Sovaldi 400 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sovaldi 400 mg film-coated tablets

sofosbuvir

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sovaldi is and what it is used for
2. What you need to know before taking Sovaldi
3. How to take Sovaldi
4. Possible side effects
5. How to store Sovaldi
6. Contents of the pack and other information

1. What Sovaldi is and what it is used for

Sovaldi contains the active substance sofosbuvir, which is used to treat hepatitis C virus infection in adults and adolescents from 12 years of age up to 18 years of age.

Hepatitis C is a viral infection of the liver. This medicine works by reducing the amount of hepatitis C virus in the body and eliminating the virus from the blood after a certain period of time.

Sovaldi is always taken with other medicines for hepatitis C. It does not work alone. It is commonly taken with:

• Ribavirin, or
• Peginterferon alfa and ribavirin

It is very important that you also read the package leaflets of the other medicines you will be taking with Sovaldi. If you have any questions about your medicines, consult your doctor or pharmacist.

2. What you need to know before starting to take Sovaldi

Do not take Sovaldi

• If you are allergic to sofosbuvir or to any of the other ingredients of this medicine

(listed in section 6 of this leaflet).

→If this applies to you, inform 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 (Hypericum perforatum, a herbal medicine used to treat depression);
  • Carbamazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures).

Warnings and precautions

Sovaldi is always taken together with other medicines to treat hepatitis C (see section 1 above).

Talk to your doctor or pharmacist before taking this medicine if:

• You are currently taking or have stopped taking amiodarone within the last few months to treat irregular heartbeat (your doctor may consider alternative treatments if you have taken this medicine).
• You have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplant.
• You currently have or have previously had an infection caused by the hepatitis B virus, as your doctor may want to monitor you more closely.
• You have kidney problems. Talk to your doctor or pharmacist if you have severe kidney problems or are on kidney dialysis, as the effects of Sovaldi have not been fully studied in patients with severe kidney problems.
• You have diabetes. After starting Sovaldi, you may require close monitoring of your blood glucose levels and/or adjustment of your antidiabetic medication. Some diabetic patients have experienced low blood sugar levels (hypoglycaemia) after starting treatment with medicines such as Sovaldi.

Contact your doctor immediately if you are taking any medicine for heart problems and, during treatment, experience:

• shortness of breath or worsening of pre-existing shortness of breath
• dizziness
• palpitations
• fainting

Blood tests

Your doctor will perform blood tests before, during, and after treatment with Sovaldi. These tests will allow your doctor to:

• Determine which other medicines you should take with Sovaldi and for how long.
• Confirm that the treatment has been effective and that you no longer have the hepatitis C virus.

Children and adolescents

Do not give this medicine to children under 12 years of age. The use of Sovaldi has not yet been studied in children under 12 years of age.

Other medicines and Sovaldi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Warfarin and other similar medicines called vitamin K antagonists, used to thin the blood. Your doctor may increase the number of blood tests to monitor your blood clotting.

Talk to your doctor about taking Sovaldi if you are taking any of the following medicines:

• Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
• Modafinil (a medicine used to treat people with narcolepsy and help them stay awake);
• Rifapentine (a medicine used to treat infections, including tuberculosis); because these may make Sovaldi less effective.

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

• Amiodarone, used to treat irregular heartbeat.

If you have any doubts about which medicines can be taken with Sovaldi, speak with your doctor or pharmacist.

Pregnancy and contraception

Pregnancy must be avoided due to the use of Sovaldi together with ribavirin. Ribavirine can be highly harmful to the unborn baby. Therefore, you and your partner must take special precautions during sexual activity if there is any possibility of pregnancy.

• Sovaldi is frequently used together with ribavirin. Ribavirin can cause harm to the unborn baby. Therefore, it is very important that you (or your partner) do not become pregnant during this treatment.
• You or your partner must use an effective method of contraception during treatment and after treatment has ended. It is very important that you read the "Pregnancy" section of the ribavirin package leaflet carefully. Ask your doctor which effective contraceptive method is suitable for you.
• If you or your partner becomes pregnant during treatment with Sovaldi or in the months following treatment, you must contact your doctor immediately.

Breast-feeding

You must not breast-feed during treatment with Sovaldi. It is unknown whether sofosbuvir, the active substance in Sovaldi, passes into human breast milk.

