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 pack 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 carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any 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.
Table of contents of the leaflet
- What Selexipag Polpharma is and what it is used for
- Important information 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 therapies known as endothelin receptor antagonists (ERA) and phosphodiesterase type 5 inhibitors (PDE-5). Selexipag Polpharma 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 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 reduces blood pressure in the pulmonary arteries, alleviates PAH symptoms, and slows disease progression.
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 diseases such as:
- poor blood flow to the heart muscle (severe coronary artery disease or unstable angina pectoris); 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;
- heart valve disorders (congenital or acquired) with impaired heart function (not related 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 lipid levels).
Warnings and precautions
Before starting Selexipag Polpharma, discuss with your 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 body fluids, e.g. due to severe diarrhoea or vomiting;
- has thyroid function disorders;
- has severe kidney function impairment or is undergoing dialysis;
- currently or previously had severe liver function impairment.
If the patient notices any of the above signs or experiences a change in health status,
they should inform their doctor immediately.
Children and adolescents
This medicine should 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 with other medicines
Tell your 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 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 during treatment with 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 their ability to drive.
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 exactly as directed by the physician.
In case of doubt, consult your doctor.
Inform your doctor if you experience any adverse reactions, as the doctor may recommend adjusting the dose of Selexipag Polpharma.
Inform your doctor if you have liver function problems or are taking other medications, as the doctor may recommend a lower dose of Selexipag Polpharma, administered twice daily or even once daily.
Patients with visual impairments or who are blind 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 your doctor prescribes 200 microgram tablets
At the beginning of treatment, most patients will receive one 200 microgram tablet to be taken in the morning and another 200 microgram tablet to be taken in the evening, approximately 12 hours apart.
It is recommended to start therapy in the evening. Your doctor will instruct you on how to gradually increase the dose of the medicine. This period is called the dose-titration phase. 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 you receive will contain light yellow 200 microgram tablets.
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 be taken each morning and each evening during the first four dose-titration stages.
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 continue increasing 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 Polpharma is 1600 micrograms in the morning and 1600 micrograms in the evening. However, not every patient will receive this dose, as individual patients may 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 your doctor prescribes 100 microgram tablets
This medicine is not available in a 100 microgram strength; therefore, if such a dose is required, other available medicines with the appropriate strength 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 one week. If your doctor instructs you to extend each titration stage beyond one week, additional pages in the dose-titration diary allow for this recording. Remember to maintain regular contact with your PAH-treating physician or nurse during the dose-titration period.
Dose reduction due to adverse reactions
During dose titration, you may experience adverse reactions such as headache, diarrhea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, or facial flushing (see section 4). If these adverse reactions are difficult to tolerate, discuss with your doctor possible ways to reduce or manage them.
Various treatments are available to help alleviate adverse reactions. For example, pain relievers 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, your doctor may instruct you 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 on the doctor’s instruction.
If the adverse reactions become tolerable after 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 by the patient during dose titration 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 taking multiple 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, your doctor may adjust the maintenance dose as appropriate.
If, at any time during prolonged use of the same dose, you experience adverse reactions that are not tolerable or that interfere with your daily activities, contact your doctor, as your current dose may need to be adjusted. Your doctor may prescribe a lower dose. Remember to dispose of 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 than the recommended dose of Selexipag Polpharma
If you take more tablets than prescribed by your doctor, contact your doctor immediately.
Missing a dose of Selexipag Polpharma
If you forget to take Selexipag Polpharma, take the missed dose as soon as possible, then continue taking the tablets at your regular times. If it is almost time for your next dose (within 6 hours before the next scheduled dose), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.
Stopping Selexipag Polpharma
Suddenly stopping Selexipag Polpharma may lead to worsening of symptoms. Do not discontinue Selexipag Polpharma without your doctor’s instruction.
Your doctor may instruct you to gradually reduce the dose before completely stopping the medicine.
If, for any reason, you stop taking Selexipag Polpharma for more than 3 consecutive days (you miss 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 reactions. Your doctor may decide to restart treatment with 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 everyone 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 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 need to be reduced.
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 redness of the skin
- 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 not listed in this leaflet, inform a doctor. Adverse reactions can be reported directly to the Department of Monitoring of 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "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.
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 will help protect the environment.
6. Contents of the pack and other information
What Selexipag Polpharma contains
- The active substance is selexipag. Each coated tablet contains 200 micrograms, 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1400 micrograms, or 1600 micrograms of selexipag.
- 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 strengths), red iron oxide (E172) (only for 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1600 micrograms strengths), black iron oxide (E172) (only for 400 micrograms, 800 micrograms, 1200 micrograms, 1600 micrograms strengths), carnauba wax.
