ADEMPAS (Ah-Dem-Pas) Riociguat

® ADEMPAS (Ah-Dem-Pas) riociguat

Consumer Medicine Information

ADEMPAS may cause birth defects and must not be taken during pregnancy.

CTEPH it can sometimes be • riociguat, the active WHAT IS IN THIS treated with surgery. Adempas ingredient in Adempas LEAFLET may be used if surgery is not • any of the ingredients listed possible or if there is still high at the end of this leaflet This leaflet answers some blood pressure in the lung common questions about vessels after surgery. Some of the symptoms of an Adempas. It does not contain allergic reaction may include: all the available information. It High blood pressure in the lung • shortness of breath does not take the place of vessels means that the heart • wheezing or difficulty talking to your doctor or needs to work harder to pump breathing pharmacist. blood through the lungs. This • swelling of the face, lips, may cause you to feel tired, tongue or other parts of the All medicines have risks and dizzy and short of breath. body benefits. Your doctor has • rash, itching or hives on the weighed the risks of you taking Adempas contains the active skin Adempas against the benefits substance riociguat. Riociguat they expect it will have for you. is a soluble guanylate cyclase Do not take this medicine if (sGC)-stimulator. you are pregnant, think you If you have any concerns might be pregnant or if you about taking this medicine, Adempas relaxes the lung could become pregnant ask your doctor or vessels making it easier for the because you are not using pharmacist. heart to pump blood through reliable birth control them. This lowers the pressure (contraception). Keep this leaflet with the in these vessels, relieves the It may affect the development medicine. symptoms, and can lead to an of your baby if you take it You may need to read it again. improvement in the ability to during pregnancy or if you exercise and perform physical become pregnant within one WHAT ADEMPAS IS tasks. month of stopping Adempas. USED FOR Ask your doctor if you have If you could become pregnant, any questions about why this Adempas is used to treat adults your doctor will ask you to take medicine has been prescribed with high blood pressure in the a pregnancy test before you for you. lung vessels caused by: start Adempas. Your doctor may have

prescribed it for another reason. • blood clots in the lungs (known as chronic Women must not become This medicine is only available pregnant for at least 1 month thromboembolic pulmonary with a doctor’s prescription. hypertension or CTEPH) after stopping treatment with • narrowing of the vessels that BEFORE YOU TAKE Adempas. carry blood from the heart to the lungs (known as ADEMPAS Do not use Adempas if you are pulmonary arterial breast-feeding. If you are hypertension or PAH) When you must not take breast-feeding, ask your doctor it or pharmacist for advice before taking Adempas because it If the high blood pressure in the Do not take Adempas if you might harm your baby. A lung vessels is caused by have an allergy to: 180619 Adempas® CMI 1 decision must be made whether If the packaging is damaged, contraceptive advice if you are to discontinue breast feeding or return it to your pharmacist for unsure of what to do. to stop therapy with Adempas. disposal. Tell your doctor if you are Do not take this medicine if you If you are not sure whether breast-feeding or planning to are taking nitrate medicines you should start taking this breast-feed. which include: medicine, talk to your doctor. Adempas should not be used • glyceryl trinitrate (also while breast-feeding. called nitroglycerine) Adempas is not recommended If you are breast-feeding, ask • nicorandil for children or adolescents. The your doctor or pharmacist for safety and efficacy of Adempas advice before taking Adempas • sodium nitroprusside has not been proven in patients because it might harm your • isosorbide mononitrate less than 18 years of age. baby. A decision must be made • isosorbide dinitrate whether to discontinue breast • amyl nitrite (also known as Before you start to take feeding or to stop therapy with ‘poppers’, ‘amyl’ or ‘rush’) it Adempas.

