400 mg / 100 mg film-coated tablets, 200 mg / 50 mg film-coated tablets 
sofosbuvir / velpatasvir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

If your child has been prescribed Epclusa, note that all information in this leaflet is addressed to your child (in this case, read “your child” instead of “you”).

In this leaflet: 
1. What Epclusa is and what it is used for 
2. What you need to know before taking Epclusa 
3. How to take Epclusa 
4. Possible side effects 
5. How to store Epclusa 
6. Contents of the packaging and other information 

1. What Epclusa is and what it is used for

Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. It is given to treat a chronic (long-term) viral infection in the liver called hepatitis C, in patients aged 6 years and older, and weighing at least 17 kg.

The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce, which makes it possible to permanently remove an infection from the body.

Epclusa is sometimes taken with another medicine, ribavirin.

It is very important that you also read the package leaflets for the other medicines that you are taking with Epclusa. If you have any further questions on the use of this product, ask your doctor or pharmacist.

2. What you need to know before taking Epclusa

Do not take Epclusa

  • 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 Epclusa but 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 mild depression)
  • carbamazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent epileptic seizures).

Warnings and cautions

Talk to a doctor if you:

  • have other liver problems in addition to hepatitis C, for example
    • have or have had an infection with hepatitis B – the virus, because the doctor wants to monitor you more closely
    • has undergone a liver transplant.
  • have kidney problems or if you receive kidney dialysis, as Epclusa has not been fully tested in patients with certain severe kidney problems
  • undergoing treatment for HIV – infection (human immunodeficiency virus), as your doctor may need to monitor you more closely.

Talk to your doctor or pharmacist before taking Epclusa if:

  • you are currently taking, or in recent months, have been taking the drug amiodarone to treat irregular heartbeats, as it can cause your heart rate to drop to a life-threatening level. Your doctor may consider alternative treatments if you have taken this medicine. If you need treatment with Epclusa, extracardiac monitoring may be necessary.
  • have diabetes. Your blood sugar levels may need to be monitored more closely and/or adjustment of your diabetes medicines may be needed after you start taking Epclusa. In some diabetic patients, blood sugar levels have dropped (hypoglycemia) after starting treatment with medicines such as Epclusa.

Tell your doctor immediately if you are currently taking, or have taken any medicines for heart problems in the last few months, and your experience during treatment:

  • slow or irregular heartbeat, or problems with heart rhythm
  • shortness of breath or worsening of pre-existing shortness of breath
  • chest pain
  • dizziness
  • palpitation
  • that you almost faint or faint

Blood tests

Your doctor will examine your blood before, during, and after treatment with Epclusa. This is to:

  • Your doctor should be able to decide if you should take Epclusa and for how long.
  • Your doctor should be able to confirm that the treatment has worked and that you no longer carry the hepatitis C virus.

Children and young people

Do not give this medicine to children under 6 years of age or weighing less than 17 kg. The use of Epclusa in patients under 6 years of age has not yet been studied.

Other medicines and Epclusa

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 are used to thin the blood. Your doctor may need to test your blood more often to check your blood’s coagulation ability.

The function of your liver may change with the treatment of hepatitis C and may therefore affect other medicines (eg medicines used to suppress your immune system, etc.). Your doctor may need to monitor these other medicines you are taking care and adjustments may need to be made after starting treatment with Epiclusa.

If you are not sure, talk to your doctor or pharmacist.

Some medicines should not be taken with Epclusa.

  • Do not take any other medicine that contains sofosbuvir, one of the active substances in Epclusa.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • amiodarone is used to treat irregular heartbeats
  • rifapentine (an antibiotic used to treat infections, including tuberculosis )
  • oxcarbazepine (a medicine used to treat epilepsy and prevent epileptic seizures)
  • tenofovir disoproxil fumarate, or any medicine containing tenofovir, which is used to treat HIV – infection
  • efavirenz is used to treat HIV – infection
  • digoxin used to treat heart disease
  • dabigatran used to thin the blood
  • modafinil used to treat sleep disorders
  • rosuvastatin or other statins used to treat high cholesterol.

If you take Epclusa with any of these medicines, the medicines may not work properly or any side effects may get worse. Your doctor may need to give you another medicine or change the dose of medicine you are taking. This change may apply to Epclusa or any other medicine you are taking.

