SOVALDI 400 mg Фильм-Coated Таблетки

Содержание инструкции

1. Sovaldi 400 mg film-coated tablets, 200 mg film-coated tablets
   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
2. Sovaldi 150 mg coated granules in sachet, 200 mg coated granules in sachet
   1. What is Sovaldi and what is it 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

Sovaldi 400 mg film-coated tablets, 200 mg film-coated tablets

sofosbuvir

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

apply to your child (in this case, read “your child” instead of “you”).

1. What Sovaldi is and what it is used for

Sovaldi contains the active substance sofosbuvir, and is administered to treat infection from the hepatitis C virus, in adults and children aged 3 years or older.
Hepatitis C is a liver infection caused by a virus. This medicine works by lowering the amount of hepatitis C virus in the body and eliminating the virus from the blood after a certain period of time.
Sovaldi must always be taken with other medicines for the treatment of hepatitis C, because it has no effect on its own. It is usually taken with:

• ribavirin (in children and adult patients), or
• peginterferon alfa and ribavirin (in adult patients).

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

2. What you need to know before taking Sovaldi

Do not take Sovaldi

• if you are allergic to sofosbuvir or any of the other ingredients of this medicine
• if you are currently taking any of the following medicines:
• rifampicin(an antibiotic used to treat infections such as tuberculosis);
• St John's wortor Hypericum perforatum (a herbal medicine used to treat depression);
• carbamazepine, phenobarbital and phenytoin(medicines used to treat epilepsy and prevent convulsions).
• If any of these conditions apply to you, tell your doctor immediately.

Warnings and precautions
Sovaldi must always be taken with other medicines for the treatment of hepatitis C (see
section 1 above). Talk to your doctor or pharmacist before taking this medicine if:

• you are taking or have taken amiodarone in the last few months, a medicine for the treatment of irregular heartbeat, as it can cause a slowing of the heartbeat with fatal outcome. Your doctor may consider different treatments if you have taken this medicine. If treatment with Sovaldi is necessary, you may undergo additional heart monitoring
• you have liver problems other than hepatitis C, for example, if you are waiting for a liver transplant
• you have or have had an infection with the hepatitis B virus, as your doctor may decide on closer observation
• you have diabetes. After starting therapy with Sovaldi, more careful monitoring of blood glucose levels and/or modification of antidiabetic therapy may be necessary. Some diabetic patients have experienced low blood sugar levels (hypoglycemia) after starting treatment with medicines such as Sovaldi.

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

• slowed or irregular heartbeat, or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• mild confusion;
• palpitations;
• feeling faint or fainting.

Blood tests
Your doctor will perform certain blood tests before, during and after treatment with Sovaldi. In
this way, the doctor can:

• decide which other medicines you need to take together with Sovaldi and for how long;
• confirm that the treatment has been effective and that the hepatitis C virus is no longer present in you.

Children and adolescents
Donot give this medicine to children under 3 years of age. The use of Sovaldi in children under 3 years of age has not yet been studied.

Other medicines and Sovaldi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Warfarin and other similar medicines called vitamin K antagonists are used to
thin the blood. Your doctor may increase the frequency of blood tests to check
that coagulation is occurring correctly.
Liver function may change with the treatment of hepatitis C and, therefore, have
consequences for other medicines (e.g. medicines used to suppress the immune system,
etc.). Your doctor may need to carefully monitor these other medicines you are
taking and adjust the dose after starting therapy with Sovaldi.
Talk to your doctor before taking Sovaldi if you are taking any of the following medicines:

• oxcarbazepine (a medicine used to treat epilepsy and prevent convulsions);
• modafinil (a medicine used to treat people suffering from narcolepsy and help them stay awake);
• rifapentine (a medicine used to treat infections, including tuberculosis); because these medicines can reduce the effectiveness of Sovaldi.

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

• amiodarone, used for the treatment of irregular heartbeat.

If you have any doubts about the medicines you can take with Sovaldi, talk to your doctor or
pharmacist.

Pregnancy and breastfeeding
If you are using Sovaldi together with ribavirin, pregnancy must be avoided. It is very important
Ribavirin can be very harmful to the fetus. You must take particular precautions
in sexual activity if there is any possibility of pregnancy.

• Sovaldi is normally used with ribavirin. Ribavirin can harm the fetus. It is therefore very important that you (or your partner) avoid pregnancyduring treatment.
• You or your partner must use an effective method of contraception during and aftertreatment. It is very important to read the “Pregnancy” paragraph very carefully.

suitable for you.

• If you or your partner becomes pregnant during treatment with Sovaldi or in the months following, you must tell your doctor immediately.

Driving and using machines
During the taking of Sovaldi together with other medicines for the treatment of hepatitis C
infection, patients have experienced fatigue, dizziness, blurred vision and reduced
attention. If you feel tired or dizzy, have blurred vision or reduced
attention after taking Sovaldi, you must not engage in activities such as driving vehicles or
motorcycles or using machinery.

Sovaldi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Sovaldi

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Recommended dose
Take Sovaldi following the doctor's instructions. The recommended dose of Sovaldi in adultsis
one tablet (400 mg) once a day, with food. Your doctor will tell you how long
you will need to take Sovaldi.
The recommended dose of Sovaldi in children aged 3 years or older is based on body weight.
Take Sovaldi with food, following the doctor's instructions.
Swallow the tablets whole. Do not chew, break or crush them as they have a very
bitter taste. Tell your doctor or pharmacist if you have difficulty swallowing the tablets.
Sovaldi must always be taken together with other medicines used for the treatment of hepatitis C
following the doctor's instructions.
If you vomit within 2 hoursof taking Sovaldi, take another dose. If you vomit after 2 hours
of taking Sovaldi, you should not take another dose until the next dose at the scheduled time.

Kidney problems
Tell your doctor if you have kidney problems or if you are undergoing renal dialysis.

If you take more Sovaldi than you should
If you accidentally take a higher dose than recommended, consult your
doctor or the nearest emergency room immediately. Bring the bottle containing the tablets with you,
so that you can easily explain what you have taken.

If you forget to take Sovaldi
It is important not to forget any dose of this medicine.
If you forget a dose:

• and if you notice it within 18 hoursfrom the time you usually take Sovaldi, you should take the dose as soon as possible. Then take the next dose at the usual time.
• and if you notice it 18 or more hoursafter the time you usually take Sovaldi ,wait and take the next dose at the usual time. Do not take a double dose (two doses at a short distance from each other).

Do not stop treatment with Sovaldi
Do not stop treatment with this medicineunless your doctor has told you to.
It is very important to complete the entire treatment to give the medicines the chance to
fight the hepatitis C virus infection.
If you have any doubts 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 you take Sovaldi in combination with amiodarone (a medicine used for heart problems),
you may experience one or more of the following side effects:

• slowed or irregular heartbeat or heart rhythm problems
• shortness of breath or worsening of pre-existing shortness of breath. If you experience any of the above side effects during therapy, contact your doctor or pharmacist.

When you take Sovaldi with ribavirin or 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
• difficulty sleeping (insomnia)
• feeling tired and irritable
• headache
• skin rash, itching
• loss of appetite, decreased appetite
• feeling dizzy
• muscle discomfort and pain, joint pain
• shortness of breath, cough

Blood tests may show:

• a low red blood cell count (anaemia); signs may include feeling tired, headache, shortness of breath on exertion
• a low white blood cell count (neutropenia); signs may include a greater number of infections with fever and chills or sore throat or mouth ulcers
• a low platelet count
• changes in the liver (shown by higher amounts of a substance called bilirubin in the blood)

Common side effects
( may affect up to 1 in 10 people)

• mood changes, depressed mood, feeling anxious and feeling agitated
• blurred vision
• severe headache (migraine), memory loss, difficulty concentrating
• weight loss
• shortness of breath on exertion
• stomach discomfort, constipation, dry mouth, indigestion, acid reflux
• hair loss and thinning hair
• dry skin
• back pain, muscle spasms
• chest pain, feeling weak
• common cold (nasopharyngitis)

Other effects that may be observed during treatment with sofosbuvir:
The frequency of the following side effects is not known (frequency cannot be estimated on the
basis of available data).