Tell your doctor if you have Tell your doctor if you smoke. Do not take this medicine if you allergies to any medicines, are taking: The metabolism of Adempas is foods, preservatives or dyes. affected by smoking, making it • medicines known as PDE-5 inhibitors, such as less effective. You should not Tell your doctor if you have smoke while taking Adempas. sildenafil, vardenafil or or have had any of the tadalafil (used to treat high following medical conditions: If you have not told your blood pressure in lung • recent serious bleeding, vessels in men and women doctor about any of the especially from the lungs, or above, tell him/her before you and/or erectile dysfunction if you have undergone start taking Adempas. in men) treatment to stop coughing up blood (bronchial arterial • medicines known as non- Taking other medicines specific PDE inhibitors, embolization) such as dipyridamole or • problems with your heart Tell your doctor or theophylline used in and circulation pharmacist if you are taking cardiovascular and • low blood pressure any other medicines, respiratory conditions • liver disease including any that you get • kidney disease without a prescription from Do not take this medicine if you your pharmacy, supermarket have increased pressure in your Tell your doctor if you are or health food shop. pulmonary circulation pregnant, or think you might Do not take this medicine if you associated with scarring of the be pregnant or if you could are taking: lungs, of unknown cause become pregnant because you • medicines known as nitrate (idiopathic pulmonary are not using reliable birth medicine such as glyceryl pneumonia). control (contraception). trinitrate, isosorbide Do not take this medicine mononitrate, nicorandil, after the expiry date printed Women who may become amyl nitrite (also known as on the pack and blister. pregnant should have a ‘poppers’, ‘amyl’ or ‘rush’) The expiry date is printed on negative pregnancy test prior or sodium nitroprusside the carton and on each blister to starting treatment with • medicines known as PDE-5 after “EXP” (e.g. 11 18 refers Adempas. inhibitors, such as to November 2018). The expiry If there is a chance that you sildenafil, vardenafil or date refers to the last day of that could become pregnant, use at tadalafil (used to treat high month. If it has expired return it least two reliable forms of birth blood pressure in lung to your pharmacist for disposal. control (contraception) while vessels in men and women Do not take this medicine if you are taking Adempas. You and/or erectile dysfunction the packaging is torn or must continue to use in men) shows signs of tampering. contraception for at least 1 month after stopping Adempas. • medicines known as non- Speak with a gynaecologist for specific PDE inhibitors,

180619 Adempas® CMI 2 such as dipyridamole or need to take different theophylline used in medicines. Adempas can be taken with or cardiovascular and without food. respiratory conditions Your doctor and pharmacist have more information on In particular, tell your doctor When to take it medicines to be careful with or if you are taking: Take your medicine three avoid while taking Adempas. • medicines known as times a day at about the same protease inhibitors for the HOW TO TAKE time each day. treatment of HIV infection, Taking it at the same time each such as ritonavir ADEMPAS day will have the best effect. It will also help you remember • medicines used to treat Follow all directions given to when to take it. Each dose fungal infections such as you by your doctor or ketoconazole or itraconazole should be 6 to 8 hours apart. It pharmacist carefully. does not matter if you take this It is not recommended to take They may differ from the medicine before or after food. Adempas at the same time as information in this leaflet. these other medicines. If you are taking an antacid If you do not understand the (a medicine to treat stomach Also tell your doctor if you instructions printed on the are taking: disease or heartburn), take it label, ask your doctor or at least 1 hour after taking • cancer medicines called pharmacist for help. Adempas. tyrosine kinase inhibitors such as erlotinib or gefitinib How much to take Transitioning between • cyclosporin, a medicine used The recommended starting dose sildenafil or tadalafil and to prevent rejection of of Adempas is one 1 mg tablet, Adempas transplanted organs three times daily for 2 weeks. Stop taking sildenafil at least 24 • epoprostenol, a medicine Your doctor may advise you to hours before you start taking used to treat pulmonary start on a lower dose. Take Adempas. arterial hypertension Adempas exactly as your doctor • antacids, used to treat tells you. Stop taking tadalafil at least 48 heartburn (indigestion) hours before you start taking After 2 weeks, your doctor will Adempas. • granisetron, a medicine used adjust your dose depending on to prevent nausea and your blood pressure and your Stop taking Adempas at least 24 vomiting response to the medicine. At the hours before you start taking • medicines used to treat start of treatment your doctor sildenafil or tadalafil. epilepsy, e.g. phenytoin, will measure your blood carbamazepine, pressure at least every two How long to take it phenobarbitone weeks. Continue taking Adempas for