What Selexipag Polpharma looks like and contents of the pack
Selexipag Polpharma 200 micrograms: round, light yellow film-coated tablets with "A2" embossed on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma 400 micrograms: round, violet film-coated tablets with "A4" embossed on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma 600 micrograms: round, red film-coated tablets with "A6" embossed on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma 800 micrograms: round, brown film-coated tablets with "A8" embossed on one side and smooth on the other, approximately 5.5 mm in diameter.
Selexipag Polpharma 1000 micrograms: round, red film-coated tablets with "A10" embossed on one side and smooth on the other, approximately 5.6 mm in diameter.
Selexipag Polpharma 1200 micrograms: round, violet film-coated tablets with "A12" embossed on one side and smooth on the other, approximately 6.5 mm in diameter.
Selexipag Polpharma 1400 micrograms: round, light yellow film-coated tablets with "A14" embossed on one side and smooth on the other, approximately 6.6 mm in diameter.
Selexipag Polpharma 1600 micrograms: round, brown film-coated tablets with "A16" embossed 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, and 60 or 140 tablets (titration packs), or in unit dose blisters containing 10x1 or 60x1 tablets, and 60x1 or 140x1 tablets (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 Member States of 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
TITRATION GUIDE – TITRATION PACK
Page 1
Selexipag Polpharma 200 micrograms film-coated tablets
Selexipagum
Titration guide
Starting treatment with Selexipag Polpharma
Before starting treatment, read the patient information provided in the leaflet included in the pack. Inform the physician if the patient experiences any adverse reactions, as the physician may recommend adjusting the dose of Selexipag Polpharma. Inform the physician about any other medicines the patient is taking, as the physician 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 dose reduction?.............12 Dose reduction..........................................14 | When to start maintenance dosing?................................................16 Missed dose of Selexipag Polpharma……………………………………..18 Interrupting treatment with Selexipag Polpharma………………………………..........19 Dose titration diary……..................20 |
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| How to take Selexipag Polpharma? Selexipag Polpharma is a medicine taken every morning and evening for the treatment of pulmonary arterial hypertension (PAH). The initial dose of Selexipag Polpharma is 200 micrograms taken in the morning and 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: Dose titration During the first few weeks, the doctor will work together with the patient to adjust the dose of Selexipag Polpharma to find the appropriate dose for the patient. The doctor may instruct the patient to increase the dose of Selexipag Polpharma above the initial dose. The doctor may also recommend reducing the dose. This process is called dose titration. It allows the body to gradually adapt to the medicine. Maintenance treatment Once the doctor has determined the appropriate dose of the medicine for the patient, this will be the dose the patient will take regularly. This dose is called the maintenance dose. |
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| How to increase the dose of the medicine? The patient starts taking the medicine at a dose of 200 micrograms in the morning and evening, and 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 step | Every patient with COPD requires individual dosing. For each patient, the maintenance dose may be different. Some patients may take 200 micrograms in the morning and evening as the maintenance dose, whereas other patients may take the maximum dose of 1600 micrograms in the morning and evening as |
| of dose escalation 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. | the 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 medication, 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. Treatments are available to help alleviate these adverse reactions. The most common adverse reactions (may occur in more than 1 in 10 patients) during treatment with Selexipag Polpharma include: headache, diarrhea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, facial flushing. A complete list of adverse reactions is provided in the patient information leaflet. | If the patient does not tolerate the adverse reactions despite attempts by the doctor or nurse to manage them, 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 performed after discussing it with the physician managing the PAH treatment. This dose-titration process helps determine the dose most appropriate for the patient. This is called the maintenance dose. |
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| When to start maintenance dosing The highest dose that the patient can tolerate during the dose titration period will become their maintenance dose. The maintenance dose is the dose the patient will take regularly from now on. The doctor may prescribe a single tablet of equivalent strength as the maintenance dose. This way, 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 adjust the maintenance dose as necessary.  |
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| Missed dose of Selexipag Polpharma If a patient forgets to take a dose of the medicine, the dose should be taken as soon as possible, and then the tablets should be continued at the regular times. If more than 6 hours have passed since the regular time of taking the medicine, the missed dose should be skipped, and the patient should continue taking the medicine at the regular time. A double dose should not be taken to make up for the 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 consecutive doses or more), the patient should contact a doctor or nurse immediately, as it may be necessary to reduce the dose of the medicine 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 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 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 microgram and 800 microgram tablets, use pages 32 to 39 (steps 5–8). Remember to maintain regular contact with the physician managing the PAH treatment or the nurse. Record the instructions given by 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 TNP 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 |