Spiolto® Respimat® 2.5 micrograms / 2.5 micrograms Solution for Inhalation Tiotropium (as bromide monohydrate) / Olodaterol (as hydrochloride) Consumer Medicine Information What is in this leaflet COPD is a serious lung condition breathing problems or other that can cause difficulty in breathing symptoms of COPD. This leaflet answers some common and constant coughing. The term Ask your doctor if you have any questions about Spiolto Respimat. COPD is associated with the questions about why this medicine conditions chronic bronchitis and It does not contain all the available has been prescribed for you. emphysema. information. Your doctor may have prescribed it Symptoms of COPD include for another reason. It does not take the place of talking to shortness of breath, cough, chest your doctor or pharmacist. This medicine is available only with discomfort and coughing up phlegm. a doctor's prescription. All medicines have risks and Spiolto Respimat contains the active benefits. Your doctor has weighed ingredients, tiotropium (as bromide the risks of you using Spiolto monohydrate) and olodaterol (as Respimat against the benefits they hydrochloride). Tiotropium belongs Before you use expect it will have for you. to a group of medicines called If you have any concerns about anticholinergics. Olodaterol belongs Spiolto Respimat using this medicine, ask your to a group of medicines called long- doctor or pharmacist. acting bronchodilators. These When you must not use it This leaflet was last updated on the medicines are used to relax the Do not use Spiolto Respimat if you date at the end of this leaflet. More breathing tubes or air passages that have an allergy to: carry air to and from the lungs and to recent information may be available. • any medicine containing keep the air passages in the lungs The latest Consumer Medicine tiotropium bromide or olodaterol open and make breathing easier. Information is available from your hydrochloride (the active pharmacist, doctor or from Each dose of Spiolto Respimat will ingredients) www.medsafe.govt.nz/Consumers/ keep your air passages open for 24 • any of the ingredients listed at the cmi/CMIForm.asp and may contain hours. end of this leaflet important information about the Regular use of Spiolto Respimat can medicine and its use of which you • any medicine containing atropine also help when you have ongoing or its derivatives, e.g. ipratropium should be aware. shortness of breath related to your or oxitropium Keep this leaflet with the medicine. disease, and will help minimise the • any other anticholinergic You may need to read it again. effects of the disease on your everyday life. medicines. Spiolto Respimat is for oral Some of the symptoms of an allergic inhalation only. The solution for reaction may include: What Spiolto inhalation is contained in the Spiolto • rash, itching or hives on the skin Respimat cartridge and inhaled using Respimat is used for • swelling of the face, lips, tongue the Spiolto Respimat inhaler supplied or other parts of the body Spiolto Respimat is used for the with the medicine. • shortness of breath, wheezing or treatment of Chronic Obstructive As COPD is a long-term condition, difficulty breathing. Pulmonary Disease, also called you should take Spiolto Respimat COPD. every day even if you do not have Do not give this medicine to a child or adolescent under the age of 18 years. SPIOLTO RESPIMAT NZ CMI V02 1 Safety and effectiveness in children • diabetes glaucoma and migraine such as younger than 18 years have not been • severe liver problems. propranolol (beta-blockers) established. • Tell your doctor if you are medicines used for glaucoma, Do not use Spiolto Respimat to pregnant or plan to become including eye drops such as treat asthma. pregnant or are breast-feeding. timolol Safety and effectiveness in the Your doctor can discuss with you the • medicines used to treat treatment of asthma has not been risks and benefits involved. depression and other mental established. disorders such as tricyclic If you have not told your doctor Do not use Spiolto Respimat to antidepressants or MAO about any of the above, tell inhibitors. relieve an acute attack of him/her before you start using breathlessness or wheezing. Spiolto Respimat. These medicines may be affected by Spiolto Respimat should only be Spiolto Respimat or may affect how Do not allow the mist to enter your well it works. You may need to take used for maintenance treatment of eyes. Should this occur, your COPD. different amounts of your medicines, immediately flush your eyes with or you may need to take different Do not use this medicine after the cold tap water for several minutes, medicines. expiry date printed on the inhaler stop using Spiolto Respimat and label or carton, or if the packaging immediately consult your doctor Your doctor and pharmacist have is torn or shows signs of for further advice. more information on