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ADEMPAS® (Ah-Dem-Pas) riociguat

Consumer Medicine Information

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

WHAT IS IN THIS still high blood pressure in the lung Some of the symptoms of an LEAFLET vessels after surgery. allergic reaction may include: High blood pressure in the lung • shortness of breath This leaflet answers some common vessels means that the heart needs • wheezing or difficulty breathing questions about Adempas. It does to work harder to pump blood • swelling of the face, lips, tongue not contain all the available through the lungs. This may cause or other parts of the body information. It does not take the you to feel tired, dizzy and short of • rash, itching or hives on the skin place of talking to your doctor or breath. pharmacist. Do not take this medicine if you Adempas contains the active are pregnant, think you might be All medicines have risks and substance riociguat. Riociguat is a pregnant or if you could become benefits. Your doctor has weighed soluble (sGC)- pregnant because you are not the risks of you taking Adempas stimulator. using reliable birth control against the benefits they expect it (contraception). Adempas relaxes the lung vessels will have for you. making it easier for the heart to It may affect the development of If you have any concerns about pump blood through them. This your baby if you take it during taking this medicine, ask your lowers the pressure in these vessels, pregnancy or if you become doctor or pharmacist. relieves the symptoms, and can lead pregnant within one month of Keep this leaflet with the to an improvement in the ability to stopping Adempas. medicine. exercise and perform physical tasks. If you could become pregnant, your You may need to read it again. Ask your doctor if you have any doctor will ask you to take a questions about why this pregnancy test before you start medicine has been prescribed for Adempas. you. Women must not become WHAT ADEMPAS IS Your doctor may have prescribed it pregnant for at least 1 month USED FOR for another reason. after stopping treatment with Adempas. This medicine is only available with Adempas is used to treat adults with a doctor’s prescription. Do not use Adempas if you are high blood pressure in the lung breast-feeding. If you are breast- vessels caused by: feeding, ask your doctor or • blood clots in the lungs (known pharmacist for advice before taking as chronic thromboembolic BEFORE YOU TAKE Adempas because it might harm or ADEMPAS your baby. A decision must be CTEPH) made whether to discontinue breast feeding or to stop therapy with • narrowing of the vessels that When you must not take it carry blood from the heart to the Adempas. lungs (known as pulmonary Do not take Adempas if you have Do not take this medicine if you are arterial hypertension or PAH) an allergy to: taking medicines which If the high blood pressure in the • riociguat, the active ingredient include: lung vessels is caused by CTEPH it in Adempas • glyceryl trinitrate (also called can sometimes be treated with • any of the ingredients listed at nitroglycerine) surgery. Adempas may be used if the end of this leaflet • surgery is not possible or if there is

ADEMPAS® Published by MIMS June 2020 1 • Tell your doctor if you have or Taking other medicines • have had any of the following medical conditions: Tell your doctor or pharmacist if • you are taking any other • • amyl (also known as recent serious bleeding, medicines, including any that you ‘poppers’, ‘amyl’ or ‘rush’) especially from the lungs, or if get without a prescription from you have undergone treatment to your pharmacy, supermarket or Do not take this medicine if you are stop coughing up blood health food shop. taking: (bronchial arterial embolization) Do not take this medicine if you are • medicines known as PDE-5 • problems with your heart and taking: inhibitors, such as , circulation vardenafil or (used to • medicines known as nitrate • low blood pressure treat high blood pressure in lung medicine such as glyceryl • vessels in men and women liver disease trinitrate, isosorbide and/or erectile dysfunction in • disease mononitrate, nicorandil, amyl men) Tell your doctor if you are nitrite (also known as ‘poppers’, ‘ ’ ‘ ’ • medicines known as non- pregnant, or think you might be amyl or rush ) or sodium specific PDE inhibitors, such as pregnant or if you could become nitroprusside pregnant because you are not dipyridamole or theophylline • medicines known as PDE-5 using reliable birth control used in cardiovascular and inhibitors, such as sildenafil, (contraception). respiratory conditions vardenafil or tadalafil (used to Women who may become treat high blood pressure in lung Do not take this medicine if you pregnant should have a negative vessels in men and women have increased pressure in your pregnancy test prior to starting and/or erectile dysfunction in pulmonary circulation associated treatment with Adempas. men) with scarring of the lungs, of If there is a chance that you could • medicines known as non- unknown cause (idiopathic become pregnant, use at least two specific PDE inhibitors, such as pulmonary pneumonia). reliable forms of birth control dipyridamole or theophylline Do not take this medicine after (contraception) while you are taking used in cardiovascular and the expiry date printed on the Adempas. You must continue to use respiratory conditions pack and blister. contraception for at least 1 month The expiry date is printed on the after stopping Adempas. Speak with In particular, tell your doctor if you are taking: carton and on each blister after a gynaecologist for contraceptive “EXP” (e.g. 11 18 refers to advice if you are unsure of what to • medicines known as protease November 2018). The expiry date do. inhibitors for the treatment of refers to the last day of that month. Tell your doctor if you are breast- HIV infection, such as If it has expired return it to your feeding or planning to breast- rilpivirine, abacavir, efavirenz pharmacist for disposal. feed. and ritonavir Do not take this medicine if the Adempas should not be used while • medicines used to treat fungal packaging is torn or shows signs breast-feeding. If you are breast- infections such as ketoconazole of tampering. feeding, ask your doctor or or itraconazole If the packaging is damaged, return pharmacist for advice before taking Also tell your doctor if you are it to your pharmacist for disposal. Adempas because it might harm taking: If you are not sure whether you your baby. A decision must be • cancer medicines called tyrosine should start taking this medicine, made whether to discontinue breast kinase inhibitors such as talk to your doctor. feeding or to stop therapy with erlotinib or gefitinib Adempas. Adempas is not recommended for • cyclosporin, a medicine used to children or adolescents. The safety Tell your doctor if you smoke. prevent rejection of transplanted and efficacy of Adempas has not The metabolism of Adempas is organs been proven in patients less than 18 affected by smoking, making it less • epoprostenol, a medicine used to years of age. effective. You should not smoke treat pulmonary arterial while taking Adempas. hypertension Before you start to take it If you have not told your doctor • antacids, used to treat heartburn about any of the above, tell Tell your doctor if you have (indigestion) allergies to any medicines, foods, him/her before you start taking • granisetron, a medicine used to preservatives or dyes. Adempas. prevent nausea and vomiting

