Patient leaflet - Selexipag 400 microgram film-coated tablets
1. What Selexipag tablets are and what they are used for
Selexipag tablets are medicines that 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 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 tablets can be used on its 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 tablets lowers the pressure in the pulmonary arteries, it relieves the symptoms of PAH and slows down progression of PAH disease.
2. What you need to know before you take Selexipag tablets
Do not take Selexipag tablets if you:
are allergic to selexipag or any of the other ingredients of this medicine (listed in section
6).
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)
•
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)
- 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 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 tablets in patients older than 75 years. Selexipag tablets should be used with caution in this age group.
Other medicines and Selexipag tablets
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Taking other medicines may affect how Selexipag tablets works.
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 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 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 tablets can cause side effects such as 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.
3. How to take Selexipag tablets
Selexipag tablets should only be prescribed by a doctor experienced in the treatment of PAH. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are in doubt or have any questions.
Tell your doctor if you experience side effects, as your doctor may recommend that you change your Selexipag 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 tablets twice daily or take it only once daily.
If you have poor vision or experience any type of blindness, get help from another person when taking Selexipag tablets during the titration period (process of gradually increasing your dose).
Finding the right dose for you
If 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 the new medicine. The goal of titration is to reach the most appropriate dose. This will be the highest dose you can tolerate, 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 light
-yellow 200 microgram tablets.
Your doctor will tell you to increase your dose in steps, usually every week but the interval between increases could be longer.
With each step, you will add one 200 microgram tablet to your morning dose and another 200 microgram tablet to your evening dose. The first intake of the increased 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.
STARTING DOSE
A
2
A
2 A
A
2 A
2 A
A
2 A
2 A
2 A Each dosing step lasts about 1 week.
A
2 200 microgram tablet STEP 1
Morning: One
200 microgram
tablet
Evening: One
200 microgram
tablet
(total daily dose:
400 microgram)
STEP 2
Morning: Two 200 microgram
tablets
Evening: Two 200 microgram
tablets
(total daily dose: 800 microgram)
STEP 3
Morning: Three 200 microgram
tablets
Evening: Three 200 microgram
tablets
(total daily dose: 1200 microgram)
STEP 4
Morning: Four 200 microgram tablets
Evening: Four 200 microgram tablets
(total daily dose: 1600 microgram)
If your doctor tells you to increase your dose further, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose with each new step. The first intake of the increased dose is recommended to be in the evening.
If your doctor instructs you to further increase your dose and move to step 5, this may be done by taking one brown 800 microgram tablet and one light
-yellow 200 microgram tablet in the morning and one 800 microgram tablet and one 200 microgram tablet in the evening.
The maximum dose of Selexipag tablets is 1600 micrograms in the morning and 1600 micrograms in the 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.
STEP 5
Morning: One
800 and one
200 microgram
tablet
Evening: One
800 and one
200 microgram
tablet
(total daily dose:
2000 microgram)
STEP 6
Morning: One 800 and two 200 microgram
tablets
Evening: One 800 and two 200 microgram
tablets
(total daily dose: 2400 microgram)
STEP 7 Morning: One 800 and three 200 microgram tablets
Evening: One 800 and three 200 microgram tablets
(total daily dose: 2800 microgram)
STEP 8
Morning: One 800 and four 200 microgram tablets
Evening: One 800 and four 200 microgram tablets
(total daily dose: 3200 microgram) A
2
A
8
200 microgram tablet
800 microgram tablet (Use with steps 5 through 8 to reduce the number of tablets needed per dose.)
HIGHEST
DOSE
A
8A
8 A
2
A
8A
8 A
2 A
2
A
8A
8 A
2 A
2 A
2
A
8A
8 A
2 A
2 A
2 A
2
If your doctor prescribes 100 microgram tablets
This medicinal product is not available in 100 micrograms, therefore in case this strength is required, other medicinal products available on the market should be used.
Using the titration guide during titration
You will receive the titration pack which contains a titration guide and patient leaflet. The titration guide is providing information on the titration process and is allowing you to record the 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 titration step longer than 1
week, there are additional diary pages to allow you to track this. Remember to talk to your PAH doctor or nurse regularly during titration.
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 reddening of the face (see section
4).
If these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them. There are treatments available that can help relieve the side effects. For example, painkillers such as paracetamol may help treat pain and headache.
If 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 light
-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
START SET UP STEP DOWN
A
2
A
2
A
8
A
2 A
2 A
8
A
2
A
8
STEP 1
Morning: One 200 microgram
tablet
Evening: One 200 microgram
tablet
(total daily dose: 400 microgram)
STEP 2-5
Increase your dose about every week
by adding a 200 microgram tablet to your morning and evening dose
STEP 6
The goal is to reach the highest dose with side effects that you can tolerate
Step down if side effects cannot be tolerated
BACK TO STEP 5
If 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 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 tablets, including colours and marking, please see section 6 of this leaflet.
