Stayveer
bosentan monohydrate
bosentan
Keep this leaflet. You may need to read it again.
If you have any further questions, please 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.
What STAYVEER is and what it is used for
What you need to know before you take STAYVEER
How to take STAYVEER
Possible side effects
How to store STAYVEER
Contents of the pack and other information
STAYVEER tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
STAYVEER is used to treat:
STAYVEER is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms. The ‘class’ reflects the seriousness of the disease: ‘class III’ involves marked limitation of physical activity. Some improvements have also been shown in patients with class II PAH. ‘Class II’ involves slight limitation of physical activity. The PAH for which STAYVEER is indicated can be:
primary (with no identified cause or familial);
caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
STAYVEER reduces the number of new finger and toe ulcers that appear.
If any of these apply to you, tell your doctor.
a blood test to check your liver function
a blood test to check for anaemia (low haemoglobin)
a pregnancy test if you are a woman of childbearing potential
Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level.
For all these tests please refer also to the Patient Alert Card (inside your pack of STAYVEER tablets). It is important that you have these regular blood tests as long as you are taking STAYVEER. We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due.
These will be done every month for the duration of treatment with STAYVEER. After an increase in dose an additional test will be done after 2 weeks.
These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking STAYVEER may get anaemia.
If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with STAYVEER and to perform further tests to investigate the cause.
STAYVEER is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease. Please see also section 3. How to take STAYVEER.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking:
cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with STAYVEER.
sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER.
glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (a medicine against fungal infections), ketoconazole (a medicine used to treat Cushing’s syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be used together with STAYVEER.
other medicines for the treatment of HIV infection, which may require special monitoring if used together with STAYVEER.
hormonal contraceptives, which are not effective as the sole method of contraception when you take STAYVEER. Inside your pack of STAYVEER tablets you will find a Patient Alert Card which you
should read carefully. Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
warfarin (an anticoagulant agent);
simvastatin (used to treat hypercholesterolaemia).
STAYVEER has no or negligible influence on the ability to drive and use machines. However, STAYVEER can induce hypotension (decrease of your blood pressure) which can make you feel dizzy,
affect your vision and affect your ability to drive and use machines. Therefore, if you feel dizzy or that
your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines.
Do NOT take STAYVEER if you are pregnant or planning to become pregnant.
STAYVEER may harm unborn babies conceived before starting or during treatment. If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking STAYVEER, and regularly while you are taking STAYVEER.
If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking STAYVEER. Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking STAYVEER. Because STAYVEER may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable. Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom). Inside your pack of STAYVEER tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods. Monthly pregnancy tests are recommended while you are taking STAYVEER and are of childbearing age.
Tell your doctor immediately if you become pregnant while you are taking STAYVEER, or plan to become pregnant in the near future.
If you are a man taking STAYVEER, it is possible that this medicine may lower your sperm count. It cannot be excluded that this may affect your ability to father a child. Talk to your doctor if you have any questions or concerns about this.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Treatment with STAYVEER should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
STAYVEER can be taken with or without food.
The treatment in adults is usually started for the first 4 weeks with 62.5 mg twice daily (morning and evening), from then your doctor will usually advise you to take a 125 mg tablet twice daily, depending on
how you react to STAYVEER.
The dose recommendation in children is only for PAH. For children aged 1 year and older, treatment with STAYVEER is usually started with 2 mg per kg bodyweight twice daily (morning and evening). Your
doctor will advise you on your dosing.
If you have the impression that the effect of STAYVEER is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Tablets should be taken (morning and evening), swallowed with water. The tablets can be taken with or without food.
If you take more tablets than you have been told to take, contact your doctor immediately.
If you forget to take STAYVEER, take a dose as soon as you remember, then continue to take your tablets at the usual times. Do not take a double dose to make up for forgotten tablets.
Suddenly stopping your treatment with STAYVEER may lead to your symptoms getting worse. Do not stop taking STAYVEER unless your doctor tells you to. Your doctor may tell you to reduce the dose over
a few days before stopping completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects with STAYVEER are
Abnormal liver function which may affect more than 1 in 10 people
Anaemia (low blood value) which may affect up to 1 in 10 people. Anaemia may occasionally require blood transfusion
Your liver and blood values will be monitored during treatment with STAYVEER (see section 2). It is
important that you have these tests as ordered by your doctor.
Signs that your liver may not be working properly include:
nausea (urge to vomit)
vomiting
fever (high temperature)
pain in your stomach (abdomen)
jaundice (yellowing of your skin or the whites of your eyes)
dark-coloured urine
itching of your skin
lethargy or fatigue (unusual tiredness or exhaustion)
flu-like syndrome (joint and muscle pain with fever)
If you notice any of these signs tell your doctor immediately.
Other side effects
Headache
Oedema (swelling of the legs and ankles or other signs of fluid retention)
Flushed appearance or redness of skin
Hypersensitivity reactions (including skin inflammation, itching and rash)
Gastrooesophageal reflux disease (acid reflux)
Diarrhoea
Syncope (fainting)
Palpitations (fast or irregular heart beats)
Low blood pressure
Nasal congestion
Thrombocytopenia (low number of blood platelets)
Neutropenia/leukopenia (low number of white blood cells)
Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes, lips, tongue or throat)
Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
The side effects that have been reported in children treated with STAYVEER are the same as those in adults.
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 the national reporting system 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 on the blister after “EXP”. For white high-density polyethylene bottles, use within 30 days after the first opening.
For PVC/PE/PVDC/aluminium-blisters: Do not store above 30°C.
For white high-density polyethylene bottles:
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.
oxide red (E172) and ethylcellulose.
STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Do not swallow the desiccant.
Not all pack sizes may be marketed.
Marketing authorisation holder: Janssen-Cilag International NV Turnhoutseweg 30
B-2340 Beerse Belgium
Janssen Pharmaceutica NV Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00
Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Janssen-Cilag A/S Tlf: +45 4594 8282
AM MANGION LTD Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
Janssen-Cilag B.V. Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Janssen-Cilag AS Tlf: +47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
Johnson & Johnson România SRL Tel: +40 21 207 1800
Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
Janssen_safety_slo@its.jnj.com
Janssen-Cilag AB c/o Vistor hf.
Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700
Janssen-Cilag AB Tfn: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561
Janssen Sciences Ireland UC Tel: +44 1 494 567 444