VOSEVI 400MG/100MG/100MG F.C.TABLET

Sofosbuvir /velpatasvir/voxilaprevir 400 mg/100 mg/100 mg film-coated tablets

What Sofosbuvir /velpatasvir/voxilaprevir is used for:

• It is given to adults of 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.

Do not use Sofosbuvir /velpatasvir/voxilaprevir:

• If you are allergic to sofosbuvir, velpatasvir, voxilaprevir or any of the other ingredients of this medicine
• If this applies to you, do not take Sofosbuvir /velpatasvir/voxilaprevir and tell your doctor immediately.
• If you are currently taking any of the following medicines:
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
• St. John’s wort (a herbal medicine used to treat depression);
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
• rosuvastatin (a medicine used to treat high blood cholesterol or decrease the risk of certain cardiovascular events);
• dabigatran (a medicine used to prevent blood clots);
• ethinylestradiol containing medicines, including many contraceptives.

Warnings and Precautions:

• Talk to your doctor if you:
• have liver problems other than from hepatitis C, for instance
• if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
• if you have had a liver transplant.
• are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.

Possible side effects:

• Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing.
• Stop using the product if you develop hives or itching of the face or body.

Other medicines and Sofosbuvir /velpatasvir/voxilaprevir:

• Tell your doctor or pharmacist if you are taking any of the medicines below:
• amiodarone, used to treat irregular heartbeats;
• rifapentine (an antibiotic used to treat infections, including tuberculosis);
• oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
• tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
• atazanavir, efavirenz or lopinavir, used to treat HIV infection;
• digoxin, used to treat heart conditions;
• modafinil, used to treat sleep disorders;
• atorvastatin, pravastatin, or other statins, used to treat high cholesterol;
• ciclosporin, used to suppress the immune system.
• Taking Sofosbuvir /velpatasvir/voxilaprevir with any of these may stop your medicines

How to use Sofosbuvir /velpatasvir/voxilaprevir:

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Recommended dose: The recommended dose is one tablet once a day for 8 or 12 weeks.
• Swallow the tablet whole with food. Do not chew, crush or split the tablet as it has a very bitter taste.

How to store Sofosbuvir /velpatasvir/voxilaprevir:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
• The expiry date refers to the last day of that month.
• This medicine does not require any special temperature storage conditions.
• Store in the original package in order to protect from moisture. Keep the bottle tightly closed.