Label: information for the user

Sovaldi 400 mg film-coated tablets

sofosbuvir

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, because it contains important information for you.

- Keep this label, as you may need to refer to it again.

- If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What Sovaldi is and for what it is used

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

3. How to take Sovaldi

4. Possible adverse effects

5. Storage of Sovaldi

6. Contents of the pack and additional information

Sovaldi contains the active ingredient sofosbuvir, which is administered to treat infection caused by the hepatitis C virus in adults and adolescents from 12 years old to 18 years old.

The hepatitis C is a viral infection of the liver. This medication acts by reducing the amount of hepatitis C virus in the body and eliminating the virus from the blood after a certain time.

Sovaldi is always taken with other medications to treat hepatitis C. It does not act alone. It is taken frequently with:

• Ribavirin, or

• Peginterferon alfa and ribavirin

It is very important that you also read the prospectuses of the other medications you will take with Sovaldi. If you have any doubts about your medications, consult your doctor or pharmacist.

Do not take Sovaldi

• If you are allergic to sofosbuvir or any of the other components of this medication

(listed in section 6 of this prospectus).

→If this is the case, inform your doctor immediately.

• If you are currently taking any of the following medications:

• Rifampicin and rifabutin(antibiotics used to treat infections, including tuberculosis);
• St. John's Wort(Hypericum perforatum,herbal medicine used to treat depression);
• Carbamazepine, phenobarbital, and phenytoin(medications used to treat epilepsy and prevent seizures).

Warnings and precautions

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

Consult your doctor or pharmacist before starting this medication if:

• You are currently taking or have recently stopped taking amiodarone for irregular heart rhythm (your doctor may consider alternative treatments if you have taken this medication).
• You have liver problems other than hepatitis C, for example, if you are waiting for a liver transplant.
• You have or have had 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 are undergoing renal dialysis, as Sovaldi's effects on patients with severe kidney problems have not been fully studied.
• You have diabetes. After starting Sovaldi, you may need to closely monitor your blood glucose levels and/or adjust your antidiabetic medication. Some diabetic patients have experienced low blood sugar (hypoglycemia) after starting treatment with medications like Sovaldi.

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

• shortness of breath or worsening shortness of breath you already had

• dizziness

• palpitations

• blackouts

Blood tests

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

• determine which other medications you should take with Sovaldi and for how long.

• confirm that the treatment has been effective and you no longer have the hepatitis C virus.

Children and adolescents

Do notgive this medication to children under 12 years old. Sovaldi has not yet been studied in children under 12 years old.

Other medications and Sovaldi

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Warfarin and other medications similar to warfarin, known as vitamin K antagonists, used to thin the blood. Your doctor may increase the number of blood tests to check how your blood clots.

Consult your doctor about taking Sovaldi if you are taking any of the following medications:

• Oxcarbazepine (a medication used to treat epilepsy and prevent seizures);

•Modafinil (a medication to treat people with narcolepsy and helps them stay awake).

•Rifapentine (a medication used to treat infections, including tuberculosis); This is because they may make Sovaldi less effective.

Inform your doctorif you are taking any of the following medications:

• Amiodarone, used to treat irregular heart rhythm.

If you have any doubts about which medications 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 fetus. Therefore, you and your partner should take special precautions in sexual activity if there is any possibility of pregnancy.

•Sovaldi is often used with ribavirin. Ribavirin can cause damage to the fetus. Therefore, it is very important that you (or your partner)do not become pregnantduring this treatment.

•You or your partner should use an effective method of birth controlduring treatment and after it. It is very important that you read the "Pregnancy" section of the ribavirin prospectus very carefully. Ask your doctor what effective contraceptive method is suitable for you.

•If you or your partner become pregnant during treatment with Sovaldi or in the months following it, you mustcontact your doctor immediately.

Breastfeeding

Do not breastfeed during treatment with Sovaldi.The active ingredient of Sovaldi, sofosbuvir, is unknown to pass into human breast milk.

Driving and operating machinery

Some patients reported fatigue, dizziness, blurred vision, and reduced attention when taking Sovaldi with other medications to treat hepatitis C. If you experience any of these adverse effects, do not drive or operate any tools or machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended Dose

The recommended dose isone tablet (400 mg) once a day, taken with food. Your doctor will tell you for how long you should take Sovaldi.

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

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

If you vomit withinless than 2 hoursafter taking Sovaldi, take another tablet. If you vomit more than2 hoursafter taking it, do not take another tablet until your next scheduled dose.

If you take more Sovaldi than you should

If you accidentally take a higher dose than recommended, contact your doctor or the nearest emergency service for advice. Have the tablet bottle with you to easily describe what you have taken.

If you forget to take Sovaldi

It is essential not to miss any dose of this medication.

If you miss a dose:

•And you realize within 18 hoursof the time when you normally take Sovaldi, take the tablet as soon as possible. Then, take the next dose at the usual time.

•And you realize after 18 hours or moresince the time when you normally take Sovaldi, wait and take the next dose at the usual time. Do not take a double dose (two doses in a short interval of time).

Do not interrupt Sovaldi treatment

Do not interrupt treatment with this medicationunless your doctor tells you to. It is very important to complete the entire treatment cycle so that the medications are in the optimal conditions to treat the hepatitis C virus infection.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

When you take Solvaldi in combination 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 problems with heart rhythm.

• Lack of breath or worsening of existing shortness of breath.

Inform your doctor or pharmacist if you experience any of these side effects during treatment.

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

Frequent side effects

(may affect more than 1 in 10 people)

• Fever, chills, flu-like symptoms

• Diarrhea, nausea, vomiting

• Difficulty sleeping (insomnia)

• Fatigue and irritability

• Headache

• Rash, itching on the skin

• Loss of appetite

• Dizziness

• Muscle pain, joint pain

• Lack of breath, cough

Blood tests may also show:

•Decreased red blood cell count in the blood (anemia); symptoms may include fatigue, headaches, shortness of breath with exertion

•Decreased white blood cell count in the blood (neutropenia); symptoms may include frequent infections, including fever and chills, or sore throat or ulcers in the mouth

• Decreased platelet count in the blood

•Changes in the liver (such as an increase in the amount of a substance called bilirubin in the blood)

Frequent 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

• Common cold (nasopharyngitis)

Other effects that may be observed during treatment with sofosbuvir:

We do not know the frequency of the following side effects (frequency cannot be estimated from available data).

-Severe generalized 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 consider any of the side effects you experience to be severe, inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle and the box after {CAD}. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Sovaldi

•The active ingredient issofosbuvir. Each film-coated tablet contains 400 mg of sofosbuvir.

• The other components are:

Core of the tablet:

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

Film coating:

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

Appearance of the product and contents of the pack

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

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

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

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible Person

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.