• severe widespread skin rash with peeling skin that may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes and/or genitals (Stevens-Johnson syndrome).
• If any of these side effects get worse, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 bottle and the package after
{Scad}. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sovaldi contains

• The active substance issofosbuvir. Each film-coated tablet contains 400 mg of sofosbuvir or 200 mg of sofosbuvir.
• The other ingredients areTablet core:mannitol, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

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

Description of Sovaldi and contents of the pack
Sovaldi 400 mg film-coated tablets are yellow, capsule-shaped tablets with the
writing “GSI” imprinted on one side and “7977” on the other side. One tablet is approximately 20 mm long and 9
mm wide.
Sovaldi 200 mg film-coated tablets are yellow, oval-shaped tablets with the
writing “GSI” imprinted on one side and “200” on the other side. One tablet is approximately 15 mm long and 8
mm wide.
Each bottle of Sovaldi 400 mg film-coated tablets contains a desiccant, silica gel, which must remain in the bottle to protect the tablets. The desiccant, silica gel, is contained in a sachet or separate container and must not be swallowed.
The following pack sizes are available:

• outer cartons containing 1 bottle of 28 film-coated tablets for 400 mg and 200 mg film-coated tablets
• and 84 (3 bottles of 28) film-coated tablets only for 400 mg 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
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825999

Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113700
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Sovaldi 150 mg coated granules in sachet, 200 mg coated granules in sachet

sofosbuvir

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

apply to your son/daughter (in this case, read “your son/daughter” instead of “you”).

1. What is Sovaldi and what is it used for

Sovaldi granules contain the active substance sofosbuvir, and are administered in a
granule formulation to treat hepatitis C virus infection, in adultsand children aged 3 years or
older.
Hepatitis C is a liver infection caused by a virus. This medicine works by lowering the
amount of hepatitis C virus in the body and eliminating the virus from the blood after a certain period
of time.
Sovaldi must always be taken with other medicines for the treatment of hepatitis C, because it has no
effect on its own. It is usually taken with:

• ribavirin (in children and adult patients), or
• peginterferon alfa and ribavirin (in adult patients).

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

2. What you need to know before taking Sovaldi

Do not take Sovaldi

• if you are allergic to sofosbuvir or to any of the other ingredients of this medicine
• if you are currently taking any of the following medicines:
• rifampicin(an antibiotic used to treat infections such as tuberculosis);
• St John's wortor Hypericum perforatum (a herbal medicine used to treat depression);
• carbamazepine, phenobarbital and phenytoin(medicines used to treat epilepsy and prevent convulsions).
• If any of these conditions apply to you, tell your doctor immediately.

Warnings and precautions
Sovaldi must always be taken with other medicines for the treatment of hepatitis C (see
paragraph 1 above). Talk to your doctor or pharmacist before taking this medicine if:

• you are taking or have taken amiodarone in the last few months, a medicine for the treatment of irregular heartbeat, as it can cause a slowing of the heartbeat with fatal outcome. Your doctor may consider different treatments if you have taken this medicine. If treatment with Sovaldi is necessary, you may undergo additional heart monitoring
• you have liver problems other than hepatitis C, for example, if you are waiting for a liver transplant
• you have or have had an infection with the hepatitis B virus, as your doctor may decide on closer observation
• you have diabetes. After starting therapy with Sovaldi, more careful monitoring of blood glucose levels or a modification of antidiabetic therapy may be necessary. Some diabetic patients have experienced low blood sugar levels (hypoglycemia) after starting treatment with medicines such as Sovaldi.

