Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - uptravi

Document Subject

Generated Narrative: MedicinalProductDefinition mpf797cc0b9b4e9335a18d81e479368f3c

identifier: http://ema.europa.eu/identifier/EU/1/15/1083/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Uptravi 200 microgram film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f797cc0b9b4e9335a18d81e479368f3c

identifier: http://ema.europa.eu/identifier/EU/1/15/1083/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - uptravi

Attesters

What is in 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 package and other information

Uptravi is a medicine that contains the active substance selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen. Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be used on its own if the patient is not a candidate for these medicines. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them. This may cause people to feel tired, dizzy, short of breath, or experience other symptoms. By acting in a similar way to the natural substance prostacyclin, this medicine widens the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries. Uptravi lowers the pressure in the pulmonary arteries, it relieves the symptoms of PAH and slows down progression of PAH disease.

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 a heart problem, such as:

poor blood flow to the heart muscles (severe coronary heart disease or unstable angina); symptoms can include chest pain

heart attack within the last 6 months

weak heart (decompensated cardiac failure) that is not under close medical observation

severe irregular heartbeat

defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension)

if you have had a stroke within the last 3 months, or any other occurrence that reduced the blood supply to the brain (e.g., transient ischaemic attack)

if you are taking gemfibrozil (medicine used to lower the level of fats [lipids] in the blood) Warnings and precautions Talk to your PAH doctor or nurse before taking Uptravi if you

are taking medicines for high blood pressure

have low blood pressure associated with symptoms such as dizziness

have recently experienced significant blood loss or fluid loss such as severe diarrhoea or vomiting

have problems with your thyroid gland

have severe problems with your kidneys or are undergoing dialysis

have or have had severe problems with your liver not working properly If you notice any of the above signs or your condition changes, 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 older than 75 years. Uptravi should be used with caution in this age group. Other medicines and Uptravi Tell your doctor if you are taking, have recently taken, or might take any other medicines. Taking other medicines may affect how Uptravi works. Talk to your PAH 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 blood clots in coronary artery disease)

Deferasirox (medicine used to remove iron from the blood stream)

Teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis)

Carbamazepine (medicine used to treat some forms of epilepsy, nerve pain or to help control serious mood disorders when some other medicines do not work)

Phenytoin (medicine used to treat epilepsy)

Valproic acid (medicine used to treat epilepsy)

Probenecid (medicine used to treat gout)

Fluconazole, rifampicin or rifapentine (antibiotics used to treat infections) Pregnancy and breast-feeding Uptravi is not recommended during pregnancy and breast-feeding. If you are a woman who can have children, you should use an effective contraceptive method while taking Uptravi. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines Uptravi can cause side effects such as headaches and low blood pressure (see section 4), which may affect your ability to drive; the symptoms of your condition can also make you less fit to drive.

