies has been reported during treatment with alpha interferons. Clinical manifestations of autoimmune disease during interferon therapy occur more frequently in subjects predisposed to the development of autoimmune disorders. In patients with an underlying or clinical history of auto-immune diso