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Olysio

Generic Name: Simeprevir (sim E pre vir)
Brand Name: Olysio

  • You will be tested for hepatitis B before starting Olysio (simeprevir). In people who have had hepatitis B before or carry the virus, the virus has become active again during or after treatment with drugs like this one. This can lead to very bad and sometimes deadly liver problems. People who have hepatitis B and hepatitis C need to be watched closely during and after treatment with this medicine. If you have questions, talk with your doctor.

Uses of Olysio:

  • It is used to treat long-term hepatitis C infections.

What do I need to tell my doctor BEFORE I take Olysio?

  • If you have an allergy to simeprevir or any other part of Olysio.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver problems other than hepatitis C.
  • If you are not taking other drugs to treat hepatitis C.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Olysio.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Olysio with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Olysio?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have a sulfa (sulfonamide) allergy, talk with your doctor.
  • If you are of East Asian descent, talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Very bad skin reactions to sunlight have happened with Olysio. Sometimes, this has led to need to go to the hospital. Talk with the doctor.
  • Slow heartbeat and the need to get a pacemaker have happened when amiodarone was given with sofosbuvir and certain other hepatitis C drugs. Sometimes, this has been deadly. Slow heartbeat has happened up to 2 weeks after starting hepatitis C treatment. You will need to be watched closely if you will be taking amiodarone with hepatitis C treatment. Follow what your doctor has told you to do. Call your doctor right away if you have signs of slow heartbeat like chest pain, confusion, dizziness, passing out or near-passing out, memory problems, shortness of breath, tiredness, or weakness.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • This medicine must be taken with other drugs to treat hepatitis C. Be sure you know about the warnings, benefits, and risks of the other drugs. Talk with your doctor if you have questions or concerns about any of your drugs used to treat hepatitis C.
  • If you stop taking any of your other drugs to treat hepatitis C, talk with your doctor. You may need to stop taking this medicine also.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Olysio with your other drugs.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Olysio while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Olysio) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take Olysio (simeprevir) with food.
  • Swallow whole. Do not chew, open, or crush.
  • Take this medicine at the same time of day.
  • Keep taking Olysio as you have been told by your doctor or other health care provider, even if you feel well.
  • It is important that you do not miss or skip a dose of this medicine during treatment.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Shortness of breath.
  • Red, blistered, or swollen skin.
  • Very bad skin irritation.
  • Mouth sores.
  • Eye irritation.
  • Very bad and sometimes deadly liver problems have happened with Olysio. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Olysio?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Itching.
  • Upset stomach.
  • Muscle pain.
  • Loose stools (diarrhea).
  • Dizziness.
  • Headache.
  • Feeling tired or weak.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Olysio?

  • Store in the original container at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Olysio or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Olysio. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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