Package Leaflet: Information for the User

STAYVEER 62.5 mg Film-Coated Tablets

bosentan

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

STAYVEER tablets contain bosentan, which blocks the natural hormone called endothelin-1 (ET-1), and causes narrowing of blood vessels. STAYVEER therefore causes dilation of blood vessels and belongs to the class of medications called “endothelin receptor antagonists”.

STAYVEER is used to treat:

• Pulmonary arterial hypertension(PAH): PAH is a severe narrowing of the blood vessels in the lungs resulting in an increase in blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that can reach the blood in the lungs, making physical activity more difficult. STAYVEER widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure and alleviates symptoms.

STAYVEER is used to treat patients with PAH in class III to improve symptoms and exercise capacity (the ability to perform physical activity). The “class” reflects the severity of the disease: ‘class III’ implies a marked limitation of physical activity. Some improvements have been observed in patients with PAH class II. The ‘class II’ implies a slight limitation of physical activity. The PAH for which STAYVEER is indicated may be:

• primary (in which the cause or hereditary is not identified),
• caused by scleroderma (also called systemic sclerosis, a disease in which there is abnormal growth of connective tissue that forms the support of the skin and other organs),
• caused by congenital heart defects (at birth) with short circuits (abnormal communications) that cause abnormal blood flow between the heart and lungs.

• Digital ulcers(ulcers on the fingers of the hands and feet) in adult patients with a disease called scleroderma. STAYVEER reduces the number of new digital ulcers (on hands and feet) that appear.

Do not take STAYVEER:

• if you are allergic to bosentanor to any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems(ask your doctor)
• if you are pregnant, or could be pregnantsince you are not using reliable contraceptive methods. Please read the information in the section “Contraceptives” and “Other medicines and STAYVEER”
• if you are taking ciclosporin A(a medicine used after a transplant or to treat psoriasis)

If you have any of these conditions, inform your doctor.

Warnings and precautions

Tests your doctor will perform before prescribing the treatment

• a blood test to assess liver function
• a blood test to detect if there is anemia (low hemoglobin)
• a pregnancy test if you are a fertile woman

Abnormalities in liver function tests and anemia have been found in some patients taking STAYVEER.

Tests your doctor will perform during the treatment

During treatment with STAYVEER, your doctor will schedule regular blood tests to monitor changes in your liver function and hemoglobin levels.

Please refer to the Patient Alert Card (inside the STAYVEER packaging) for these tests. It is essential to perform regular blood tests while taking STAYVEER. We suggest that you write the date of the most recent test and your next test date (ask your doctor for the date) on the Patient Alert Card to help you remember when your next visit is.

Liver function tests

These tests must be performed monthly throughout the duration of treatment with STAYVEER. After a dose increase, an additional test should be performed after 2 weeks.

Anemia tests

These tests will be performed monthly during the first 4 months of treatment and then every 3 months, as patients taking STAYVEER may develop anemia.

If these tests are abnormal, your doctor may decide to reduce the dose or discontinue treatment with STAYVEER and perform additional tests to investigate the cause.

Children and adolescents

STAYVEER is not recommended for pediatric patients with systemic sclerosis and active digital ulceration. See also section 3. How to take STAYVEER.

Taking STAYVEER with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription. It is especially important to inform your doctor if you take:

Driving and operating machines

STAYVEER has no influence or has a negligible influence on driving and operating machines. However, STAYVEER may induce hypotension (low blood pressure) that may cause dizziness, affect your vision, and affect your ability to drive and operate machines. Therefore, if you feel dizzy or see blurry while taking STAYVEER, do not drive or operate tools or machinery.

Women of childbearing age

DO NOT TAKE STAYVEER if you are pregnant or plan to become pregnant

Pregnancy tests

STAYVEER may affect unborn babies conceived before or during treatment. If you are a fertile woman, your doctor will ask you to perform a pregnancy test before starting treatment with STAYVEER, and regularly while taking STAYVEER.

