Patient leaflet - Selexipag 200 microgram film-coated tablets
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 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.
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 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 Film-coated 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.
If 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 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 micrograms 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.
Morning Dose
Evening Dose
STEP 4 STEP 1 STEP 2 STEP 3
STARTING DOSE
Each dosing step lasts about 1 week.
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
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 green 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 Film-coated 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.
One
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 μg
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 information on the titration process and allows 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.
If 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 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 200 microgram 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
Morning Dose
Evening Dose
Back to STEP 5
STEP 1 STEP 2-5 STEP 6
total daily dose 400 μg
One
200 μg
tablet
One
200 μg
tablet
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
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
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 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,
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 single-tablet
strength. Please remember to dispose of unused tablets (see
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.
If you take more Selexipag Film-coated 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 Film-coated Tablets
If 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.
If 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.
If, 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
increasing to your previous maintenance dose.
If 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
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: 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
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
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
information 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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Selexipag
200 microgram Film-coated Tablets
Titration Guide
Starting Treatment with Selexipag 200 microgram Film-coated Tablets
Please read the accompanying patient information leaflet before starting treatment. Tell your doctor if you experience side effects, as your doctor may recommend that you change your Selexipag 200 microgram Film-coated Tablets dose. Tell your doctor if you are taking other medications as your doctor may recommend that you take Selexipag 200 microgram Film-coated Tablets only once daily.
Contents
How should you take Selexipag 200 microgram Film-coated Tablets?..4
How should you step up your dose?.....................................................................6
What are the steps?.....................................................................................................8
When should you step down?...............................................................................10
Stepping down............................................................................................................12
2
When you move to your maintenance dose....................................................14
If you forget to take Selexipag 200 microgram Film-coated Tablets...16
If you stop taking Selexipag 200 microgram Film-coated Tablets ........17
Titration diary..............................................................................................................18
3 How should you take Selexipag 200 microgram Film-coated Tablets?
Selexipag 200 microgram Film-coated Tablets is a medicine taken every morning and evening for the treatment of pulmonary arterial hypertension, also called PAH.
The starting dose for Selexipag 200 microgram Film-coated Tablets is 200 micrograms once in the morning and once in the evening. The first intake of Selexipag 200 microgram Film-coated Tablets should be in the evening. You should take each dose with a glass of water, preferably during a meal.
4 There are 2 phases of treatment with Selexipag 200 microgram Film-coated Tablets:
Titration
In the first several weeks, you will work with your doctor to find the dose of Selexipag 200 microgram Film-coated Tablets that is right for you. Your doctor may have you step up from the starting dose to higher doses of Selexipag 200 microgram Film-coated Tablets. Your doctor may step you down to a lower dose. This process is called titration. It lets your body gradually adjust to the medicine.
Maintenance
Once your doctor has found the dose that is right for you, this will be the dose you take on a regular basis. This is called the maintenance dose.
5 How should you step up your dose?
You will start at the 200 microgram dose in the morning and in the evening and after discussing with your doctor or nurse step up to the next dose. The first intake of the increased dose should be in the evening. Each step usually lasts about 1 week. It could take several weeks to find the dose that is right for you.
The goal is to reach the dose that is most appropriate to treat you.
This dose will be your maintenance dose.
6
Every patient with PAH is different. Not everyone will end up on the same maintenance dose.
Some patients may have 200 micrograms in the morning and in the evening as their maintenance dose, while some will reach the highest dose of 1600 micrograms in the morning and in the evening. Others may reach a maintenance dose somewhere in between. What is important is that you reach the dose that is most appropriate to treat you.
7
Morning Dose (Tablets are not actual size.)
Evening Dose
STEP 4
STEP 1 STEP 2 STEP 3 STARTING DOSE
What are the next steps?
Each dosing step lasts about 1 week.
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 μg
tablet
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
8
One
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 μg
One
200 μg
tablet
One
800 μg
tablet
One
800 μg
tablet
One
800 μg
tablet
One 800 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
Three
200 μg
tablet
Three 200 μg tablet
Four
200 μg tablet
Four 200 μg tablet 200 microgram tablet
800 microgram tablet (use with steps 5 through 8 to reduce the number of tablets needed per dose.)
9 When should you step down?
As with all medicines, you may experience side effects with Selexipag 200 microgram Film-coated Tablets as you step up to higher doses. Talk to your doctor or nurse if you have side effects. There are treatments available that can help relieve them.
The most common side effects (may affect more than 1 in 10 people) you may experience while taking Selexipag 200 microgram Film-coated Tablets are:
- Headache • Diarrhoea • Nausea • Vomiting • Jaw pain • Muscle pain • Leg pain • Joint pain • Facial redness
For a full list of side effects see package leaflet for further information.
10
If you cannot tolerate the side effects even after your doctor or nurse has tried to treat them, he or she may recommend you step down to a lower dose.
If your doctor or nurse tells you to step down to a lower dose, you should take one less 200 microgram tablet in the morning and one less in the evening.