ADEMPAS® Published by MIMS June 2020 2 • medicines used to treat epilepsy, dose every 2 weeks. The doctor If you forget to take it e.g. phenytoin, carbamazepine, may increase your dose up to a If it is almost time for your next phenobarbitone maximum of 2.5 mg three times a dose, skip the dose you missed and • anticoagulants, which are day. take the next dose when you are medicines used to prevent blood Tell your doctor if you have any meant to. clots side effects as they may need to Do not take a double dose to • other medicines used to treat lower your dose. make up for the dose that you blood pressure missed. • clarithromycin, an antibiotic How to take it This may increase the chance of you • St. John’s Wort, a herbal Swallow the tablet whole with getting an unwanted side effect. treatment for depression water. If you are not sure what to do, ask These medicines may be affected by Adempas can be taken with or your doctor or pharmacist. Adempas or may affect how well it without food. If you have trouble remembering to works. You may need different take your medicine, ask your amounts of your medicines, or you When to take it pharmacist for some hints. may need to take different Take your medicine three times a medicines. day at about the same time each If you take too much Your doctor and pharmacist have day. (overdose) more information on medicines to Taking it at the same time each day be careful with or avoid while will have the best effect. It will also Immediately telephone your doctor taking Adempas. help you remember when to take it. or the Poisons Information Centre Each dose should be 6 to 8 hours (Australia: 13 11 26) for advice, or apart. It does not matter if you take go to Accident and Emergency at this medicine before or after food. the nearest hospital, if you think that you or anyone else may have HOW TO TAKE If you are taking an antacid (a taken too much Adempas. Do this ADEMPAS medicine to treat stomach disease even if there are no signs of or heartburn), take it at least 1 Follow all directions given to you hour after taking Adempas. discomfort or poisoning. You may by your doctor or pharmacist need urgent medical attention. Transitioning between sildenafil carefully. or tadalafil and Adempas They may differ from the information in this leaflet. Stop taking sildenafil at least 24 hours before you start taking If you do not understand the WHILE YOU ARE instructions printed on the label, Adempas. TAKING ADEMPAS ask your doctor or pharmacist for Stop taking tadalafil at least 48 help. hours before you start taking Things you must do Adempas. How much to take If you are about to start on any new Stop taking Adempas at least 24 medicine, remind your doctor and The recommended starting dose of hours before you start taking pharmacist that you are taking Adempas is one 1 mg tablet, three sildenafil or tadalafil. Adempas. times daily for 2 weeks. How long to take it Tell any other doctors, dentists, and Your doctor may advise you to start pharmacists who treat you that you on a lower dose. Take Adempas Continue taking Adempas for as are taking this medicine. exactly as your doctor tells you. long as your doctor tells you. Tell your doctor if your shortness Adempas helps to control your After 2 weeks, your doctor will of breath is getting worse during adjust your dose depending on your condition, but does not cure it. It is treatment with Adempas. blood pressure and your response to important to keep taking Adempas This can be caused by a build-up of the medicine. At the start of even if you feel well. fluid in the lungs due to another treatment your doctor will measure In case treatment has to be lung vessel disease, known as your blood pressure at least every interrupted for 3 days or more, pulmonary veno-occlusive disease. two weeks. please contact your doctor before restarting Adempas. If you have no side effects and your blood pressure is above a certain level, your doctor will increase your

ADEMPAS® Published by MIMS June 2020 3 If you are going to have surgery, Things to be careful of • anaemia (decrease in red blood tell the surgeon or anaesthetist cells) that you are taking this medicine. Be careful driving or operating machinery until you know how • fast or irregular heart beats It may affect other medicines used Adempas affects you. • nosebleed during surgery. Dizziness is a common side effect • nasal congestion If there is a chance you could of Adempas. If you experience become pregnant, you should • heartburn dizziness during treatment, do not have a negative pregnancy test • difficulty in swallowing drive or operate machinery. monthly during treatment and • constipation If you feel light-headed, dizzy or one month after you stop taking • stomach pain Adempas. You should use two faint when getting out of bed or reliable forms of contraception standing up, get up slowly. • stomach bloating while you are taking Adempas. If Standing up slowly, especially The above list includes the more you become pregnant while when you get up from bed or chairs, common side effects of your taking Adempas, tell your doctor will help your body get used to the medicine. immediately. You must continue change in position and blood If any of the following happen, to use contraception for at least 1 pressure. tell your doctor immediately or go month after stopping Adempas. Tell your doctor if you feel dizzy or to Accident and Emergency at Do not smoke while taking faint. They may want to check your your nearest hospital: Adempas. Tell your doctor if you blood pressure. • coughing up blood stop or start smoking during treatment. The most serious side effects are Smoking may reduce the coughing up blood and bleeding effectiveness of Adempas and your from the lungs which can be fatal. doctor may have to adjust your dose SIDE EFFECTS You may need urgent medical if required. Tell your doctor or pharmacist as attention or hospitalisation. These If treatment is interrupted for 3 soon as possible if you do not feel side effects are not common. days or more, contact your doctor well while you are taking Tell your doctor or pharmacist if before restarting Adempas. Adempas. you notice anything that is Keep all of your doctor’s All medicines can have side effects. making you feel unwell. appointments so that your Sometimes they are serious, most of Other side effects not listed above progress can be checked. the time they are not. You may need may also occur in some people. Your doctor will measure your medical attention if you get some of blood pressure and do other tests the side effects. from time to time to make sure the Do not be alarmed by the medicine is working and to check following lists of side effects. You AFTER TAKING for unwanted side effects. may not experience any of them. ADEMPAS Things you must not do Ask your doctor or pharmacist to answer any questions you may Storage Do not take Adempas to treat any have. other complaints unless your Keep your tablets in the pack Tell your doctor or pharmacist if doctor tells you to. until it is time to take them. you notice any of the following If you take the tablets out of the Do not give your medicine to and they worry you: pack they may not keep well. anyone else, even if they have the • light headedness (hypotension) same condition as you. Keep the medicine in a cool dry • dizziness place where the temperature Do not stop taking your medicine stays below 30°C. or lower the dose without • headache checking with your doctor. • indigestion Do not store it or any other If you stop taking it, your condition • diarrhoea medicine in the bathroom, near a sink, or on a window-sill. may worsen. • nausea Do not leave it in the car. • vomiting Heat and damp can destroy some • swelling of extremities (hands, medicines. ankles or feet) • tiredness (may be due to decrease in red blood cells)

