Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about OLYSIO capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given OLYSIO against the benefits this medicine is expected to have for you.
If you have any concerns about being given OLYSIO ask your doctor.
Keep this leaflet while you are taking OLYSIO. You may need to read it again.
What OLYSIO is used for
OLYSIO contains the active substance simeprevir. It acts against the virus that causes hepatitis C infection, called hepatitis C virus (HCV).
OLYSIO must not be used by itself. OLYSIO can be used with other medicines for treating hepatitis C infection; these medicines are called peginterferon alfa, ribavirin and sofosbuvir.
OLYSIO is used with peginterferon alfa and ribavirin or sofosbuvir to treat chronic hepatitis C infection.
- It is used in adult patients with liver disease that is stable.
- It is used to treat hepatitis C infection caused by ‘genotype 1’ or ‘genotype 4’ HCV.
- It is used in patients with hepatitis C infection with or without Human Immunodeficiency Virus-1 (HIV-1) co-infection.
OLYSIO helps to fight hepatitis C infection by preventing HCV from multiplying. When used with peginterferon alfa and ribavirin or sofosbuvir, OLYSIO helps to get rid of HCV from your body.
Ask your doctor if you have any questions about why OLYSIO has been prescribed for you.
This medicine is available only with a doctor’s prescription.
Before you take OLYSIO
When you must not use it:
Do not take OLYSIO:
- if you are allergic (hypersensitive) to simeprevir, or other ingredients of OLYSIO. See Product Description at the end of this leaflet for a list of ingredients.
Do not take OLYSIO:
- if the packaging is torn or shows signs of tampering.
- if the expiry date (month and year) printed on the pack has passed. If you take OLYSIO after the expiry date it may not work.
OLYSIO must be used with ribavirin, which can affect your unborn baby. This means:
- You or your female partner must not become pregnant while taking ribavirin.
- You or your female partner must also not become pregnant for 6 months after you stopped taking ribavirin.
If you or your female partner becomes pregnant during this period, you must contact your doctor straight away. Please also read the Consumer Medicine Information for ribavirin for information regarding pregnancy.
If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- You and your female partner must use two effective methods of birth control during the entire treatment.
- You must also do this for several months after you stop taking OLYSIO.
Please read the Consumer Medicine Information for ribavirin for continued birth control requirements.
Do not use OLYSIO while breast-feeding. Talk to your doctor if you are breast-feeding before taking OLYSIO. This is important since it is not known whether OLYSIO can pass into breast milk. The doctor will advise you to discontinue breast-feeding or to discontinue OLYSIO while breast-feeding.
OLYSIO should not be used by anyone under 18 years of age because it has not been studied in this age group.
Before you start to use it:
Tell your doctor if you have or have had any medical conditions, especially the following:
- you are a woman who is, may be or plans to become pregnant
- you are a man with a female partner who is, may be or plans to become pregnant
- you have hepatitis B infection
- you had or are going to have an organ transplant
- you have any other liver problems in addition to hepatitis C
- you have hepatitis C that is not genotype 1 or genotype 4
- you have taken the medicines telaprevir or boceprevir
- you have any other medical condition.
Your doctor will do blood tests before you start your treatment and regularly during your treatment. These blood tests are done to help your doctor to:
- check if the treatment is working for you.
- decide how long you need to take OLYSIO, peginterferon alfa and ribavirin or sofusbuvir.
Taking other medicines:
Tell your doctor if you take any of the following medicines:
- amiodarone, digoxin, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone or quinidine. These medicines are used to treat irregular heartbeat.
- clarithromycin, erythromycin, azithromycin or telithromycin. These medicines are used to treat bacterial infections.
- warfarin to prevent blood clots.
- carbamazepine, oxcarbazepine, phenobarbital or phenytoin to prevent seizures.
- astemizole or terfenadine to treat allergies.
- itraconazole, ketoconazole, posaconazole, flucanazole or voriconazole (when taken by mouth). These medicines are used to treat fungal infections.
- rifabutin, rifampicin, bedaquiline or rifapentine to treat infections like tuberculosis.
- amlodipine, bepidril, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or verapamil. These medicines are used to decrease blood pressure.
- dexamethasone (when given through injection or taken by mouth). This medicine is used to treat asthma or inflammation and auto-immune diseases.
- cisapride to treat stomach problems.
- cobicistat a product that blocks some liver enzymes and increases the levels of some medicines used to treat HIV infections.
- atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, maraviroc, nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir. These medicines are used to treat HIV infection.
- atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin. Medicines used to lower cholesterol levels.
