Auro – Ribavirin 200 mg Tablets

AURO - RIBAVIRIN TABLETS 200 mg, in combination with peginterferons, is indicated for the treatment of chronic hepatitis C. AURO - RIBAVIRIN TABLETS 200 mg must not be used alone. AURO - RIBAVIRIN TABLETS 200 mg is only indicated for the treatment of adult patients over the age of 18 years with chronic hepatitis C, who have elevated transaminases who are positive for serum HCV RNA and who have compensated liver disease.

Do not use AURO - RIBAVIRIN in:

• Patients with hypersensitivity to the active substance or to any of the excipients
• Women who are pregnant or who intend to become pregnant
• Men whose female partners are pregnant
• Patients with haemoglobinopathies (e.g. thalassemia major or sickle-cell anaemia)
• Patients with autoimmune hepatitis
• Patients with moderate to severe hepatic impairment (Child-Pugh class B and C)
• Patients with moderate to severe renal impairment (Ccr < 50 ml/min)

Take special care with AURO - RIBAVIRIN:

• AURO - RIBAVIRIN TABLETS 200 mg must not be used alone as AURO - RIBAVIRIN TABLETS 200 mg monotherapy is not effective for the treatment of chronic hepatitis C.
• AURO - RIBAVIRIN TABLETS 200 mg used in combination therapy should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of further therapy.
• If severe side effects or laboratory abnormalities develop during therapy with AURO - RIBAVIRIN TABLETS 200 mg, modify the dosage until the severe side effects abate. If intolerance persists after dose adjustment, discontinuation of AURO - RIBAVIRIN TABLETS 200 mg may be necessary.

Pregnancy and Breast-feeding: AURO - RIBAVIRIN TABLETS 200 mg must not be used in women who are pregnant or intend to become pregnant. AURO - RIBAVIRIN TABLETS 200 mg may cause birth defects and/or death of the exposed foetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. AURO - RIBAVIRIN TABLETS 200 mg therapy must not be started unless a report of a negative pregnancy test has been obtained prior to the planned initiation of therapy. Prior to initiation of treatment with AURO - RIBAVIRIN TABLETS 200 mg the physician must comprehensively inform the patient of the teratogenic risk of AURO - RIBAVIRIN TABLETS 200 mg, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during treatment with AURO - RIBAVIRIN TABLETS 200 mg.

If you are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Taking other medicines with AURO - RIBAVIRIN: AURO - RIBAVIRIN TABLETS 200 mg was shown in-vitro to inhibit phosphorylation of zidovudine and stavudine. The clinical significance of these findings is unknown. However, these in-vitro findings raise the possibility that concurrent use of AURO - RIBAVIRIN TABLETS 200 mg with either zidovudine or stavudine might lead to increased HIV plasma viremia. Therefore, it is recommended that plasma HIV RNA levels be closely monitored in patients treated with AURO - RIBAVIRIN TABLETS 200 mg concurrently with either of these two agents. If HIV RNA levels increase, the use of AURO - RIBAVIRIN TABLETS 200 mg concomitantly with reverse transcriptase inhibitors must be reviewed. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of AURO - RIBAVIRIN with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.

Always take AURO - RIBAVIRIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of AURO - RIBAVIRIN is too strong or too weak, talk to your doctor or pharmacist. The tablets should not be broken or crushed. Since AURO - RIBAVIRIN TABLETS 200 mg is considered a potential teratogen, caution should be observed in handling broken tablets. Avoid direct contact of broken or crushed tablets with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with sterile water, or plain water if sterile water is unavailable.

Standard dosage: The daily dose of AURO - RIBAVIRIN TABLETS 200 mg is to be administered orally in two divided doses, morning and evening, with food (see Table 1).

Table 1: AURO - RIBAVIRIN TABLETS 200 mg Dosing Recommendations in combination with peginterferons

* sustained virologic response is highest in patients treated for 48 weeks with 1000 mg or 1200 mg of AURO - RIBAVIRIN TABLETS 200 mg.

