SOVALDI 150 MG COATED GRANULES - patient leaflet, side effects, dosage

What is in this leaflet

iJ What Sovaldi is and what it is

used for

3.

you take Sovaldi

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”).

Do not take Sovaldi

• ■ 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.

Warnings and precautions

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

Blood tests

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.

Children

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.

Other medicines and Sovaldi

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 and contraception

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.

Driving and using machines

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.

Sovaldi granules contain lactose

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

Sovaldi granules contain sodium

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

3.

Giving Sovaldi granules without food or water or with water to aid swallowing:

• 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

Kidney problems

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

If you take more Sovaldi 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 sachet carton with you so that you can easily describe what you have taken.

If you forget to take Sovaldi

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).

Do not stop taking Sovaldi

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.