• anticoagulants, which are as long as your doctor tells If you have no side effects and medicines used to prevent you. your blood pressure is above a blood clots Adempas helps to control your certain level, your doctor will condition, but does not cure it. • other medicines used to treat increase your dose every 2 It is important to keep taking blood pressure weeks. The doctor may increase Adempas even if you feel well. • clarithromycin, an antibiotic your dose up to a maximum of 2.5 mg three times a day. In case treatment has to be • St. John’s Wort, a herbal interrupted for 3 days or treatment for depression Tell your doctor if you have more, please contact your These medicines may be any side effects as they may doctor before restarting affected by Adempas or may need to lower your dose. Adempas. affect how well it works. You may need different amounts of How to take it If you forget to take it your medicines, or you may Swallow the tablet whole with If it is almost time for your next water. dose, skip the dose you missed

180619 Adempas® CMI 3 and take the next dose when Do not stop taking your you are meant to. If you are going to have medicine or lower the dose surgery, tell the surgeon or without checking with your Do not take a double dose to anaesthetist that you are doctor. make up for the dose that you taking this medicine. If you stop taking it, your missed. It may affect other medicines condition may worsen. This may increase the chance of used during surgery. you getting an unwanted side Things to be careful of effect. If there is a chance you could Be careful driving or become pregnant, you should operating machinery until If you are not sure what to do, have a negative pregnancy you know how Adempas ask your doctor or pharmacist. test monthly during treatment affects you. and one month after you stop Dizziness is a common side If you have trouble taking Adempas. You should effect of Adempas. If you remembering to take your use two reliable forms of experience dizziness during medicine, ask your pharmacist contraception while you are treatment, do not drive or for some hints. taking Adempas. If you operate machinery. become pregnant while taking If you feel light-headed, dizzy Adempas, tell your doctor If you take too much or faint when getting out of immediately. You must (overdose) bed or standing up, get up continue to use contraception slowly. Immediately telephone your for at least 1 month after Standing up slowly, especially doctor or the Poisons stopping Adempas. when you get up from bed or Information Centre (Australia: chairs, will help your body get 13 11 26) for advice, or go to Do not smoke while taking used to the change in position Accident and Emergency at the Adempas. Tell your doctor if and blood pressure. nearest hospital, if you think you stop or start smoking that you or anyone else may during treatment. Tell your doctor if you feel have taken too much Adempas. Smoking may reduce the dizzy or faint. They may want Do this even if there are no effectiveness of Adempas and to check your blood pressure. signs of discomfort or your doctor may have to adjust poisoning. You may need your dose if required. SIDE EFFECTS urgent medical attention. If treatment is interrupted for Tell your doctor or WHILE YOU ARE 3 days or more, contact your pharmacist as soon as TAKING ADEMPAS doctor before restarting possible if you do not feel well Adempas. while you are taking Things you must do Adempas. Keep all of your doctor’s If you are about to start on any appointments so that your new medicine, remind your All medicines can have side progress can be checked. doctor and pharmacist that you effects. Sometimes they are Your doctor will measure your are taking Adempas. serious, most of the time they blood pressure and do other are not. You may need medical tests from time to time to make Tell any other doctors, dentists, attention if you get some of the sure the medicine is working and pharmacists who treat you side effects. and to check for unwanted side that you are taking this effects. medicine. Do not be alarmed by the following lists of side effects. Tell your doctor if your Things you must not do You may not experience any shortness of breath is getting Do not take Adempas to treat of them. worse during treatment with any other complaints unless Adempas. your doctor tells you to. Ask your doctor or This can be caused by a build- pharmacist to answer any up of fluid in the lungs due to Do not give your medicine to questions you may have. another lung vessel disease, anyone else, even if they have known as pulmonary veno- the same condition as you. Tell your doctor or occlusive disease. pharmacist if you notice any