Uptravi should only be prescribed by a doctor experienced in the treatment of PAH. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are in doubt or have any questions. Tell your doctor if you experience side effects, as your doctor may recommend that you change your Uptravi dose. Tell your doctor if you are taking other medicines as your doctor may recommend that you take Uptravi only once daily. If you have poor vision or experience any type of blindness, get help from another person when taking Uptravi during the titration period (process of gradually increasing your dose). Finding the right dose for you At the start of treatment, you will take the lowest dose. This is one 200 microgram tablet in the morning and another 200 microgram tablet in the evening, about 12 hours apart. It is recommended to initiate treatment in the evening. Your doctor will instruct you to gradually increase your dose. This is called titration. It lets your body adjust to the new medicine. The goal of titration is to reach the most appropriate dose. This will be the highest dose you can tolerate, which may reach the maximum dose of 1,600 micrograms in the morning and in the evening. The first pack of tablets you receive will contain the light-yellow 200 microgram tablets. Your doctor will tell you to increase your dose in steps, usually every week but the interval between increases could be longer. With each step, you will add one 200 microgram tablet to your morning dose and another 200 microgram tablet to your evening dose. The first intake of the increased dose is recommended to be in the evening. The diagram below shows the number of tablets to take every morning and every evening for the first 4 steps. If your doctor tells you to increase your dose further, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose with each new step. The first intake of the increased dose is recommended to be in the evening. If your doctor instructs you to further increase your dose and move to step 5, this may be done by taking one green 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 Uptravi is 1,600 micrograms in the morning and 1,600 micrograms in the evening. However, not every patient will reach this dose, because different patients require different doses. The diagram below shows the number of tablets to take every morning and every evening at each step, starting with step 5. You will receive the titration pack which contains a titration guide and Patient Leaflet. The titration guide is providing information on the titration process and is allowing you to record the number of tablets you take every day. Remember to record the number of tablets you take every day in your titration diary. The titration steps usually last about 1 week. If your doctor instructs you to prolong each titration step longer than 1 week, there are additional diary pages to allow you to track this. Remember to talk to your PAH doctor or nurse regularly during titration. Stepping down to a lower dose due to side effects During titration, you may experience side effects such as headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face (see section 4). If these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them. There are treatments available that can help relieve the side effects. For example, painkillers such as paracetamol may help treat pain and headache. If the side effects cannot be treated or do not gradually get better on the dose you are taking, your doctor may adjust your dose by reducing the number of 200 microgram light-yellow tablets you take by one in the morning and by one in the evening. The diagram below shows stepping down to a lower dose. Do this only if instructed to do so by your doctor. If your side effects are manageable after stepping down your dose, your doctor may decide that you should stay on that dose. Please see section Maintenance dose below for more information. Maintenance dose The highest dose that you can tolerate during titration will become your maintenance dose. Your maintenance dose is the dose you should continue to take on a regular basis. Your doctor will prescribe a suitable tablet strength for your maintenance dose. This allows you to take one tablet in the morning and one in the evening, instead of multiple tablets each time. For a full description of Uptravi tablets, including colours and marking, please see section 6 of this leaflet. Over time, your doctor may adjust your maintenance dose as needed. If, at any time, after taking the same dose for a long time, you experience side effects that you cannot tolerate or side effects that have an impact on your normal daily activities, contact your doctor as your dose may need to be reduced. The doctor may then prescribe you a lower single-tablet strength. Please remember to dispose of unused tablets (see section 5). Take Uptravi once in the morning and once in the evening, about 12 hours apart. Take the tablets with meals as you might tolerate your medicine better. The tablet coating provides protection. Swallow the tablets whole with a glass of water. Do not split, crush or chew the tablets. If you take more Uptravi than you should If you have taken more tablets than you have been 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, then continue to take your tablets at the usual times. If it is nearly time for your next dose (within 6 hours before you would normally take it), you should skip the missed dose and continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten tablet. If you stop taking Uptravi Suddenly stopping your treatment with Uptravi might lead to your symptoms getting worse. Do not stop taking Uptravi unless your doctor tells you to. Your doctor may tell you to reduce the dose gradually before stopping completely. If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you missed 3 morning and 3 evening doses, or 6 doses in a row or more), contact your doctor immediately as your dose may need to be adjusted to avoid side effects. Your doctor may decide to restart your treatment on a lower dose, gradually increasing to your previous maintenance dose. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. You may experience side effects not only during the titration period when your dose is being increased, but also later after taking the same dose for a long time. If you experience any of these side effects: headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face, that you cannot tolerate or that cannot be treated, you should contact your doctor as 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 (reddening of the face)

Nausea and vomiting (feeling sick and being sick)

Diarrhoea

Jaw pain, muscle pain, joint pain, leg pain

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

Anaemia (low red blood cell levels)

Hyperthyroidism (overactive thyroid gland)

Reduced appetite

Weight loss

Hypotension (low blood pressure)

Stomach pain, including indigestion

Pain

Changes in some blood test results including those measuring blood cell counts or your thyroid function

Rashes, including hives, may cause a burning or stinging sensation and skin redness Uncommon side effects (may affect up to 1 in 100 people)

Increased heart rate Reporting of side effects If you have any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use Uptravi after the expiry date, which is stated on the carton and on the blister after EXP.
The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. No special requirements for disposal.