Driving and use of machines

Some patients reported fatigue, dizziness, blurred vision, and reduced attention when taking Sovaldi together with other medicines for hepatitis C infection. If you experience any of these side effects, do not drive or operate any tools or machinery.

3. How to take Sovaldi

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose

The recommended dose is one tablet (400 mg) once daily , taken with food. Your doctor will tell you how long you should take Sovaldi.

Swallow the tablet whole. Do not chew, crush, or split the tablet, as it has a very bitter taste. Inform your doctor or pharmacist if you have difficulty swallowing the tablets.

Sovaldi must always be taken in combination with other medicines used to treat hepatitis C.

If you vomit within 2 hours after taking Sovaldi, take another tablet. If you vomit more than 2 hours after taking it, there is no need to take another tablet until your next regularly scheduled dose.

If you take more Sovaldi than you should

If you accidentally take more than the recommended dose, you must contact your doctor or the nearest emergency department for advice. Keep the tablet bottle with you so you can easily describe what you have taken.

If you forget to take Sovaldi

It is important that you do not miss any doses of this medicine.

If you miss a dose:

• And you remember within 18 hours of your usual Sovaldi dosing time, take the tablet as soon as possible. Then take your next dose at the usual time.
• And you remember 18 hours or more after your usual Sovaldi dosing time, wait and take the next dose at the usual time. Do not take a double dose (two doses within a short interval of time).

Do not stop treatment with Sovaldi

Do not stop treatment with this medicine unless instructed by your doctor. It is very important that you complete the full course of treatment so that the medicines are in the best possible conditions to treat hepatitis C virus infection.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When you take Sovaldi in combination with amiodarone (a medicine used for heart problems), you may experience one or more of the following adverse effects:

• Slow or irregular heartbeat, or problems with heart rhythm.
• Shortness of breath or worsening of pre-existing shortness of breath.

Inform your doctor or pharmacist if you notice any of these adverse effects during treatment.

When you take Sovaldi with ribavirin or with peginterferon alfa plus ribavirin, you may experience one or more of the following adverse effects:

Very common adverse effects

(may affect more than 1 in 10 people)

• Fever, chills, flu-like symptoms
• Diarrhea, nausea, vomiting
• Trouble sleeping (insomnia)
• Fatigue and irritability
• Headache
• Rash, itching of the skin
• Loss of appetite
• Dizziness
• Muscle pain, joint pain
• Shortness of breath, cough

Blood tests may also show:

• Decreased red blood cell count (anemia); signs may include fatigue, headache, shortness of breath on exertion
• Decreased white blood cell count (neutropenia); signs may include increased susceptibility to infections, including fever and chills, or sore throat or mouth ulcers
• Decreased platelet count
• Changes in liver function (such as increased levels of a substance called bilirubin in the blood)

Common adverse effects

(may affect up to 1 in 10 people)

• Changes in mood, depression, anxiety, and agitation
• Blurred vision
• Severe headaches (migraine), memory loss, difficulty concentrating
• Weight loss
• Shortness of breath on exertion
• Abdominal discomfort, constipation, dry mouth, indigestion, acid reflux
• Hair loss and thinning
• Dry skin
• Back pain, muscle spasms
• Chest pain, weakness
• Colds (nasopharyngitis)

Other effects that may occur during treatment with sofosbuvir:

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

• Severe generalized rash with skin peeling, which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes and/or genitals (Stevens-Johnson syndrome).

→If you consider any of the adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sovaldi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and carton following {EXP}. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sovaldi

• The active substance is sofosbuvir. Each film-coated tablet contains 400 mg of sofosbuvir.

• The other components are:

Tablet core:

Manitol, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Film coating:

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.

Appearance of the product and contents of the pack

The film-coated tablets are yellow, capsule-shaped tablets, with "GSI" engraved on one side and "7977" on the other.

Each bottle contains a desiccant silica gel packet (drying agent) which should be kept in the bottle to help protect the tablets. The silica gel desiccant is packaged in a separate sachet or container and must not be swallowed.

The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and 84 film-coated tablets (3 bottles of 28 tablets). Only certain pack sizes may be marketed in your country.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.