UPTRAVI 200 MICROGRAMS Фильм-coated таблетки

Содержание инструкции

1. Uptravi 200 micrograms film-coated tablets, 400 micrograms film-coated tablets, 600 micrograms film-coated tablets, 800 micrograms film-coated tablets, 1,000 micrograms film-coated tablets, 1,200 micrograms film-coated tablets, 1,400 micrograms film-coated tablets
   1. What is Uptravi and what it is used for
   2. What you need to know before taking Uptravi
   3. How to take Uptravi
   4. Possible side effects
   5. Come conservare Uptravi
   6. Contenuto della confezione e altre informazioni

Uptravi 200 micrograms film-coated tablets, 400 micrograms film-coated tablets, 600 micrograms film-coated tablets, 800 micrograms film-coated tablets, 1,000 micrograms film-coated tablets, 1,200 micrograms film-coated tablets, 1,400 micrograms film-coated tablets

Uptravi 1,600 micrograms film-coated tablets
selexipag

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, talk to your doctor or nurse (see section 4).

Contents of this leaflet

• 1. What Uptravi is and what it is used for
• 2. What you need to know before you take Uptravi
• 3. How to take Uptravi
• 4. Possible side effects
• 5. How to store Uptravi
• 6. Contents of the pack and other information

1. What is Uptravi and what it is used for

Uptravi is a medicine that contains the active substance selexipag. It acts on blood vessels in
a similar way to the natural substance prostacyclin, causing them to relax and widen.
Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH)
in adult patients who are inadequately controlled with other types of medicines for PAH known
as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Uptravi
can be used alone if the patient cannot take these medicines.
PAH is characterized by high pressure in the blood vessels that carry blood from the heart
to the lungs (pulmonary arteries). In people with PAH, these arteries narrow and therefore the
heart has to work harder to pump blood through them. This results in a feeling of fatigue,
dizziness, shortness of breath or other symptoms.
By acting in a similar way to the natural substance prostacyclin, this medicine widens the
pulmonary arteries and reduces their stiffness, making it easier for the heart to pump blood
through the pulmonary arteries. Uptravi reduces the pressure in the pulmonary arteries, relieves the symptoms
of PAH and slows the progression of the disease.

2. What you need to know before taking Uptravi

Do not take Uptravi:

• if you are allergic to selexipag or any of the other ingredients of this medicine (listed in section 6).
• if you have heart problems such as:
• insufficient blood flow to the heart (severe coronary artery disease or unstable angina); symptoms may include chest pain
• a heart attack in the last 6 months
• heart failure (congestive heart failure) that is not kept under strict medical supervision
• severely irregular heartbeat
• a defect in the heart valves (present from birth or acquired) that causes inadequate heart function (not caused by pulmonary hypertension)
• if you have had a stroke in the last 3 months, or any other event that has reduced the oxygen supply to the brain (for example, transient ischemic attack).
• if you are taking gemfibrozil (medicine used to lower the level of fats [lipids] in the blood)

Warnings and precautions
Talk to your doctor experienced in PAH or your nurse before taking Uptravi if:

• you are taking medicines for high blood pressure
• you have low blood pressure, associated with symptoms such as dizziness
• you have recently suffered from significant blood loss or fluid loss as happens with severe diarrhea or vomiting
• you have problems with your thyroid gland
• you have severe kidney problems or are undergoing dialysis
• you have or have had serious problems with the proper functioning of your liver

If you notice any of these signs or a change in your condition, tell your doctor immediately.

Children and adolescents
Do not give this medicine to children under 18 years of age, because Uptravi has not been tested in
children.

Elderly patients
There is limited experience with Uptravi in patients over 75 years of age. Uptravi should be
used with caution in this group of patients.

