Olysio
simeprevir
simeprevir
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What OLYSIO is and what it is used for
What you need to know before you take OLYSIO
How to take OLYSIO
Possible side effects
How to store OLYSIO
Contents of the pack and other information
Medicinal product no longer authorised
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 must always be used as part of a course of
treatment with other medicines for treating chronic hepatitis C infection. It is therefore important that you also read the package leaflets that are provided with these other medicines before you start taking OLYSIO. If you have any further questions about any of these medicines, ask your doctor or pharmacist.
OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying. When used
together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from your body.
Talk to your doctor or pharmacist about all your medical conditions before taking OLYSIO in
particular if:
you have hepatitis C that is not ‘genotype 1’ or ‘genotype 4’;
you have ever taken any medicines to treat hepatitis C;
you have any other liver problems in addition to hepatitis C;
you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
you have had or are going to have an organ transplant.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking OLYSIO.
When taking OLYSIO combination treatment, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems:
notice yellowing of your skin or eyes
your urine is darker than normal
notice swelling of your stomach area.
This is particularly significant if these are accompanied by either of the following symptoms:
feel sick (nauseous), are sick (vomit) or lose your appetite
confusion.
OLYSIO combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat irregular heart beat.
Tell your doctor if any of the following applies:
you currently take, or have taken in the last few months, the medicine amiodarone (your doctor may consider alternative treatments if you have taken this medicine)
you take other medicines to treat irregular heart beat or high blood pressure.
Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience:
shortness of breath
Medicinal product no longer authorised
light-headedness
palpitations
fainting.
Sensitivitytosunlight
You may be more sensitive to sunlight (photosensitivity) when taking OLYSIO (see section 4 for information about side effects).
During your treatment with OLYSIO, use appropriate sun protection (such as a sun hat, sunglasses and
sunscreen). Especially avoid intense or prolonged exposure to sunlight (including tanning devices). If you develop a photosensitivity reaction during treatment, contact your doctor immediately.
Rash
You may experience a rash during treatment with OLYSIO. Rash may become severe. If you develop a rash during treatment, contact your doctor immediately.
Bloodtests
Your doctor will test your blood before you start your treatment and regularly during your treatment. These blood tests help your doctor to
check if the treatment is working for you
check your liver function.
OLYSIO must not be used in children and adolescents (under 18 years of age) because it has not been
studied in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because OLYSIO and other medicines may interact with each other. In particular tell your doctor or pharmacist if you take any of the following medicines:
digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth) or amiodarone to treat irregular heart beat
clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to
treat bacterial infections
warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can
clot.
carbamazepine, oxcarbazepine, phenobarbital or phenytoin to prevent seizures
astemizole or terfenadine to treat allergies
itraconazole, fluconazole, ketoconazole, posaconazole or voriconazole (when taken by mouth or given by injection) to treat fungal infections
rifabutin, rifampicin or rifapentine to treat infections like tuberculosis
amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or verapamil (when taken by mouth) to decrease blood pressure
dexamethasone (when given by injection or taken by mouth) to treat asthma or inflammation
and auto-immune diseases
cisapride to treat stomach problems
milk thistle (a herbal medicine) for liver problems
St John’s wort (Hypericum perforatum, a herbal medicine) for anxiety or depression
ledipasvir to treat hepatitis C infection
cobicistat to increase levels of some medicines used to treat HIV infection
atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection
atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels
ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures
Medicinal product no longer authorised
sildenafil or tadalafil to treat ‘pulmonary arterial hypertension’
midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking OLYSIO.
In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood pressure.
Pregnancy
If you are pregnant, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not take OLYSIO unless specifically directed by the doctor.
When OLYSIO is used with ribavirin, please read the package leaflet for ribavirin for information regarding pregnancy. Ribavirin can affect your unborn baby.
If you are a woman, you must not become pregnant during treatment and for several
If you are a man, your female partner must not become pregnant during your treatment and for several months afterwards.
If pregnancy occurs during this period, you must contact your doctor straight away.
Contraception
Women must use an effective method of contraception during treatment with OLYSIO.
When OLYSIO is used with ribavirin, read the package leaflet for ribavirin for information regarding contraception requirements. You and your partner must use an effective method of contraception
during treatment and for several months afterwards.
Breast-feeding
Talk to your doctor if you are breast-feeding before taking OLYSIO. This is important because it is not known whether simeprevir can pass into breast milk. The doctor will advise you to stop
breast-feeding or to stop taking OLYSIO while breast-feeding.
Combination treatment of OLYSIO with other medicines used for treating your chronic hepatitis C
infection may affect your ability to drive and use machines. Do not drive or use machines if you feel faint or have problems with your vision. Read the package leaflets for these other medicines for
information regarding driving and using machines.
OLYSIO contains lactose (a type of sugar). If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You must take OLYSIO as part of a course of treatment with other medicines for treating your chronic hepatitis C infection. A course of OLYSIO lasts for either 12 or 24 weeks but you may need to take
the other medicines for longer, according to your doctor’s instructions. Read the package leaflets for
these medicines for their dosage and directions on ‘how to take’ them.
The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Medicinal product no longer authorised
The days of the week are printed on the blister strip - this will help you remember to take your capsule.
