Selexipag 800 microgram – patient leaflet, side effects, dosage

1. What Selexipag Film-coated Tablets are and what they are used for

These medicinal products contain the active substance selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen.

Selexipag Film-coated Tablets are used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Selexipag Film-coated Tablets can be used on their own if the patient is not a candidate for these medicines.

PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them. This may cause people to feel tired, dizzy, short of breath, or experience other symptoms.

By acting in a similar way to the natural substance prostacyclin, this medicine widens the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries. Selexipag Film-coated Tablets lower the pressure in the pulmonary arteries, they relieve the symptoms of PAH and slow down progression of PAH disease.

2. What you need to know before you take

Selexipag Film-coated Tablets

Do not take Selexipag Film-coated Tablets

• if you are allergic to selexipag or any of the other

  ingredients of this medicine (listed in section 6).

• if you have a heart problem, such as:
• poor blood flow to the heart muscles (severe coronary heart disease or unstable angina); symptoms can include chest pain
• heart attack within the last 6 months
• weak heart (decompensated cardiac failure) that is not under close medical observation
• severe irregular heartbeat

• defect of the heart valves (inborn or acquired) that

  causes the heart to work poorly (not related to pulmonary hypertension)

• if you have had a stroke within the last 3 months, or any other occurrence that reduced the blood supply to the brain (e.g. transient ischaemic attack)
• if you are taking gemfibrozil (medicine used to lower the level of fats [lipids] in the blood).

Warnings and precautions

Talk to your PAH doctor or nurse before taking Selexipag Film-coated Tablets if you:

• are taking medicines for high blood pressure
• have low blood pressure associated with symptoms such

as dizziness

• have recently experienced significant blood loss or fluid

loss such as severe diarrhoea or vomiting

• have problems with your thyroid gland

• have severe problems with your kidneys or are

  undergoing dialysis

• have or have had severe problems with your liver not working properly.

If you notice any of the above signs or your condition changes, tell your doctor immediately.

Children and adolescents

Do not give this medicine to children under 18 years of age.

Elderly patients

There is limited experience with Selexipag Film-coated Tablets in patients older than 75 years. Selexipag Film-coated Tablets should be used with caution in this age group.

Other medicines and Selexipag Film-coated Tablets

Tell your doctor if you are taking, have recently taken, or might take any other medicines. Taking other medicines may affect how Selexipag Film-coated Tablets work.

Talk to your PAH doctor or nurse if you are taking any of the following medicines:

• gemfibrozil (medicine used to lower the level of fats

  [lipids] in the blood)

• clopidogrel (medicine used to inhibit blood clots in

  coronary artery disease)

• deferasirox (medicine used to remove iron from the blood stream)
• teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis)
• carbamazepine (medicine used to treat some forms of epilepsy, nerve pain or to help control serious mood disorders when some other medicines do not work)
• phenytoin (medicine used to treat epilepsy)
• valproic acid (medicine used to treat epilepsy)
• probenecid (medicine used to treat gout)

• fluconazole, rifampicin or rifapentine (antibiotics used to treat infections).

  Pregnancy and breast-feeding

  Selexipag Film-coated Tablets are not recommended during pregnancy and breast-feeding. If you are a woman who can have children, you should use an effective contraceptive method while taking Selexipag Film-coated Tablets. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

  Driving and using machines

  Selexipag Film-coated Tablets can cause side effects such a

  s headaches and low blood pressure (see section 4), which may affect your ability to drive; the symptoms of your condition can also make you less fit to drive.

  Selexipag Film-coated Tablets contains

  Selexipag 600 microgram Film-coated Tablets contain Allura

  Red AC Aluminum Lake (E129). This is a coloring agent, which may cause allergic reactions.

  Selexipag 1200 microgram Film-coated Tablets contain Red AC Aluminum Lake (E129). This is a coloring agent, which may cause allergic reactions.

3. How to take Selexipag Film-coated Tablets

Selexipag Film-coated Tablets should only be prescribed by a doctor experienced in the treatment of PAH. Always take t

his medicine exactly as your doctor has told you. Check wit

h your doctor if you are in doubt or have any questions.

Tell your doctor if you experience side effects, as your docto

r may recommend that you change your Selexipag Film-coate

d

Tablets dose.

Tell your doctor if you have problems with your liver not working properly or are taking other medicines as your doctor may recommend that you take a lower dose of Selexipag Film-coated Tablets twice daily or take it only once daily.

