Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - opsumit

Document Subject

Generated Narrative: MedicinalProductDefinition mp86f804709e3279dcca0da696e8a674dd

identifier: http://ema.europa.eu/identifier/EU/1/13/893/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Opsumit 10 mg 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-86f804709e3279dcca0da696e8a674dd

identifier: http://ema.europa.eu/identifier/EU/1/13/893/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - opsumit

Attesters

What is in this leaflet

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

Opsumit contains the active substance macitentan, which belongs to the class of medicines called endothelin receptor antagonists . Opsumit is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults; it can be used on its own or with other medicines for PAH. 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 get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy, and short of breath. Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure, relieves the symptoms and improves the course of the disease.

Do not take Opsumit

if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6).

if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). See section Pregnancy and breastfeeding .

if you are breastfeeding. See section Pregnancy and breastfeeding .

if you have liver disease or if you have very high levels of liver enzymes in your blood. Talk to your doctor, who will decide whether this medicine is suitable for you. If any of these apply to you, please tell your doctor. Warnings and precautions Talk to your doctor or pharmacist before taking Opsumit. You will need blood tests, as indicated by your doctor: Your doctor will take blood test before you start treatment with Opsumit and during treatment to test:

whether you have anaemia (a reduced number of red blood cells)

whether your liver is working properly If you have anaemia (a reduced number of red blood cells), you may have the following signs:

dizziness

fatigue/malaise/weakness

fast heart rate, palpitations

pallor If you notice any of these signs, tell your doctor. Signs that your liver may not be working properly include:

feeling sick (nausea)

vomiting

fever

pain in your stomach (abdomen)

yellowing of your skin or the whites of your eyes (jaundice)

dark-coloured urine

itching of your skin

unusual tiredness or exhaustion (lethargy or fatigue)

flu-like syndrome (joint and muscle pain with fever) If you notice any of these signs, tell your doctor immediately. If you have kidney problems, talk to your doctor before using Opsumit. Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems. In patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Opsumit, may lead to pulmonary oedema. If you have signs of pulmonary oedema when using Opsumit, such as a sudden, important increase in breathlessness and low oxygen, tell your doctor immediately. Your doctor may perform additional tests, and will determine what treatment regimen is most suitable for you. Children and adolescents Do not give this medicine to children and adolescents below 18 years because Opsumit has not been tested in children. Other medicines and Opsumit Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Opsumit can affect other medicines. If you take Opsumit together with other medicines including those listed below, the effects of Opsumit or the other medicines might be altered. Please talk to your doctor or pharmacist if you are taking any of the following medicines:

rifampicin, clarithromycin, telithromycin, ciprofloxacin, erythromycin (antibiotics used to treat infections),

phenytoin (a medicine used to treat seizures),

carbamazepine (used to treat depression and epilepsy),

St. John s Wort (an herbal preparation used to treat depression),

ritonavir, saquinavir (used to treat HIV infections),

nefazodone (used to treat depression),

ketoconazole (except shampoo), fluconazole, itraconazole, miconazole, voriconazole (medicines used against fungal infections)

amiodarone (to control the heartbeat)

cyclosporine (used to prevent organ rejection after transplant)

diltiazem, verapamil (to treat high blood pressure or specific heart problems) Opsumit with food If you are taking piperine as a dietary supplement, this may alter how the body responds to some medicinal products, including Opsumit. Please talk to your doctor or pharmacist should this be the case. Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Opsumit may harm unborn babies conceived before, during or soon after treatment.

If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you are taking Opsumit. Talk to your doctor about this.

Do not take Opsumit if you are pregnant or planning to become pregnant.

If you become pregnant or think that you may be pregnant while you are taking Opsumit, or shortly after stopping Opsumit (up to 1 month), see your doctor immediately. If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Opsumit and regularly (once a month) while you are taking Opsumit. It is not known if Opsumit is transferred to breast milk. Do not breastfeed while you are taking Opsumit. Talk to your doctor about this. Fertility If you are a man taking Opsumit, it is possible that this medicine may lower your sperm count. Talk to your doctor if you have any questions or concerns about this. Driving and using machines Opsumit can cause side effects such as headaches and hypotension (listed in section 4), and the symptoms of your condition can also make you less fit to drive. Opsumit contains lactose, lecithin from soya and sodium Opsumit contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Opsumit contains lecithin derived from soya. If you are allergic to soya, do not use this medicine (see section 2 Do not take Opsumit ). This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Opsumit should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The recommended dose of Opsumit is one 10 mg tablet, once a day. Swallow the whole tablet, with a glass of water, do not chew or break the tablet. You can take Opsumit with or without food. It is best to take the tablet at the same time each day. If you take more Opsumit than you should If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting. Ask your doctor for advice. If you forget to take Opsumit If you forget to take Opsumit, take a dose as soon as you remember, then continue to take your tablets at the usual times. Do not take a double dose to make up for a forgotten tablet. If you stop taking Opsumit Opsumit is a treatment that you will need to keep on taking to control your PAH. Do not stop taking Opsumit unless you have agreed this with your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon side effects (may affect up to 1 in 100 people)

Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or rash) If you notice any of these signs, tell your doctor immediately. Very common side effects (may affect more than 1 in 10 people)

Anaemia (low number of red blood cells) or reduced haemoglobin

Headache

Bronchitis (inflammation of the airways)

Nasopharyngitis (inflammation of the throat and nasal passages)

Oedema (swelling), especially of the ankles and feet Common side effects (may affect up to 1 in 10 people)

Pharyngitis (inflammation of the throat)

Influenza (flu)

Urinary tract infection (bladder infection)

Hypotension (low blood pressure)

Nasal congestion (blocked nose)

Elevated liver tests

Leukopenia (decreased white blood cell counts)

Thrombocytopenia (decreased blood platelet counts)

Flushing (redness of the skin) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 Opsumit after the expiry date which is stated on the carton and blister after EXP . The expiry date refers to the last day of that month. Do not store above 30 C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help to protect the environment.

What Opsumit contains

The active substance is macitentan. Each tablet contains 10 mg macitentan.

The other ingredients are lactose monohydrate (see section 2 Opsumit contains lactose, lecithin from soya and sodium ), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 Opsumit contains lactose, lecithin from soya and sodium ), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 Opsumit contains lactose, lecithin from soya and sodium ) and xanthan gum (E415). What Opsumit looks like and contents of the pack Opsumit 10 mg tablets are white to off-white, biconvex, round, film-coated tablets with 10 on both sides. Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15 or 30 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 T l/Tel: +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 . . . . : +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: