Patient Leaflet Updated 07-Jan-2021 | Merck Sharp & Dohme (UK) Limited
Adempas 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg film-coated tablets
Package Leaflet: Information for the user
Adempas 0.5 mg film-coated tablets
Adempas 1 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
riociguat
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 (sGC)-stimulator. It works by widening 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 narrowed, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels. Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath. By widening the narrowed arteries, Adempas leads to an improvement in your ability to carry out physical activity.
Adempas is used in either of two types of pulmonary hypertension:
2. What you need to know before you take Adempas
Do not take Adempas:
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 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:
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”.
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.
Crushed tablets:
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 apple sauce, immediately before you take 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, 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 are transitioning between sildenafil or tadalafil and Adempas
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:
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
Common: may affect up to 1 in 10 people
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
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
What Adempas looks like and contents of the pack
Adempas is a film-coated tablet:
Adempas 0.5 mg film-coated tablets
Adempas 1 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
They are available in packs of:
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.
This leaflet was last revised in 02/2019.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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