Selexipag stada

Package leaflet: Information for the patient

Selexipag STADA, 200 micrograms, film-coated tablets
Selexipag STADA, 400 micrograms, film-coated tablets
Selexipag STADA, 600 micrograms, film-coated tablets
Selexipag STADA, 800 micrograms, film-coated tablets
Selexipag STADA, 1000 micrograms, film-coated tablets
Selexipag STADA, 1200 micrograms, film-coated tablets
Selexipag STADA, 1400 micrograms, film-coated tablets
Selexipag STADA, 1600 micrograms, film-coated tablets
selexipag
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet contents

1. What Selexipag is and what it is used for
2. Important information before taking Selexipag
3. How to take Selexipag
4. Possible side effects
5. How to store Selexipag
6. Contents of the pack and other information

1. What Selexipag is and what it is used for

Selexipag contains the active substance selexipag. Selexipag affects blood vessels in a similar way to prostacyclin – a substance naturally present in the human body – causing them to relax and dilate.
Selexipag is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients who are not adequately controlled with other PAH therapies known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors.
Selexipag may be used as monotherapy in patients who are not eligible for treatment with these therapies.
PAH means high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries). In people with PAH, these arteries are narrowed, so the heart must work harder to pump blood through them. This may lead to symptoms such as fatigue, dizziness, shortness of breath, or other symptoms.
By acting similarly to the natural substance prostacyclin, this medicine dilates the pulmonary arteries and reduces their stiffness. This makes it easier for the heart to pump blood through the pulmonary arteries. Selexipag reduces pressure in the pulmonary arteries, alleviates PAH symptoms, and slows disease progression.

2. Important information before taking Selexipag

When not to take Selexipag

• if the patient is allergic to selexipag or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart conditions such as:
• poor blood flow to the heart muscle (severe coronary artery disease or unstable angina); symptoms may include chest pain;
• myocardial infarction (heart attack) within the last six months;
• weakened heart (decompensated heart failure), if the patient is not under close medical supervision;
• severe cardiac arrhythmias;
• heart valve disease (congenital or acquired) causing abnormal heart function (unrelated to pulmonary hypertension);
• if the patient has had a stroke within the last 3 months or another event causing reduced blood flow to the brain (e.g. transient ischaemic attack);
• if the patient is taking gemfibrozil (a medicine used to lower blood fat [lipid] levels).

Warnings and precautions
Before starting treatment with Selexipag, discuss with the doctor managing the patient's
PAH treatment if the patient:

• is taking medicines that lower high blood pressure;
• has low blood pressure associated with symptoms such as dizziness;
• has recently lost a significant amount of blood or body fluids, for example due to severe diarrhoea or vomiting;
• has thyroid function disorders;
• has severe kidney function impairment or is undergoing dialysis;
• currently has or has previously had severe liver function impairment.

If the patient notices any of the above signs or experiences a change in their health status, they should
inform their doctor immediately.
Children and adolescents
Do not give this medicine to children under 18 years of age.
Elderly patients
Clinical experience with the use of Selexipag in patients over 75 years of age is limited.
Selexipag should be used with caution in this age group.
Selexipag and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Inform the doctor managing the patient's PAH treatment or the nurse if the patient
is taking any of the following medicines:

• gemfibrozil (a medicine used to lower blood fat [lipid] levels),
• clopidogrel (a medicine used to prevent blood clots in coronary artery disease),
• deferasirox (a medicine used to remove iron from the bloodstream),
• teriflunomide (a medicine used to treat relapsing-remitting multiple sclerosis),
• carbamazepine (a medicine used to treat certain types of epilepsy, neuralgia, or to manage severe affective disorders when other medicines are ineffective),
• phenytoin (a medicine used to treat epilepsy),
• valproic acid (a medicine used to treat epilepsy),
• probenecid (a medicine used to treat gout),
• fluconazole, rifampicin or rifapentine (antibiotics used to treat infections).

Pregnancy and breastfeeding
Selexipag is not recommended during pregnancy and breastfeeding. Women of childbearing age
should use an effective method of contraception during treatment with Selexipag. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
Selexipag may cause adverse effects such as headache and low blood pressure (see section 4), which may affect the ability to drive; the patient's underlying disease symptoms may also impair their ability to drive.