Other medicines and Uptravi
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Taking other medicines can change the way Uptravi works.
Tell your doctor or nurse if you are taking any of the following medicines:

• Gemfibrozil (medicine used to lower the level of fats [lipids] in the blood)
• Clopidogrel (medicine used to inhibit the formation of blood clots in coronary artery disease)
• Deferasirox (medicine used to remove iron from the bloodstream)
• Teriflunomide (medicine used to treat relapsing-remitting forms of multiple sclerosis)
• Carbamazepine (medicine used to treat certain forms of epilepsy, neuralgia or to help control severe mood disorders when other medicines do not work)
• Phenytoin (medicine used for epilepsy)
• Valproic acid (medicine used for epilepsy)
• Probenecid (medicine used for gout)
• Fluconazole, rifampicin or rifapentine (antibiotics used to treat infections)

Pregnancy and breastfeeding
The use of Uptravi is not recommended during pregnancy and breastfeeding. If you are a woman of
childbearing potential, you must use effective contraception during treatment with Uptravi. If you are
pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.

Driving and using machines
Uptravi can cause side effects such as headache and low blood pressure
(see section 4) that may affect your ability to drive; also, the symptoms of your
illness may make you less fit to drive.

3. How to take Uptravi

Uptravi can only be prescribed by a doctor with experience in the treatment of pulmonary arterial hypertension. Take this medicine following exactly the instructions of your doctor. If you have doubts or questions, consult your doctor. Inform your doctor if any undesirable effects occur, as they may recommend a modification of the Uptravi dose. Inform your doctor if you are taking other medicines, as they may recommend that you take Uptravi only once a day. If you have vision problems or experience any type of blindness, always have another person help you during the intake of Uptravi during the titration period (process of gradual dose increase).

How to find the right dose for you
At the beginning of treatment you will take the lowest dose, which consists of one 200 microgram tablet in the morning and another 200 microgram tablet in the evening, at an interval of approximately 12 hours. It is recommended to start treatment in the evening. The doctor will instruct you on how to gradually increase the dose. This procedure is called titration and allows the body to adapt to the new medicine. The goal of titration is to reach the most appropriate dose, i.e. the highest dose you can tolerate, which can reach a maximum dose of 1,600 micrograms in the morning and in the evening.
The first pack of tablets you receive will contain light yellow 200 microgram tablets.
The doctor will tell you to increase the dose in successive steps, usually every week, but the interval between dose increases may be longer.
With each increase, you will need to add a 200 microgram tablet to the morning dose and another 200 microgram tablet to the evening dose. It is recommended to take the first increased dose in the evening.The diagram below shows the number of tablets to take each morningand each eveningfor the first 4 steps.

If the doctor tells you to increase the dose further, you will add a 200 microgram tablet to the morning dose and a 200 microgram tablet to the evening dose at each new step. It is recommended to take the first increased dose in the evening.
If the doctor gives you instructions to further increase the dose and move to phase 5, this can be done by taking one 800 microgram green 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 Uptravi is 1,600 micrograms in the morning and 1,600 micrograms in the evening. However, not all patients will reach this dose, because different patients may need different doses.
The diagram below shows the number of tablets to take each morningand each eveningat each stage starting from phase 5.

for the patient. The titration guide provides information on the titration process and allows you to record the number of tablets you take each day.
Remember to record the number of tablets you take each day in the titration diary. Titration steps usually last about 1 week. If the doctor tells you to extend each titration step for more than 1 week, some additional pages of the diary are available to allow you to keep track of it. Remember to talk to your PAH expert doctor or nurse regularly during titration.
Decreasing to a lower dose due to undesirable effects
During titration you may notice the onset of undesirable effects such as headache, diarrhea, feeling unwell (nausea), vomiting, jaw pain, muscle pain, leg pain, joint pain, or facial redness (see section 4). If you find these undesirable effects difficult to tolerate, consult your doctor about how to manage or treat them. Several treatments are available that can help relieve the undesirable effects. For example, pain relievers such as paracetamol may be useful in treating pain and headache.
If these undesirable effects cannot be treated or do not gradually improve at the dose you are taking, the doctor may adjust the dose by removing one light yellow 200 microgram tablet from the morning administration and one light yellow 200 microgram tablet from the evening administration. The diagram below shows the steps to decrease the dose. Proceed as shown in the figure, only if indicated by the doctor.

If, after decreasing the dose, the undesirable effects are manageable, the doctor may decide not to change the dose further. For more information, see the section below “Maintenance dose”.