What Uptravi contains The active substance is selexipag. Uptravi 200 microgram film-coated tablets contain 200 micrograms of selexipag Uptravi 400 microgram film-coated tablets contain 400 micrograms of selexipag Uptravi 600 microgram film-coated tablets contain 600 micrograms of selexipag Uptravi 800 microgram film-coated tablets contain 800 micrograms of selexipag Uptravi 1,000 microgram film-coated tablets contain 1,000 micrograms of selexipag Uptravi 1,200 microgram film-coated tablets contain 1,200 micrograms of selexipag Uptravi 1,400 microgram film-coated tablets contain 1,400 micrograms of selexipag Uptravi 1,600 microgram film-coated tablets contain 1,600 micrograms of selexipag The other ingredients are: Tablet core Mannitol (E421) Maize starch Low-substituted hydroxypropylcellulose Hydroxypropylcellulose Magnesium stearate Film coating Hypromellose Propylene glycol Titanium dioxide (E171) Iron oxides (E172) Carnauba wax Uptravi 200 microgram film-coated tablets contain iron oxide yellow (E172). Uptravi 400 microgram film-coated tablets contain iron oxide red (E172). Uptravi 600 microgram film-coated tablets contain iron oxide red and iron oxide black (E172). Uptravi 800 microgram film-coated tablets contain iron oxide yellow and iron oxide black (E172). Uptravi 1,000 microgram film-coated tablets contain iron oxide red and iron oxide yellow (E172). Uptravi 1,200 microgram film-coated tablets contain iron oxide black and iron oxide red (E172). Uptravi 1,400 microgram film-coated tablets contain iron oxide yellow (E172). Uptravi 1,600 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172). What Uptravi looks like and contents of the pack Uptravi 200 microgram film-coated tablets: Round, light-yellow, film-coated tablets with 2 marked on one side. Uptravi 400 microgram film-coated tablets: Round, red, film-coated tablets with 4 marked on one side. Uptravi 600 microgram film-coated tablets: Round, light-violet, film-coated tablets with 6 marked on one side. Uptravi 800 microgram film-coated tablets: Round, green, film-coated tablets with 8 marked on one side. Uptravi 1,000 microgram film-coated tablets: Round, orange, film-coated tablets with 10 marked on one side. Uptravi 1,200 microgram film-coated tablets: Round, dark-violet, film-coated tablets with 12
marked on one side. Uptravi 1,400 microgram film-coated tablets: Round, dark-yellow, film-coated tablets with 14
marked on one side. Uptravi 1,600 microgram film-coated tablets: Round, brown, film-coated tablets with 16 marked on one side. Uptravi 200 microgram film-coated tablets are supplied in blister packs of 10 or 60 tablets and 60 or 140 tablets (titration packs). Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets are supplied in blister packs of 60 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: +353 1 800 709 Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. TITRATION GUIDE - TITRATION PACK Page 1 Uptravi film-coated tablets selexipag Titration Guide Starting Treatment with Uptravi Please read the accompanying patient information leaflet before starting treatment. Tell your doctor if you experience side effects, as your doctor may recommend that you change your Uptravi dose. Tell your doctor if you are taking other medications as your doctor may recommend that you take Uptravi only once daily. Page 2 Page 3 Contents How should you take Uptravi? ...................................4 How should you step up your dose? ...........................6 What are the steps? .....................................................8 When should you step down? ...................................Stepping down ..When you move to your maintenance dose.............If you forget to take Uptravi.....................................If you stop taking Uptravi.........................................Titration diary...........................................................Page 4 Page 5 How should you take Uptravi? Uptravi is a medicine taken every morning and evening for the treatment of pulmonary arterial hypertension, also called PAH. The starting dose for Uptravi is 200 micrograms once in the morning and once in the evening. The first intake of Uptravi should be in the evening. You should take each dose with a glass of water, preferably during a meal. There are 2 phases of treatment with Uptravi: Titration In the first several weeks, you will work with your doctor to find the dose of Uptravi that is right for you. Your doctor may have you step up from the starting dose to higher doses of Uptravi. Your doctor may step you down to a lower dose. This process is called titration. It lets your body gradually adjust to the medicine. Maintenance Once your doctor has found the dose that is right for you, this will be the dose you take on a regular basis. This is called the