Patient Leaflet Updated 12-Nov-2021 | Gilead Sciences Ltd
Harvoni 33.75 mg/150 mg coated granules in sachet
Package leaflet: Information for the user
Harvoni 33.75 mg/150 mg coated granules in sachet
ledipasvir/sofosbuvir
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Harvoni is and what it is used for
2. What you need to know before you take Harvoni
3. How to take Harvoni
4. Possible side effects
5. How to store Harvoni
6. Contents of the pack and other information
If Harvoni 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”).
1. What Harvoni is and what it is used for
Harvoni granules are a medicine that contain the active substances ledipasvir and sofosbuvir which are given in a granule formulation. Harvoni is given to treat chronic (long-term) hepatitis C virus infection in adults and children 3 years of age and older.
Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Harvoni is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other medicines that you will be taking with Harvoni. If you have any questions about your medicines, please ask your doctor or pharmacist.
2. What you need to know before you take Harvoni
Do not take Harvoni
Warnings and precautions
Your doctor will know if any of the following conditions apply to you. These will be considered before treatment with Harvoni is started.
Talk to your doctor or pharmacist before taking Harvoni if:
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:
Blood tests
Your doctor will test your blood before, during and after your treatment with Harvoni. This is so that:
Children and adolescents
Do not give this medicine to children under 3 years of age. 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 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 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 Harvoni.
If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
Some medicines should not be taken with Harvoni.
Taking Harvoni with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
These medicines can decrease the amount of ledipasvir in your blood. If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Pregnancy and contraception
The effects of Harvoni during pregnancy are not known. 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 Harvoni is taken 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.
Breast-feeding
Do not breast-feed during treatment with Harvoni. It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Driving and using machines
If you feel tired after taking Harvoni you should not take part in activities that require concentration, for example, do not drive, ride a bike or operate machines.
Harvoni granules contain lactose
Harvoni granules contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
3. How to take Harvoni
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose
Harvoni is to be taken as advised by your doctor. Your doctor will tell you for how long you should take Harvoni and how many sachets you should take.
The recommended dose is the entire contents of the sachet(s), taken once daily with or without food.
Giving Harvoni granules with food 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. 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 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.
Giving Harvoni 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 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 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 are sick (vomit) after taking Harvoni it may affect the amount of Harvoni in your blood. This may make Harvoni work less well.
If you take more Harvoni 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 and carton with you so that you can easily describe what you have taken.
If you forget to take Harvoni
It is important not to miss a dose of this medicine.
If you do miss a dose, work out how long it is since you last took your Harvoni:
Do not stop taking Harvoni
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 medicine 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 may cause side effects. If you take Harvoni you may get one or more of the side effects below:
Very common side effects
(may affect more than 1 in 10 people)
Common side effects
(may affect up to 1 in 10 people)
Other effects that may be seen during treatment with Harvoni
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
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).
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 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.
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 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 protect the environment.
6. Contents of the pack and other information
What Harvoni contains
The active substances are ledipasvir and sofosbuvir.
What Harvoni looks like and contents of the pack
The granules are orange and contained in a sachet.
The following pack sizes is available:
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 09/2021
280 High Holborn, London, WC1V 7EE, UK
+353 214 825 999 (Ireland)
+44 (0)203 681 4681
+44 (0)203 681 4500
08000 113 700 (UK)
+353 1 291 3580 (Ireland)