180619 Adempas® CMI 4 of the following and they AFTER TAKING side and 1 and an “R” on the worry you: other side. • light headedness ADEMPAS (hypotension) Adempas 1.5 mg tablets: • dizziness Storage Yellow-orange, tablets marked • headache Keep your tablets in the pack with the Bayer cross on one • indigestion until it is time to take them. side and 1.5 and an “R” on the • diarrhoea If you take the tablets out of the other side. • nausea pack they may not keep well. • vomiting Adempas 2 mg tablets: • swelling of extremities Keep the medicine in a cool Pale orange, tablets marked (hands, ankles or feet) dry place where the with the Bayer cross on one • tiredness (may be due to temperature stays below side and 2 and an “R” on the decrease in red blood cells) 30°C. other side. • anaemia (decrease in red blood cells) Do not store it or any other Adempas 2.5 mg tablets: • fast or irregular heart beats medicine in the bathroom, Red-orange, tablets marked • nosebleed near a sink, or on a window- with the Bayer cross on one • nasal congestion sill. side and 2.5 and an “R” on the • heartburn other side. • difficulty in swallowing Do not leave it in the car. • constipation Heat and damp can destroy Ingredients • stomach pain some medicines. Active ingredients: • stomach bloating • Adempas 0.5 mg Keep it where children cannot contains 0.5 mg of The above list includes the reach it. riociguat more common side effects of A locked cupboard at least one- • Adempas 1 mg contains your medicine. and-a half metres above the 1 mg of riociguat ground is a good place to store • Adempas 1.5 mg If any of the following medicines. contains 1.5 mg of happen, tell your doctor riociguat immediately or go to Accident Disposal • Adempas 2 mg contains and Emergency at your If your doctor tells you to stop 2 mg of riociguat nearest hospital: taking Adempas or the expiry • Adempas 2.5 mg • coughing up blood date has passed, ask your contains 2.5 mg of

pharmacist what to do with riociguat The most serious side effects any medicine that is left over. are coughing up blood and Inactive ingredients: bleeding from the lungs which PRODUCT • cellulose microcrystalline can be fatal. • crospovidone DESCRIPTION • You may need urgent medical hypromellose attention or hospitalisation. What it looks like • lactose monohydrate • magnesium stearate These side effects are not Adempas tablets are round • sodium lauryl sulfate common. film-coated tablets supplied in • hyprolose blister packs of 21, 42 or 84 • Tell your doctor or tablets (not all pack sizes may propylene glycol pharmacist if you notice be marketed). • titanium dioxide anything that is making you • iron oxide yellow (1 mg, 1.5 feel unwell. Adempas 0.5 mg tablets: mg, 2 mg and 2.5 mg) Other side effects not listed White, tablets marked with the • iron oxide red (2 mg and 2.5 above may also occur in some Bayer cross on one side and 0.5 mg) people. and an “R” on the other side. Suppliers Adempas 1 mg tablets: Made in Germany for: Pale yellow, tablets marked Bayer Australia Ltd with the Bayer cross on one

Australian registration number

Adempas 0.5 mg - AUST R 207595 Adempas 1 mg - AUST R 207599 Adempas 1.5 mg - AUST R 207597 Adempas 2 mg - AUST R 207598 Adempas 2.5 mg - AUST R 207596

Date of preparation June 2018

See TGA website

(www.ebs.tga.gov.au) for latest

Australian Consumer Medicine

Information.

180619 Adempas® CMI 6