OPSUMIT 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Opsumit 10mg 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Opsumit and what is it 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 with other medicines for PAH. 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 can become narrowed, so the heart has to work harder to pump blood through them. As a result, people with PAH 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, alleviates symptoms, and improves the progression of the disease.

2. What you need to know before you take Opsumit

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 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 breast-feeding”.
• if you are breast-feeding. See section “Pregnancy and breast-feeding”.
• if you have liver disease or if you have very high levels of liver enzymes in your blood. Consult your doctor, who will decide if the medicine is suitable for you.

If you meet any of the above points, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting 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:

• if you have anaemia (reduced number of red blood cells)
• if your liver is working properly

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

• dizziness
• fatigue/general malaise/weakness
• rapid heart rate, palpitations
• pallor

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

The signs that your liver may not be working properly are:

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

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

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

The use of medicines for the treatment of PAH, including Opsumit, in patients with pulmonary veno-occlusive disease (obstruction of the pulmonary veins) may cause 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 oxygen, talk to your doctor immediately. Your doctor may perform additional tests and determine the most suitable 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 tested 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

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

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

• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
• phenytoin (medicine used to treat seizures),
• carbamazepine (used to treat depression and epilepsy),
• St. John's Wort (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 breast-feeding

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.

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

• If you can become pregnant, use a reliable method of contraception while taking Opsumit. Talk to your doctor about this.
• Do not take Opsumit if you are pregnant or plan to become pregnant.
• If you become pregnant or think you may have become pregnant during treatment with Opsumit, or shortly after stopping treatment (up to 1 month), consult your doctor immediately.

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

It is not known if Opsumit passes into breast milk. Do not breast-feed during treatment with Opsumit. Talk to your doctor about this.

Driving and using machines

Opsumit may cause side effects such as headaches and hypotension (listed in section 4) and the symptoms of the disease can also make you less fit to drive.

Opsumit contains lactose, soya lecithin, and sodium

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

Opsumit contains soya lecithin. If you are allergic to soya, do not take this medicine (see section 2 ‘Do not take Opsumit’).

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

3. How to take Opsumit

Opsumit should only be prescribed by a doctor with experience in the treatment of pulmonary arterial hypertension.

Follow the instructions for administration given by your doctor. If you are unsure, consult your doctor again.

The recommended dose of Opsumit is one 10 mg tablet once a day. Swallow the tablet whole, with a glass of water, and do not chew or break it. Opsumit can 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 you should, you will experience headache, nausea, or vomiting. Seek advice from your doctor.

If you forget to take Opsumit

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

If you stop taking Opsumit

Opsumit is a treatment that you should continue to take to control 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Allergic reactions (inflammation around the eyes, face, lips, tongue, or throat, itching and/or skin rash)

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

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

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

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

• Pharyngitis (inflammation of the throat)
• Influenza
• Urinary tract infection (infection of the bladder)
• Hypotension (low blood pressure)
• Nasal congestion (stuffy nose)
• Elevated liver tests
• Leucopenia (reduced white blood cell count)
• Thrombocytopenia (reduced platelet count)

Reporting of side effects

If you experience 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.

5. Storage of Opsumit

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, bottle, and on the blister after “EXP”. The expiry date refers to the last day of the month shown.

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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Opsumit contains

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

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

Appearance and packaging

Opsumit 10 mg film-coated tablets are white to off-white, round, and have “10” engraved 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.

Not all pack sizes may be marketed.

Marketing authorisation 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

You can get more information on this medicine by contacting the representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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