ADEMPAS® Published by MIMS June 2020 4 Keep it where children cannot • Adempas 2 mg contains 2 mg of reach it. riociguat A locked cupboard at least one-and- • Adempas 2.5 mg contains 2.5 a half metres above the ground is a mg of riociguat good place to store medicines. Inactive ingredients: Disposal • cellulose microcrystalline • crospovidone If your doctor tells you to stop taking Adempas or the expiry • hypromellose date has passed, ask your • lactose monohydrate pharmacist what to do with any • magnesium stearate medicine that is left over. • sodium lauryl sulfate • hyprolose • propylene glycol PRODUCT • titanium dioxide DESCRIPTION • iron oxide yellow (1 mg, 1.5 mg, 2 mg and 2.5 mg) What it looks like • iron oxide red (2 mg and 2.5 mg) Adempas tablets are round film- coated tablets supplied in blister Suppliers packs of 21, 42 or 84 tablets (not all pack sizes may be marketed). Made in Germany for: Adempas 0.5 mg tablets: White, Bayer Australia Ltd tablets marked with the Bayer cross ABN 22 000 138 714 on one side and 0.5 and an “R” on 875 Pacific Highway the other side. Pymble NSW 2073 Adempas 1 mg tablets: Pale yellow, www.bayer.com.au tablets marked with the Bayer cross on one side and 1 and an “R” on the Australian registration other side. number Adempas 1.5 mg tablets: Yellow- Adempas 0.5 mg - AUST R 207595 orange, tablets marked with the Adempas 1 mg - AUST R 207599 Bayer cross on one side and 1.5 and an “R” on the other side. Adempas 1.5 mg - AUST R 207597 Adempas 2 mg tablets: Pale orange, Adempas 2 mg - AUST R 207598 tablets marked with the Bayer cross Adempas 2.5 mg - AUST R 207596 on one side and 2 and an “R” on the other side. Date of preparation Adempas 2.5 mg tablets: Red- 29 April 2020 orange, tablets marked with the See TGA website Bayer cross on one side and 2.5 and (www.ebs.tga.gov.au) for latest an “R” on the other side. Australian Consumer Medicine Ingredients Information. ® Registered Trademark of the Active ingredients: Bayer Group, Germany • Adempas 0.5 mg contains 0.5 © Bayer Australia Ltd mg of riociguat • Adempas 1 mg contains 1 mg of All rights reserved. riociguat • Adempas 1.5 mg contains 1.5 mg of riociguat

ADEMPAS® Published by MIMS June 2020 5