Over time, your doctor may adjust your maintenance dose as needed.
If, 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 dose.
Please remember to dispose of unused tablets (see section 5).
Take Selexipag 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.
If you take more Selexipag tablets than you should
If you have taken more tablets than you have been told to take, ask your doctor for advice.
If you forget to take Selexipag tablets
If you forget to take Selexipag 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.
If you stop taking Selexipag tablets
Suddenly stopping your treatment with Selexipag tablets might lead to your symptoms getting worse. Do not stop taking Selexipag tablets unless your doctor tells you to. Your doctor may tell you to reduce the dose gradually before stopping completely.
If, for any reason, you stop taking Selexipag 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 increasing to your previous maintenance dose. If you have any further questions on the use of this medicine, ask your doctor or nurse.
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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 is being increased, but also later after taking the same dose for a long time.
If you experience swollen face, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing (angioedema), you should contact your doctor immediately.
If you experience any of these side effects: headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw 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 side effects (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 side effects (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 side effects (may affect up to 1 in 100 people):
- Increased heart rate.
Reporting of side effects
If you have any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 information on the safety of this medicine.
5. How to store Selexipag 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 blister after ‘EXP’. The expiry date refers to the last day of that month.
Do not store 200 and 400 microgram tablets above 30°C. The 600, 800, 1000, 1200, 1400 and 1600 microgram tablets do 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 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 are mannitol, maize starch, hydroxypropylcellulose, methacrylic acid-methyl methacrylate copolymer (1:1), magnesium stearate (tablet core); hypromellose, propylene glycol (E1520), titanium dioxide (E171), iron oxides (E172), carnauba wax (tablet coating).
Selexipag 200 microgram film-coated tablets contain iron oxide yellow (E172).
Selexipag 400 microgram film-coated tablets contain iron oxide black and iron oxide red (E172).
Selexipag 600 microgram film-coated tablets contain iron oxide red (E172).
Selexipag 800 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172).
Selexipag 1000 microgram film-coated tablets contain iron oxide red (E172).
Selexipag 1200 microgram film-coated tablets contain iron oxide black and iron oxide red (E172).
Selexipag 1400 microgram film-coated tablets contain iron oxide yellow (E172).
Selexipag 1600 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172).
What Selexipag tablets look like and contents of the pack
Selexipag 200 microgram film-coated tablets: Round, light yellow, film-coated tablets debossed with “A2” on one side. The tablets are approximately 7 mm in diameter.
Selexipag 400 microgram film-coated tablets: Round, purple, film-coated tablets debossed with “A4” on one side. The tablets are approximately 7 mm in diameter.
Selexipag 600 microgram film-coated tablets: Round, red, film-coated tablets debossed with “A6” on one side. The tablets are approximately 7 mm in diameter.
Selexipag 800 microgram film-coated tablets: Round, brown, film-coated tablets debossed with “A8” on one side. The tablets are approximately 5.5 mm in diameter.
Selexipag 1000 microgram film-coated tablets: Round, red, film-coated tablets debossed with “A10” on one side. The tablets are approximately 5.6 mm in diameter.
Selexipag 1200 microgram film-coated tablets: Round, purple, film-coated tablets debossed with “A12” on one side. The tablets are approximately 6.5 mm in diameter.
Selexipag 1400 microgram film-coated tablets: Round, light yellow, film-coated tablets debossed with “A14” on one side. The tablets are approximately 6.6 mm in diameter.
Selexipag 1600 microgram film-coated tablets: Round, brown, film-coated tablets debossed with “A16” on one side. The tablets are approximately 7 mm in diameter.
Selexipag 200 microgram film-coated tablets are available in oPA/Al/PE-Al blisters containing 60 or 140 (titration pack) tablets and oPA/Al/PE-Al unit-dose blisters containing 60 x 1 or 140 x 1 (titration pack) tablets.
Selexipag 400, 600, 800, 1000, 1200, 1400 and 1600 microgram film-coated tablets are available in oPA/Al/PE-Al blisters containing 60 tablets and oPA/Al/PE-Al unit-dose blisters containing 60 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF, United Kingdom
Manufacturers
Synthon Hispania S.L.
Calle De Castello 1,
Sant Boi De Llobregat,
Barcelona, 08830,
Spain
Synthon B.V.
Microweg 22
Nijmegen
Gelderland, 6545 CM
Netherlands
Synthon s.r.o.
Brnenska 597/32, Blansko,
Jihomoravsky, 678 01,
Czechia
This leaflet was last revised in August 2026
If you would like a
leaflet with larger text,
please contact
01271 385257
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