Sovaldi 200 mg coated granules in sachet

• 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.

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

If Sovaldi has been prescribed for your child, please note that all the information in this leaflet is applicable to your child (in this case please read “your child” instead of “you”).

• If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
• If you are currently taking any of the following medicines:
  • Rifampicin (antibiotic used to treat infections, including tuberculosis);
  • St. John’s wort (herbal medicine used to treat depression);
  • Carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).

• If any of these conditions apply to you, tell your doctor immediately.

Sovaldi is always taken with other medicines to treat hepatitis C (see section 1 above). Talk to your doctor or pharmacist before taking this medicine if you:

• Currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats, as it may result in a life-threatening slowing of your heart beat. Your doctor may consider different treatments if you have taken this medicine. If treatment with Sovaldi is needed, you may require additional heart monitoring;
• have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation;
• have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
• have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sovaldi. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sovaldi.

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

• slow or irregular heartbeat, or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest-pain;
• light-headedness;
• palpitations
• near fainting or fainting

Your doctor will test your blood before, during and after your treatment with Sovaldi. This is so your doctor can:

• Decide what other medicines you should take with Sovaldi and for how long;
• Confirm that your treatment has worked and you are free of the hepatitis C virus.

Do not 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.

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 increase the frequency of your blood tests to check how well your blood can clot.

Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Sovaldi.

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 to treat people with narcolepsy to help you stay awake).
• Rifapentine (a medicine used to treat infections, including tuberculosis);

This is because they may make Sovaldi work less well.

Tell your doctor if you take any of the following medicines:

• amiodarone, used to treat irregular heartbeats.

If you are not sure of what medicines can be taken with Sovaldi, talk to your doctor or pharmacist.

Pregnancy must be avoided due to the use of Sovaldi together with ribavirin. It is very important that you read the "Pregnancy" section in the ribavirin package leaflet very carefully. Ribavirin can be very damaging to an unborn baby. Therefore, special precautions in sexual activity must be taken if there is any chance for pregnancy to occur.

• Sovaldi is commonly used together with ribavirin. Ribavirin can damage your unborn baby. It is therefore very important that you (or your partner) do not become pregnant during this therapy.
• You or your partner must use an effective birth control method during treatment and afterwards. It is very important that you read the “Pregnancy” section in the ribavirin package leaflet very carefully. Ask your doctor for an effective contraceptive method suitable for you.
• If you or your partner become pregnant during Sovaldi treatment or in the months that follow, you must contact your doctor immediately.

Breast-feeding

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

When taking Sovaldi together with other medicines for the treatment of hepatitis C infection, patients have reported tiredness, dizziness, blurred vision and reduced attention. If you feel tired, dizzy, have blurred vision or reduced attention after taking Sovaldi you should not take part in activities such as driving, riding a bike or operating machines.

• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.

Sovaldi is to be taken as advised by your doctor. Your doctor will tell you for how long you should take Sovaldi and how many sachets you should take.

The recommended dose is the entire contents of the sachet(s), taken once daily shortly before food, shortly after food, or with food.

To help with swallowing of the Sovaldi oral granules you can use food or water as detailed below. Alternatively, Sovaldi can be swallowed without food or water.

Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C as advised by your doctor.

1. Hold sachet with cut line on top
2. Shake sachet gently to settle contents
3. Tear sachet open along cut line, or use scissors to cut across line
4. Carefully pour entire contents of sachet onto one or more spoonfuls of non-acidic soft food such as, chocolate syrup, mashed potato or ice-cream at or below room temperature
5. Make sure that no granules remain in the sachet
6. Take all the granules within 30 minutes of gently mixing with food
7. Swallow combination of food and granules without chewing to avoid a bitter taste. Make sure that all the food is eaten.

1. Hold sachet with cut line on top
2. Shake sachet gently to settle contents
3. Tear sachet open along cut line, or use scissors to cut across line
4. The granules can be taken directly in the mouth and swallowed without chewing to avoid a bitter taste or with or without non-acidic liquids such as water. Do not use fruit juices, for example apple, cranberry, grape, orange, pineapple as these are acidic and should not be used.
5. Make sure no granules remain in the sachet
6. Swallow all the granules.

If you are sick (vomit) less than 2 hours after taking Sovaldi, take another sachet(s). If you vomit more than 2 hours after taking Sovaldi, you do not need to take another dose until your next regularly scheduled dose

Tell your doctor if you have kidney problems or if you are on kidney dialysis.

If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. Keep the sachet carton with you so that you can easily describe what you have taken.

It is important not to miss a dose of this medicine.

If you do miss a dose:

• and you notice within 18 hours of the time you usually take Sovaldi, you must take the dose as soon as possible. Then take the next dose at your usual time.
• and you notice 18 hours or more after the time you usually take Sovaldi, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).

You should not stop taking this medicine unless your doctor tells you. It is very important that you complete the full course of treatment to give the medicines the best chance to treat your hepatitis C virus infection.

If you get 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

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is sofosbuvir.

• Sovaldi 150 mg coated granules in sachet contains 150 mg sofosbuvir.
• Sovaldi 200 mg coated granules in sachet contains 200 mg sofosbuvir.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, macrogol 400, amino methacrylate copolymer, talc, stearic acid, sodium lauryl sulfate.

The granules are white to off-white and contained in a sachet.

The following pack size is available:

• outer carton containing 28 sachets.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: