Manufacturer: Mylan Pharmaceuticals Pvt Ltd
Salt Composition : Sofosbuvir(400mg)
SOVALDI 400MG TABLET is not recommended for use in patients allergic to Sofosbuvir.
Before taking SOVALDI 400MG TABLET, inform your doctor if you have a history of hepatitis B virus infection, and/or suffer from diabetes, heart problems, kidney problems, and/or other liver problems.
SOVALDI 400MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy since Ribavirin (antiviral medicine used with Sofosbuvir) may cause harm to the unborn baby. Women of childbearing potential should use effective contraceptive measures to avoid getting pregnant and undergo a routine pregnancy test during and after treatment (for 9 months). If accidental pregnancy occurs, then it should be informed to the doctor immediately. The medicine is also not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breast milk.
SOVALDI 400MG TABLET is not recommended for use in children (aged below 3 years) and is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.
The most common side effects of taking SOVALDI 400MG TABLET are fever, chills, diarrhoea, nausea, vomiting, dizziness, feeling depressed/anxious/agitated, and/or headache. Consult with your doctor if any of these symptoms worsen.
Sofosbuvir works by lowering the load of hepatitis C virus in the body by binding to hepatitis C virus RNA and interfering with its life cycle thus preventing the viral replication in the body and treating the infection in affected individuals.
Pharmacokinetics. Sofosbuvir is only administered orally. The peak concentration after oral administration is 0.5–2 hours post-dose, regardless of initial dose. Peak plasma concentration of the main circulating metabolite GS-331077 occurs 2–4 hours post-dose.
COMMON
Fever, chills, flu-like symptoms
Diarrhoea, nausea, vomiting
Trouble sleeping, feeling tired, irritability, dizziness, changes in mood, feeling depressed/anxious/agitated
Headache, blurred vision
Memory loss, loss of concentration
Rash, itchy skin
Loss of appetite, decreased appetite
Muscle aches, joint pain
Shortness of breath, cough
Signs of anaemia such as feeling tired, headaches, shortness of breath
Signs of low white blood cells such as getting more prone to infections, fever, chills, sore throat, mouth ulcers
Signs of low blood platelet count such as excessive bruising, prolonged bleeding from cuts, blood in urine/stools
Weight loss
Shortness of breath (while exercising)
Stomach discomfort, constipation, dry mouth, indigestion, acid reflux
Hair loss and thinning hair
Dry skin
Back pain, muscle spasms
Chest pain, weakness
Common cold
RARE
Stop taking SOVALDI 400MG TABLET, if you experience any of the following symptoms:
Signs of heart problems (in patients who had/currently taking medicines for heart problems like amiodarone) such as slow/irregular heartbeat, heart rhythm problems, shortness of breath/worsening of the existing condition, chest pain, light-headedness, palpitations, and/or fainting
Hypersensitivity.
Pregnancy or planning pregnancy, including men whose female partners are pregnant/planning to get pregnant.
CrCl less than 50 mL/min.
Pancreatitis.
Hemoglobinopathies (e.g., thalassemia major, sickle cell anemia)
Coadministration with diagnosing.
SOVALDI 400MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy since Ribavirin (antiviral medicine used with Sofosbuvir) may cause harm to the unborn baby. Women of childbearing potential should use effective contraceptive measures to avoid getting pregnant and undergo a routine pregnancy test during and after treatment (for 9 months). If accidental pregnancy occurs, then it should be informed to the doctor immediately. Consult your doctor before taking the medicine.
SOVALDI 400MG TABLET is not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breast milk. Consult your doctor before taking the medicine.
Sofosbuvir is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen.
Drug-Drug Interaction: SOFOSBUVIR may interact with anticonvulsants (oxcarbazepine, carbamazepine, phenytoin, phenobarbital), wakefulness-promoting agents (modafinil), antibiotics (rifapentine, rifabutin, rifampin), anti-HIV drug (tipranavir) and medicine used to treat irregular heartbeats (amiodarone).
Drug-Food Interaction: Avoid taking SOFOSBUVIR with St. John’s wort (Hypericum perforatum) or a product containing St. John’s wort (herbal medicine used to treat depression).
Drug-Disease Interaction: If you have diabetes or liver problems other than hepatitis C (if you are awaiting liver transplantation), inform your doctor before taking SOFOSBUVIR.
Drug-Drug Interactions Checker List:
OXCARBAZEPINE
CARBAMAZEPINE
PHENYTOIN
PHENOBARBITAL
MODAFINIL
RIFABUTIN
RIFAMPICIN
TIPRANAVIR
AMIODARONE
Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.
Keep SOVALDI 400MG TABLET out of reach from children
Store SOVALDI 400MG TABLET at room temperature
If you or anyone else accidentally take too much of SOVALDI 400MG TABLET, consult your doctor immediately or visit the nearby hospital to manage overdose symptoms.
Take SOVALDI 400MG TABLET as advised by your doctor. Swallow the medicine along with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.
What is SOVALDI 400MG TABLET used for?
SOVALDI 400MG TABLET is used with Ribavirin/ Peginterferon alfa and ribavirin (antiviral medicines) to treat hepatitis C viral infection in adults and children (aged 3 years/above), which is a type of viral infection that infects the liver.
What are the side effects of SOVALDI 400MG TABLET?
The most common side effects of taking SOVALDI 400MG TABLET are fever, chills, diarrhoea, nausea, vomiting, dizziness, feeling depressed/anxious/agitated, and/or headache. Consult with your doctor if any of these symptoms worsen.
How SOVALDI 400MG TABLET work?
Sofosbuvir works by lowering the load of hepatitis C virus in the body by binding to hepatitis C virus RNA and interfering with its life cycle thus preventing the viral replication in the body and treating the infection in affected individuals.