3. How to take Selexipag

Selexipag should only be prescribed by a physician experienced in the treatment of PAH. This medicine must always be taken exactly as directed by the physician. If in doubt or if you have any questions, consult your doctor.
Inform your doctor if you experience any adverse effects, as the doctor may recommend adjusting the dose of Selexipag.
Inform your doctor if you have impaired liver function or are taking other medications, as the doctor may recommend a lower dose of Selexipag taken twice daily or even once daily.
Patients with visual impairment or blindness should receive assistance from another person when taking Selexipag during the dose-titration period (the process of gradually increasing the dose).

Dose Titration
If your doctor prescribes 200 microgram tablets:
At the beginning of treatment, most patients will start with one 200 microgram tablet in the morning and another 200 microgram tablet in the evening, approximately 12 hours apart. It is recommended to start treatment in the evening. Your doctor will instruct you on how to gradually increase the dose. This period is called the dose-titration phase. It allows the body to adapt gradually to the new medicine. The goal of dose titration is to find the most appropriate dose for you—the highest dose that you can tolerate, up to a maximum of 1600 micrograms taken in the morning and 1600 micrograms in the evening.
The first pack of tablets you receive will contain light yellow tablets of 200 micrograms.

Your doctor will instruct you to gradually increase the dose, usually at weekly intervals, although the intervals between dose increases may be longer.
Each time the dose is increased, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose. The first increased dose should preferably be taken in the evening. The diagram below shows the number of tablets to take each morning and each evening during the first four stages of dose titration.

If your doctor instructs you to continue increasing the dose, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose at each subsequent stage. The first increased dose should preferably be taken in the evening.
If your doctor instructs you to further increase the dose and you proceed to stage 5, this may involve 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 is 1600 micrograms in the morning and 1600 micrograms in the evening. However, not all patients will receive this dose, as individual patients require different doses.
The diagram below shows the number of tablets to take each morning and each evening from stage 5 onwards.

If your doctor prescribes 100 microgram tablets:
This medicinal product is not available in 100 microgram tablets; therefore, if needed, other commercially available medicinal products containing selexipag should be used.

Using the Dose-Titration Guide
You will receive a dose-titration pack containing a dose-titration guide and a patient leaflet. The dose-titration guide provides information about the titration process and allows you to record the number of tablets taken daily.
Remember to record the number of tablets taken each day in the dose-titration diary. Each titration stage usually lasts 1 week. If your doctor instructs you to extend any titration stage beyond 1 week, additional pages in the dose-titration diary allow you to record this. Remember to maintain regular contact with your PAH specialist doctor or nurse during the dose-titration period.

Reducing the dose due to adverse effects
During dose titration, you may experience adverse effects such as headache, diarrhoea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, or facial flushing (see section 4). If these adverse effects are difficult to tolerate, discuss with your doctor possible ways to reduce or manage them.
Medicines are available to help relieve these adverse effects. For example, pain relievers such as paracetamol may help relieve pain and headache.
If adverse effects cannot be relieved or do not gradually improve at the current dose, your doctor may instruct you to reduce the dose by decreasing the number of light yellow tablets by one in the morning and one in the evening. The scheme below illustrates the stepwise dose reduction. This should only be done under the doctor’s instruction.

If the adverse effects experienced by the patient are tolerable after the dose reduction, your doctor may decide to continue treatment at this dose. Additional information is provided below under "Maintenance Dose".

Maintenance Dose
The highest dose tolerated during the titration phase becomes the maintenance dose. This is the dose the patient will take regularly.
Your doctor will prescribe the appropriate tablets corresponding to this dose. This may allow you to take one tablet in the morning and one tablet in the evening instead of multiple tablets each time.
A full description of Selexipag tablets, including their colours and markings, is provided in section 6 of this leaflet.
Over time, your doctor may adjust the maintenance dose as appropriate.
If, at any time during long-term treatment with the same dose, you experience adverse effects that you cannot tolerate or that interfere with your daily activities, contact your doctor, as your dose may need to be adjusted. Your doctor may prescribe a lower dose. Remember to dispose of any unused tablets (see section 5).

Selexipag should be taken in the morning and evening, approximately 12 hours apart.
Take the tablets with food, as this may improve tolerability. The tablet coating provides protection. Swallow the tablets whole with a glass of water.
Do not split or crush the tablets.

Taking more Selexipag than prescribed
If you take more tablets than your doctor has prescribed, contact your doctor immediately.