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f you have poor vision or experience any type of blindness, get help from another person when taking Selexipag Film-coated Tablets during the titration period (process of gradually increasing your dose).

Finding the right dose for you I

f your doctor prescribes 200 microgram tablets

At the start of treatment, most patients will take a 200 microgram tablet in the morning and another 200 microgram tablet in the evening, about 12 hours apart. It is recommended to initiate treatment in the evening. Your doctor will instruct you to gradually increase your dose. This is called titration. It lets your body adjust to t

he new medicine. The goal of titration is to reach the most appropriate dose. This will be the highest dose you can t

olerate, which may reach the maximum dose of 1600 micrograms in the morning and in the evening.

The first pack of tablets you receive will contain the l

ight-yellow 200 microgram tablets. Your doctor will tell you

t

o increase your dose in steps, usually every week but the i

nterval between increases could be longer. With each step, you will add one 200 microgram tablet to your morning dose and another 200 micrograms t

ablet to your evening dose. The first intake of the i

ncreased dose is recommended to be in the evening.

The diagram below shows the number of tablets to take every morning and every evening for the first 4 steps.

Morning Dose

Evening Dose

STARTING DOSE

Each dosing step lasts about 1 week

STEP 4 STEP 1 STEP 2 STEP 3

.

total daily dose 400 μg

total daily dose 800 μg

total daily dose 1200 μg

total daily dose 1600 μg

One

200 μg tablet

One

200 μgtablet

200 microgram tablet

Two

200 μg tablet

Two

200 μg tablet

Three

200 μg tablet

Three

200 μg tablet

Four

200 μg tablet

Four 200 μg tablet

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f your doctor tells you to increase your dose further, you wi

ll add one 200 microgram tablet to your morning dose and on

e

200 microgram tablet to your evening dose with each new step. The first intake of the increased dose is recommended

t

o be in the evening.

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f your doctor instructs you to further increase your dose an

d move to step 5, this may be done by taking one green 800 microgram tablet and one light-yellow 200 microgram t

ablet in the morning and one 800 microgram tablet and on

e

200 microgram tablet in the evening.

The maximum dose of Selexipag Film-coated Tablets is 1600 micrograms in the morning and 1600 micrograms in t

he evening. However, not every patient will reach this dose

, because different patients require different doses.

The diagram below shows the number of tablets to take every morning and every evening at each step, starting with step 5.

On

e

STEP 8 STEP 5 STEP 6 STEP 7

HIGHEST DOSE total daily dose 2000 μg

total daily dose 2400 μg

total daily dose 2800 μg

total daily dose 3200 μ

g

One200 μgtablet

One800 μgtablet

One800 μgtablet

One800 μgtablet

One800 μgtablet

One800 μgtablet

One800 μgtablet

One800 μgtablet

One800 μgtablet

One200 μgtablet

Two

200 μg tablet

Two200 μg tablet

Three200 μg tablet

Three

200 μgtablet

Four 200 μg tablet

Four200 μg tablet 200 microgram tablet

800 microgram tablet (use with steps

5 through 8 to reduce the number of tablets needed per dose.)

Using the titration guide during titration

You will receive the titration pack which contains a titration guide and Patient Leaflet. The titration guide provides i

nformation on the titration process and allows you to recor

d t

he number of tablets you take every day.

Remember to record the number of tablets you take every day in your titration diary. The titration steps usually last about 1 week. If your doctor instructs you to prolong each t

itration step longer than 1 week, there are additional diary pages to allow you to track this. Remember to talk to you

r

PAH doctor or nurse regularly during titration.

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f your doctor prescribes 100 microgram tablets

These medicinal products are not available in 100 micrograms, therefore in case this strength is required, other medicinal products containing selexipag 100 micrograms available on the market should be used.

Stepping down to a lower dose due to side effects

During titration, you may experience side effects such as headache, diarrhoea, feeling sick (nausea), being sick

(

vomiting), jaw pain, muscle pain, leg pain, joint pain, or r

eddening of the face (see section 4). If these side effects are difficult for you to tolerate, talk to your doctor about ho

w t

o manage or treat them. There are treatments available tha

t can help relieve the side effects. For example, painkillers such as paracetamol may help treat pain and headache.

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f the side effects cannot be treated or do not gradually get better on the dose you are taking, your doctor may adjust your dose by reducing the number of 200 microgram l

ight-yellow tablets you take by one in the morning and by one in the evening. The diagram below shows stepping down to a lower dose. Do this only if instructed to do so by your doctor.

