Sovaldi
sofosbuvir
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.
What Sovaldi is and what it is used for
What you need to know before you take Sovaldi
How to take Sovaldi
Possible side effects
How to store Sovaldi
Contents of the pack and other information
Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and children 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:
Ribavirin (children and adult patients), or
Peginterferon alfa and ribavirin (adult patients)
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.
If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
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.
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.
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 them stay awake).
Rifapentine (a medicine used to treat infections, including tuberculosis); This is because they may make Sovaldi work less well.
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.
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 tablet, 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.
The recommended dose of Sovaldi in children aged 3 years and above is based on weight. Take Sovaldi with food, as advised by your doctor.
Swallow the tablet(s) whole. Do not chew, crush or split the tablet as it has a very bitter taste. Tell your doctor or pharmacist if you have problems swallowing tablets.
Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C as advised by your doctor.
If you are sick (vomit) less than 2 hours after taking Sovaldi, take another dose. 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 tablet bottle 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:
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:
slow or irregular heartbeat or heart rhythm problems
shortness of breath or worsening of any shortness of breath you already have
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:
(may affect more than 1 in 10 people)
fever, chills, flu-like symptoms
diarrhoea, feeling sick (nausea), being sick (vomiting)
trouble sleeping (insomnia)
feeling tired and irritable
headache
rash, itchy skin
loss of appetite, decreased appetite
feeling dizzy
muscle aches and pains, pain in the joints
shortness of breath, cough
Blood tests may also show:
low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
low white blood cell count (neutropenia); the signs may include getting more infections than usual, including fevers and chills, or sore throat or mouth ulcers
low blood platelet count
changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
(may affect up to 1 in 10 people)
changes in your mood, feeling depressed, feeling anxious and feeling agitated
blurred vision
severe headaches (migraine), memory loss, loss of concentration
weight loss
shortness of breath when exercising
stomach discomfort, constipation, dry mouth, indigestion, acid reflux
hair loss and thinning hair
dry skin
back pain, muscle spasms
chest pain, feeling weak
getting a cold (nasopharyngitis)
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).
a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
If any of the side effects get serious tell your doctor. Reporting of side effects
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 any side effects directly to the national reporting system listed in Appendix V. 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 bottle 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.
Tablet core:
Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Film-coating:
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide yellow.
Sovaldi 400 mg film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side. The tablet is approximately 20 mm long and 9 mm wide.
Sovaldi 200 mg film-coated tablets are yellow, oval-shaped, film-coated tablets, debossed with “GSI” on one side and “200” on the other side. The tablet is approximately 15 mm long and 8 mm wide.
Each bottle of Sovaldi 400 mg film-coated tablets contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
The following pack sizes are available:
outer cartons containing 1 bottle of 28 film-coated tablets for the 400 mg and 200 mg film- coated tablets
and 84 (3 bottles of 28) film-coated tablets for the 400 mg film coated tablets only. Not all pack sizes may be marketed in your country.
County Cork, T45 DP77 Ireland
Gilead Sciences Ireland UC
IDA Business & Technology Park Carrigtohill
County Cork Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
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Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
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