LEDIPASVIR/SOFOSBUVIR - ORAL

PHONETIC PRONUNCIATION: (le-DIP-as-vir/soe-FOS-buer-vir)

COMMON BRAND NAME(S): Harvoni

GENERIC NAME(S): ledipasvir/sofosbuvir

Uses

USES: This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.

How to use LEDIPASVIR/SOFOSBUVIR - ORAL

HOW TO USE: Read the Patient Information Leaflet 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. 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 indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent ledipasvir from working. Ask your doctor or pharmacist how to use these medications safely.

Side Effects

SIDE EFFECTS: See also Warning section. Tiredness, headache, nausea, diarrhea, 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: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble 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.

Precautions

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: kidney disease, other liver problems (such as hepatitis B). 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 condoms, birth 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.

Interactions

DRUG 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. One example is 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 rifampin, rifabutin), St. John's wort, tipranavir/ritonavir, drugs used to treat seizures (such as phenobarbital, carbamazepine, phenytoin, primidone), among others. Do not take this medication with other products that contain sofosbuvir.

Overdose

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.

Images

HARVONI 90-400 MG TABLET

color: orange
shape: diamond
imprint: GSI, 7985

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Warning

WARNING: Although this medication helps many people with hepatitis C, it may cause people who also have another liver problem called hepatitis B to get worse. Before starting this medication, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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