Package leaflet: Information for the user
Sofosbuvir 400mg film-coated tablets
sofosbuvir
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 to talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sofosbuvir is and what it is used for
2. What you need to know before you take Sofosbuvir
3. How to take Sofosbuvir
4. Possible side effects
5. How to store Sofosbuvir
6. Contents of the pack and other information
1. What Sofosbuvir is and what it is used for
Sofosbuvir contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and adolescents from the age of 12 years up to the age of 18 years.
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.
Sofosbuvir is always taken with other medicines to treat hepatitis C. It will not work on its own. It is commonly taken with either:
- Ribavirin, or
- Peginterferon alfa and ribavirin
It is very important that you also read the leaflets for the other medicines that you will be taking with Sofosbuvir. If you have any questions about your medicines, please ask your doctor or pharmacist.
2. What you need to know before you take Sofosbuvir
Do not take Sofosbuvir
- If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
- If this applies to you, tell your doctor immediately.
- If you are currently taking any of the following medicines:
- Rifampicin?(an 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).
Warnings and precautions
Sofosbuvir 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 (your doctor may consider alternative treatments if you have taken this medicine);
- Have liver problems other than hepatitis C, e.g. if you are awaiting 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 Sofosbuvir. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sofosbuvir.
Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
- shortness of breath or worsening of any shortness of breath you already have
- light-headedness
- palpitations
- fainting
Blood tests
Your doctor will test your blood before, during and after your treatment with Sofosbuvir. This is so your doctor can:
- Decide what other medicines you should take with Sofosbuvir and for how long;
- Confirm that your treatment has worked and you are free of the hepatitis C virus.
Children and adolescents
Do not give this medicine to children under 12 years of age. The use of Sofosbuvir in children under 12 years of age has not yet been studied.
Other medicines and Sofosbuvir
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 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 the 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 Sofosbuvir.
Talk to your doctor about taking Sofosbuvir 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 Sofosbuvir 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 Sofosbuvir, talk to your doctor or pharmacist.
Pregnancy and contraception
Pregnancy must be avoided due to the use of Sofosbuvir together with ribavirin. Ribavirin can be very damaging to an unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur.
- Sofosbuvir 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 effective contraceptive method suitable for you.
- If you or your partner become pregnant during Sofosbuvir treatment or in the months that follow, you must?contact your doctor immediately.
Breast-feeding
You should not breast-feed during treatment with Sofosbuvir. It is not known whether sofosbuvir, the active substance of Sofosbuvir, passes into human breast milk.
Driving and using machines
When taking Sofosbuvir together with other medicines for the treatment of hepatitis C infection, patients have reported tiredness, dizziness, blurred vision and reduced attention. If you have any of these side effects, do not drive or use any tools or machines.
3. How to take Sofosbuvir
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose
The recommended dose is one tablet (400mg) once a day with food. Your doctor will tell you for how long you should take Sofosbuvir.
Swallow the tablet 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.
Sofosbuvir should always be taken in combination with other medicinal products for use against hepatitis C.
Kidney problems
Tell your doctor if you have kidney problems or if you are on kidney dialysis.
If you are sick (vomit) less than 2 hours after taking Sofosbuvir, take another tablet. If you vomit more than 2 hours after taking it you do not need to take another tablet until your next regularly scheduled tablet.
If you take more Sofosbuvir than you should
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.
If you forget to take Sofosbuvir
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 Sofosbuvir, you must take the tablet 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 Sofosbuvir, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).
Do not stop taking Sofosbuvir
Do not stop taking this medicine unless your doctor tells you to. 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you take Sofosbuvir 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 Sofosbuvir 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)
- 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
- 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)
Common side effects
(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 to 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sofosbuvir
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.
6. Contents of the pack and other information
What Sofosbuvir contains
- The active substance is?sofosbuvir. Each film-coated tablet contains 400mg of sofosbuvir.
- The other ingredients are
Tablet core:
Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Film-coating:
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
What Sofosbuvir looks like and contents of the pack
The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with ?GSI? and ?7977? on the other side.
Each bottle 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 and 84 (3 bottles of 28) film-coated tablets. Not all pack sizes may be marketed in your country.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)