Selexipag polpharma
Poland
Table of Contents
Patient Information Leaflet
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 this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet for future reference.
- If you have any questions, ask your doctor or nurse.
- This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm others, even if their symptoms are the same as yours.
- 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
- 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 suitable candidates for 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 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 pressure in the pulmonary arteries, alleviates symptoms of PAH, and slows disease progression.
2. Important information before taking Selexipag Polpharma
When not to take Selexipag Polpharma
- if the patient has hypersensitivity 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 (unrelated to pulmonary hypertension);
- if the patient has had a stroke within the last 3 months or another event causing reduced cerebral blood flow (e.g. transient ischaemic attack);
- if the patient is taking gemfibrozil (a medicine used to lower blood lipid levels).
Warnings and precautions
Before starting treatment with Selexipag Polpharma, the patient should discuss with their doctor or
nurse if they:
- are taking medicines to lower high blood pressure;
- have hypotension associated with symptoms such as dizziness;
- have recently lost a significant amount of blood or body fluids, e.g. due to severe diarrhoea or vomiting;
- have thyroid dysfunction;
- have severe renal impairment or are undergoing dialysis;
- currently have or have previously had severe hepatic impairment.
If the patient notices any of the above signs or experiences a change in their health status,
they should immediately inform their doctor.
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
The patient should inform their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their treating physician or nurse if they are 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 excess iron from the bloodstream),
- teriflunomide (a medicine used to treat relapsing-remitting multiple sclerosis),
- carbamazepine (a medicine used to treat certain types of epilepsy, neuropathic pain, 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, breastfeeding, suspects she may be pregnant, or is planning 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 medical condition 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.
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 who are blind should receive assistance from another person when taking Selexipag Polpharma during the dose-escalation period (the process of gradually increasing the dose).
Dose escalation
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. This period is called the dose-escalation phase. It allows the body to gradually adapt to the new medicine. The goal of dose escalation is to find the most appropriate dose. This will be the highest dose tolerated by the patient, with a maximum of 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 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 stages of dose escalation.
If the physician instructs further dose increases, 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 increased dose should preferably be taken in the evening.
If the physician instructs further dose escalation 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-escalation guide
The patient will receive a dose-escalation pack containing a dose-escalation guide and a patient leaflet. The dose-escalation guide provides information about the dose-escalation 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-escalation diary. Each dose-escalation stage usually lasts one week. If the physician instructs the patient to extend each dose-escalation stage beyond one week, additional pages in the dose-escalation diary allow for this recording. Remember to maintain regular contact with the physician managing PAH treatment or with a nurse during the dose-escalation period.
Dose reduction due to adverse reactions
During dose escalation, 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 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 on the physician’s instruction.
If the adverse reactions experienced by the patient become 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 escalation becomes the maintenance dose. This is the dose the patient will take regularly.
The physician will prescribe the appropriate tablets corresponding to this dose. 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 their colours and 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 tolerable 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 dispose of 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 divide or crush the tablets.
Taking more than the recommended dose of Selexipag Polpharma
If more tablets are taken than prescribed, 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 usual times. If the next scheduled dose is due within 6 hours, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping treatment with Selexipag Polpharma
Abruptly stopping Selexipag Polpharma may lead to worsening of symptoms. Do not discontinue treatment with Selexipag Polpharma without medical advice.
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 (missing 3 morning and 3 evening doses, or 6 consecutive doses or more), the patient should contact the physician immediately, as dose reduction may be necessary 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 any medicine, 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, during prolonged administration of the same dose.
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 medication, the patient should consult a doctor, as the dose being taken may be too high and may require dose reduction.
Very common (occurs in more than 1 out of 10 patients):
- headache
- sudden facial flushing
- nausea and vomiting
- diarrhoea
- jaw pain, muscle pain, joint pain, leg pain
- nasopharyngitis (nasal congestion).
Common (occurs in less than 1 out of 10 patients):
- 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 (occurs in less than 1 out of 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 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 for this medicine.