- cyclosporin, sirolimus or tacrolimus. These medicines are used to lower your immune response or prevent organ transplant failures.
- midazolam or triazolam (when taken by mouth). These medicines are used to help you sleep or for anxiety.
- milk thistle a herbal medicine used for liver problems.
- St. John’s wort, a herbal medicine used for anxiety.
- escitalopram, a medicine used to treat depression.
- dextromethorphan – a medicine used to control coughing.
- sildenafil, tadalafil or vardenafil. These medicines are used to treat erectile dysfunction or pulmonary arterial hypertension.
- sofosuvir and daclatasvir. These are medicines used to treat viruses.
OLYSIO might interact with other medicines. This may result in greater or lesser effects or even side effects from these medicines.
Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. Your doctor can tell you whether you can continue the medicines you are taking or reduce the dose.
Always take OLYSIO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You must take OLYSIO along with peginterferon alfa and ribavirin or sofosbuvir. Read the Consumer Medicine Information of these medicines for the dosage and how to take instructions.
Avoid excessive sun exposure and use of tanning devices. Use sun protective measures during OLYSIO treatment.
How much OLYSIO to take:
The recommended dose of OLYSIO is one capsule (150 mg) once a day.
- Always take OLYSIO with food. The type of food is not important.
- Take this medicine by mouth.
- Swallow the capsule as a whole.
- Try to take OLYSIO at the same time each day.
How long to take
- Take OLYSIO with peginterferon alfa and ribavirin for 12 weeks.
- After 12 weeks, continue to use peginterferon alfa and ribavirin without OLYSIO. Your doctor will decide how long you must use peginterferon alfa and ribavirin based on the results of your blood tests.
- Take OLYSIO with sofosbuvir for 12 weeks or up to 24 weeks.
What do I do if I forget to take OLYSIO?
- If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food. Then continue taking OLYSIO at the usual scheduled time.
- If it is less than 12 hours until your next dose, skip the missed dose. Then take the next dose of OLYSIO at the usual scheduled time.
- Do not take a double dose to make up for a forgotten dose.
If you are not sure what to do, contact your doctor or pharmacist.
What do I do if I take too much? (overdose):
If you think you or anybody else has taken too much OLYSIO, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
- Australia: 13 11 26.
- New Zealand: 0800 POISON or 0800 764 766.
While you are taking OLYSIO
Things you must do:
Do not stop taking OLYSIO in order to ensure that your medicine continues to work against the virus, unless your doctor tells you to.
Be sure to keep all your doctor’s appointments so your progress can be checked.
Be sure to follow up your doctor’s instructions about other medicines you should take, and other things you should do.
Ask your doctor or pharmacist if you have any questions.
Tell any other doctors and pharmacists who are treating you that you are taking OLYSIO.
If you are about to be started on any new medicines, tell your doctor or pharmacist that you are taking OLYSIO.
If you have any further questions on the use of this product, ask your doctor.
Things to be careful of
Driving and using machines
Combination treatment of OLYSIO, peginterferon alfa and ribavirin or sofosbuvir may affect your ability to drive and use machines. Read the Consumer Medicine Information for peginterferon alfa, ribavirin and sofosbuvir for information regarding driving and using machines. Do not drive or use machines if you feel faint or have problems with your vision.
Read the Consumer Medicine Information for peginterferon alfa, ribavirin and sofosbuvir for side effects reported with these medicines.
Like all medicines, OLYSIO can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
- itching of the skin
- skin rash
- increased bilirubin levels in your blood
- being sensitive to light (photosensitivity)
Do not be alarmed by this list of possible side effects. You may not experience any of them.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this package insert.
Store below 30°C. Keep capsules in the original container. Protect from light.
Do not store it or any medicines in the bathroom or near a sink. Heat and dampness can destroy some medicines.
Keep this medicine out of the sight and reach of children. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Do not use this medicine after the expiry date which is stated on the package after EXP.
What it looks like:
The capsules are white, with ‘TMC435 150’ printed in black ink.
OLYSIO is supplied in PVC/PE/PVDC aluminium push through blister strips of 7 capsules contained within an outer carton. Pack sizes of 7 or 28 capsules. Not all pack sizes may be marketed.
Each capsule contains simeprevir sodium salt equivalent to 150 mg of simeprevir.
- colloidal anhydrous silica
- croscarmellose sodium
- sodium lauryl sulphate
- magnesium stearate
- titanium dioxide (E171)
- iron oxide black (E172)
- shellac (E904).
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
150 mg capsule: AUST R 211697
This leaflet was prepared in January 2016.
® OLYSIO is a registered trademark of Janssen-Cilag.
Published by MIMS December 2016