Special dosage instructions: Dosage modification for adverse reactions: If severe adverse reactions or laboratory abnormalities develop during therapy with AURO - RIBAVIRIN TABLETS 200 mg, the dosages of AURO - RIBAVIRIN TABLETS 200 mg should be modified until the adverse reactions abate. Guidelines were developed in clinical trials for dose modification (see Table 2). Because of the recognized haemolysis associated with AURO - RIBAVIRIN TABLETS 200 mg therapy, separate guidelines are provided for patients with a history of cardiovascular disease. If intolerance persists after dose adjustment, discontinuation of AURO - RIBAVIRIN TABLETS 200 mg may be necessary.

Table 2: AURO - RIBAVIRIN TABLETS 200 mg Dosage Modification Guidelines for Management of Treatment - Emergent Anaemia

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center. If you forget to take AURO - RIBAVIRIN: Do not take a double dose to make up for forgotten individual doses.

AURO - RIBAVIRIN can have side effects. Blood and the lymphatic system disorders: Frequent: Anaemia. The following side effects have been reported but the frequencies are unknown: lymphadenopathy.

Endocrine disorders: The following side effects have been reported but the frequencies are unknown: Hyperthyroidism, hypothyroidism.

Metabolism and nutritional disorders: Less frequent: Anorexia. The following side effects have been reported but the frequencies are unknown: Weight decrease.

Psychiatric disorders: Frequent: Depression, irritability, concentration impairment. Less frequent: Taste disturbance, mood alteration, insomnia. The following side effects have been reported but the frequencies are unknown: Dizziness, memory impairment, paraesthesia, hypaesthesia, tremor, emotional disorders, nervousness, aggression, libido decrease, impotence, anxiety.

Eye disorders: The following side effects have been reported but the frequencies are unknown: Blurred vision, xerophthalmia, eye inflammation, eye pain.

Cardiac disorders: The following side effects have been reported but the frequencies are unknown: Palpitations.

Respiratory, thoracic and mediastinal disorders: Frequent: Dyspnoea. Less frequent: Sinus congestion, cough, chest tightness. The following side effects have been reported but the frequencies are unknown: Upper respiratory tract infection, sore throat, rhinitis, nasopharyngitis, pulmonary congestion, dyspnoea exertional, epistaxis.

Gastrointestinal disorders: Frequent: Abdominal pain, dyspepsia. Less frequent: Vomiting, nausea. The following side effects have been reported but the frequencies are unknown: Diarrhoea, gastritis, flatulence, dry mouth, mouth ulceration, gingival bleeding, gingivitis, cheilitis, constipation.

Skin and subcutaneous tissue disorders: Frequent: Pruritis. The following side effects have been reported but the frequencies are unknown: Alopecia, dermatitis, dry skin, skin disorder, rash, eczema, psoriasis, urticaria, photosensitivity reaction, increased sweating, night sweats.

Musculoskeletal, connective tissue and bone disorders: Less frequent: Myalgia, muscle cramps, musculoskeletal pain. The following side effects have been reported but the frequencies are unknown: Bone pain, back pain, neck pain, muscle weakness.

General disorders and administration site conditions: Frequent: Asthenia, rigors, chest pain. Less frequent: Fatigue. The following side effects have been reported but the frequencies are unknown: Headache, pyrexia, pain, injection site reaction, influenza-like illness, malaise, lethargy, shivering, hot flushes, weakness, weight decrease.

Investigations: Most cases of anaemia, leucopenia and thrombocytopenia were mild. Please refer to WARNINGS. An increase in uric acid and indirect bilirubin values associated with haemolysis were observed in some patients treated with AURO - RIBAVIRIN TABLETS 200 mg used in combination with peginterferons alfa and values returned to baseline levels within 4 weeks after the end of therapy. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Keep all medicines out of the reach and sight of children. Store below 25 °C. KEEP OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).