Missing a dose of Selexipag
If you forget to take your Selexipag dose, take it as soon as possible, then continue taking your tablets at the regular times. If it is almost time for your next dose (within 6 hours of the scheduled dose), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Selexipag
Stopping Selexipag suddenly may lead to worsening of symptoms. Do not stop taking Selexipag without your doctor’s instruction. Your doctor may instruct you to gradually reduce the dose before completely stopping treatment.
If, for any reason, you stop taking Selexipag for more than 3 consecutive days (you missed 3 morning and 3 evening doses, or 6 consecutive doses or more), you should contact your doctor immediately, as it may be necessary to reduce the dose to avoid adverse effects. Your doctor may decide to restart treatment at a lower dose and gradually increase it back to the previous maintenance dose.

If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions may occur in patients not only during the dose-titration period, when the dose of the medicine is being increased, but also later, while taking the same dose for a prolonged period.
If the patient develops swelling of the face, lips, tongue or throat, which may lead to
difficulty in swallowing or breathing (angioedema), contact a doctor immediately.
If the patient experiences any of the following adverse reactions: headache,
diarrhoea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain or
facial flushing, which the patient cannot tolerate or which cannot be relieved
with medication, the patient should consult a doctor, as the dose being taken
may be too high and may require dose reduction.
Very common adverse reactions (may affect more than 1 in 10 people)

• headache
• sudden facial flushing
• nausea and vomiting
• diarrhoea
• jaw pain, muscle pain, joint pain, leg pain
• nasopharyngitis (nasal congestion).

Common adverse reactions (may affect up to 1 in 10 people):

• anaemia (low number of red blood cells)
• hyperthyroidism
• decreased appetite
• weight loss
• hypotension (low blood pressure)
• abdominal pain, including dyspepsia
• pain
• changes in certain blood test results, including blood cell counts or thyroid function
• skin rashes, including urticaria, which may cause burning, stinging or skin redness
• angioedema and its symptoms described at the beginning of this section.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• increased heart rate.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your anaesthesiologist or another doctor. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Selexipag

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
Do not store the 200- and 400-microgram tablets at temperatures above 30°C.
The 600-, 800-, 1000-, 1200-, 1400-, and 1600-microgram tablets do not require any special
storage conditions.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures help protect
the environment.

6. Contents of the pack and other information

What Selexipag STADA contains
The active substance is selexipag.
Selexipag, 200 microgram tablets: film-coated tablets containing 200 micrograms of selexipag
Selexipag, 400 microgram tablets: film-coated tablets containing 400 micrograms of selexipag
Selexipag, 600 microgram tablets: film-coated tablets containing 600 micrograms of selexipag
Selexipag, 800 microgram tablets: film-coated tablets containing 800 micrograms of selexipag
Selexipag, 1000 microgram tablets: film-coated tablets containing 1000 micrograms of selexipag
Selexipag, 1200 microgram tablets: film-coated tablets containing 1200 micrograms of selexipag
Selexipag, 1400 microgram tablets: film-coated tablets containing 1400 micrograms of selexipag
Selexipag, 1600 microgram tablets: film-coated tablets containing 1600 micrograms of selexipag

The other ingredients are: mannitol, corn starch, hydroxypropyl cellulose, copolymer of methacrylic acid and methyl methacrylate (1:1), magnesium stearate (tablet core);
hypromellose type 2910, propylene glycol, titanium dioxide (E 171), iron oxides (E 172), carnauba wax (tablet coating).
Selexipag, 200 microgram tablets contain yellow iron oxide (E 172).
Selexipag, 400 microgram tablets contain black iron oxide (E 172) and red iron oxide (E 172).
Selexipag, 600 microgram tablets contain red iron oxide (E 172).
Selexipag, 800 microgram tablets contain black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).
Selexipag, 1000 microgram tablets contain red iron oxide (E 172).
Selexipag, 1200 microgram tablets contain black iron oxide (E 172) and red iron oxide (E 172).
Selexipag, 1400 microgram tablets contain yellow iron oxide (E 172).
Selexipag, 1600 microgram tablets contain black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).

What Selexipag looks like and contents of the pack
Selexipag, 200 microgram film-coated tablets: round, light yellow film-coated tablets (tablets) with the engraved mark "A2" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 400 microgram film-coated tablets: round, violet film-coated tablets (tablets) with the engraved mark "A4" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 600 microgram film-coated tablets: round, red film-coated tablets (tablets) with the engraved mark "A6" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 800 microgram film-coated tablets: round, brown film-coated tablets (tablets) with the engraved mark "A8" on one side and smooth on the other side. The tablets have a diameter of approximately 5.5 mm.
Selexipag, 1000 microgram film-coated tablets: round, red film-coated tablets (tablets) with the engraved mark "A10" on one side and smooth on the other side. The tablets have a diameter of approximately 5.6 mm.
Selexipag, 1200 microgram film-coated tablets: round, violet film-coated tablets (tablets) with the engraved mark "A12" on one side and smooth on the other side. The tablets have a diameter of approximately 6.5 mm.
Selexipag, 1400 microgram film-coated tablets: round, light yellow film-coated tablets (tablets) with the engraved mark "A14" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 1600 microgram film-coated tablets: round, brown film-coated tablets (tablets) with the engraved mark "A16" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.

Selexipag, 200 microgram film-coated tablets are available in blister packs containing 10 or 60 film-coated tablets and 60 or 140 film-coated tablets (dose titration packs), or in unit-dose blister packs containing 10x1 or 60x1 tablets and 60x1 or 140x1 tablets (dose titration packs).
Selexipag, 400 microgram, 600 microgram, 800 microgram, 1000 microgram, 1200 microgram, 1400 microgram and 1600 microgram film-coated tablets are available in blister packs containing 60 tablets, or in unit-dose blister packs containing 60x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
Synthon Hispania S.L.
Calle De Castello 1
08830 Sant Boi De Llobregat
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon s.r.o.
Brnenska 597/32
678 01 Blansko
Czech Republic

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicine is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

200 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 200 microgram film-coated tablets
Germany: Selexipag AL 200 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 200 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 200 microgram film-coated tablets
Iceland: Selexipag STADA 200 μg film-coated tablets
Lithuania: Selexipag STADA 200 microgram plėvele dengtos tabletės
Latvia: Selexipag STADA 200 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 200 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 200 mikrogram filmdragerade tabletter

400 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 400 microgram film-coated tablets
Germany: Selexipag AL 400 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 400 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 400 microgram film-coated tablets
Iceland: Selexipag STADA 400 μg film-coated tablets
Lithuania: Selexipag STADA 400 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 400 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 400 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 400 mikrogram filmdragerade tabletter

600 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 600 microgram film-coated tablets
Germany: Selexipag AL 600 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 600 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 600 microgram film-coated tablets
Iceland: Selexipag STADA 600 μg film-coated tablets
Lithuania: Selexipag STADA 600 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 600 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 600 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 600 mikrogram filmdragerade tabletter

800 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 800 microgram film-coated tablets
Germany: Selexipag AL 800 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 800 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 800 microgram film-coated tablets
Iceland: Selexipag STADA 800 μg film-coated tablets
Lithuania: Selexipag STADA 800 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 800 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 800 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 800 mikrogram filmdragerade tabletter

1000 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 1000 microgram film-coated tablets
Germany: Selexipag AL 1000 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 1000 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 1000 microgram film-coated tablets
Iceland: Selexipag STADA 10 μg film-coated tablets
Lithuania: Selexipag STADA 1000 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 1000 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 1000 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 1000 mikrogram filmdragerade tabletter

1200 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 1200 microgram film-coated tablets
Germany: Selexipag AL 1200 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 1200 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 1200 microgram film-coated tablets
Iceland: Selexipag STADA 1200 μg film-coated tablets
Lithuania: Selexipag STADA 1200 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 1200 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 1200 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 1200 mikrogram filmdragerade tabletter

1400 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 1400 microgram film-coated tablets
Germany: Selexipag AL 1400 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 1400 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 1400 microgram film-coated tablets
Iceland: Selexipag STADA 1400 μg film-coated tablets
Lithuania: Selexipag STADA 1400 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 1400 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 1400 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 1400 mikrogram filmdragerade tabletter

1600 micrograms
Netherlands: Selexipag STADA Arzneimittel AG 1600 microgram film-coated tablets
Germany: Selexipag AL 1600 microgram film-coated tablets
Denmark: Selexipag STADA
Estonia: Selexipag STADA
Spain: Selexipag STADA 1600 mcg film-coated tablets EFG
Ireland: Selexipag Clonmel 1600 microgram film-coated tablets
Iceland: Selexipag STADA 1600 μg film-coated tablets
Lithuania: Selexipag STADA 1600 mikrogramų plėvele dengtos tabletės
Latvia: Selexipag STADA 1600 mikrogrami apvalkotās tabletes
Malta: Selexipag Clonmel 1600 microgram film-coated tablets
Norway: Selexipag STADA
Poland: Selexipag STADA
Sweden: Selexipag STADA 1600 mikrogram filmdragerade tabletter