Maintenance dose
The maximum tolerated dose during titration will become your maintenance dose. The maintenance dose is the dose you must continue to take regularly.
The doctor will prescribe you the tablet with the dosage suitable for your maintenance dose. This allows you to take one tablet in the morning and one in the evening, instead of taking multiple tablets at the same time.
For a complete description of the Uptravi tablets, specifying the colors and the marking, see paragraph 6 of this leaflet.
Over time, the doctor may decide to adjust the maintenance dose if necessary.
If, at any time, after taking the same dose for a long time, undesirable effects occur that you cannot tolerate or undesirable effects that affect normal daily activities, contact your doctor as it may be necessary to reduce the dose. The doctor may then prescribe you a single tablet with a lower dose. Remember to dispose of unused tablets correctly (see section 5).

Take Uptravi once in the morning and once in the evening, at an interval of approximately 12 hours.
Take the tablets with meals as you may tolerate the medicine better. The tablet coating provides protection. Swallow the tablet whole with a glass of water. Do not break, crush or chew the tablets.

If you take more Uptravi than you should
If you have taken more tablets than you were told to take, ask your doctor for advice.

If you forget to take Uptravi
If you forget to take Uptravi, take a dose as soon as you remember and then take the tablets at the usual times. If you are close to the time you have to take the next dose (within 6 hours before taking the dose normally scheduled), do not take the forgotten dose and continue to take the medicine at the scheduled time. Do not take a double dose to make up for the forgotten one.

If you stop taking Uptravi
An abrupt interruption of treatment with Uptravi may lead to a worsening of symptoms. Do not stop treatment with Uptravi unless it has been agreed with your doctor.
The doctor may tell you to gradually reduce the dose before stopping treatment completely.
If, for any reason, you stop taking Uptravi for more than 3 consecutive days (e.g. if you do not take the dose for 3 mornings and 3 evenings in a row or 6 consecutive doses or more), contact your doctor immediately as it may be necessary to adjust the dose to avoid undesirable effects. The doctor may decide to restart treatment at a lower dose, gradually increasing to the previous maintenance dose.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may notice some side effects not only during the titration period, when the dose is increased, but also
after taking the same dose for long periods of time.

If you experience any of these side effects: headache, diarrhoea, nausea, vomiting,
jaw pain, muscle pain, leg pain, joint pain or flushing of the face, that you cannot tolerate or that
cannot be treated, contact your doctor because the dose you are taking may be too high for you and
may need to be reduced. Very common side effects(may affect more than 1 in 10 people)

• Headache
• Flushing of the face
• Nausea and vomiting
• Diarrhoea
• Jaw pain, muscle pain, joint pain, leg pain
• Nasopharyngitis (nasal congestion)

Common side effects(may affect up to 1 in 10 people)

• Anemia (reduced number of red blood cells in the blood)
• Hyperthyroidism (overactivity of the thyroid gland)
• Decreased appetite
• Weight loss
• Hypotension (low blood pressure)
• Stomach pain, including dyspepsia
• Pain
• Changes in some blood test results, including the number of red blood cells or indicators of thyroid function
• Skin rashes, including urticaria, may cause a burning or stinging sensation and reddened skin

Uncommon side effects(may affect up to 1 in 100 people)

• Increased heart rate

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. Come conservare Uptravi

Keep this medicine out of the sight and reach of children.
Do not use Uptravi after the expiry date which is stated on the pack after “Scad.” and on the blister after
“EXP”.
The expiry date refers to the last day of the month indicated.
This medicine does not require any particular storage conditions.
No special instructions for disposal.

6. Contenuto della confezione e altre informazioni

Cosa contiene Uptravi
The active ingredient is selexipag.
Each 200 microgram Uptravi tablet, film-coated, contains 200 micrograms of
selexipag
Each 400 microgram Uptravi tablet, film-coated, contains 400 micrograms of
selexipag
Each 600 microgram Uptravi tablet, film-coated, contains 600 micrograms of
selexipag
Each 800 microgram Uptravi tablet, film-coated, contains 800 micrograms of
selexipag
Each 1,000 microgram Uptravi tablet, film-coated, contains 1,000 micrograms of
selexipag
Each 1,200 microgram Uptravi tablet, film-coated, contains 1,200 micrograms of
selexipag
Each 1,400 microgram Uptravi tablet, film-coated, contains 1,400 micrograms of
selexipag
Each 1,600 microgram Uptravi tablet, film-coated, contains 1,600 micrograms of
selexipag
The other ingredients are:
Tablet core
Mannitol (E421)
Corn starch
Low substitution hydroxypropylcellulose
Hydroxypropylcellulose,
Magnesium stearate
Coating
Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxides (E172)
Carnauba wax
Each 200 microgram Uptravi tablet, film-coated, contains yellow iron oxide
(E172).
Each 400 microgram Uptravi tablet, film-coated, contains red iron oxide
(E172).
Each 600 microgram Uptravi tablet, film-coated, contains red iron oxide and
black iron oxide (E172).
Each 800 microgram Uptravi tablet, film-coated, contains yellow iron oxide and
black iron oxide (E172).
Each 1,000 microgram Uptravi tablet, film-coated, contains red iron oxide and
yellow iron oxide (E172).
Each 1,200 microgram Uptravi tablet, film-coated, contains black iron oxide and
red iron oxide (E172).
Each 1,400 microgram Uptravi tablet, film-coated, contains yellow iron oxide
(E172).
Each 1,600 microgram Uptravi tablet, film-coated, contains black iron oxide,
red iron oxide and yellow iron oxide (E172).

Descrizione dell'aspetto di Uptravi e contenuto della confezione
Uptravi 200 microgrammifilm-coated tablets: Film-coated tablets of light yellow color, round, with "2" imprinted on one side.

Uptravi 400 microgrammifilm-coated tablets: Film-coated tablets of red color, round, with "4" imprinted on one side.

Uptravi 600 microgrammifilm-coated tablets: Film-coated tablets of light purple color, round, with "6" imprinted on one side.

Uptravi 800 microgrammifilm-coated tablets: Film-coated tablets of green color, round, with "8" imprinted on one side.

Uptravi 1.000 microgrammifilm-coated tablets: Film-coated tablets of orange color, round, with "10" imprinted on one side.

Uptravi 1.200 microgrammifilm-coated tablets: Film-coated tablets of dark purple color, round, with "12" imprinted on one side.

Uptravi 1.400 microgrammifilm-coated tablets: Film-coated tablets of dark yellow color, round, with "14" imprinted on one side.

Uptravi 1.600 microgrammifilm-coated tablets: Film-coated tablets of brown color, round, with "16" imprinted on one side.
Uptravi 200 microgram film-coated tablets are available in blisters of 10, 60 or
140 tablets (titration pack).
Uptravi 400 microgram, 600 microgram, 800 microgram,

• 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets are available in blisters of 60 tablets.

Not all pack sizes may be marketed.

Titolare dell'autorizzazione all'immissione in commercio
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Produttore
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf: +45 4594 8282
[email protected]

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137 955 955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Τηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

IrelandSlovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

ÍslandSlovenská republika

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

GUIDE TO TITRATION - TITRATION PACK
Page 1
Uptravi film-coated tablets
selexipag
Guide to gradual dose increase (titration)
Starting Treatment with Uptravi
Inform your doctor if you experience any side effects, as they may recommend a change
in your dose of Uptravi. Inform your doctor if you are taking other medicines, as they may
recommend that you take Uptravi only once a day.

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The transition to the maintenance dose The maximum dose tolerated during titration will become the maintenance dose. The maintenance dose is the dose you need to continue taking regularly. Your doctor or nurse may prescribe a single tablet corresponding to the dose needed for the maintenance dose. This allows you to take one tablet in the morning and one in the evening, instead of taking multiple tablets for each dose.

r a For example, if the maximum dose tolerated during F titration was 1,200 micrograms in the morning and in the evening: l e d Over time, your doctor or nurse may decide to adjust the maintenance dose as needed.

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Use the following diary pages if your doctor or nurse prescribes 800 n microgram tablets together with 200 microgram tablets. a Using the diary, check that you i have taken an 800 microgram l tablet a every day in the morning and evening and write the t number of 200 microgram prescribed tablets. I a i

a Remember to talk to your IAP specialist doctor or nurse regularly. Write down the instructions provided by your doctor or nurse here: Doctor's office phone number or email: Pharmacist's phone number: Notes:

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