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

• slow or irregular heartbeat, or heart rhythm disturbances;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• mild confusion;
• palpitations;
• feeling faint or fainting.

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

• decide which other medicines you need to take together with Sovaldi and for how long;
• confirm that the treatment has been effective and that the hepatitis C virus is no longer present in you.

Children
Donot give this medicine to children under 3 years of age. The use of Sovaldi in children under 3 years of age has not yet been studied.

Other medicines and Sovaldi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Warfarin and other similar medicines called vitamin K antagonists are used to make the
blood more fluid. Your doctor may increase the frequency of your blood tests to check
that coagulation is occurring correctly.
Liver function may change with hepatitis C treatment and may interfere with other
drugs (e.g. medicines for suppressing your immune system, etc.). Your doctor may need to
carefully monitor other medicines you are taking and make changes after starting
taking Sovaldi
Talk to your doctor before taking Sovaldi if you are taking any of the following medicines:

• oxcarbazepine (a medicine used to treat epilepsy and prevent convulsions);
• modafinil (a medicine used to treat people suffering from narcolepsy and help them stay awake);
• rifapentine (a medicine used to treat infections, including tuberculosis); because these medicines may reduce the effectiveness of Sovaldi.

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

• amiodarone, used for the treatment of irregular heartbeat.

If you have any doubts about the medicines you can take with Sovaldi, talk to your doctor or
pharmacist.

Pregnancy and breastfeeding
If you are taking Sovaldi together with ribavirin, pregnancy must be avoided. It is very important
Ribavirin can be very harmful to the fetus. Particular precautions must be taken
in sexual activity if there is any possibility of pregnancy.

• Sovaldi is normally used with ribavirin. Ribavirin can harm the fetus. It is therefore very important that you (or your partner) avoid pregnancyduring treatment.
• You or your partner must use an effective method of contraception during and aftertreatment. It is very important to read the “Pregnancy” paragraph very carefully.

suitable for you.

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

Breastfeeding
You must not breastfeed during treatment with Sovaldi.It is not known whether
sofosbuvir, the active ingredient of Sovaldi, passes into breast milk.

Driving and using machines
During the intake of Sovaldi together with other medicines for the treatment of hepatitis C
infection, patients have experienced fatigue, dizziness, blurred vision and reduced
attention. If you experience fatigue or dizziness, blurred vision or reduced
attention after taking Sovaldi, you should not engage in activities such as driving vehicles or
motorcycles or using machinery.

Sovaldi granules contain lactose

• If your doctor has diagnosed you with an intolerance to certain sugars, tell your doctorbefore taking this medicine.

Sovaldi granules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.

3. How to take Sovaldi

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
Take Sovaldi following your doctor's instructions. Your doctor will tell you how long you will need to take Sovaldi and how many sachets you should take.
The recommended dose is the entire contents of the sachet(s), once a dayshortly before food, shortly after food, or with food.
To make it easier to swallow the Sovaldi oral granules, you can use food or water as described below. Alternatively, Sovaldi can be swallowed without food or water.
Sovaldi must always be taken with other medicines used for the treatment of hepatitis C following your doctor’s instructions.

How to give Sovaldi granules with food to help with swallowing:

• 1. Hold the sachet with the tear line facing upwards
• 2. Gently shake the sachet to allow the contents to settle
• 3. Open the sachet by tearing it along the tear line, or use a pair of scissors to cut along the line
• 4. Carefully pour the entire contents of the sachet into one or more spoonfuls of a soft, non-acidifying food, such as chocolate syrup, mashed potatoes, or ice cream, at room temperature or below
• 5. Make sure no granules remain in the sachet
• 6. Take all the granules within 30 minutes of being mixed with the food
• 7. The combination of food and granules should be swallowed without chewing, to avoid the bitter taste. Make sure you have eaten all the food.

