Sofosbuvir 400 mg.
MPIviropack is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
• The recommended dose is one 400 mg tablet, taken orally, once daily with food.
• MPIviropack should be used in combination with other medicinal products. Monotherapy of MPIviropack is not recommended.
Hypersensitivity to the active substance or to any of the excipients.
During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
• There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
As a precautionary measure, it is preferable to avoid the use of MPIviropack during pregnancy.
• It is unknown whether sofosbuvir and its metabolites are excreted in human milk.
Therefore, MPIviropack should not be used during breast-feeding.
• MPIviropack is always taken with other medicines. Talk to your doctor or pharmacist before taking this medicine if you:
- Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation.
- Have hepatitis B, since your doctor may want to monitor you more closely.
- Have kidney problems. Talk to your doctor or pharmacist if you have severe kidney problems or if you are on kidney dialysis as the effects of Sofosbuvir on patients with severe kidney problems have not been fully tested.
• Do not give this medicine to children and adolescents under 18 years of age. The use of MPIviropack in children and adolescents has not yet been studied.
Manufactured by Marcyrl