Selexipag polpharma
PolandTable of Contents
- Package leaflet: Information for the patient
- 1. What Selexipag Polpharma is and what it is used for
- 2. Important information before taking Selexipag Polpharma
- 3. How to take Selexipag Polpharma
- 4. Possible adverse reactions
- 5. How to store Selexipag Polpharma
- 6. Contents of the package and other information
Package leaflet: Information for the patient
Selexipag Polpharma, 200 micrograms, film-coated tablets
Selexipag Polpharma, 400 micrograms, film-coated tablets
Selexipag Polpharma, 600 micrograms, film-coated tablets
Selexipag Polpharma, 800 micrograms, film-coated tablets
Selexipag Polpharma, 1000 micrograms, film-coated tablets
Selexipag Polpharma, 1200 micrograms, film-coated tablets
Selexipag Polpharma, 1400 micrograms, film-coated tablets
Selexipag Polpharma, 1600 micrograms, film-coated tablets
Selexipagum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.
Leaflet contents
- What Selexipag Polpharma is and what it is used for
- What you need to know before taking Selexipag Polpharma
- How to take Selexipag Polpharma
- Possible side effects
- How to store Selexipag Polpharma
- Contents of the pack and other information
1. What Selexipag Polpharma is and what it is used for
Selexipag Polpharma 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 Polpharma is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients who are not adequately controlled with other PAH treatments known as endothelin receptor antagonists (ERAs) and phosphodiesterase type 5 (PDE-5) inhibitors. Selexipag Polpharma may be used as monotherapy in patients who are not eligible for treatment with these drugs.
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 in a similar way to a naturally occurring substance called 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 Polpharma lowers blood pressure in the pulmonary arteries, alleviates PAH symptoms, and slows the progression of the disease.
2. Important information before taking Selexipag Polpharma
When not to take Selexipag Polpharma
- 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 within the last 6 months;
- weakened heart (decompensated heart failure), if the patient is not under close medical supervision;
- severe cardiac arrhythmias;
- valvular heart disease (congenital or acquired) with impaired heart function (unrelated to pulmonary hypertension);
- stroke within the last 3 months or other event causing reduced cerebral perfusion (e.g. transient ischaemic attack);
- if the patient is taking gemfibrozil (a medicine used to lower blood lipid levels).
Warnings and precautions
Before starting Selexipag Polpharma, discuss with the doctor or
nurse if the patient:
- is taking medicines to lower high blood pressure;
- has hypotension associated with symptoms such as dizziness;
- has recently lost a significant amount of blood or bodily fluids, e.g. due to severe diarrhoea or vomiting;
- has thyroid dysfunction;
- has severe renal impairment or is undergoing dialysis;
- currently or previously had severe hepatic impairment.
If the patient experiences any of the above signs or a change in health status,
the doctor should be informed immediately.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Elderly patients
Clinical experience with Selexipag Polpharma in patients over 75 years of age is limited. Selexipag Polpharma should be used with caution in this age group.
Selexipag Polpharma and other medicines
Inform 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 PAH treatment or the nurse if the patient is taking any of the following medicines:
- gemfibrozil (a medicine used to lower blood 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 Polpharma is not recommended during pregnancy and breastfeeding. Women of childbearing potential should use an effective method of contraception while taking Selexipag Polpharma. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Driving and operating machinery
Selexipag Polpharma 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 driving ability.
3. How to take Selexipag Polpharma
Selexipag Polpharma should only be prescribed by a physician experienced in the treatment of PAH. This medicine must always be taken as directed by the physician.
If in doubt, consult the physician.
Inform the physician if the patient experiences any adverse reactions, as the physician may decide to adjust the dose of Selexipag Polpharma.
Inform the physician if the patient has problems with impaired liver function or is taking other medications, as the physician may recommend a lower dose of Selexipag Polpharma administered twice daily or once daily.
Patients with visual impairments or blindness should receive assistance from another person when taking Selexipag Polpharma during the dose-titration period (the process of gradually increasing the dose).
Dose Titration
If the physician prescribes 200 microgram tablets
At the beginning of treatment, most patients will receive one 200 microgram tablet taken in the morning and another 200 microgram tablet taken in the evening, approximately 12 hours apart.
It is recommended to start therapy in the evening. The physician will instruct the patient on how to gradually increase the dose of the medicine. This period is called the dose-titration period. It allows the body to gradually adapt to the new medicine. The goal of dose titration is to find the most appropriate dose. This will be the highest dose tolerated by the patient, which may be up to 1600 micrograms taken in the morning and 1600 micrograms in the evening.
The first pack of tablets the patient receives will contain light yellow 200 microgram tablets.
