MSD

0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg film-coated tablets 
riociguat

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Adempas is and what it is used for

Adempas contains the active substance riociguat. Riociguat is a type of medicine called a guanylate cyclase (GC) stimulant. It works by dilating the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs. Adempas can be used to treat adults with certain forms of pulmonary hypertension, a condition in which these blood vessels become narrow, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels. Because the heart has to work harder than normal, people with pulmonary hypertension feel tired, dizzy, and short of breath. By widening the repressed arteries lead to the use of Adempas to improve your ability to be physically active.

Adempas is used for two types of pulmonary hypertension:

  • chronic thromboembolic pulmonary hypertension (CTEPH).In CTEPH, the blood vessels in the lungs are clogged or narrowed due to blood clots. Adempas can be used in patients with CTEPH who cannot be operated on and in patients who, after an operation, still have high blood pressure or who regain high blood pressure in their lungs.
  • certain types of pulmonary arterial hypertension (PAH).In PAH, the vessel walls in the lungs are thickened so that the vessels become narrow. Adempas is only prescribed for certain forms of PAH, namely idiopathic pah (the cause of PAH is unknown), hereditary PAH, and PAH caused by connective tissue disease. Your doctor will check this. Adempas can be taken alone or with some other medicines used to treat PAH.

2. What you need to know before taking Adempas

Do not take Adempas:

  • if you are taking certain medicines called PDE -5 inhibitors (eg sildenafil, tadalafil, vardenafil). These drugs are used to treat high blood pressure in the pulmonary arteries (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 used to treat high blood pressure, chest pain, or heart disease. This also applies to “party drugs”, ie. so-called “poppers”
  • if you have low blood pressure (systolic blood pressure below 95 mmHg) before the first treatment with this medicine
  • if you have increased pressure in your lung circulation due to scarring of the lungs, of unknown cause ( idiopathic pulmonary pneumonia )

If any of these apply to you, do not take Adempas without talking to your doctor first.

Warnings and cautions

Talk to your doctor or pharmacist before taking Adempas if:

  • you have recently had severe bleeding in the lung or if you have undergone treatment to stop coughing up blood (bronchial arterial embolization)
  • you are taking blood thinners ( anticoagulants ) as this may cause bleeding in the lungs. Your doctor will follow you up regularly
  • you become short of breath during treatment with this drug, this may be due to accumulation of fluid in the lungs. Talk to your doctor if this happens
  • you have symptoms of low blood pressure ( hypotension ) such as dizziness, dizziness, or fainting or if you are taking blood pressure-lowering medicines or medicines that may increase urination or if you have problems with your heart or circulation. Your doctor may then decide to check your blood pressure. If you are older than 65 years, you have an increased risk of developing low blood pressure.
  • you are taking medicines to treat fungal infections (eg, ketoconazole, posaconazole, itraconazole) or medicines for the treatment of HIV – infection(eg, abacavir, atazanavir, cobicistat, darunavir, raltegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir). Your doctor will check your health condition and should consider reducing the starting dose of Adempas.
  • your kidneys are not working properly ( creatinine clearance <30 ml/min) or if you are being treated with 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, as it may affect the level of riociguat in your blood.

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

Children and young people

The use of Adempas in children and adolescents (under 18 years of age) should be avoided as 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, especially medicines used for:

  • high blood pressure or heart disease (such as nitrates and amyl nitrite) in any form, as you should not take these medicines with Adempas.
  • high blood pressure in the pulmonary vessels (pulmonary arteries), as you should not take certain medicines (sildenafil and tadalafil) with Adempas. Other medicines for high blood pressure in the pulmonary vessels (PAH) such as bosentan and iloprost can be taken with Adempas, but you should still talk to your doctor.
  • erectile dysfunction (such as sildenafil, tadalafil, vardenafil), as you should not take these medicines with Adempas.
  • fungal infections (such as ketoconazole, posaconazole, itraconazole) or HIV – infection (such as abacavir, atazanavir, cobicistat, darunavir, raltegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine, or ritonavir) because the treatment can be considered. If you are already taking one of these medicines and are starting treatment with Adempas, your doctor will check your health and should consider reducing the starting dose of Adempas.
  • epilepsy (eg phenytoin, carbamazepine, phenobarbitone)
  • mild depression and mild anxiety ( St. John’s wort )
  • prevention of transplant rejection (cyclosporine)
  • joint and muscle pain (niflumic acid)
  • cancer (such as erlotinib, gefitinib)
  • heart disease or heartburn (antacids such as aluminum hydroxide/magnesium hydroxide). These antacids should be taken at least two hours before or one hour after taking Adempas.
  • nausea, vomiting (such as granisetron).

Smoking

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

Pregnancy and breastfeeding

Pregnancy

Do not take Adempas during pregnancy. If there is a possibility that you may become pregnant, use a reliable method of contraception while 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 as it may harm your baby. You should not breast-feed while taking this medicine. Your doctor will decide with you whether to stop breast-feeding or stop treatment with Adempas.

Driving and using machines

Adempas has a moderate effect on the ability to drive and use machines. It can 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 your 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, ie essentially ‘sodium-free’.

