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Harvoni (ledipasvir and sofosbuvir) is used to treat Hepatitis C. Includes Harvoni side effects, interactions and indications.

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How to use Harvoni

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking ledipasvir/sofosbuvir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.

If you are using the pellet form of this medication, gently shake the packet before use. To take this medication without food, open the packet and pour the pellets directly into your mouth. Swallow the pellets without chewing. You may drink water after swallowing the pellets if needed. Repeat these steps if your dose is for more than one packet. If you are taking this medication with food, open the packet(s) and pour the pellets into a small bowl with one or more spoonfuls of non-acidic soft food (such as pudding, mashed potato, ice cream). The soft food should be at or below room temperature. After gently mixing, take all of the mixture without chewing within 30 minutes.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Tell your doctor if you vomit within 5 hours after taking this medication. You may need to take another dose.

Continue to take ledipasvir/sofosbuvir for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Antacids lower the absorption of ledipasvir. If you are taking an antacid, take it at least 4 hours before or 4 hours after this medication.

Other acid-lowering medications for indigestionheartburn, or ulcers (such as prescription or over-the-counter medications including famotidineomeprazole) may prevent ledipasvir from working. Ask your doctor or pharmacist how to use these medications safely.

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Side Effects

See also Warning section.

Tiredness, headachenauseadiarrhea, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rashitching/swelling (especially of the face/tongue/throat), severe dizzinesstrouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Precautions

Before taking ledipasvir/sofosbuvir, tell your doctor or pharmacist if you are allergic to either of the drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems (such as hepatitis B), diabetes.

If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hungerblurred visiondizziness, or tingling hands/feet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Ledipasvir/sofosbuvir, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condomsbirth control pills) must be used whenever at least one sexual partner is using these medicines together, and for six months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. Breast-feeding is not recommended if this medication is used in combination with ribavirin.

Consult your pharmacist or physician.

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Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: amiodarone, a certain other medication used to treat chronic hepatitis C (simeprevir).

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples include flibanserin, rosuvastatin, among others.

Other medications can affect the removal of ledipasvir/sofosbuvir from your body, which may affect how this medication works. Examples include rifamycins (such as rifampinrifabutin), St. John’s wort, tipranavir/ritonavir, drugs used to treat seizures (such as phenobarbitalcarbamazepine, phenytoin, primidone), among others.

Do not take this medication with other products that contain sofosbuvir.

Does Harvoni interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab tests (such as liver functiontests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.

If you are using this medication with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. A pregnancy test should also be taken every month while using this medication and for 6 months after treatment ends to make sure no pregnancy occurs.

Missed Dose

If you miss a dose, take it as soon as you remember, unless it is less than 6 hours until the next dose. In that case, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Store the tablets in the original container. Keep the pellets in the packets and do not open the packets until ready for use. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Images

Harvoni 45 mg-200 mg tablet

Harvoni 45 mg-200 mg tablet

Color: white

Shape: oblong

Imprint: GSI HRV

This medicine is a white, oblong, film-coated, tablet imprinted with “GSI” and “HRV”.

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