The physician will instruct the patient to gradually increase the dose, usually at weekly intervals, although the intervals between dose increases may be longer.
Each time the dose is increased, the patient will add one 200 microgram tablet to the morning dose and another 200 microgram tablet to the evening dose. The first intake of the increased dose is recommended in the evening. The diagram below shows the number of tablets to be taken each morning and each evening during the first four stages of dose titration.
If the physician instructs the patient to further increase the dose, the patient will add one 200 microgram tablet to the morning dose and one 200 microgram tablet to the evening dose at each subsequent stage. The first intake of the increased dose is recommended in the evening.
If the physician instructs the patient to further increase the dose and the patient progresses 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 Polpharma is 1600 micrograms in the morning and 1600 micrograms in the evening. However, not every patient will receive this dose, as individual patients require different doses.
The diagram below shows the number of tablets to be taken each morning and each evening at each stage, starting from stage 5.
If the physician prescribes 100 microgram tablets
This medicine is not available in a 100 microgram strength; therefore, if such a dose is required, other medicines available on the market in the appropriate strength should be used.
Using the Dose-Titration Guide
The patient will receive a dose-titration pack containing a dose-titration guide and a patient leaflet. The dose-titration guide contains information about the dose-titration process and allows the patient 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 the physician instructs the patient to extend each titration stage beyond 1 week, additional pages in the dose-titration diary allow for this recording. Remember to maintain regular contact with the physician managing PAH treatment or with a nurse during the dose-titration period.
Dose Reduction Due to Adverse Reactions
During dose titration, the patient may experience adverse reactions such as headache, diarrhoea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, or facial flushing (see section 4). If these adverse reactions are difficult for the patient to tolerate, discuss with the physician possible ways to reduce or manage them.
Medicines are available to help alleviate adverse reactions. For example, analgesics such as paracetamol may help relieve pain and headache.
If adverse reactions cannot be alleviated or do not gradually improve while taking the current dose, the physician may instruct the patient to adjust the dose by reducing 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 physician's instruction.
If the adverse reactions experienced by the patient are tolerable after dose reduction, the physician may decide to continue treatment at this dose. Additional information is provided below under "Maintenance Dose".
Maintenance Dose
The highest dose tolerated by the patient during dose titration becomes the maintenance dose. This is the dose the patient will take regularly.
The physician will prescribe the appropriate tablets corresponding to this dose for the patient to take. This may allow the patient to take one tablet in the morning and one tablet in the evening instead of several tablets each time.
A full description of Selexipag Polpharma tablets, including colors and tablet markings, is provided in section 6 of this leaflet.
Over time, the physician may adjust the maintenance dose as appropriate.
If, at any time during prolonged use of the same dose, the patient experiences adverse reactions that are not tolerated or that interfere with daily activities, contact the physician, as the dose being taken may need to be changed. The physician may prescribe a lower dose. Remember to remove any unused tablets (see section 5).
Selexipag Polpharma should be taken in the morning and evening, approximately 12 hours apart.
The tablets should be taken 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 Polpharma than prescribed
If more tablets are taken than prescribed by the physician, contact the physician immediately.
Missing a dose of Selexipag Polpharma
If the patient forgets to take a dose of Selexipag Polpharma, take the missed dose as soon as possible, then continue taking the tablets at the regular times. If the next scheduled dose is due within 6 hours, skip the missed dose and continue taking the medicine at the regular times. Do not take a double dose to make up for a missed dose.
Stopping treatment with Selexipag Polpharma
Suddenly stopping treatment with Selexipag Polpharma may lead to worsening of symptoms in the patient. Do not discontinue Selexipag Polpharma without the physician's instruction.
The physician may instruct the patient to gradually reduce the dose before completely stopping treatment.
If, for any reason, the patient stops taking Selexipag Polpharma for more than 3 consecutive days (the patient missed 3 morning and 3 evening doses, or 6 consecutive doses or more), the patient should contact the physician immediately, as it may be necessary to reduce the dose to avoid adverse reactions. The physician may decide to restart treatment with a lower dose and gradually increase it back to the previous maintenance dose.
If there are any further questions about the use of this medicine, consult the physician or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions may occur 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), seek immediate medical attention.
If the patient experiences any of the following adverse reactions: headache,
diarrhoea, nausea (feeling sick), vomiting, jaw pain, muscle pain, leg pain, joint pain or
facial flushing, which the patient cannot tolerate, or which cannot be relieved with medicines,
the patient should consult a doctor, as the dose being taken may be too high and may require reduction.
Very common (occur in more than 1 in 10 patients):
- headache
- sudden facial flushing
- nausea and vomiting
- diarrhoea
- jaw pain, muscle pain, joint pain, leg pain
- nasopharyngitis (nasal and throat congestion).
