SOVALDI 400mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sovaldi 400 mg film-coated tablets

sofosbuvir

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section 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, 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Sovaldi and what is it used for

Sovaldi contains the active substance sofosbuvir, which is used to treat hepatitis C virus infection in adults and adolescents from 12 years 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 removing the virus from the blood after some time.

Sovaldi is always taken with other medicines to treat hepatitis C. It does not work on its own. It is often taken with:

• ribavirin, or
• peginterferon alfa and ribavirin

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

2. What you need to know before you take Sovaldi

Do not take Sovaldi

• If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6).

(including those listed in section 6 of this leaflet).

→If this is the case, 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(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 with other medicines to treat hepatitis C (see section 1 above).

Tell your doctor or pharmacist before you start taking this medicine if:

• You are currently taking or have recently stopped taking the medicine amiodarone to treat irregular heart rhythm (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 waiting for a liver transplant.
• You have had or currently have a hepatitis B virus infection, 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 if you are on dialysis, as the effects of Sovaldi in patients with severe kidney problems have not been fully studied.
• You have diabetes. After starting Sovaldi, you may need close monitoring of your blood glucose levels and/or adjustment of your diabetes medication. After starting treatment with medicines like Sovaldi, some diabetic patients have experienced low blood sugar levels (hypoglycaemia).

Tell your doctor immediatelyif you are taking any medicine for heart problems and, during treatment, you experience:

• shortness of breath or worsening of shortness of breath you already have
• dizziness
• palpitations
• fainting

Blood tests

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

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

Children and adolescents

Do notgive this medicine to children under 12 years of age. 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 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 check how your blood clots.

Ask 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 to treat people who have narcolepsy and helps them stay awake);
• Rifapentine (a medicine used to treat infections, including tuberculosis); This is because they may make Sovaldi work less well.

Tell your doctorif you are taking any of the following medicines:

• Amiodarone, used to treat irregular heart rhythm.

If you are unsure about which medicines can be taken with Sovaldi, talk to your doctor or pharmacist.

Pregnancy and contraception

Pregnancy should be avoided due to the use of Sovaldi with ribavirin. Ribavirin can be very harmful to the unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance of pregnancy.

• Sovaldi is often used with ribavirin. Ribavirin can cause harm to the unborn baby. 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 birth control during treatment and after treatment. 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 become pregnant during treatment with Sovaldi or in the months after, you must contact your doctor immediately.

Breast-feeding

Do notbreast-feed during treatment with Sovaldi. It is not known if sofosbuvir, the active substance of Sovaldi, passes into human breast milk.

Driving and using machines

Some patients reported feeling tired, dizzy, blurry vision and reduced attention when taking Sovaldi with other medicines to treat hepatitis C. If you notice any of these side effects, do not drive or use any tools or machines.

3. How to take Sovaldi

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

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

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

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

If you vomit less than 2 hoursafter taking Sovaldi, take another tablet. If you vomit more than 2 hoursafter taking it, you do not need to take another tablet until the next one is due.

If you take more Sovaldi than you should

If you accidentally take more than the recommended dose, contact your doctor or the nearest emergency department for advice. Have the pack of tablets with you to show the doctor what you have taken.

If you forget to take Sovaldi

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

If you miss a dose:

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

Do not stop taking Sovaldi

Do not stop taking this medicineunless your doctor tells you to. It is very important that you complete the full treatment course so that the medicines are in the best condition to treat the hepatitis C virus infection.

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

4. Possible side effects

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

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

• Slow or irregular heart rhythm, or heart rhythm problems.
• Shortness of breath or worsening of shortness of breath you already have.

Tell your doctor or pharmacist if you notice any of these side effects during treatment.

When taking Sovaldi with ribavirin or with peginterferon alfa and ribavirin, you may experience one or more of the following side effects:

Very common side effects

(may affect more than 1 in 10 people)

• fever, chills, flu-like symptoms
• diarrhoea, nausea, vomiting
• sleeping problems (insomnia)
• fatigue and irritability
• headache
• rash, itching of the skin
• loss of appetite
• dizziness
• muscle pain, pain in the joints
• shortness of breath, cough

Blood tests may also show:

• reduced red blood cell count (anaemia); signs include fatigue, headaches, shortness of breath with exertion
• reduced white blood cell count (neutropenia); signs include getting more infections than usual, including fever and chills, or sore throat or mouth ulcers
• reduced platelet count in the blood
• changes in the liver (such as shown by increased levels of a substance called bilirubin in the blood)

Common side effects

(may affect up to 1 in 10 people)

• mood changes, depression, anxiety and agitation
• blurred vision
• severe headaches (migraine), memory loss, loss of concentration
• weight loss
• shortness of breath with exertion
• abdominal discomfort, constipation, dry mouth, indigestion, acid reflux
• hair loss and thinning
• dry skin
• back pain, muscle spasms
• chest pain, weakness
• cold (nasopharyngitis)

Other effects that may be seen during treatment with sofosbuvir:

The frequency of the following side effects cannot be estimated from the available data.

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

→If you think you have any of the side effects that are serious, tell your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and blister after {EXP}. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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 protect the environment.

6. Contents of the pack and other information

What Sovaldi contains

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

• The other ingredients are:

Tablet core:

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

film coating:

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

Appearance and packaging

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

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

The following pack sizes are available: outer cartons with 1 bottle of 28 film-coated tablets and 84 (3 bottles of 28) film-coated tablets. Not all pack sizes may be marketed in your country.

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

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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