You should only step down after speaking with your PAH doctor or nurse. This stepping-down process will help you find the dose that is right for you, also called your maintenance dose.
11
Morning Dose
Evening Dose
STEP 4 STEP 1 STEP 2 STEP 3 Stepping down
Each dosing step lasts about 1 week
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 μg
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
12
The goal is to reach the highest dose with side effect you can tolerate Increase your dose about every week by adding a 200 microgram tablet to your morning and evening
800 microgram tablet
(use with steps 5 through 8 to reduce the number of tablets needed per dose.) Start STEP UP
200 microgram tablet
SINGLE TABLET, SAME DOSE Begin taking the single-tablet version of your highest tolerated dose STEP 5 STEP 6 Back to STEP 5
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
total daily dose 2000 μg
One
1000 μg
tablet
One 1000 μg tablet STEP DOWN MAINTENANCE
DOSE STEP UP
13 When you move to your 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 or nurse can prescribe an equivalent single-tablet strength for your maintenance dose. This lets you take just one tablet in the morning and one in the evening, instead of multiple tablets for each dose.
14
For example, if your highest tolerated dose during titration was 1200 micrograms once in the morning and once in the evening:
Over time, your doctor or nurse may adjust your maintenance dose as needed.
15
Morning
Evening Maintenance dose
Highest tolerated dose
Maintenance dose
Highest tolerated dose If you forget to take Selexipag 200 microgram Film-coated Tablets
If you miss a dose, take the dose as soon as you remember, then continue to take your tablets at the usual times. If it is within 6 hours of when you would normally take your next dose, 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.
16 If you stop taking Selexipag 200 microgram Film-coated Tablets
Do not stop taking Selexipag 200 microgram Film-coated Tablets unless your doctor or nurse tells you to. If, for any reason, you stop taking Selexipag 200 microgram Film-coated Tablets for more than 3 consecutive days (if you missed 6 doses in a row), contact your PAH doctor or nurse immediately as your dose may need to be adjusted to avoid side effects.
Your doctor or nurse may have you resume treatment at a lower dose, gradually increasing to your previous maintenance dose.
17 Titration diary
Please read the instructions in the package leaflet carefully.
The following diary pages help you keep track of the number of tablets you need to take in the morning and evening during titration.
Use them to write down the number of tablets you take in the morning and the evening.
Each step usually lasts about 1 week, unless your doctor or nurse instructs you otherwise. If your titration steps last longer than 1 week there are additional diary pages to track this.
Use pages 20 to 27 to track the first weeks of treatment, when you are using 200 microgram tablets only (steps 1–4).
If you have been prescribed both 200 and 800 microgram tablets, use pages 30 to 37 (steps 5–8).
18 Remember to talk to your PAH doctor or nurse regularly.
Write down your doctor or nurse’s instructions:
Doctor’s office telephone and e-mail:
Pharmacist’s telephone:
Notes:
19
200
micrograms
200
micrograms
The first intake of Selexipag should be in the evening
0 # # # # # #
# # # # # # # WEEK
1
Every day write down in the boxes below how many tablets you take in the morning and evening. I spoke with my doctor or nurse on
DD/MM/YY 20 200
micrograms
200
micrograms
The first intake of increased dose of Selexipag should be in the evening
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
21
200
micrograms
200
micrograms
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
22
200
micrograms
200
micrograms
Skip to page 28 if your doctor prescribes 800 microgram tablets
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
23
200
micrograms
200
micrograms
Skip to page 28 if your doctor prescribes 800 microgram tablets
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
24
200
micrograms
200
micrograms
Skip to page 28 if your doctor prescribes 800 microgram tablets
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
25
200
micrograms
200
micrograms
Skip to page 28 if your doctor prescribes 800 microgram tablets
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
26
200
micrograms
200
micrograms
Skip to page 28 if your doctor prescribes 800 microgram tablets
# # # # # # #
# # # # # # # WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
27
Use the following diary pages if your doctor or nurse prescribes 800 microgram tablets in addition to your 200 microgram tablets.
On the diary pages, check off that you have taken one 800 microgram tablet every day in the morning and in the evening with your prescribed number of 200 microgram tablets.
200 microgram tablet
800 microgram tablet (use with steps
5 through 8 to reduce the number
of tablets needed per dose.)
28 Remember to talk to your PAH doctor or nurse regularly.
Write down your doctor or nurse’s instructions:
Doctor’s office telephone and e-mail:
Pharmacist’s telephone:
Notes:
29
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
30
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
31
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
32
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
33
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
34
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
35
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
36
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1
200micrograms
800micrograms
#
1
#
1
#
1
#
1
#
1
#
1
#
1 WEEK
#
Write down the number of the week of the treatment in the upper left corner.
Every day write down in the boxes below how many tablets you take in the morning and evening.
I spoke with my doctor or nurse on
DD/MM/YY
37
Notes 38
39 40
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