Try to take OLYSIO at the same time each day.
Always take OLYSIO with food. The type of food is not important.
Take this medicine by mouth.
Swallow the capsule whole.
Press either edge of the pocket to push the capsule through the foil, as
shown.
damage or break open the capsule.
If the capsule shell has been broken or opened, some medicine may be lost and you should take a new capsule. If the capsule shell is indented or bent - without being broken or opened - the capsule can still be used.
If you take more OLYSIO than you should, talk to your doctor or pharmacist immediately.
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.
Do not stop taking OLYSIO unless your doctor tells you to. If you do, your medicine may not work properly.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, OLYSIO can cause side effects, although not everybody gets them.
The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people:
itching of the skin
skin rash*
constipation
being sensitive to sunlight (photosensitivity)
increased ‘bilirubin’ levels in your blood (bilirubin is a pigment made by the liver).
Skin rash may affect more than 1 in 10 people (very common) when OLYSIO is used in combination with sofosbuvir for 24 weeks.
The following side effects may happen with OLYSIO when used in combination with peginterferon alfa and ribavirin:
feeling sick (nausea)
itching of the skin
skin rash
Medicinal product no longer authorised
being short of breath.
increased ‘bilirubin’ levels in your blood (bilirubin is a pigment made by the liver)*
being sensitive to sunlight (photosensitivity)
constipation.
In a clinical study in Asian patients from China and South-Korea, increased blood ‘bilirubin’ levels were reported in more than 1 in 10 people (very common).
Read the package leaflets for the other medicines used for treating your hepatitis C infection for side effects reported with these medicines.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Store in the original package in order to protect from light.
This medicine may pose a risk to the environment. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is simeprevir. Each capsule contains simeprevir sodium equivalent to 150 milligrams of simeprevir.
The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
The hard capsules are white, with ‘TMC435 150’ printed in black ink.
OLYSIO is supplied in push-through blister strips of 7 capsules. The days of the week are printed on the blister strip.
OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters). Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Medicinal product no longer authorised
B-2340 Beerse
Tel/Tél: +32 14 64 94 11
UAB "JOHNSON & JOHNSON"
Geležinio Vilko g. 18A LT-08104 Vilnius
Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД ж.к. Младост 4
Бизнес Парк София, сграда 4
София 1766
Тел.: +359 2 489 94 00
B-2340 Beerse Belgique/Belgien
Tél/Tel: +32 14 64 94 11
CZ-150 00 Praha 5 - Smíchov
Tel: +420 227 012 227
H-Budapest, 1123
Tel.: +36 1 884 2858
Janssen-Cilag A/S Bregnerødvej 133
DK-3460 Birkerød Tlf: ++45 45 94 82 82
AM MANGION LTD.
Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000
Tel: +356 2397 6000
Janssen-Cilag GmbH
Johnson & Johnson Platz 1 D-41470 Neuss
Tel: +49 2137 955-955
Janssen-Cilag B.V.
Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2
EE-11415 Tallinn Tel: +372 617 7410
Janssen-Cilag AS Postboks 144
NO-1325-Lysaker Tlf: +47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Λεωφόρος Ειρήνης 56
GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH
Vorgartenstraße 206B A-1020 Wien
Tel: +43 1 610 300
Janssen-Cilag, S.A.
Paseo de las Doce Estrellas, 5-7 E-28042 Madrid
Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24
PL-02-135 Warszawa Tel.: +48 22 237 60 00
Janssen-Cilag
1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda.
Estrada Consiglieri Pedroso, 69 A Queluz de Baixo
PT-2734-503 Barcarena
Tel: +351 21 43 68 835
Johnson & Johnson S.E. d.o.o.
Medicinal product no longer authorised
Oreškovićeva 6h 10010 Zagreb
Tel: +385 1 6610 700
Johnson & Johnson România SRL
Str. Tipografilor nr. 11-15
Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA
Tel: +40 21 207 1800
Janssen-Cilag Ltd.
50-100 Holmers Farm Way High Wycombe
Buckinghamshire HP12 4EG
United Kingdom
Tel: +44 1 494 567 444
Johnson & Johnson d.o.o.
Šmartinska cesta 53 SI-1000 Ljubljana
Tel: +386 1 401 18 30
Janssen-Cilag AB
c/o Vistor hf. Hörgatúni 2
IS-210 Garðabær
Sími: +354 535 7000
Tel: +421 232 408 400
Janssen-Cilag SpA
Via M.Buonarroti, 23
I-20093 Cologno Monzese MI Tel: +39 02 2510 1
Janssen-Cilag Oy
Vaisalantie/Vaisalavägen 2 FI-02130 Espoo/Esbo
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ, Λεωφόρος Γιάννου Κρανιδιώτη 226
Λατσιά
CY-2234 Λευκωσία Τηλ: +357 22 207 700
Janssen-Cilag AB Box 4042
SE-16904 Solna
Tel: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Mūkusalas iela 101
Rīga, LV-1004
Tel: +371 678 93561
Janssen-Cilag Ltd.
50-100 Holmers Farm Way High Wycombe
Buckinghamshire HP12 4EG - UK
Tel: +44 1 494 567 444
Medicinal product no longer authorised