Sovaldi 400mg Tablet (28'S)

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.


Basic Information

Mechanism Of Action

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.


Pharmacokinets

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.

Side Effects

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

Contra Indications

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.

Pregnancy Related Information

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.


Breast Feeding Related Information

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.


Indications

Sofosbuvir is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen.

Interactions

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

Typical Dosage

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.

Storage Requirements

Keep SOVALDI 400MG TABLET out of reach from children

Store SOVALDI 400MG TABLET at room temperature

Effects Of Overdose

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.

How To Use

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.

FAQs

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.