33.75 mg / 150 mg and 45 mg / 200 mg coated granules in sachets
ledipasvir / sofosbuvir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get side effects are, speak with your doctor or apotekspersonal. Detta includes any possible adverse effects not listed in this leaflet.

In this leaflet you will find information about:
1. What Harvoni is and what it is used for
2. What you need to know before using Harvoni
3. How to use Harvoni
4. Possible side effects
5. How to store Harvoni
6. Contents of the packaging and other information

1. What Harvoni is and what it is used for

Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in the form of a granulate. Harvoni was given to treat chronic (long-term) infection with hepatitis C virus in adults and children from 3 years of age.

Hepatitis C is an infection of the liver caused by a virus. The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce, which makes it possible to permanently remove an infection from the body.

Harvoni is sometimes taken with another medicine, ribavirin.

It is very important that you also read the package leaflets for the other medicines that you are taking with Harvoni. If you have any further questions on the use of this product, ask your doctor or pharmacist.

2. What you need to know before using Harvoni

Do not use Harvoni

  • If you are allergic to ledipasvir, 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 and rifabutin ( antibiotics used to treat infections , including tuberculosis )
    • St. John’s wort (herbal medicine used to treat mild depression)
    • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent epileptic seizures)
    • rosuvastatin (a medicine used to treat high cholesterol ).

→ If any of these apply to you, do not take Harvoni but tell your doctor immediately.

Warnings and cautions

Your doctor knows if you have any of the following conditions. These will be considered before starting treatment with Harvoni.

  • other liver problems in addition to hepatitis C, for example
    • if you are waiting for a liver transplant.
    • if you have or have had an infection with the hepatitis B virus , because the doctor then want to monitor you more closely.
  • kidney problems or if you receive dialysis , as Harvoni has not been fully tested in patients with severe kidney problems.
  • ongoing treatment for HIV – infection , because your doctor may need to monitor you more closely.

Talk to your doctor or pharmacist before taking Harvoni if:

  • you are currently taking, or in recent months, have been taking the drug amiodarone to treat irregular heartbeats as it may cause your heart rate to drop to a life-threatening level. Your doctor may consider other treatments if you have taken this medicine. If you need treatment with Harvoni, extra cardiac monitoring may be necessary.
  • have diabetes . Your blood sugar levels may need to be monitored more closely and / or adjustment of your diabetes medications may be needed after you start taking Harvoni. In some diabetic patients, blood sugar levels have dropped ( hypoglycaemia ) after starting treatment with medicines such as Harvoni.

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

  • slow or irregular heartbeat, or problems with heart rhythm
  • shortness of breath or worsening of pre-existing shortness of breath
  • chest pain
  • dizziness
  • palpitation er (palpitations)
  • that you almost faint, or faint

Blood tests

Your doctor will examine your blood before, during, and after treatment with Harvoni to:

  • Your doctor should be able to decide if you should take Harvoni and for how long.
  • Your doctor should be able to confirm that the treatment has worked and that you no longer carry the hepatitis C virus .

Children and young people

Do not give this medicine to children under 3 years. The use of Harvoni in children under 3 years of age has not yet been studied.

Other medicines and Harvoni

Tell your doctor or pharmacist if you 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 test your blood more often to check your blood coagulation ability.

The function of your liver can change with the treatment of hepatitis C and can therefore affect other drugs (eg drugs used to inhibit your immune system, etc.). Your doctor may need to monitor these other medicines that you are taking care and adjustments may need to be made after starting treatment with Harvoni.

Talk to your doctor or pharmacist if you are not sure if you should take any medicine.

Some medicines should not be taken with Harvoni.

  • Do not take any other medicine that contains sofosbuvir, one of the active substances in Harvoni.
  • Tell your doctor or pharmacist if you are taking any of the following medicines:
    • amiodarone used to treat irregular heartbeats
    • tenofovir disoproxil fumarate, or any medicine containing tenofovir, which is used to treat HIV – infection
    • digoxin used to treat heart disease
    • dabigatran used to thin the blood
    • statins used to treat high cholesterol
    • rifapentine ( antibiotic used to treat infections , including tuberculosis )
    • oxcarbazepine (a medicine used to treat epilepsy and prevent epileptic seizures)
    • tipranavir (used to treat HIV – infection ).

If you take Harvoni with any of these medicines, your medicines may not work properly or any side effects may get worse. Your doctor may need to give you another medicine or change the dose of medicine you are taking.

  • Ask your doctor or pharmacist for advice if you are taking medicines used to treat stomach ulcers , heartburn or acid reflux. These are:
    • antacids (eg aluminum / magnesium hydroxide or calcium carbonate ). These should be taken at least 4 hours before or 4 hours after Harvoni.
    • proton pump inhibitors (eg omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). These should be taken at the same time as Harvoni. Do not take proton pump inhibitors before Harvoni. Your doctor may give you another medicine or change the dose of medicine you are taking.
    • 2 Receptor antagonists (eg famotidine, cimetidine, nizatidine or ranitidine). Your doctor may give you another medicine or change the dose of medicine you are taking.

These medicines may reduce the amount of ledipasvir in your blood. If you are taking any of these medicines, your doctor will either give you another medicine for stomach ulcers, heartburn, or acid reflux or recommend how and when to take it.

