Package leaflet: Information for the user
Sofosbuvir/Velpatasvir 400 mg/100 mg film-coated tablets
sofosbuvir/velpatasvir
?This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects to talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sofosbuvir/Velpatasvir
is and what it is used for
2. What you need to know before you take Sofosbuvir/Velpatasvir
3. How to take Sofosbuvir/Velpatasvir
4. Possible side effects
5. How to store Sofosbuvir/Velpatasvir
6. Contents of the pack and other information
1. What Sofosbuvir/Velpatasvir is and what it is used for
Sofosbuvir/Velpatasvir is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. It is given to treat chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older.
The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Sofosbuvir/Velpatasvir is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other medicines that you will be taking with Sofosbuvir/Velpatasvir. If you have any questions about your medicines, please ask your doctor or pharmacist.
2. What you need to know before you take Sofosbuvir/Velpatasvir
Do not take Sofosbuvir/Velpatasvir
- If you are allergic?to sofosbuvir, velpatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
- If this applies to you,?do not take Sofosbuvir/Velpatasvir 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?(herbal medicine used to treat depression);
- carbamazepine, phenobarbital?and?phenytoin?(medicines used to treat epilepsy and prevent seizures).
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
- have kidney problems or if you are on kidney dialysis since Sofosbuvir/Velpatasvir has not been fully tested in patients with some severe kidney problems;
- are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.
Talk to your doctor or pharmacist before taking Sofosbuvir/Velpatasvir if:
- you currently take or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).
- you have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sofosbuvir/Velpatasvir. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sofosbuvir/Velpatasvir.
Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
- shortness of breath;
- light-headedness;
- palpitations;
- fainting.
Blood tests
Your doctor will test your blood before, during and after your treatment with Sofosbuvir/Velpatasvir. This is so that:
- Your doctor can decide if you should take Sofosbuvir/Velpatasvir and for how long;
- Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. The use of Sofosbuvir/Velpatasvir in children and adolescents has not yet been studied.
Other medicines and Sofosbuvir/Velpatasvir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Your liver function may change with the treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Sofosbuvir/Velpatasvir.
If you are not sure to talk to your doctor or pharmacist.
Some medicines should not be taken with Sofosbuvir/Velpatasvir.
- Do not take any other medicine that contains sofosbuvir, one of the active substances in Sofosbuvir/Velpatasvir.
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?(a medicine used to treat epilepsy and prevent seizures);
- tenofovir disoproxil fumarate?or any medicine containing tenofovir disoproxil fumarate used to treat HIV infection;
- efavirenz?used to treat HIV infection;
- digoxin?used to treat heart conditions;
- dabigatran?used to thin the blood;
- modafinil?used to treat sleep disorders;
- rosuvastatin?or?other statins?used to treat high cholesterol.
Taking Sofosbuvir/Velpatasvir with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking. This change could be to Sofosbuvir/Velpatasvir or another medicine you are taking.
- Get advice from a doctor or pharmacist?if you take medicines used to treat?stomach ulcers, heartburn or acid reflux?as they can decrease the amount of velpatasvir in your blood. These medicines include:
- antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These should be taken at least 4 hours before or 4 hours after Sofosbuvir/Velpatasvir;
- proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). Sofosbuvir/Velpatasvir should be taken with food 4 hours before using a proton pump inhibitor.
- H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine). If you need high doses of these medicines your doctor may give you a different medicine instead or adjust the dose of the medicine you are taking.
These medicines can decrease the amount of velpatasvir in your blood. If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux or recommend how and when you take that medicine.
Pregnancy and contraception
The effects of Sofosbuvir/Velpatasvir during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Sofosbuvir/Velpatasvir is sometimes used together with ribavirin. Ribavirin can harm your unborn baby. It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after completing treatment. You must read the ?Pregnancy? section in the ribavirin package leaflet very carefully. Ask your doctor for an effective contraception method suitable for you and your partner.
Breast-feeding
Do not breast-feed during treatment with Sofosbuvir/Velpatasvir. It is not known whether sofosbuvir or velpatasvir, the two active substances of Sofosbuvir/Velpatasvir, pass into human breast milk.
Driving and using machines
Sofosbuvir/Velpatasvir should not affect your ability to drive or use any tools or machinery.
3. How to take Sofosbuvir/Velpatasvir
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 12 weeks.
Swallow the tablet whole with or without food. Do not chew, crush or split the tablet as it has a very bitter taste.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Sofosbuvir/Velpatasvir.
If you are taking a proton pump inhibitor, take Sofosbuvir/Velpatasvir with food 4 hours before using a proton pump inhibitor.
If you are sick (vomit) after taking Sofosbuvir/Velpatasvir it may affect the amount of Sofosbuvir/Velpatasvir in your blood. This may make Sofosbuvir/Velpatasvir work less well.
- If you are sick (vomit)?less than 3 hours after?taking Sofosbuvir/Velpatasvir, take another tablet.
- If you are sick (vomit)?more than 3 hours after?taking Sofosbuvir/Velpatasvir, you do not need to take another tablet until your next scheduled tablet.
If you take more Sofosbuvir/Velpatasvir than you should
If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
If you forget to take Sofosbuvir/Velpatasvir
It is important not to miss a dose of this medicine.
If you do miss a dose, work out how long it is since you last took your Sofosbuvir/Velpatasvir:
- If you notice within 18 hours?of the time you usually take Sofosbuvir/Velpatasvir, you must take the tablet as soon as possible. Then take the next dose at your usual time.
- If it?s 18 hours or more?after the time you usually take Sofosbuvir/Velpatasvir, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).
Do not stop taking Sofosbuvir/Velpatasvir
Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Other effects that may be seen during treatment with sofosbuvir:
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
- a widespread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
- If you get any side effects to tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sofosbuvir/Velpatasvir
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 storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sofosbuvir/Velpatasvir contains
- The active substances are?sofosbuvir and velpatasvir. Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
- The other ingredients are
Tablet core:
Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Film-coating:
Polyvinyl alcohol, titanium dioxide, polyethene glycol, talc, iron oxide red
What Sofosbuvir/Velpatasvir looks like and contents of the pack
Film-coated tablets
The following pack sizes are available:
- outer cartons containing 1 bottle of 28 film-coated tablets
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)
Free Phone: (1800-222-434 / 1800-222-825)