3. How to take Adempas

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Treatment should only be started and followed up by a doctor who has experience in the treatment of CTEPH or PAH. During the first weeks of treatment, your doctor will need to measure your blood pressure at regular intervals. Adempas is available in different strengths and your doctor will make sure you get the right dose by checking your blood pressure regularly at the beginning of treatment.

Crushed tablets:

Talk to your doctor about other ways to take Adempas if you have difficulty swallowing the entire tablet. The tablet can be crushed and mixed with water or soft food, e.g. apple puree, immediately before taking it.

Dose

The recommended starting dose is a 1 mg tablet taken 3 times a day for 2 weeks.

The tablets should be taken 3 times a day at approximately 6 to 8-hour intervals. They can be taken with or without food. However, if you have a tendency to have low blood pressure ( hypotension ), do not switch between taking Adempas with food and Adempas without food, as it may affect how you react to Adempas.

Your doctor will increase your dose every two weeks to a maximum of 2.5 mg 3 times a day (maximum daily dose of 7.5 mg) if you do not experience side effects or very low blood pressure. In this case, your doctor will prescribe Adempas at the highest dose that you feel good about. For some patients, a lower dose three times a day may be enough; Your doctor will choose the dose that is best for you.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Dose one may need to be adjusted.

If you have severe liver problems (Child-Pugh C), do not take Adempas.

65 years or older

If you are 65 years of age or older, your doctor will adjust your dose of Adempas especially carefully, as you may have an increased risk of low blood pressure.

Special considerations for patients who smoke

You should tell your doctor if you start or stop smoking during treatment with this medicine. Your dose may need to be adjusted.

If you take more Adempas than you should

If you take more tablets than you should and experience side effects (see section 4), contact your doctor. If your blood pressure drops (which can cause dizziness) 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 first talking to your doctor as this medicine will prevent the further development of the disease. If you have to stop treatment for 3 days or more, tell your doctor before starting treatment again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you switch between sildenafil or tadalafil and Adempas

  • If you stop taking sildenafil, wait at least 24 hours before starting treatment with Adempas.
  • If you stop taking tadalafil, wait at least 48 hours before starting treatment with Adempas.
  • If you stop taking Adempas to switch to a medicine called PDE-5 inhibitor (eg sildenafil or tadalafil), wait at least 24 hours from your last dose of Adempas before starting treatment with the PDE-5 inhibitor.

4. Possible side effects

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

The most serious side effects are:

  • bloody cough (hemoptysis) (common side effect, may affect up to 1 in 10 people)
  • acute hemorrhage in the lungs( pulmonary hemorrhage) which may lead to bloody coughing, fatal cases have been observed (less common side effect, may affect up to 1 in 100 people).

If this happens, consult a doctor immediately as you may need urgent medical attention.

The overall list of possible side effects:

Very common: may affect more than 1 in 10 people

  • headache
  • dizziness
  • indigestion ( dyspepsia )
  • swollen arms and legs (peripheral edema )
  • diarrhea
  • nausea or vomiting

Common: may affect up to 1 in 10 people

  • inflammation of the stomach ( gastritis )
  • inflammation of the digestive tract ( gastroenteritis )
  • decreased number of red blood cells ( anemia ) which manifests itself as pale skin, weakness, or shortness of breath
  • experience of irregular, hard or fast heartbeat ( palpitation )
  • low blood pressure ( hypotension )
  • nosebleeds ( epistaxis )
  • difficulty breathing through the nose (nasal congestion)
  • pain in the abdomen, intestines, or abdomen (gastrointestinal and abdominal pain)
  • heartburn ( gastroesophageal reflux disease )
  • difficulty swallowing ( dysphagia )
  • constipation
  • gas formation (swollen abdomen)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Adempas

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • 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 tabletsEach film-coated tablet contains 1 mg of riociguat.Adempas 1.5 mg film-coated tabletsEach film-coated tablet contains 1.5 mg of riociguat.Adempas 2 mg film-coated tabletsEach film-coated tablet contains 2 mg of riociguat.Adempas 2.5 mg film-coated tabletsEach film-coated tablet contains 2.5 mg of riociguat.
  • The other ingredients are: 
    Tablet core: microcrystalline cellulose, crospovidone (type B), hypromellose 5 cP, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate (see the end of section 2 for more information on lactose ). 
    Film coating * hydroxypropyl cellulose, hypromellose 3 cP, propylene glycol (E 1520), and titanium dioxide (E 171). 
    Adempas * 1 mg, 1.5 mg tablets also contain: iron oxide yellow (E 172). 
    Adempas * 2 mg and 2.5 mg tablets also contain iron oxide yellow (E 172) and iron oxide red (E 172).

What the medicine looks like and the 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: light 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: light 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 with 21 tablets each.
  • 84 tablets: four transparent calendar blisters with 21 tablets each.
  • 90 tablets: five transparent blisters with 18 tablets each.
  • 294 tablets: fourteen transparent calendar blisters with 21 tablets each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine

Belgium / Belgique / BelgienMSD Belgium BVBA / SPRLTel / Tel: +32 (0) 27766211 
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Muhammad Nadeem

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