Adempas 1.0 mg film-coated tablets

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.

What is in this leaflet

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

Do not take Adempas:

• if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). These are medicines used for the treatment of high blood pressure in the arteries of the lungs (PAH) or erectile dysfunction.
• if you have severe liver problems (severe hepatic impairment, Child Pugh C).
• if you are allergic to riociguat or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.
• if you are taking nitrates or nitric oxide donors (such as amyl nitrite) in any form, medicines often used to treat high blood pressure, chest pain or heart disease. This also includes recreational drugs called poppers.
• if you have low blood pressure (systolic blood pressure less than 95 mmHg) before starting first treatment with this medicine.
• if you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).

If any of these applies to you, talk to your doctor first and do not take Adempas.

Warnings and precautions

Talk to your doctor or pharmacist before taking Adempas if:

• you have recently experienced serious bleeding from the lung, or if you have undergone treatment to stop coughing up blood (bronchial arterial embolisation).
• you take blood-thinning medicines (anticoagulants) since this may cause bleeding from the lungs. Your doctor will regularly monitor you.
• you feel short of breath during treatment with this medicine, this can be caused by a build-up of fluid in the lungs. Talk to your doctor if this happens.
• you have any symptoms of low blood pressure (hypotension) such as dizziness, lightheadedness, or fainting or if you are taking medicines to lower your blood pressure or medicines that cause an increase in urination or if you have problems with your heart or circulation. Your doctor may decide to monitor your blood pressure. If you are older than 65 years, you have an increased risk of developing low blood pressure.
• you take medicines used to treat fungal infections (e.g. ketoconazole, posaconazole, itraconazole) or medicines for the treatment of HIV infection (e.g. abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir). Your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
• your kidneys do not work properly (creatinine clearance < 30 ml/min) or if you are on dialysis as the use of this medicine is not recommended.
• you have moderate liver problems (hepatic impairment, Child Pugh B).
• you start or stop smoking during treatment with this medicine, because this may influence the level of riociguat in your blood.

You will receive Adempas only for special types of pulmonary arterial hypertension (PAH), see section 1. There is no experience in the use of Adempas in other types of PAH. Use of Adempas in other types of PAH is therefore not recommended. Your doctor will check if Adempas is suitable for you.

Children and adolescents

The use of Adempas in children and adolescents (under 18 years of age) should be avoided because efficacy and safety have not been established for this age group.

Other medicines and Adempas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular, medicines used for:

• high blood pressure or heart disease (such as nitrates and amyl nitrite) in any form, as you must not take those medicines together with Adempas.
• high blood pressure in the lung vessels (the pulmonary arteries), as you must not take certain medicines (sildenafil and tadalafil) together with Adempas. Other medicines for high blood pressure in the lung vessels (PAH), such as bosentan and iloprost, can be used with Adempas, but you should still tell your doctor.
• erectile dysfunction (such as sildenafil, tadalafil, vardenafil), as you must not take those medicines together with Adempas.
• fungal infections (such as ketoconazole, posaconazole, itraconazole) or HIV infection (such as abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine or ritonavir) because alternative treatment options may be considered. If you already take one of these medicines and start treatment with Adempas, your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
• epilepsy (e.g. phenytoin, carbamazepine, phenobarbitone).
• depression (St. John’s Wort).
• preventing rejection of transplanted organs (ciclosporin).
• joint and muscular pain (niflumic acid).
• cancer (such as erlotinib, gefitinib).
• stomach disease or heartburn (antacids such as aluminium hydroxide/magnesium hydroxide). These antacid medicines should be taken at least two hours before or one hour after taking Adempas.
• nausea, vomiting (feeling or being sick) (such as granisetron).

Smoking

If you smoke, it is recommended that you stop, as smoking may reduce the effectiveness of these tablets. Please tell your doctor if you smoke or if you stop smoking during treatment.

Pregnancy and breast-feeding

Pregnancy

Do not take Adempas during pregnancy. If there is a chance you could become pregnant, use reliable forms of contraception while you are taking these tablets. You are also advised to take monthly pregnancy tests. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding

If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine because it might harm your baby. You should not breast-feed while taking this medicine. Your doctor will decide with you if you either should stop breast-feeding or stop treatment with Adempas.

Driving and using machines

Adempas has moderate influence on the ability to drive and use machines. It may cause side effects such as dizziness. You should be aware of the side effects of this medicine before driving or using machines (see section 4).

Adempas contains lactose

If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Adempas contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.

If you take more Adempas than you should

If you have taken more tablets than you should and experience any side effects (see section 4), please contact your doctor. If your blood pressure drops (which can make you feel dizzy) then you may need immediate medical attention.

If you forget to take Adempas

Do not take a double dose to make up for a forgotten dose. If you miss a dose, continue with the next dose as planned.

If you stop taking Adempas

Do not stop taking this medicine without talking to your doctor first, because this medicine prevents the progression of the disease. If your treatment has to be stopped for 3 days or more, please tell your doctor before restarting your treatment.

If you are transitioning between sildenafil or tadalafil and Adempas

• If you are stopping sildenafil, you must wait at least 24 hours before you take Adempas.
• If you are stopping tadalafil, you must wait at least 48 hours before you take Adempas.
• If you are stopping Adempas to change to another medicine called a PDE5 inihibitor (e.g. sildenafil or tadalafil) you must wait at least 24 hours from your last dose of Adempas before you take the PDE5 inhibitor.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

Malta

What Adempas contains

• The active substance is riociguat.
  Adempas 0.5 mg film-coated tablets
  Each film-coated tablet contains 0.5 mg riociguat.
  Adempas 1 mg film-coated tablets
  Each film-coated tablet contains 1 mg riociguat.
  Adempas 1.5 mg film-coated tablets
  Each film-coated tablet contains 1.5 mg riociguat.
  Adempas 2 mg film-coated tablets
  Each film-coated tablet contains 2 mg riociguat.
  Adempas 2.5 mg film-coated tablets
  Each film-coated tablet contains 2.5 mg riociguat.
• The other ingredients are:
  Tablet core: cellulose microcrystalline, crospovidone (type B), hypromellose 5 cP, lactose monohydrate, magnesium stearate and sodium laurilsulfate (see end of section 2 for further information on lactose).
  Film-coat: hydroxypropylcellulose, hypromellose 3 cP, propylene glycol (E 1520) and titanium dioxide (E 171).
  Adempas 1 mg, 1.5 mg tablets also contains iron oxide yellow (E 172).
  Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).

What Adempas looks like and contents of the pack

Adempas is a film-coated tablet:

Adempas 0.5 mg film-coated tablets

• 0.5 mg tablet: white, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 0.5 and an “R” on the other side.

Adempas 1 mg film-coated tablets

• 1 mg tablet: pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1 and an “R” on the other side.

Adempas 1.5 mg film-coated tablets

• 1.5 mg tablet: yellow-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1.5 and an “R” on the other side.

Adempas 2 mg film-coated tablets

• 2 mg tablet: pale orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2 and an “R” on the other side.

Adempas 2.5 mg film-coated tablets

• 2.5 mg tablet: red-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2.5 and an “R” on the other side.

They are available in packs of:

• 42 tablets: two transparent calendar blisters of 21 tablets each.
• 84 tablets: four transparent calendar blisters of 21 tablets each.
• 90 tablets: five transparent blisters of 18 tablets each.
• 294 tablets: fourteen transparent calendar blisters of 21 tablets each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.