Selexipag polpharma: detailed information

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 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, please 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 adverse reactions, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet

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 acts on 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 treated with other PAH therapies 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 suitable candidates 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 can 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 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:
reduced 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;
valvular heart disease (congenital or acquired) with impaired heart function (not related 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 your doctor or
nurse if the patient:

is taking medicines to lower high blood pressure;
has hypotension 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 renal impairment or is undergoing dialysis;
currently or previously has severe hepatic impairment.

If the patient notices any of the above signs or there is a change in their health status,
they should inform their doctor 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 with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan 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 is planning to have a baby, 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 should 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 recommend adjusting 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 of the medicine. 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, up to a maximum of 1600 micrograms taken in the morning and 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 escalation.

Drug dosing chart divided into four weekly stages, showing dose escalation from 400 to 1600 micrograms per day using A2 tablets

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 escalation stage. The first intake of the increased dose is recommended in the evening.
If the physician instructs further dose escalation and the patient proceeds 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.

Stepwise drug dosing chart from stage 5 to 8, showing number and type of 200 and 800 microgram tablets taken in the morning and evening

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 contains 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 1 week. If the physician instructs the patient to extend each dose-escalation stage beyond 1 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 the nurse during the dose-escalation period.

Dose reduction due to adverse reactions
During dose escalation, the patient 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 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.

Treatment phase chart with stages: initiation, dose escalation, and dose reduction, including dosing in micrograms and instructions to return to stage 5

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 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, 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 adjusted. 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 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 Selexipag Polpharma
Abruptly stopping Selexipag Polpharma may lead to worsening of symptoms in the patient. Do not stop taking 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 has 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 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), seek immediate medical attention.
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 (occurs in more than 1 in 10 patients):

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

Common (occurs 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 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 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 of the 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 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 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.
The other ingredients are:
Tablet core: mannitol, maize 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 strengths 200 micrograms, 800 micrograms, 1400 micrograms, 1600 micrograms), red iron oxide (E172) (only for strengths 400 micrograms, 600 micrograms, 800 micrograms, 1000 micrograms, 1200 micrograms, 1600 micrograms), black iron oxide (E172) (only for strengths 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 engraved mark "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 engraved mark "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 engraved mark "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 engraved mark "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 engraved mark "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 engraved mark "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 engraved mark "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 engraved mark "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

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 package leaflet. Inform the doctor if the patient experiences any adverse reactions, as the doctor may 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.

Page 2 Page 3

Table of contents
How to take Selexipag Polpharma?........4
How to increase the dose of the medicine?...6
What are the steps for increasing the dose?...8
When to start reducing the dose?...........12
Reducing the dose..................................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 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, the doctor will adjust the dose of Selexipag Polpharma together with the patient to find the appropriate dose for the individual. 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. It 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 dose is called the maintenance dose.

Page 6 Page 7

How to increase the dose of the medicine?
The patient starts taking the medicine at a dose of 200 micrograms in the morning and in the evening. With agreement from the doctor or nurse, the dose may be increased to the next level.
The first increased dose should be taken in the evening. Each dosing step 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 will be the maintenance dose.

Each patient with PH requires an individual dose. The maintenance dose may differ for each patient.
Some patients may take 200 micrograms in the morning and evening as their maintenance dose, whereas others may take the maximum dose of 1600 micrograms in the morning and evening as their 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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Drug dosing schedule showing two stages, each lasting one week, with instructions on number and timing of 200 microgram tablet intake

Drug dosing schedule: Stage 3 is 3 tablets in the morning and 3 in the evening of 200 micrograms each, Stage 4 is 4 tablets in the morning and 4 in the evening of 200 micrograms each

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Drug dosing schedule divided into stages 5, 6, 7, and 8, with morning and evening doses and total daily dose in micrograms

Page 12 Page 13

↓ 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, and facial flushing.
A complete list of adverse reactions is provided in the patient leaflet.