How to give Sovaldi granules without food or water or with water to help with swallowing:

• 1. Hold the sachet with the tear line facing upwards
• 2. Gently shake the sachet to allow the contents to settle
• 3. Open the sachet by tearing it along the tear line, or use a pair of scissors to cut along the line
• 4. The granules can be poured directly into your mouth and swallowed without chewing, to avoid the bitter taste, or with or without non-acidifying liquids such as water. Do not usefruit juices, such as apple, blueberry, grape, orange or pineapple, as they are acidifying and should not be used.
• 5. Make sure no granules remain in the sachet
• 6. Swallow all the granules.

If you vomit within 2 hoursof taking Sovaldi, take another dose. If you vomit after 2 hoursof taking Sovaldi, you should not take another dose until the next scheduled dose.

Kidney problems
Tell your doctor if you have kidney problems or if you are undergoing renal dialysis.

If you take more Sovaldi than you should
If you accidentally take a higher dose than recommended, consult your doctor or the nearest emergency room immediately. Bring the box containing the sachets with you, so you can easily explain what you have taken.

If you forget to take Sovaldi
It is important not to forget any dose of this medicine.
If you forget a dose:

• and notice it within 18 hoursof when you usually take Sovaldi, you should take the dose as soon as possible. Then take the next dose at the usual time.
• and notice it 18 or more hoursafter when you usually take Sovaldi, wait and take the next dose at the usual time. Do not take a double dose (two doses at a short interval).

Do not stop treatment with Sovaldi
Do not stop treatment with this medicineunless your doctor has told you to do so. It is very important to complete the entire treatment to give the medicines the chance to fight the hepatitis C virus infection.
If you have any doubts about using 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 you take Sovaldi in combination with amiodarone (a medicine used for heart problems),
you may experience one or more of the following side effects:

• slowed or irregular heartbeat or heart rhythm problems
• shortness of breath or worsening of existing shortness of breath. If you experience any of the above side effects during therapy, contact your doctor or pharmacist.

When you take Sovaldi with ribavirin or 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
• difficulty sleeping (insomnia)
• feeling tired and irritable
• headache
• skin rash, itching
• loss of appetite, decreased appetite
• feeling dizzy
• muscle discomfort and pain, joint pain
• shortness of breath, cough

Blood tests may show:

• a low red blood cell count (anaemia); signs may include feeling tired, headache, shortness of breath on exertion
• a low white blood cell count (neutropenia); signs may include a greater number of infections with fever and chills or sore throat or mouth ulcers
• a low platelet count
• changes in the liver (shown by higher amounts of a substance called bilirubin in the blood)

Common side effects
( may affect up to 1 in 10 people)

• mood changes, depressed mood, feeling anxious and feeling agitated
• blurred vision
• severe headache (migraine), memory loss, difficulty concentrating
• weight loss
• shortness of breath on exertion
• stomach discomfort, constipation, dry mouth, indigestion, acid reflux
• hair loss and thinning hair
• dry skin
• back pain, muscle spasms
• chest pain, feeling weak
• common cold (nasopharyngitis)

Other effects that may be observed during treatment with sofosbuvir:
The frequency of the following side effects is not known (frequency cannot be estimated based on
available data).

• severe widespread skin rash with peeling skin that may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes and/or genitals (Stevens-Johnson syndrome).
• If any of these side effects get serious, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 sachet and on the pack after
{Scad}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sovaldi contains
The active ingredient is sofosbuvir.

• Sovaldi 150 mg coated granules in a sachetcontains 150 mg of sofosbuvir.
• Sovaldi 200 mg coated granules in a sachetcontains 200 mg of sofosbuvir.
• The other ingredients arelactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, anhydrous colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, macrogol 400, amino methacrylate copolymer, talc, stearic acid, sodium lauryl sulfate.

Description of Sovaldi and contents of the pack
The granules are white to off-white and are contained in a sachet.
The following pack is available:

• outer carton containing 28 sachets.

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
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu