Introduction

Prospect: Information for the Patient

Uptravi 200microgram film-coated tablets

Uptravi 400microgram film-coated tablets

Uptravi 600microgram film-coated tablets

Uptravi 800microgram film-coated tablets

Uptravi 1,000microgram film-coated tablets

Uptravi 1,200microgram film-coated tablets

Uptravi 1,400microgram film-coated tablets

Uptravi 1,600microgram film-coated tablets

selexipag

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before taking this medicine, as it contains important information for you.

Keep this prospectus, as you may need to read it again.
If you have any doubts, consult your doctor or nurse.
This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospectus (see section 4).

1.What is Uptravi and what is it used for

2.What you need to know before starting to take Uptravi

3.How to take Uptravi

4.Possible adverse effects

5.Storage of Uptravi

6.Contents of the package and additional information

1. What is Uptravi and how is it used

Uptravi is a medication that contains the active ingredient selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, causing them to relax and dilate.

Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in controlled adult patients who are insufficiently treated with other types of PAH medications known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be used alone if the patient is not a candidate for these medications.

Pulmonary arterial hypertension (PAH) is a disease characterized by high blood pressure that affects the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries are narrower, so the heart has to work harder to pump blood. This can cause fatigue, dizziness, difficulty breathing, or other symptoms.

In the same way that prostacyclin does, Uptravi dilates the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood along the pulmonary arteries. It alleviates PAH symptoms and improves the course of the disease.

2. What you need to know before starting Uptravi

Do not take Uptravi

if you are allergic to selexipag or any of the other ingredients of this medicine (listed in section 6).
if you have any heart problems, such as:

severe reduced blood flow to the heart muscles (severe ischemic cardiomyopathy or unstable angina); symptoms may include chest pain
myocardial infarction in the past 6 months
uncompensated heart failure without strict medical supervision
severe irregular heartbeat
heart valve defects (congenital or acquired) that make the heart work with difficulty (not related to pulmonary hypertension)

if you have had a stroke in the past 3 months, or any other event that reduces blood flow to the brain (e.g., transient ischemic attack)

if you are taking gemfibrozil (a medicine used to reduce the level of fats (lipids) in the blood)

Warnings and precautions

Consult your doctor or nurse before starting to take Uptravi if you:

are taking medicines for high blood pressure (hypertension)
have low blood pressure associated with symptoms such as dizziness
have recently experienced significant blood loss or fluid loss such as severe diarrhea or vomiting
have thyroid problems
have severe kidney problems or are being treated with dialysis
have or have had severe liver function problems

If you experience any of the above signs or your condition changes, report immediately to your doctor.

Children and adolescents

Do not administer this medicine to children under 18 years of age, as Uptravi has not been evaluated in children.

Older adults

There is limited experience with Uptravi in patients over 75 years of age. Uptravi should be used with caution in patients of this age group.

Other medicines and Uptravi

Inform your doctor if you are taking, have taken recently, or plan to take any other medicine.

Taking other medicines may affect the functioning of Uptravi.

Inform your doctor or nurse specializing in HAP if you are taking any of the following medicines:

Gemfibrozil (a medicine used to reduce the levels of fats [lipids] in the blood)
Clopidogrel (a medicine used to prevent the formation of blood clots [thrombi] in coronary artery disease)
Deferasirox (a medicine used to remove excess iron from the body)
Teriflunomida (a medicine used to treat relapsing-remitting multiple sclerosis)
Carbamazepina (a medicine used to treat certain types of epilepsy, neuralgia, or to help control severe behavioral disorders when other medicines do not work)
Fenitoína (a medicine used to treat epilepsy)
Ácido valproico (a medicine used to treat epilepsy)
Probenecid (a medicine used to treat gout)
Fluconazol, rifampicina, or rifapentina (antibiotics used to treat infections)

Pregnancy and breastfeeding

Uptravi is not recommended for use during pregnancy and breastfeeding. If you are a woman and may become pregnant, use a reliable contraceptive method while taking Uptravi. If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and operating machines

Uptravi may cause side effects such as headaches and decreased blood pressure (see section 4), which may affect your ability to drive; your disease symptoms may also reduce your ability to drive.

3. How to Take Uptravi

The treatment with Uptravi should be initiated and monitored by a doctor with experience in treating pulmonary arterial hypertension (PAH). Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Inform your doctor if you experience any adverse effects, as they may recommend changing your Uptravi dose.

Inform your doctor if you are taking other medications, as they may recommend taking Uptravi only once a day.

If you have poor vision or experience any type of blindness, ask someone else to help you take Uptravi during the dose adjustment period.

Dose adjustment tailored to you

At the beginning of treatment, you will take the lowest dose. This is 200 micrograms in the morning and another 200 micrograms at night. Treatment should start at night. Your doctor will indicate that you should increase the dose gradually. This is what is called dose adjustment, and it allows your body to adapt to the new medication. The goal of dose adjustment is to reach the most suitable dose. This will be the highest dose you can tolerate, which may reach a maximum dose of 1,600 micrograms in the morning and 1,600 micrograms at night.

The first pack of tablets you receive will contain the yellowish-colored tablets of 200 micrograms.

Your doctor will indicate that you should increase the dose in phases, usually every week, although the interval between increments may be longer.

In each phase, you will add one 200 microgram tablet to the morning dose and another 200 microgram tablet to the night dose. The first intake of the increased dose should be taken at night. The following diagram shows the number of tablets you should take each morning and each night in the first 4 phases.

If your doctor indicates that you should continue increasing the dose and proceed to phase 5, you can do so by taking one green tablet of 800 micrograms and one yellowish-colored tablet of 200 micrograms in the morning and one 800 microgram tablet and one 200 microgram tablet at night.

If your doctor indicates that you should continue increasing the dose, you will add one 200 microgram tablet to the morning dose and one 200 microgram tablet to the night dose in each new phase. The first intake of the increased dose should be taken at night. The maximum dose of Uptravi is 1,600 micrograms in the morning and 1,600 micrograms at night. However, not all patients will reach this dose, as each patient requires a different dose.

The following diagram shows the number of tablets you should take each morning and each night in each phase, starting from phase 5.

The dose adjustment pack also contains a guide that provides information on the dose adjustment process and allows you to record the number of tablets you take daily.

Remember to record the number of tablets you take each day in your dose adjustment diary.The dose adjustment phases usually last approximately 1 week. If your doctor indicates that you should prolong each dose adjustment phase beyond 1 week, you have additional pages in the diary that allow you to do so.Remember to communicate with your doctor or PAH specialist nurse periodically during the dose adjustment phase.

Dose reduction due to adverse effects

During dose adjustment, you may experience adverse effects such as headache, diarrhea, nausea, vomiting, jaw pain, muscle pain, lower limb pain, joint pain, or facial flushing (see section 4). If these adverse effects are difficult to tolerate, consult your doctor about how to control or treat them. There are treatments available to help alleviate these adverse effects. For example, analgesics such as paracetamol can help treat pain and headache.

If the adverse effects cannot be treated or do not improve gradually with the dose you are taking, your doctor may adjust the dose by reducing the number of yellowish-colored tablets of 200 micrograms you take, removing one tablet in the morning and one at night. The following scheme shows how to reduce the dose. This should only be done if your doctor indicates so.

If the adverse effects you experience can be controlled after reducing the dose, your doctor may decide that you should maintain that dose. For additional information, see the following section on Maintenance Dose.

Maintenance Dose

The highest dose you can tolerate during the dose adjustment phase will become your maintenance dose. Your maintenance dose is the dose you should take habitually.

Your doctor will prescribe a single tablet with the appropriate potency for your maintenance dose.This allows you to take one tablet in the morning and another at night, instead of several tablets each time.

To consult the complete description of Uptravi tablets, including colors and engraving, see section 6 in this prospectus.

Over time, your doctor may adjust your maintenance dose if necessary.

If, at any time, after taking the same dose for a long period, you experience adverse effects that you cannot tolerate or adverse effects that affect daily activities, contact your doctor, as you may need to reduce the dose. Your doctor may, in this case, prescribe a single tablet with a lower concentration. Remember to discard unused tablets (see section 5).

Take Uptravi once in the morning and once at night, with an interval of approximately 12 hours.

Take the tablets with meals, as this may help you tolerate the medication better. Swallow the tablets whole with a glass of water.

If you take more Uptravi than you should

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

If you forget to take Uptravi

If you forget to take Uptravi, take a dose as soon as you remember, and then continue taking the tablets at the usual time. If it is almost time to take your next dose (within 6 hours of the time you usually take it), do not take the missed dose and continue taking the medication at the usual time. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Uptravi

Stopping treatment with Uptravi abruptly may worsen your symptoms.Do not stop taking Uptravi unless your doctor tells you to.Your doctor may indicate that you should gradually reduce the dose before stopping treatment completely.

If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you have forgotten 3 morning doses and 3 night doses, or 6 consecutive doses or more),contact your doctor immediately, as you may need to adjust the dose to avoid adverse effects. Your doctor may decide to restart treatment at a lower dose, gradually increasing it to reach your maintenance dose.

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

4. Possible Adverse Effects

Like all medications, Uptravi may cause adverse effects. You may experience adverse effects not only during the dose adjustment phase, when your dose is being increased, but also later, after taking the same dose for a long period.

If you experience any of the following adverse effects: headache, diarrhea, feeling of discomfort (nausea), discomfort (vomiting), jaw pain, muscle pain, lower limb pain, joint pain, or facial redness, that you cannot tolerate or is not treatable, you must contact your doctor, as the dose you are taking may be too high for you and may require a reduction.

Very Common Adverse Effects(may affect more than 1 in 10people)

Headache
Facial flushing (redness)
Nausea and vomiting
Diarrhea
Jaw pain, muscle pain, joint pain, lower limb pain
Pharyngitis (nasal congestion)

Common Adverse Effects(may affect up to 1 in 10people)

Anemia (low red blood cell count)
Hyperthyroidism (overactive thyroid gland)
Loss of appetite
Weight loss
Hypotension (low blood pressure)
Abdominal pain
Pain
Changes in some laboratory results, including those that measure blood cell counts and thyroid function
Rashes, including urticaria, which may cause a burning or itchy sensation and skin redness

Uncommon Adverse Effects (may affect up to 1 in 100people)

Increased heart rate

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus.You can also report them directlythrough thenational reporting system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Uptravi Storage

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

Do not use Uptravi after the expiration date that appears on the box and on the blister after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

No special precautions are required for disposal.

6. Contents of the packaging and additional information

Composition of Uptravi

-The active ingredient is selexipag.

Uptravi 200microgram tablets coated with a film contain 200micrograms of selexipag

Uptravi 400microgram tablets coated with a film contain 400micrograms of selexipag

Uptravi 600microgram tablets coated with a film contain 600micrograms of selexipag

Uptravi 800microgram tablets coated with a film contain 800micrograms of selexipag

Uptravi 1.000microgram tablets coated with a film contain 1.000micrograms of selexipag

Uptravi 1.200microgram tablets coated with a film contain 1.200micrograms of selexipag

Uptravi 1.400microgram tablets coated with a film contain 1.400micrograms of selexipag

Uptravi 1.600microgram tablets coated with a film contain 1.600micrograms of selexipag

-The other components are:

In the core of the tablets:

Manitol (E421), cornstarch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, and magnesium stearate.

In the film coating:

Hydroxypropylmethylcellulose, propylene glycol, titanium dioxide (E171), carnauba wax, and iron oxides (see below).

Uptravi 200microgram tablets coated with a film contain yellow iron oxide (E172).

Uptravi 400microgram tablets coated with a film contain red iron oxide (E172).

Uptravi 600microgram tablets coated with a film contain red iron oxide and black iron oxide (E172).

Uptravi 800microgram tablets coated with a film contain yellow iron oxide and black iron oxide (E172).

Uptravi 1.000microgram tablets coated with a film contain red iron oxide and yellow iron oxide (E172).

Uptravi 1.200microgram tablets coated with a film contain black iron oxide and red iron oxide (E172).

Uptravi 1.400microgram tablets coated with a film contain yellow iron oxide (E172).

Uptravi 1.600microgram tablets coated with a film contain black iron oxide, red iron oxide, and yellow iron oxide (E172).

Appearance of Uptravi and contents of the package

Uptravi 200microgram tablets coated with a film: Yellowish-colored round film-coated tablets, marked with a «2» on one side.

Uptravi 400microgram tablets coated with a film:Red-colored round film-coated tablets, marked with a «4» on one side.

Uptravi 600microgram tablets coated with a film:Light violet-colored round film-coated tablets, marked with a «6» on one side.

Uptravi 800microgram tablets coated with a film:Green-colored round film-coated tablets, marked with an «8» on one side.

Uptravi 1.000microgram tablets coated with a film:Orange-colored round film-coated tablets, marked with a «10» on one side.

Uptravi 1.200microgram tablets coated with a film:Dark violet-colored round film-coated tablets, marked with a «12» on one side.

Uptravi 1.400microgram tablets coated with a film:Dark yellow-colored round film-coated tablets, marked with a «14» on one side.

Uptravi 1.600microgram tablets coated with a film:Brown-colored round film-coated tablets, marked with a «16» on one side.

Uptravi 200microgram tablets coated with a film are supplied in blister packs containing 10 or 60 tablets and 60 or 140 tablets (dose adjustment packs).

Uptravi 400microgram, 600microgram, 800microgram, 1.000microgram, 1.200microgram, 1.400microgram, and 1.600microgram tablets coated with a film are supplied in blister packs containing 60 tablets.

It is possible that not all formats will be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Actelion Manufacturing GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

Actelion Pharmaceuticals Belgium NV

Bedrijvenlaan 1

2800 Mechelen

Belgium

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien