What is OLYSIO (Simeprevir)?
OLYSIO is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults.
It is not known if OLYSIO is safe and effective in children under 18 years of age.
What is the most important information I should know about OLYSIO?
- If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO. It is not known if OLYSIO will harm your unborn baby. Also read the Medication Guides for peginterferon alfa and ribavirin if your healthcare provider prescribes these medications for you in combination with OLYSIO.
- Females must use an effective form of birth control during treatment with OLYSIO. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO.
- Females must use an effective form of birth control during treatment with OLYSIO. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO.
OLYSIO can cause serious side effects. These serious side effects include:
- OLYSIO combination treatment with sofosbuvir (Sovaldi®) may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems.
- If you are taking OLYSIO with sofosbuvir and amiodarone and you get any of the following symptoms, or if you have a slow heart rate call your healthcare provider right away:
- Fainting or near-fainting
- Dizziness or lightheadedness
- Weakness, extreme tiredness
- Chest pain, shortness of breath
- Confusion or memory problems
- OLYSIO may cause severe liver problems in some patients.
- Your healthcare provider may do blood tests to check your liver function during treatment with OLYSIO.
- Your healthcare provider may tell you to stop taking OLYSIO if you develop signs and symptoms of liver problems.
- Tell your healthcare provider right away if you develop any of the symptoms, or if they worsen during treatment with OLYSIO: Weakness, Tiredness, Loss of appetite, Nausea and vomiting, Yellowing of your skin or eyes, Color changes in your stools
- OLYSIO combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO.
- Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO.
- Limit sunlight exposure during treatment with OLYSIO.
- Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO.
- Call your healthcare provider right away if you get any of the symptoms such as: Burning, redness, swelling or blisters on your skin, Mouth sores or ulcers, Red or inflamed eyes, like “pink eye” (conjunctivitis)
- The most common side effects of OLYSIO when used in combination with peginterferon alfa and ribavirin include: Skin rash, Itching, Nausea
- The most common side effects of OLYSIO when used in combination with sofosbuvir include: Tiredness, Headache, Nausea
How should I take OLYSIO?
- Take OLYSIO exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
- Do not stop taking OLYSIO unless your healthcare provider tells you to. If you think there is a reason to stop taking OLYSIO, talk to your healthcare provider before doing so.
- Take 1 OLYSIO capsule each day with food.
- Swallow OLYSIO capsules whole
- If you miss a dose of OLYSIO and it is more than 12 hours until your next dose, take the missed dose as soon as possible with food. Take the next dose of OLYSIO at your regular time.
- If you miss a dose of OLYSIO and it is less than 12 hours until your next dose, skip the missed dose. Take the next dose of OLYSIO at your regular time.
- Do not take two doses of OLYSIO at the same time to make up for a missed dose.
- If you take too much OLYSIO, call your healthcare provider right away or go to the nearest hospital emergency room.
Important Safety Information
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- Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO
- Limit sunlight exposure during treatment with OLYSIO
- You should not take OLYSIO alone. OLYSIO should be used together with other medicines to treat chronic hepatitis C infection
- Do not take two doses of OLYSIO at the same time to make up for a missed dose.
- If you take too much OLYSIO, call your healthcare provider right away or go to the nearest hospital emergency room
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking OLYSIO?
Before taking OLYSIO, tell your healthcare provider if you:
- Have liver problems other than hepatitis C virus infectio
- Have ever taken any medicine to treat hepatitis C virus infection
- Had a liver transplant
- Are receiving phototherapy
- Have any other medical condition
- Are of East Asian descent
- Are breastfeeding. It is not known if OLYSIO passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO or breastfeed. You should not do both
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
General information about OLYSIO
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OLYSIO for a condition for which it was not prescribed. Do not give your OLYSIO to other people, even if they have the same symptoms that you have. It may harm them
What are the ingredients in OLYSIO ?
Active ingredient: simeprevir
Other ingredient: ccolloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulphate. The white capsule contains gelatin and titanium dioxide (E171) and is printed with ink containing iron oxide black (E172) and shellac (E904).