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, 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 person only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of 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 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 controlled with other PAH therapies known as endothelin receptor antagonists (ERA) and phosphodiesterase type 5 (PDE-5) inhibitors. 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 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 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 (unrelated to pulmonary hypertension);
if the patient has had a stroke within the last 3 months or another 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 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 dysfunction;
has severe renal impairment or is undergoing dialysis;
currently or previously had severe hepatic impairment.

If the patient notices any of the above signs or experiences a change in health status,
it is essential to inform the 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 and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor managing the patient's PAH treatment or the nurse if the patient is taking any of the following medicines:

gemfibrozil (a medicine used to lower blood 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 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 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 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-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.
Starting therapy in the evening is recommended. The physician will instruct the patient on how to gradually increase the dose. 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 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 titration.

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 stage. The first increased dose should preferably be taken in the evening.
If the physician instructs further dose increases 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 all patients 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.

Drug dosing schedule showing stages 5 to 8 with morning and evening doses and specified numbers of 200 and 800 microgram tablets

If the physician prescribes 100 microgram tablets
This medicine is not available in a 100 microgram strength; therefore, if such a dose is required, another medicine available on the market at the appropriate strength should be used.

Using the dose-titration guide
The patient will receive a titration pack containing a dose-titration guide and a patient leaflet. The dose-titration guide contains information about the titration process and allows the patient to record the number of tablets taken each day.
Remember to record the daily number of tablets taken 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 recording this. Remember to maintain regular contact with the physician managing the PAH treatment or with the 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.
Various measures 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 at the current dose, the physician may instruct the patient to reduce the dose by decreasing the number of light yellow tablets by one in the morning and one in the evening. The scheme below illustrates the stepwise dose reduction. This should only be done under the physician’s instruction.

Treatment phase diagram showing stages: starting dose of 200 micrograms, weekly dose escalation, stage 6 with 8/2 dose, and dose reduction in case of side effects

If the adverse reactions become tolerable after dose reduction, the physician may decide to continue treatment at this reduced dose. Additional information is provided below under "Maintenance dose".

Maintenance dose
The highest dose tolerated by the patient during titration becomes the maintenance dose. This is the dose the patient will take regularly.
The physician will prescribe 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 multiple 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 long-term treatment with the same dose, the patient experiences adverse reactions that are not tolerated or that interfere with daily activities, contact the physician, as the current dose may need to be adjusted. The physician may prescribe a lower dose. Remember to dispose of any unused tablets (see section 5).

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

Taking more Selexipag Polpharma than prescribed
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 regular 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 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 (i.e., misses 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 at 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 will experience them.
Adverse reactions may occur in patients not only during the dose-titration period, when the dose of the medicine is being increased, but also later, while taking the same dose for a prolonged period.

If the patient develops swelling of the face, lips, tongue or throat, which may lead to
difficulty in swallowing or breathing (angioedema), seek immediate medical advice.

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 (affects 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 (affects 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 or stinging sensations and skin redness
angioedema and its symptoms described at the beginning of this section.

Uncommon (affects 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 authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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-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 engraved mark "A2" on one side and smooth on the other side, 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 side, 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 side, 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 side, 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 side, 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 side, 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 side, 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 side, 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 (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 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

DOSING GUIDE – DOSE TITRATION PACK
Page 1
Selexipag Polpharma 200 micrograms film-coated tablets
Selexipagum
Dosing guide
Starting treatment with Selexipag Polpharma
Before starting treatment, read the patient information provided in the package leaflet. 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 medications 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 increasing the dose?.....................8
When to start reducing the dose?.............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 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 2 phases:
Dose titration
During the first few weeks, your doctor will work together with you to adjust the dose of Selexipag Polpharma to find the right dose for you. Your doctor may instruct you to increase the dose of Selexipag Polpharma from the initial dose. Your doctor may also instruct you to reduce the dose. This process is called dose titration. It allows your body to gradually adapt to the medicine.
Maintenance treatment
Once your doctor has determined the appropriate dose of the medicine for you, this will be the dose you 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 in the 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 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 the maintenance dose, whereas others may take the maximum dose of 1600 micrograms in the morning and evening as the
lasts approximately 1 week. Finding the appropriate dose for the patient may take several weeks. The aim 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 dose levels. The most important aspect is finding the most appropriate dose for the patient.

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Drug dosing schedule showing two weekly stages: Stage 1 with one 200-microgram tablet in the morning and evening, Stage 2 with two tablets in the morning and evening

Drug dosing schedule: Stage 3 with three 200-microgram tablets in the morning and evening, Stage 4 with four 200-microgram tablets in the morning and evening

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Drug dosing schedule divided into stages 5, 6, 7, and 8, indicating numbers of 800 and 200 microgram tablets taken in the morning and evening, and total daily dose

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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. There are measures available to help alleviate adverse reactions.
The most commonly occurring 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, and facial flushing.
A full 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 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 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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Drug dosing schedule divided into five weekly stages, describing dose increase by 200 micrograms each week

Drug dosing schedule showing Stage 6 and return to Stage 5, a timeline, and information on the maintenance dose consisting of one tablet

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When to start the maintenance dose
The maintenance dose will be the highest dose the patient can tolerate during the dose titration period. The maintenance dose is the dose the patient will take regularly from then on. The doctor may prescribe a single tablet containing an 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 by the patient was 1200 micrograms taken in the morning and evening:
The doctor may, if necessary, adjust the maintenance dose over time.

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

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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, then continue taking the 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 regular time.
The patient should not take a double dose to make up for a missed dose.

Interrupting treatment with Selexipag Polpharma
Patients must not stop taking Selexipag Polpharma without medical advice. 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), the patient should contact their 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
Read the patient leaflet carefully.
The following pages of the titration diary will help the patient record the number of tablets taken in the morning and in the evening during the dose 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 doctor advises otherwise. If the titration steps last longer than 1 week, additional pages in the titration diary will allow recording of this information.
Use pages 22 to 29 to record medication taken during the first 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 light cream-colored circular background

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 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:

Two circles with letter and number: a light cream circle with black letter A and number 2, and a dark brown circle with white letter A and number 8

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

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Table for recording 200-microgram drug dose in the morning and evening, with fields for week number, date, and daily tablet count

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

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

Table for monitoring treatment with fields for week number, number of 200-microgram tablets taken in the morning and evening, and date of physician consultation

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

Table for monitoring treatment with fields for week number, date, and number of 200-microgram tablets taken in the morning and evening

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The next pages of the diary should be used if the doctor has prescribed 800 microgram tablets 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.

Text information on dosing: A2 tablet containing 200 micrograms and A8 tablet containing 800 micrograms, to be used in stages 5 to 8

Remember to maintain regular contact with the doctor managing the PH 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:

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