Titration with 200 microgram tablets

Morning Dose

Evening Dose

Back to STEP 5 STEP 1 STEP 2-5 STEP 6

Increase your dose about every week by adding a

200 microgram tablet to your morning and evening dose

The goal is reach the highest dose with side effects that you can tolerate

total daily dose 400 μg

One

200 μg

tablet

One

200 μg

tablet

Step down if side effects cannot be tolerated

total daily dose 2000 μg total daily dose 2400 μg

One

200 μg

tablet

One

800 μg

tablet

One 800 μg tablet One

800 μg

tablet

One

800 μg

tablet

One 200 μg tablet Two

200 μg

tablet

Two

200 μg

tablet

total daily dose 2000 μg

One

200 μg

tablet

One

800 μg

tablet

One

800 μg

tablet

One

200 μg

tablet

STEP UP STEP DOWN START

I

f your side effects are manageable after stepping down your dose, your doctor may decide that you should stay on that dose. Please see section Maintenance dose below for more information.

Maintenance dose

The highest dose that you can tolerate during titration will become your maintenance dose. Your maintenance dose is the dose you should continue to take on a regular basis.

Your doctor will prescribe a suitable tablet strength(s) for your maintenance dose. This may allow you to take one tablet in the morning and one in the evening, instead of multiple tablets each time.

For a full description of Selexipag Film-coated Tablets,

i

ncluding colours and marking, please see section 6 of this leaflet.

Over time, your doctor may adjust your maintenance dose as needed.

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f, at any time, after taking the same dose for a long time, you experience side effects that you cannot tolerate or side effects that have an impact on your normal daily activities, contact your doctor as your dose may need to be reduced. The doctor may then prescribe you a lower single-tablet strength. Please remember to dispose of unused tablets (see

section 5).

Take Selexipag Film-coated Tablets once in the morning and once in the evening, about 12 hours apart.

Take the tablets with meals as you might tolerate your medicine better. The tablet coating provides protection. Swallow the tablets whole with a glass of water. Do not split

or crush the tablets.

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f you take more Selexipag Film-coated Tablets than you should

I

f you have taken more tablets than you have been told to take, ask your doctor for advice.

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f you forget to take Selexipag Film-coated Tablets

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f you forget to take Selexipag Film-coated Tablets, take a dose as soon as you remember, then continue to take your tablets at the usual times. If it is nearly time for your next dose (within 6 hours before you would normally take it), you should skip the missed dose and continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten tablet.

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f you stop taking Selexipag Film-coated Tablets

Suddenly stopping your treatment with Selexipag Film-coated Tablets might lead to your symptoms getting worse. Do not stop taking Selexipag Film-coated Tablets unless your

doctor tells you to. Your doctor may tell you to reduce the dose gradually before stopping completely.

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f, for any reason, you stop taking Selexipag Film-coated Tablets for more than 3 consecutive days (if you missed 3 morning and 3 evening doses, or 6 doses in a row or more),

contact your doctor immediately as your dose may need

to be adjusted to avoid side effects. Your doctor may decide to restart your treatment on a lower dose, gradually

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ncreasing to your previous maintenance dose.

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f you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You may experience side effects not only during the titration period when your dose

i

s being increased, but also later after taking the same dose for a long time.

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f you experience swollen face, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing (angioedema), you should contact your doctor immediately.

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f you experience any of these side effects: headache, diarrhoea, feeling sick (nausea), being sick (vomiting), j

aw pain, muscle pain, leg pain, joint pain, or reddening of the face, that you cannot tolerate or that cannot be treated, you should contact your doctor as the dose you

are taking may be too high for you and may need to be reduced.

Very common: may affect more than 1 in 10 people

• headache
• flushing (reddening of the face)
• nausea and vomiting (feeling sick and being sick)
• diarrhoea
• jaw pain, muscle pain, joint pain, leg pain
• nasopharyngitis (stuffy nose).

Common: may affect up to 1 in 10 people

• anaemia (low red blood cell levels)
• hyperthyroidism (overactive thyroid gland)
• reduced appetite
• weight loss
• hypotension (low blood pressure)
• stomach pain, including indigestion
• pain

• changes in some blood test results including those

  measuring blood cell counts or your thyroid function

• rashes, including hives, may cause a burning or stinging

  sensation and skin redness

• angioedema and its symptoms as described at the

  beginning of this section.

Uncommon: may affect up to 1 in 100 people

• increased heart rate.

Reporting of side effects

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f you get any side effects, talk to your doctor, or pharmacist.