Medicines must 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 packaging 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.
- The other ingredients are:
Tablet core: mannitol, corn starch, hydroxypropyl cellulose, 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 packaging
Selexipag Polpharma, 200 micrograms: round, light yellow coated tablets (tablets) with embossed marking “A2” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 400 micrograms: round, violet coated tablets (tablets) with embossed marking “A4” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 600 micrograms: round, red coated tablets (tablets) with embossed marking “A6” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma, 800 micrograms: round, brown coated tablets (tablets) with embossed marking “A8” on one side and smooth on the other, approximately 5.5 mm in diameter.
Selexipag Polpharma, 1000 micrograms: round, red coated tablets (tablets) with embossed marking “A10” on one side and smooth on the other, approximately 5.6 mm in diameter.
Selexipag Polpharma, 1200 micrograms: round, violet coated tablets (tablets) with embossed marking “A12” on one side and smooth on the other, approximately 6.5 mm in diameter.
Selexipag Polpharma, 1400 micrograms: round, light yellow coated tablets (tablets) with embossed marking “A14” on one side and smooth on the other, approximately 6.6 mm in diameter.
Selexipag Polpharma, 1600 micrograms: round, brown coated tablets (tablets) with embossed marking “A16” on one side and smooth on the other, approximately 7 mm in diameter.
Selexipag Polpharma 200 micrograms, coated tablets, are packaged in blisters containing 10 or 60 tablets, and 60 or 140 tablets (dose titration packs), or in unit dose blisters containing 10x1 or 60x1 tablets, and 60x1 or 140x1 tablets (dose titration packs).
Selexipag Polpharma 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1400 micrograms, and 1600 micrograms, coated tablets, are packaged 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
DOSING GUIDELINE – DOSE TITRATION PACK
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Selexipag Polpharma 200 micrograms, coated tablets
Selexipagum
Dosing guideline
Starting treatment with Selexipag Polpharma
Before starting treatment, read the patient information provided in the package leaflet. Inform the doctor if the patient experiences any adverse reactions, as the doctor may decide to adjust the dose of Selexipag Polpharma. Inform the doctor about any other medicines 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 stages of dose escalation?.......8 When to start dose reduction?....................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 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. Take the dose 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 adjust the dose of Selexipag Polpharma together with the patient to find the appropriate dose. The doctor may recommend increasing the dose of Selexipag Polpharma from the initial dose. The 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 the doctor has determined the appropriate dose for the patient, this will be the dose the patient takes regularly. This 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 dosing step | Each 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 their maintenance dose, whereas other patients may take 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 to 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, diarrhea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, facial flushing. A full list of adverse reactions is provided in the patient leaflet. | If the patient does not tolerate 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 carried out after discussing it with the doctor 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 maintenance dose The highest dose 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 then on. The doctor may prescribe a single tablet of equivalent strength as the maintenance dose. This way, instead of taking multiple tablets at a given time of day, the patient can 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 the patient forgets to take a dose, the dose should be taken 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 The patient must not stop taking Selexipag Polpharma without consulting a doctor. If, for any reason, the patient interrupts treatment with Selexipag Polpharma for more than 3 consecutive days (the patient has missed 6 or more consecutive doses), the patient should contact a 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 diary will help the patient record the number of tablets taken in the morning and in the evening during the titration period. Use these pages to record the number of tablets taken in the morning and in the evening. Each step usually lasts 1 week, unless the physician advises otherwise. If the dose titration steps last longer than 1 week, additional diary pages are provided to record this information. Pages 22 to 29 should be used to record medication taken during the initial weeks of treatment, when the patient is taking only 200 microgram tablets (Steps 1–4).  | If the physician 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 or nurse managing PAH treatment. Record physician's or nurse's instructions here: Physician'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 physician 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 each 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 instructions given by the physician or nurse: Telephone number and email address of the physician: Pharmacist's telephone number: Notes: |
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| Notes |