Pregnancy, breastfeeding and fertility

The effect of Harvoni during pregnancy is unknown. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy must be avoided if you take Harvoni with ribavirin. You must read the section “Pregnancy” in the package leaflet of ribavirin very carefully. Ribavirin can cause serious birth defects. Therefore, special precautions must be taken during sexual intercourse if there is a risk of pregnancy occurring.

  • You or your partner must use an effective method of contraception during and for some time after treatment with Harvoni with ribavirin. It is very important that you read the section “Pregnancy” in the package leaflet of ribavirin very carefully. Ask your doctor about an effective contraceptive method that is right for you.
  • If you or your partner become pregnant during treatment with Harvoni and ribavirin or in the next few months after treatment, you must contact a doctor immediately.

Breast-feeding

Do not breastfeed during treatment with Harvoni. It is not known whether ledipasvir or sofosbuvir, the two active substances in Harvoni, pass into breast milk.

Driving and using machines

If you feel tired after taking Harvoni, do not engage in activities that require concentration, such as driving, cycling, or using machines.

Harvoni contains copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose, talc, titanium dioxide, macrogol, yellow iron oxide, red iron oxide, amino-methacrylate copolymer

Harvoni 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 medicine.

Harvoni granules contain sodium

  • This medicine contains less than 1 mmol (23 mg) sodium per sachet , ie essentially ‘ sodium – free ‘.

3. How to use Harvoni

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose

Harvoni should be taken according to the doctor’s instructions. Your doctor will tell you how long to take Harvoni and how many sachets to take.

The recommended dose of Harvoni is the entire contents of the sachet (s) once daily with or without food.

Intake of Harvoni granules with food to facilitate swallowing:

1. Hold the sachet with the dashed line facing up.

2. Shake the sachet gently to collect the contents on the bottom.

Tear or cut along the dotted line to open the sachet.

4. Carefully pour all the contents of the sachet onto one or more spoons of non-acidic food, e.g. chocolate sauce, mashed potatoes, or ice cream, at or below room temperature.

5. Check that there are no granules left in the sachet.

6. Take all granules within 30 minutes after gently mixing with food.

7. Swallow a mixture of food and granules without chewing to avoid the bitter taste. Make sure all food is swallowed.

Taking Harvoni without food or water or with water to facilitate swallowing:

1. Hold the sachet with the dashed line facing up.

2. Shake the sachet gently to collect the contents on the bottom.

Tear or cut along the dotted line to open the sachet.

The granules can be taken directly into the mouth and swallowed without chewing to avoid the bitter taste or with a liquid that is not acidic, e.g. water. Do not use fruit juices, e.g. apple, cranberry, grapefruit, orange, or pineapple juices, as they are acidic and should not be used.

5. Check that there are no granules left in the sachet.

6. Swallow all granules.

If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Harvoni.

If you are taking a proton pump inhibitor, take the proton pump inhibitor at the same time as Harvoni. Do not take it before Harvoni.

If you vomit after taking Harvoni, it may affect the amount of Harvoni in your blood. This may mean that Harvoni does not work as well.

  • If you vomit less than 5 hours after taking Harvoni, take a new dose .
  • If you vomit more than 5 hours after taking Harvoni, you do not need to take any more dose until you take the next dose according to the treatment schedule.

If you use more Harvoni than you should 

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

If you forget to use Harvoni

It is important that you do not miss a dose of this medicine.

If you miss a dose, calculate how long it has been since you last took Harvoni:

  • If you notice it less than 18 hours after the time you usually take Harvoni, you must take a dose as soon as possible. Then take the next dose at the usual time.
  • If it has been 18 hours or more after the time you usually take Harvoni, wait and take the next dose at the usual time. Do not take a double dose (two doses close together).

If you stop using Harvoni

Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the entire course of treatment to give the medicine the best conditions to treat an infection with the hepatitis C virus.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you take Harvoni, you may experience one or more of the following side effects:

Very common side effects are

may affect more than 1 in 10 people )

  • headache
  • fatigue

Common side effects are

may affect up to 1 in 10 people )

  • rash

Other side effects that may occur during treatment with Harvoni

The frequency of the following side effects is unknown (cannot be calculated from the available data):

  • swelling of the face, lips, tongue or throat ( angioedema ).

Other effects that can be seen with sofosbuvir treatment:

The frequency of the following side effects is unknown (cannot be calculated from the available data):

  • widespread, severe rash with scaly skin that may be accompanied by fever, flu-like symptoms , blisters in the mouth, eyes or genitals ( Stevens-Johnson syndrome ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Harvoni

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 can and carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are ledipasvir and sofosbuvir.

  • Harvoni 33.75 mg / 150 mg coated granules in sachets contains 33.75 mg ledipasvir and 150 mg sofosbuvir.
  • Harvoni 45 mg / 200 mg coated granules in sachets contains 45 mg ledipasvir and 200 mg sofosbuvir.
  • The other ingredients are copovidone, lactose monohydrate , microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose, talc, titanium dioxide, macrogol, yellow iron oxide, red iron oxide, amino-methacrylate copolymer.

What the medicine looks like and contents of the pack

Granules are orange and are in a sachet.

The following pack sizes are available:

  • outer carton containing 28 sachets.

Marketing Authorization Holder and Manufacturer

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Muhammad Nadeem

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