maintenance dose. Page 6 Page 7 How should you step up your dose? You will start at the 200 microgram dose in the morning and in the evening and after discussing with your doctor or nurse step up to the next dose. The first intake of the increased dose should be in the evening. Each step usually lasts about 1 week. It could take several weeks to find the dose that is right for you. The goal is to reach the dose that is most appropriate to treat you. This dose will be your maintenance dose. Every patient with PAH is different. Not everyone will end up on the same maintenance dose. Some patients may have 200 micrograms in the morning and in the evening as their maintenance dose, while some will reach the highest dose of 1,600 micrograms in the morning and in the evening. Others may reach a maintenance dose somewhere inbetween. What is important is that you reach the dose that is most appropriate to treat you. Page 8 Page 9 Page Page When should you step down? As with all medicines, you may experience side effects with Uptravi as you step up to higher doses. Talk to your doctor or nurse if you have side effects. There are treatments available that can help relieve them. The most common side effects (may affect more than 1 in 10 people) you may experience while taking Uptravi are: Headache Diarrhoea Nausea Vomiting Jaw pain Muscle pain Leg pain Joint pain Facial redness For a full list of side effects see package leaflet for further information. If you cannot tolerate the side effects even after your doctor or nurse has tried to treat them, he or she may recommend you step down to a lower dose. If your doctor or nurse tells you to step down to a lower dose, you should take one less 200 microgram tablet in the morning and one less in the evening. You should only step down after speaking with your PAH doctor or nurse. This stepping-down process will help you find the dose that is right for you, also called your maintenance dose. Page Page Page Page When you move to your maintenance dose The highest dose that you can tolerate during titration will become your maintenance dose. Your maintenance dose is the dose you should continue to take on a regular basis. Your doctor or nurse can prescribe an equivalent single-tablet strength for your maintenance dose. This lets you take just one tablet in the morning and one in the evening, instead of multiple tablets for each dose. For example, if your highest tolerated dose during titration was 1,200 micrograms once in the morning and once in the evening: Over time, your doctor or nurse may adjust your maintenance dose as needed. Page Page If you forget to take Uptravi If you miss a dose, take the dose as soon as you remember, then continue to take your tablets at the usual times. If it is within 6 hours of when you would normally take your next dose, you should skip the missed dose and continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten tablet. If you stop taking Uptravi Do not stop taking Uptravi unless your doctor or nurse tells you to. If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you missed 6 doses in a row), contact your PAH doctor or nurse immediately as your dose may need to be adjusted to avoid side effects. Your doctor or nurse may have you resume treatment at a lower dose, gradually increasing to your previous maintenance dose. Page Page Titration diary Please read the instructions in the package leaflet carefully. The following diary pages help you keep track of the number of tablets you need to take in the morning and evening during titration. Use them to write down the number of tablets you take in the morning and the evening. Each step usually lasts about 1 week, unless your doctor or nurse instructs you otherwise. If your titration steps last longer than 1 week there are additional diary pages to track this. Use pages 20 to 27 to track the first weeks of treatment, when you are using 200 microgram tablets only (steps 1 4). If you have been prescribed both 200 and 800 microgram tablets, use pages 30 to (steps 5 8). Remember to talk to your PAH doctor or nurse regularly. Write down your doctor or nurse s instructions: Doctor s office telephone and e-mail: Pharmacist s telephone: Notes: Page Page Page Page Page Page Page Page Page Page Use the following diary pages if your doctor or nurse prescribes 800 microgram tablets in addition to your 200 microgram tablets. On the diary pages, check off that you have taken one 800 microgram tablet every day in the morning and in the evening with your prescribed number of 200 microgram tablets. Remember to talk to your PAH doctor or nurse regularly. Write down your doctor or nurse s instructions: Doctor s office telephone and e-mail: Pharmacist s telephone: Notes: Page Page Page Page Page Page Page Page Page Page Notes Page 40