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If clinical hepatitis occurscharacterised by anorexianauseavomitingicterus AND laboratory findingssuch as moderate or severe liver function test abnormalitiesexcluding GGTnevirapine must be permanently stoppedViramune must not be readministered to patients who have required permanent discontinuation for clinical hepatitis due to nevirapine.

Oral hormonal contraceptives should not be used as the sole method of contraception in women taking Viramunesee section 4.4Appropriate doses for hormonal contraceptivesoral or other forms of applicationother than DMPA in combination with Viramune have not been established with respect to safety and efficacy.

Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practiceIf there is evidence of worsening liver disease in such patientsinterruption or discontinuation of treatment must be considered.

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