This includes any possible side effects not listed in this

l

eaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more

i

nformation on the safety of this medicine.

5. How to store Selexipag Film-coated Tablets

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.” The expiry date refers to the last day of that month.

Selexipag 200, 600, 1000, 1200 microgram Film-coated Tablets

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

Selexipag 400, 800, 1400, 1600 microgram Film-coated Tablets

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 medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Selexipag Film-coated Tablets contain

The active substance is selexipag.

• Selexipag 200 microgram Film-coated Tablets: each film-coated tablet contains 200 micrograms of selexipag.
• Selexipag 400 microgram Film-coated Tablets: each film-coated tablet contains 400 micrograms of selexipag.
• Selexipag 600 microgram Film-coated Tablets: each film-coated tablet contains 600 micrograms of selexipag.
• Selexipag 800 microgram Film-coated Tablets: each film-coated tablet contains 800 micrograms of selexipag.
• Selexipag 1000 microgram Film-coated Tablets: each film-coated tablet contains 1000 micrograms of selexipag.
• Selexipag 1200 microgram Film-coated Tablets: each film-coated tablet contains 1200 micrograms of selexipag.
• Selexipag 1400 microgram Film-coated Tablets: each film-coated tablet contains 1400 micrograms of selexipag.
• Selexipag 1600 microgram Film-coated Tablets: each film-coated tablet contains 1600 micrograms of selexipag.

The other ingredients in the tablet core are mannitol, maize starch, hydroxypropylcellulose low-substituted, hydroxypropylcellulose and magnesium stearate. Selexipag 200 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, calcium carbonate and iron oxide yellow (E172).

Selexipag 400 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, calcium carbonate and iron oxide red (E172).

Selexipag 600 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, calcium

carbonate, iron oxide black (E172), allura red AC aluminum lake (E129) and indigo carmine aluminum lake (E132). Selexipag 800 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, iron oxide yellow (E172), iron oxide black (E172) and indigo carmine aluminum lake (E132). Selexipag 1000 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, calcium carbonate, iron oxide red (E172), iron oxide yellow (E172) and iron oxide black (E172).

Selexipag 1200 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, calcium carbonate, iron oxide black (E172), allura red AC aluminum lake (E129) and indigo carmine aluminum lake (E132).

Selexipag 1400 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, calcium carbonat and iron oxide yellow (E172).

Selexipag 1600 microgram Film-coated Tablets: The film-coating contains hypromellose 2910,

hydroxypropylcellulose, talc, iron oxide red (E172), iron oxide yellow (E172), calcium carbonate and iron oxide black (E172).

What Selexipag Film-coated Tablets look like and contents of the pack

Selexipag 200 microgram Film-coated Tablet is a round, 7 mm diameter, light yellow film-coated

tablet with “2” debossed on one side.

Selexipag 400 microgram Film-coated Tablet is a round, 7 mm diameter, red film-coated tablet

with “4” debossed on one side.

Selexipag 600 microgram Film-coated Tablet is a round, 7 mm diameter, light violet film-coated

tablet with “6” debossed on one side.

Selexipag 800 microgram Film-coated Tablet is a round, 7 mm diameter, green film-coated tablet

with “8” debossed on one side.

Selexipag 1000 microgram Film-coated Tablet is a round, 7 mm diameter, orange film-coated tablet

with “10” debossed on one side.

Selexipag 1200 microgram Film-coated Tablet is a round, 7 mm diameter, dark violet film-coated

tablet with “12” debossed on one side.

Selexipag 1400 microgram Film-coated Tablet is a round, 7 mm diameter, dark yellow film-coated

tablet with “14” debossed on one side.

Selexipag 1600 microgram Film-coated Tablet is a round, 7 mm diameter, brown film-coated tablet

with “16” debossed on one side.

Pack sizes

Selexipag 200 microgram Film-coated Tablets: Cartons of 60, 140 film-coated tablets blister. Cartons of 60, 140 film-coated tablets perforated unit dose blister. Cartons of 60 or 140 film-coated tablets (titration pack).

Selexipag 400 microgram, 600 microgram, 800 microgram, 1000 microgram, 1200 microgram,

1400 microgram, 1600 microgram Film-coated Tablets: Cartons of 60 film-coated tablets blister.

Cartons of 60 film-coated tablets perforated unit dose blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom

Manufacturer: Rontis Hellas Medical and Pharmaceutical Products S.A. Larissa Industrial Area, P.O. Box 3012, 41500 Larissa, Greece

This leaflet was last revised in May 2026.

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