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The additional studies showed that the prolonged-release tablets were as effective as the immediate-release tablets in HIV-infected patientsThey also showed that patients can be safely switched from immediateto prolonged-release tablets.
Howeverpatients should be advised that they may experience adverse reactions such as fatigue during treatment with ViramuneThereforecaution should be recommended when driving a car or operating machineryIf patients experience fatigue they should avoid potentially hazardous tasks such as driving or operating machinery.
Liver and biliaryJaundicefulminant and cholestatic hepatitishepatic necrosishepatic failure.
The most frequently reported adverse reactions related to Viramune therapyacross all clinical studieswere rashallergic reactionshepatitisabnormal liver function testsnauseavomitingdiarrhoeaabdominal painfatiguefeverheadache and myalgia.
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.
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