  • Ask your doctor or pharmacist for advice if you are taking medicines used to treat stomach ulcers, heartburn, or acid reflux as they may reduce the amount of velpatasvir in your blood. These are:
    • antacids (eg aluminum/magnesium hydroxide or calcium carbonate ). These should be taken at least 4 hours before or 4 hours after Epclusa.
    • proton pump inhibitors (eg omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). Epclusa should be taken with food 4 hours before taking a proton pump inhibitor.
    • H 2 -receptor antagonists (eg famotidine, cimetidine, nizatidine, or ranitidine). If you need high doses of these medicines, your doctor may give you another medicine or change the dose of medicine you are taking.

These medicines can reduce the amount of velpatasvir in your blood. If you are taking any of these medicines, your doctor will either give you another medicine for stomach ulcers, heartburn, or acid reflux or recommend how and when to take it.

Pregnancy and contraception

The effect of Epclusa during pregnancy is unknown. 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.

Epclusa is sometimes used with ribavirin. Ribavirin may cause birth defects. It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after the treatment. You must read the “Pregnancy” section of the ribavirin package leaflet very carefully. Ask your doctor about an effective method of contraception that is suitable for you and your partner.

Breast-feeding

Do not breast-feed during treatment with Epclusa. It is not known whether sofosbuvir or velpatasvir, the two active substances in Epclusa, pass into breast milk.

Driving and using machines

Epclusa should not affect your ability to drive or use any tools or machines.

3. How to take Epclusa

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose

The recommended dose of Epclusa in adults is one 400 mg / 100 mg tablet once daily for 12 weeks.

The recommended dose of Epclusa in patients aged 6 years to less than 18 years, weighing at least 17 kg, is by weight. Take Epclusa exactly as your doctor has told you.

Swallow the tablet (s) whole/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 Epclusa.

If you take a proton pump inhibitor, take Epclusa with food 4 hours before proton pump inhibitors are taken.

If you vomit after taking Epclusa, it may affect the amount of Epclusa in your blood. This may mean that Epclusa does not work as well.

  • If you vomit less than 3 hours after taking Epclusa, take a new tablet.
  • If you vomit more than 3 hours after taking Epclusa, you do not need to take any more tablets until you take the next tablet according to the treatment schedule.

If you take more Epclusa then you should

If you accidentally take more than the recommended dose, contact your doctor, hospital, or Poison Information Center immediately for advice. Bring the jar of tablets with you so that you can easily describe what you have taken.

If you forget to take Epclusa

You mustn’t miss a dose of this medicine.

If you miss a dose, calculate how long it has been since you last took Epclusa:

  • If you notice it less than 18 hours after the time you usually take Epclusa, you must take the tablet as soon as possible. Then take the next dose at the usual time.
  • If it has been 18 hours or more after the time you usually take Epclusa, wait and take the next dose at the usual time. Do not take a double dose (two doses close together).

Do not stop taking Epclusa

Do not stop taking this medicine unless your doctor tells you to. You must complete the entire course of treatment to give the medicine the best conditions to treat an infection with the hepatitis C virus.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects are

(may affect up to 1 in 10 users)

  • rash

Uncommon side effects are

(may affect up to 1 in 100 people)

  • swelling of the face, lips, tongue, or throat ( angioedema ).

Other effects that can be seen with sofosbuvir treatment:

The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).

  • widespread, severe rash with scaly skin that may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Steven-Johnson syndrome).

→ If you get any side effects, talk to your doctor.

5. How to store Epclusa

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 can and carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are sofosbuvir and velpatasvir. Each film-coated tablet contains either 400 mg sofosbuvir and 100 mg velpatasvir or 200 mg sofosbuvir and 50 mg velpatasvir.
  • Other ingredients are tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
    Film coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide.

What the medicine looks like and the contents of the pack

Epclusa 400 mg / 100 mg film-coated tablets are pink, diamond-shaped tablets, debossed with “GSI” on one side and “7916” on the other side. The tablet is 20 mm long and 10 mm wide.

Epclusa 200 mg / 50 mg film-coated tablets are pink, oval tablets, debossed with “GSI” on one side and “S / V” on the other side. The tablet is 14 mm long and 7 mm wide.

The following pack sizes are available for both 400 mg / 100 mg and 200 mg / 50 mg film-coated tablets:

  • outer cartons containing 1 jar of 28 film-coated tablets.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Muhammad Nadeem

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