medicines to be careful with or avoid while using this tampering. If the mist enters the eye, it may medicine. If it has expired or is damaged, return result in eye pain or discomfort, it to your pharmacist for disposal. blurred vision, seeing halos around If you are not sure whether you lights or coloured images in should start taking this medicine, association with red eyes (i.e. narrow How to use Spiolto talk to your doctor. angle glaucoma). Eye symptoms may be accompanied by headache, nausea Respimat or vomiting. Before you start to use it Follow all directions given to you Use this medicine only with the Tell your doctor if you have any by your doctor or pharmacist Respimat device. allergies to any other medicines or carefully. any other substances, such as They may differ from the Taking other medicines foods, preservatives or dyes. information contained in this leaflet. Tell your doctor or pharmacist if Tell your doctor if you have, or If you do not understand the you are using any other medicines, have had, any of the following instructions on the box, ask your including any that you get without medical conditions: doctor or pharmacist for help. a prescription from your • asthma (you should not use pharmacy, supermarket or health Spiolto Respimat for the How much to use food shop. treatment of asthma) Take TWO PUFFS, once a day at Some medicines and Spiolto • acute worsening of your the same time of the day. Respimat may interfere with each breathing problems other. These include: You need to take two puffs to get the • heart problems full dose. Two puffs are equal to one • similar medicines used to treat dose. • high blood pressure your breathing problems, including other anticholinergic • seizures How to use it medicines such as ipratropium • overactive thyroid gland Spiolto Respimat is for inhalation (thyrotoxicosis) • medicines that can lower the amount of potassium in your use only. • high pressure in the eye blood. These include medicines Make sure that you know how to (glaucoma) used to treat breathing problems use your Spiolto Respimat inhaler • kidney or liver problems such as theophylline, steroids properly. • problems with passing urine such as prednisolone and The instructions for use are provided diuretics (water tablets) • problems with your prostate at the end of this leaflet. • gland medicines used to treat high Carefully read the instructions for blood pressure, heart conditions, use and follow the diagrams that SPIOLTO RESPIMAT NZ CMI V02 2 show you how to use the Spiolto If you are not sure what to do, ask While you are using Respimat inhaler. your doctor or pharmacist. Spiolto Respimat If you do not understand the If you have trouble remembering instructions on how to use the to take your medicine, ask your Things you must do Spiolto Respimat inhaler, ask your pharmacist for some hints. doctor or pharmacist for help. Stop using Spiolto Respimat and tell your doctor immediately if you Use the Spiolto Respimat inhaler If you use too much get sudden tightness of the chest, supplied in the pack to breathe in (overdose) coughing, wheezing or the solution containing the Immediately telephone your doctor breathlessness immediately after medicine from the Spiolto or the Poisons Information Centre using the Spiolto Respimat. Respimat cartridge. (telephone 0800 764 766) for These may be signs of a condition Insert the Spiolto Respimat advice, or go to Emergency at your called bronchospasm. cartridge into the Spiolto Respimat nearest hospital, if you think that inhaler to prepare the inhaler for you or anyone else may have used If you are about to be started on first use. too much Spiolto Respimat. Do any new medicine, remind your doctor or pharmacist that you are The Spiolto Respimat inhaler this even if there are no signs of using Spiolto Respimat. releases a mist of solution slowly and discomfort or poisoning. gently, making it easy to inhale it You may need urgent medical Tell any other doctors, dentists and into your lungs where it is needed. attention. pharmacists who are treating you The mist containing the medication is Symptoms of an overdose may that you are using this medicine. released by pressing the dose release include: If you become pregnant while button. • high or low blood pressure, using this medicine, tell your dizziness, light-headedness doctor immediately. When to use it If you are a smoker, you should • blurred vision Take your medicine at about the stop smoking. • changes in heart rate (fast, slow same time each day. Your doctor or pharmacist can advise or irregular), palpitations Taking it at the same time each day you on the steps to take to quit will have the best effect. It will also • nervousness or feeling anxious smoking. help you remember when to take it. • inability to sleep Keep all of your doctor's • headache appointments so that your progress How long to use it • shaking or tremors can be checked.