Contraceptives

If you may become pregnant, use a reliable contraceptive method (contraception) while taking STAYVEER. Your doctor or gynecologist will advise you on suitable contraceptive methods while taking STAYVEER. Since STAYVEER may make hormonal contraceptives ineffective (e.g., oral, injection, implant, or skin patches), this method alone is not reliable. Therefore, if you use hormonal contraceptives, you must also use a barrier method (e.g., female condom, diaphragm, spermicide, or your partner must also use a condom). Inside the STAYVEER packaging, you will find a Patient Alert Card that you must complete and bring to your doctor's next visit so that your doctor or gynecologist can determine if you need an alternative or additional reliable contraceptive method. It is recommended to perform a pregnancy test monthly while taking STAYVEER and are of childbearing age.

Inform your doctor immediately if you become pregnant while taking STAYVEER, or plan to become pregnant in the near future.

Breastfeeding

Inform your doctorimmediately if you are inthe breastfeeding period. We recommend that you stop breastfeeding if you are prescribed STAYVEER, as it is not known if this medicine passes into breast milk.

Fertility

If you are a man and taking STAYVEER, it is possible that this medicine may reduce the number of sperm. It cannot be ruled out that it may affect your ability to father a child. Discuss any concerns or doubts with your doctor.

STAYVEER treatment should only be initiated and monitored by a doctor with experience in HAP or systemic sclerosis treatment. Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

STAYVEER with food and drink

STAYVEER can be administered with or without food.

Recommended dose is:

Adult

The treatment in adults usually starts with 62.5 mg twice a day (morning and night) for the first 4 weeks, after which your doctor will normally advise you to take one 125 mg tablet twice a day, depending on how you react to STAYVEER.

Children and adolescents

The recommended dose in children is only for HAP. For children aged 1 year or older, STAYVEER treatment usually starts with 2 mg per kg of body weight twice a day (morning and night). Your doctor will advise you on the dose.

If you feel that the effect of STAYVEER is too strong or too weak, consult your doctor to verify if you need a dose adjustment.

How to take STAYVEER

The tablets should be taken (morning and night) with water. The tablets can be taken with or without food.

If you take more STAYVEER than you should

If you take more tablets than you should, consult your doctor immediately.

If you forget to take STAYVEER

If you forget to take STAYVEER, take the dose as soon as you remember and continue taking it at your usual schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt STAYVEER treatment

If you suddenly stop taking STAYVEER, your symptoms may worsen. Do not stop taking STAYVEER unless your doctor tells you to. Your doctor may advise you to reduce the dose for a few days before stopping it completely.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effects with STAYVEER are:

Your liver and blood values will be analyzed during treatment with STAYVEER (see section 2). It is essential to have these analyses done as prescribed by your doctor.

The signs that your liver may not be functioning correctly include:

If you experience any of these symptoms,consult your doctor immediately

Other side effects:

Very common (can affectmore than 1 in 10people):

Common(can affectup to1in 10people):

Uncommon(can affectup to1in 100people):

Rare(can affectup to1in 1000people):

There have also been reported cases of blurred vision with unknown frequency (cannot be estimated from available data).

Side effects in children and adolescents

The side effects observed in children treated with STAYVEER are the same as in adults.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after “EXP”.

For high-density polyethylene bottles, use within 30 days following the first opening.

For PVC/PE/PVDC/aluminum blisters:

Do not store at a temperature above 30 °C.

For high-density polyethylene bottles:

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medication that you no longer need. In this way, you will help protect the environment.

Composition of STAYVEER

• STAYVEER 62.5 mg film-coated tablets:The active ingredient is bosentan monohydrate. Each tablet contains 62.5 mg of bosentan (as monohydrate).
• The other componentsof the tablet core are maize starch, pregelatinized starch, sodium carboxymethyl starch (Type A), povidone, glycerol dibehenate, and magnesium stearate.The film coatingcontains hypromellose, triacetin, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), and ethylcellulose.

Appearance of the product and contents of the pack

STAYVEER 62.5 mg are round, orange-white film-coated tablets, engraved with "62.5" on one side.

PVC/PE/PVDC/aluminium blisterscontaining 14 film-coated tablets. The packs contain 56 or 112 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).

High-density polyethylene (HDPE) white bottles with a silica gel desiccantcontaining 56 film-coated tablets. Carton pack containing 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).

Do not swallow the desiccant.

Only some pack sizes may be marketed.

Marketing authorisation holder:

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing:

Haupt Pharma Wülfing GmbH

Bethelner Landstraße 18

31028 Gronau/Leine

Germany

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/