If the patient does not tolerate the adverse reactions despite attempts by the doctor or nurse to alleviate them, the doctor may decide to reduce the dose.
If the doctor instructs the patient to reduce the dose, the patient should take one tablet of 200 micrograms less in the morning and one tablet of 200 micrograms less in the evening.
Dose reduction should only be carried out after discussion with the physician managing the PAH treatment. This dose-titration process helps determine the dose most appropriate for the patient. This is the maintenance dose.

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Drug dosing schedule divided into five weekly stages, describing dose increase by 200 micrograms weekly

Drug dosing schedule showing stage 6 and return to stage 5, with information on maintenance dose consisting of one 800 microgram tablet

Page 16 Page 17

When to start maintenance dose
The highest dose the patient can tolerate during the dose titration period will be their maintenance dose. The maintenance dose is the dose the patient will then take regularly. The doctor may prescribe a single tablet of equivalent 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.

Dosing schedule: maximum tolerated dose A8 A2 A2 equals maintenance dose A12 in the morning at sun icon and in the evening at moon icon

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Missed dose of Selexipag Polpharma
If the patient forgets to take a dose of the medicine, 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.
Do 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, 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 of the medicine to avoid adverse effects.
The doctor may decide to restart treatment with a lower dose and gradually increase it back to the previous maintenance dose.

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Dose Titration Diary
Please read the patient 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 otherwise directed by the physician.
If 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 intake during the initial weeks of treatment, when the patient is taking only 200 microgram tablets (Steps 1–4).

Large, dark gray letter A placed over the number 2 on a solid, light yellow, circular background

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 the PAH treatment.
Record instructions from the physician or nurse:
Physician's phone number and email address:
Pharmacist's phone number:
Notes:

Two circles with letter and number: light beige circle with black text A2 and dark gray circle with white text A8

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Two monitoring tables for Selexipag Polpharma dosing, with fields for week number, date, and number of tablets taken in the morning and evening

Page 24 Page 25

Table for recording 200 microgram drug dose in the morning and evening, with fields for week number, date, and daily number of tablets taken

Table for recording drug dose with fields for week number, date, and number of 200 microgram tablets taken in the morning and evening

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Treatment monitoring table with columns for days of the week, rows for morning and evening, and fields for number of 200 microgram tablets taken

Table for recording drug dose with fields for week number, number of tablets taken in the morning and evening, date, and space for discussion with physician

Page 28 Page 29

Table for recording drug dose with fields for week number, number of tablets in the morning and evening, date, and instructions regarding 800 microgram dose

Page 30 Page 31

The next pages of the diary should be used if the doctor has prescribed tablets of 800 micrograms in addition to tablets of 200 micrograms for the patient.
On the diary pages, mark the intake of one tablet of 800 micrograms every morning and evening, together with the prescribed number of tablets of 200 micrograms.

Text information on dosing: A2 tablet with strength of 200 micrograms and A8 tablet with strength of 800 micrograms used in stages 5 to 8

Remember to maintain regular contact with the doctor managing PAH treatment or with the nurse.
Record the doctor's or nurse's instructions:
Doctor's phone number and email address:
Pharmacist's phone number:
Notes:

Page 32 Page 33

Treatment monitoring table with fields for week number, date of physician visit, and rows for 200 and 800 microgram doses in the morning and evening

Treatment monitoring table with fields for week number, date of physician visit, and boxes for number of tablets taken in the morning and evening

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Treatment monitoring table with fields for week number, date of physician visit, and daily number of tablets taken in the morning and evening

Treatment monitoring table with fields for week number, date, and number of tablets taken in the morning and evening at doses of 200 and 800 micrograms

Page 36 Page 37

Treatment monitoring table with fields for week number, date, and number of 200 and 800 microgram tablets taken in the morning and evening

Table for recording drug dosing with morning and evening split, containing fields for number of micrograms and days of the week in grid format

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Treatment monitoring table with fields for week number, date of physician visit, and grid for marking 200 and 800 microgram doses in the morning and evening

Page 40

Notes