Patient Leaflet Updated 12-Feb-2024 | Gilead Sciences Ltd
Sovaldi 150 mg coated granules in sachet
Sovaldi 150 mg coated granules in sachet
sofosbuvir
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”).
Sovaldi granules contain the active substance sofosbuvir which is given in a granule formulation to treat hepatitis C virus infection in adults and children aged 3 years of age and older.
Hepatitis C is a virus that infects the liver. This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time.
Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own. It is commonly taken with either:
It is very important that you also read the leaflets for the other medicines that you will be taking with Sovaldi. If you have any questions about your medicines, please ask your doctor or pharmacist.
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:
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:
Your doctor will test your blood before, during and after your treatment with Sovaldi. This is so your doctor can:
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:
This is because they may make Sovaldi work less well.
Tell your doctor if you take any of the following medicines:
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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:
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 get one or more of the side effects below:
Tell your doctor or your pharmacist if you notice any of the above side effects during therapy.
When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below:
Very common side effects
(may affect more than 1 in 10 people)
Blood tests may also show:
Common side effects
(may affect up to 1 in 10 people)
Other effects that may be seen during treatment with sofosbuvir:
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
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.
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 carton after {EXP}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is sofosbuvir.
The granules are white to off-white and contained in a sachet.
The following pack size is available:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 01/2024
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