Package Leaflet: Information for the user
Adempas 0.5 mg
Adempas 1 mg
Adempas 1.5 mg
Adempas 2 mg
Adempas 2.5 mg
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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
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
Adempas is used in either of two types of pulmonary hypertension:
chronic thromboembolic pulmonary hypertension (CTEPH).
In CTEPH, the blood vessels of the lung are blocked or narrowed with blood clots. Adempas can be used for patients with CTEPH who cannot be operated on, or after surgery for patients in whom increased blood pressure in the lungs remains or returns.
certain types of pulmonary arterial hypertension (PAH).
In PAH, the wall of the blood vessels of the lungs are thickened and the vessels become narrowed. Adempas is only prescribed for certain forms of PAH, i.e. idiopathic PAH (the cause of PAH is unknown), heritable PAH and PAH caused by connective tissue disease. Your doctor
will check this. Adempas can be taken alone or together with certain other medicines used to treat PAH.
2. What you need to know before you take Adempas
Do NOT take Adempas:
-if you are taking certain medicines called
-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
-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 feel short of breath during treatment with this medicine, this can be caused by a
-you have problems with your heart or circulation.
-you are older than 65 years.
-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.
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 medications 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, itraconazole).
-HIV infection (such as ritonavir).
-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).
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.
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.
If you are
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, tell your treating doctor before taking these tablets.
3.How to take Adempas
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Treatment should only be started and monitored by a doctor experienced 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 by checking your blood pressure regularly at the beginning of your treatment, your doctor will ensure that you are taking the appropriate dose.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Adempas. The tablet may be crushed and mixed with water or a soft food such as applesauce immediately before you take it.
The recommended starting dose is a
The tablets should be taken 3 times a day, approximately 6 to 8 hours apart. They can generally be taken with or without food.
However, if you are prone to having low blood pressure (hypotension), you should not switch from taking Adempas with food to taking Adempas without food because it may affect how you react to this medicine.
Your doctor will increase the dose every 2 weeks to a maximum of 2.5 mg 3 times a day (maximum daily dose of 7.5 mg) unless you experience any side effects or very low blood pressure. In this case, your doctor will prescribe you Adempas at the highest dose you are comfortable on. For some patients lower doses three times a day might be sufficient, the optimal dose will be selected by your doctor.
Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your dose 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 or older your doctor will take extra care in adjusting your dose of Adempas, because you may be at greater 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 be adjusted.
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 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.
The most serious side effects are:
coughing up blood (common side effect),
acute bleeding from the lungs may result in coughing up blood, cases with fatal outcomes
were observed (uncommon side effect).
If this happens, contact your doctor immediately as you may need urgent medical treatment.
Overall list of possible side effects:
Very common: may affect more than 1 in 10 people
-swelling of limbs
-feeling or being sick
Common: may affect up to 1 in 10 people
-inflammation in the digestive system
-reduction of red blood cells (anaemia) seen as pale skin, weakness or breathlessness
-awareness of an irregular, hard, or rapid heartbeat
-feeling dizzy or faint when standing up (caused by low blood pressure)
-coughing up blood
-difficulty breathing through your nose
-pain in the stomach, intestine or abdomen
-difficulty in swallowing
Uncommon: may affect up to 1 in 100 people
-acute bleeding from the lungs. Contact your doctor immediately as you may need urgent medical treatment.
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.
5.How to store Adempas
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Adempas contains
-The active substance is riociguat.
Each tablet contains 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg riociguat.
-The other ingredients are:
Tablet core: cellulose microcrystalline, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium laurilsulfate (see end of section 2 for further information on lactose).
*1 mg, 1.5 mg, 2 mg and 2.5 mg tablets also have: ferric oxide yellow (E 172) *2 mg and 2.5 mg tablets also have: ferric oxide red (E 172)
What Adempas looks like and contents of the pack
Adempas is a
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.
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.
1.5 mg tablet:
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.
2.5 mg tablet:
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België / Belgique / Belgien
MSD Belgium BVBA/SPRL
UAB Merck Sharp & Dohme
Tel/Tél: 0800 38 693 (+32(0)27766211)
Tel: + 370 5 2780247
Luxembourg / Luxemburg
Мерк Шарп и Доум България ЕООД
MSD Belgium BVBA/SPRL
Teл.: + 359 2 819 37 37
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 email@example.com
MSD Danmark ApS Tlf: + 45 4482 4000 firstname.lastname@example.org
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) email@example.com
Merck Sharp & Dohme OÜ Tel: + 372 6144 200 firstname.lastname@example.org
Τηλ: + 30 210 98 97 300 email@example.com
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 firstname.lastname@example.org
34, avenue Léonard de Vinci 92400 COURBEVOIE
Information médicale : 01 80 46 40 40
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 email@example.com
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700 firstname.lastname@example.org
Sími: + 354 535 7000
MSD Pharma Hungary Kft. Tel.: + 36 1
Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) email@example.com
Merck Sharp & Dohme BV
Tel: 0800 9999 000 (+ 31 23 5153153) firstname.lastname@example.org
MSD (Norge) AS Tlf: + 47 32 20 73 00 email@example.com
Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
MSD Polska Sp.z o.o. Tel.: +48 22 549 51 00 firstname.lastname@example.org
Merck Sharp & Dohme, Lda Tel: + 351 214465700 email@example.com
Merck Sharp & Dohme Romania S.R.L. Tel: + 40 21 529 29 00 firstname.lastname@example.org
Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201
Merck Sharp & Dohme, s. r. o. Tel: + 421 (2) 58282010 email@example.com
MSD Italia S.r.l. Tel: +39 06 361911
Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673
+357 22866700 firstname.lastname@example.org
SIA Merck Sharp & Dohme Latvija Tel: + 371 67364224 email@example.com
MSD Finland Oy
Puh/Tel: + 358 (0)9 804650 firstname.lastname@example.org
Merck Sharp & Dohme (Sweden) AB Tel: + 46 (0)77 5700488 email@example.com
Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 firstname.lastname@example.org
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.