Opsiumit 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Opsumit 10 mg film-coated tablets

macitentan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Opsumit is and what it is used for

Opsumit contains the active substance macitentan, which belongs to a 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 alone or in combination with other PAH medicines. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries). In people with PAH, these arteries may become narrowed, causing the heart to work harder to pump blood through them. As a result, affected individuals feel tired, dizzy, and have difficulty breathing.

Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them. This reduces blood pressure, relieves symptoms, and improves the course of the disease.

2. What you need to know before taking Opsumit

Do not take Opsumit

• if you are allergic to macitentan, soy, or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or planning to become pregnant, or if you could become pregnant because you are not using a reliable method of 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. Consult your doctor, who will decide whether the medicine is suitable for you.

If any of the above apply to you, inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Opsumit.

You will need to have blood tests as directed by your doctor:

Your doctor will perform blood tests before you start treatment with Opsumit and during treatment to determine:

• whether you have anaemia (reduction in the number of red blood cells)
• whether your liver is functioning properly

If you have anaemia (reduction in the number of red blood cells), you may experience the following signs:

• dizziness
• fatigue/general discomfort/weakness
• rapid heartbeat, palpitations
• paleness

If you experience any of these signs, talk to your doctor.

Signs indicating that your liver may not be functioning properly include:

• nausea
• vomiting
• fever
• stomach pain (abdominal pain)
• yellowing of the skin or whites of the eyes (jaundice)
• dark-coloured urine
• itching of the skin
• unusual tiredness or exhaustion (lethargy or fatigue)
• flu-like symptoms (joint or muscle pain with fever)

If you experience any of these signs, contact your doctor immediately.

If you have kidney problems, talk to your doctor before using Opsumit. Macitentan may cause a greater reduction in blood pressure and a decrease in haemoglobin in patients with kidney problems.

The use of medications for the treatment of PAH, including Opsumit, in patients with pulmonary veno-occlusive disease (blockage of the pulmonary veins) may lead to pulmonary oedema. If you experience signs of pulmonary oedema during treatment with Opsumit, such as a sudden and significant increase in shortness of breath and low oxygen levels, contact your doctor immediately. Your doctor may perform additional tests and determine the most appropriate treatment for you.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as Opsumit has not been studied in children.

Elderly

Information on Opsumit in patients over 75 years of age is limited. Opsumit should be used with caution in this age group.

Other medicines and Opsumit

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Opsumit may affect other medicines.

If you take Opsumit together with other medicines, including those listed below, the effects of Opsumit or other medicines may be altered. Talk to your doctor or pharmacist if you are taking any of the following medicines:

• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
• phenytoin (a medicine used to treat seizures),
• carbamazepine (used to treat depression and epilepsy),
• St. John's wort (a herbal medicine used to treat depression),
• ritonavir, saquinavir (used to treat HIV infection),
• nefazodone (used to treat depression),
• ketoconazole (except shampoo), itraconazole, voriconazole (medicines used to treat fungal infections)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Opsumit may harm fetuses conceived before, during, or shortly after treatment.

• If you could become pregnant, use a reliable method of contraception while taking Opsumit. Discuss this with your doctor.
• Do not take Opsumit if you are pregnant or planning to become pregnant.
• If you become pregnant or think you may have become pregnant during treatment with Opsumit, or shortly after stopping Opsumit (within 1 month), contact your doctor immediately.

If you are a woman of childbearing potential, your doctor will ask you to take a pregnancy test before starting Opsumit and periodically (once a month) during treatment.

It is unknown whether Opsumit passes into breast milk. Do not breastfeed during treatment with Opsumit. Talk to your doctor about this.

Driving and use of machines

Opsumit may cause adverse effects such as headache and hypotension (listed in section 4), and symptoms of the disease may also affect your ability to drive.

Opsumit contains lactose, soy lecithin, and sodium

Opsumit contains a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Opsumit contains lecithin derived from soy. If you are allergic to soy, do not take this medicine (see section 2 'Do not take Opsumit').

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this means it is essentially "sodium-free".

3. How to take Opsumit

Opsumit must only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension.

Follow exactly the administration instructions given by your physician. In case of doubt, consult your physician again.

The recommended dose of Opsumit is one 10 mg tablet once daily. Swallow the tablet whole with a glass of water; do not chew or break it. Opsumit may be taken 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 take more tablets than prescribed, you may experience headache, nausea, or vomiting. Seek medical advice from your physician.

If you forget to take Opsumit

If you forget to take Opsumit, take a dose as soon as you remember, and then continue taking the tablets at your usual times. Do not take a double dose to make up for a missed dose.

If you stop taking Opsumit

Opsumit is a treatment you must continue taking for the control of PAH. Do not stop taking Opsumit unless agreed with your physician.

If you have any further questions about the use of this medicine, ask your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 100 people):

• Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or skin redness/erythema).

If you experience any of these symptoms, speak with your doctor immediately.

Very common adverse effects (may affect more than 1 in 10 people):

• Anaemia (reduced number of red blood cells) or decreased haemoglobin
• Headache
• Bronchitis (inflammation of the airways)
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Oedema (swelling), especially in ankles and feet

Common adverse 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)
• Increased liver function tests
• Leucopenia (reduced white blood cell count in the blood)
• Thrombocytopenia (reduced platelet count in the blood)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Opsumit

Keep this medicine out of the sight and reach of children.

Do not use Opsumit after the expiry date stated on the packaging, bottle, and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Opsumit

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

• The other components are lactose monohydrate (see section 2 “Opsumit contains lactose, soy lecithin, and sodium”), microcrystalline cellulose (E460i), povidone, sodium starch glycolate type A (see section 2 “Opsumit contains lactose, soy lecithin, and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soy lecithin (E322; see section 2 “Opsumit contains lactose, soy lecithin, and sodium”), and xanthan gum (E415).

Nature of the product and contents of the pack

Opsumit 10 mg tablets are white to off-white, film-coated, round tablets, marked with “10” on both sides.

Opsumit is available as 10 mg film-coated tablets in blisters of 15 or 30 tablets, or in bottles of 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV
Turnhoutseweg 30
B 2340 Beerse
Belgium

Manufacturer

Actelion Manufacturing GmbH
Emil-Barrel-Strasse 7
79639 Grenzach-Wyhlen
Germany

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.