Common (occur in less than 1 in 10 patients):
- anaemia (low number of red blood cells)
- hyperthyroidism
- decreased appetite
- weight loss
- hypotension (low blood pressure)
- abdominal pain, including indigestion
- 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 (occur in less than 1 in 100 patients):
- increased heart rate.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Selexipag Polpharma
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.
Selexipag Polpharma 200 microgram tablets and 400 microgram tablets – do not store above 30°C.
Selexipag Polpharma 600, 800, 1000, 1200, 1400, 1600 microgram tablets – no special storage
instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the package and other information
What Selexipag Polpharma contains
- The active substance is selexipag. Each film-coated tablet contains 200 micrograms, 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1400 micrograms or 1600 micrograms of selexipag.
- The other ingredients are:
Tablet core: mannitol, corn starch, hydroxypropylcellulose, methacrylic acid and methyl methacrylate copolymer (1:1), magnesium stearate.
Tablet coating: hypromellose type 2910, propylene glycol (E1520), titanium dioxide (E171), yellow iron oxide (E172) (only for 200 micrograms, 800 micrograms, 1400 micrograms, 1600 micrograms), red iron oxide (E172) (only for 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1600 micrograms), black iron oxide (E172) (only for 400 micrograms, 800 micrograms, 1200 micrograms, 1600 micrograms), carnauba wax.
What Selexipag Polpharma looks like and contents of the pack
Selexipag Polpharma, 200 micrograms: round, light yellow film-coated tablets (tablets) with the imprint “A2” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 400 micrograms: round, violet film-coated tablets (tablets) with the imprint “A4” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 600 micrograms: round, red film-coated tablets (tablets) with the imprint “A6” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 800 micrograms: round, brown film-coated tablets (tablets) with the imprint “A8” on one side and smooth on the other, approximately 5.5 mm in diameter.
Selexipag Polpharma, 1000 micrograms: round, red film-coated tablets (tablets) with the imprint “A10” on one side and smooth on the other, approximately 5.6 mm in diameter.
Selexipag Polpharma, 1200 micrograms: round, violet film-coated tablets (tablets) with the imprint “A12” on one side and smooth on the other, approximately 6.5 mm in diameter.
Selexipag Polpharma, 1400 micrograms: round, light yellow film-coated tablets (tablets) with the imprint “A14” on one side and smooth on the other, approximately 6.6 mm in diameter.
Selexipag Polpharma, 1600 micrograms: round, brown film-coated tablets (tablets) with the imprint “A16” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 200 micrograms, film-coated tablets, are packed in blisters containing 10 or 60 tablets, or 60 or 140 tablets (dose titration packs), or in unit dose blisters containing 10x1 or 60x1 tablets, or 60x1 or 140x1 tablets (dose titration packs).
Selexipag Polpharma, 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1400 micrograms and 1600 micrograms, film-coated tablets are packed in blisters containing 60 tablets or in unit dose blisters containing 60x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer/Importer
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
Calle De Castelló 1
08830 Sant Boi De Llobregat
Spain
Synthon s.r.o.
Brnenska 597/32
678 01 Blansko
Czech Republic
This medicinal product is authorised in the European Economic Area under the following names:
Netherlands: Selexipag Synthon 200-, 400-, 600-, 800-, 1,000-, 1,200-, 1,400-, 1,600 microgram, filmomhulde tabletten
DOSING HANDBOOK – DOSE TITRATION PACK
Page 1
Selexipag Polpharma, 200 micrograms, film-coated tablets
Selexipagum
Dosing handbook
Starting treatment with Selexipag Polpharma
Before starting treatment, read the patient information provided in the leaflet included in the package. Inform the doctor if the patient experiences any adverse reactions, as the doctor may recommend adjusting the dose of Selexipag Polpharma. Inform the doctor about any other medications the patient is taking, as the doctor may recommend taking the dose of Selexipag Polpharma only once daily.
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| Table of contents How to take Selexipag Polpharma?...........4 How to increase the dose?...........................6 What are the steps for dose escalation?........8 When to start reducing the dose?..............12 Dose reduction..........................................14 | When to start maintenance dosing?...........16 Missed dose of Selexipag Polpharma...........18 Discontinuation of Selexipag Polpharma......19 Dose titration diary.....................................20 |
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| How to take Selexipag Polpharma? Selexipag Polpharma is a medicine taken twice daily, in the morning and in the evening, for the treatment of pulmonary arterial hypertension (PAH). The initial dose of Selexipag Polpharma is 200 micrograms taken in the morning and in the evening. The first dose of Selexipag Polpharma should be taken in the evening. The dose should be taken with a glass of water, preferably during a meal. | Treatment with Selexipag Polpharma consists of two phases: Titration phase During the first few weeks, your doctor will adjust the dose of Selexipag Polpharma together with you to find the right dose for your condition. Your doctor may recommend increasing the dose of Selexipag Polpharma above the initial dose. Your doctor may also recommend reducing the dose. This process is called dose titration and allows the body to gradually adapt to the medicine. Maintenance treatment Once your doctor has determined the appropriate dose for you, this will be the dose you take regularly. This dose is called the maintenance dose. |
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| How should the dose be increased? The patient starts taking the medicine at a dose of 200 micrograms in the morning and evening, and then, after agreement with the doctor or nurse, increases the dose to the next level. The first increased dose should be taken in the evening. Each dose escalation step | Each patient with TNP requires individual dosing. For each patient, the maintenance dose may be different. Some patients may take 200 micrograms in the morning and evening as their maintenance dose, while others may require the maximum dose of 1600 micrograms in the morning and evening as their |
| lasts approximately 1 week. Finding the appropriate dose for the patient may take several weeks. The goal is to find the most suitable dose for the patient. This dose will become the maintenance dose. | maintenance dose. Other patients may require a maintenance dose somewhere between these two levels. The most important aspect is finding the most appropriate dose for the patient. |
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| ↓ When should dose reduction begin? Like any medicine, Selexipag Polpharma may cause adverse reactions as the dose is increased. If a patient experiences adverse reactions, they should speak with their doctor or nurse. There are measures available to help alleviate adverse reactions. The most common adverse reactions (may occur in more than 1 in 10 patients) during treatment with Selexipag Polpharma include: headache, diarrhoea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, facial flushing. A full list of adverse reactions is provided in the patient information leaflet. | If the patient does not tolerate adverse reactions despite attempts to manage them by the doctor or nurse, the doctor may decide to reduce the dose. If the doctor instructs the patient to reduce the dose, the patient should take one 200 microgram tablet less in the morning and one 200 microgram tablet less in the evening. Dose reduction should only be carried out after discussion with the physician managing the PAH treatment. This dose reduction process helps determine the dose most suitable for the patient. This is the maintenance dose. |
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| When to start the maintenance dose The highest dose the patient can tolerate during the titration period will be their maintenance dose. The maintenance dose is the dose the patient will then take regularly. The doctor may prescribe an equivalent single tablet of the same strength as the maintenance dose. This means that instead of taking several tablets at a given time of day, the patient may take one tablet in the morning and one tablet in the evening. | For example, if the highest tolerated dose was 1200 micrograms taken in the morning and evening: Over time, the doctor may, if necessary, adjust the maintenance dose.  |
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| Missed dose of Selexipag Polpharma If a patient forgets to take a dose, they should take it as soon as possible, then continue taking tablets at the regular times. If more than 6 hours have passed since the regular dosing time, the missed dose should be skipped and the patient should continue taking the medicine at the usual time. The patient should not take a double dose to make up for a missed dose. | Interrupting treatment with Selexipag Polpharma Do not stop taking Selexipag Polpharma without consulting a doctor. If, for any reason, a patient interrupts treatment with Selexipag Polpharma for more than 3 consecutive days (the patient has missed 6 or more consecutive doses), they should contact their doctor or nurse immediately, as it may be necessary to reduce the dose to avoid adverse effects. The doctor may decide to restart treatment with a lower dose and gradually increase it to the previous maintenance dose. |
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| Dose Titration Diary Please read the patient information leaflet carefully. The following pages of the dose titration diary will help the patient record the number of tablets taken in the morning and evening during the dose titration period. Use these pages to record the number of tablets taken in the morning and evening. Each step usually lasts 1 week, unless the doctor advises otherwise. If the dose titration steps last longer than 1 week, additional pages in the dose titration diary will allow recording of this information. Use pages 22 to 29 to record medication taken during the initial weeks of treatment, when the patient is taking only 200 microgram tablets (steps 1–4).  | If the doctor has prescribed both 200 and 800 microgram tablets, use pages 32 to 39 (steps 5–8). Remember to maintain regular contact with the physician managing PAH treatment or the nurse. Record instructions from the doctor or nurse: Doctor's phone number and email address: Pharmacist's phone number: Notes:  |
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The next pages of the diary should be used if the doctor has prescribed 800 microgram tablets for the patient in addition to the 200 microgram tablets.
On the diary pages, mark the intake of one 800 microgram tablet every morning and evening, together with the prescribed number of 200 microgram tablets. | Remember to maintain regular contact with the physician managing the PH treatment or with the nurse. Record the physician's or nurse's instructions: Physician's phone number and email address: Pharmacist's phone number: Notes: |
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| Notes |