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Home , Olodaterol

Spiolto® ®

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 . Olodaterol belongs Spiolto Respimat using this medicine, ask your to a group of medicines called long- doctor or pharmacist. acting . 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 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 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 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.

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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 . 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 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 , steroids properly. • problems with passing urine such as prednisolone and The instructions for use are provided (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. Continue to use Spiolto Respimat • dry mouth Your doctor may do some tests from for as long as your doctor tells you. time to time to make sure the • muscle spasm This medicine helps to control your medicine is working and to prevent condition but it does not cure it. • feeling sick, also called nausea unwanted side effects. Therefore you must use Spiolto • stomach pain Respimat every day. It is important Things you must not do • constipation to keep taking your medicine even if Do not use Spiolto Respimat to • fatigue you feel well. treat any other complaints unless • generally feeling unwell your doctor tells you to. If you forget to use it • passing large amounts of urine, Do not give this medicine to anyone If you forget to use your Spiolto excessive thirst and having a dry else, even if they have the same Respimat, use it as soon as you mouth and skin condition as you. remember. • difficulty passing urine Do not take any other medicines If it is almost time for your next • increased rate of breathing. for your breathing problems dose, skip the dose you missed and without checking with your doctor. inhale just one dose at your usual Do not use Spiolto Respimat to time the next day. relieve an acute attack of Do not take a double dose to make breathlessness or wheezing. up for the dose that you missed. If you become wheezy or tight in This may increase the chance of you the chest before your next dose of getting an unwanted side effect.

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Spiolto Respimat is due, use a a throbbing ache, fever, stuffy Emergency at your nearest 'reliever puffer' in the usual way. nose and loss of the sense of hospital: Spiolto Respimat should only be smell • allergic reaction (shortness of used for maintenance treatment of • dry or sore mouth or throat and breath, wheezing or difficulty your COPD. discomfort when swallowing; breathing; swelling of the face, Do not stop using your medicine or swollen, red, sore tongue; lips, mouth, tongue or throat lower the dosage without checking gingivitis or tooth decay which may cause difficulty with your doctor. • flu-like symptoms, such as high swallowing or breathing; swelling of other parts of the body, rash, If you stop using it suddenly or lower temperature, sore throat, runny itching or hives on the skin) the dosage, the signs and symptoms nose, cough and chills • of your COPD may worsen. • sore, creamy-yellow, raised any side effects affecting your patches in the mouth or throat heart (such as fast or irregular Things to be careful of (thrush) heartbeats, palpitations, increase or decrease in blood pressure • Be careful driving or operating hoarse voice and/or increase in symptoms like machinery until you know how • a change in bowel movements, chest pain) Spiolto Respimat affects you. e.g. constipation • severe pain in the stomach with This medicine may cause dizziness • a burning sensation in the chest bloating, gut cramps and or blurred vision in some people. If rising up to the throat, also known vomiting. you have any of these symptoms, do as heartburn The above list includes very serious not drive, operate machinery or do • difficulty passing urine side effects. You may need urgent anything else that could be medical attention or hospitalisation. dangerous. • symptoms of urinary tract infection such as a frequent need You may also experience side effects to urinate, only passing a few which are known to occur with drops, burning pain or a 'scalding' certain similar medicines for Side effects sensation when urinating, feeling breathing problems. These may that the bladder is still full after include changes in heart rate (fast, Tell your doctor or pharmacist as urinating, pain above the pubic slow or irregular), chest pain (angina soon as possible if you do not feel bone or blood in the urine pectoris), high or low blood pressure, well while you are using Spiolto • headache shaking, nervousness, nausea, muscle spasm, fatigue, generally feeling Respimat. • dizziness unwell; passing large amounts of This medicine helps most people • trouble sleeping urine, excessive thirst and having a with COPD, but it may have • dry mouth and skin (symptoms of too unwanted side effects in a few blurred vision much sugar in the blood); and people. All medicines can have side • dehydration increased rate of breathing. effects. Sometimes they are serious, • back or joint pain, joint swelling most of the time they are not. You Tell your doctor or pharmacist if • shortness of breath, cough, or may need medical treatment if you you notice anything else that is chest infections get some of the side effects. making you feel unwell. • rash or dry skin; skin infection or Do not be alarmed by the following Other side effects not listed above skin ulcer. list of side effects. You may not may also occur in some people. experience any of them. Tell your doctor as soon as possible if you notice any symptoms that Ask your doctor or pharmacist to may indicate the level of potassium answer any questions you may in your blood is low such as muscle have. After using Spiolto spasm, muscle weakness or Respimat Tell your doctor or pharmacist if abnormal heart rhythm. you notice any of the following and These may be serious side effects they worry you: Care and cleaning that may require medical attention. • runny nose or nose bleeds Follow the instructions at the end If any of the following happen, stop of this leaflet on how to clean and • sinusitis, a feeling of tension or using the medicine and tell your take care of your Spiolto Respimat. fullness in the nose, cheeks and doctor immediately or go to behind your eyes, sometimes with

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Clean the mouthpiece including the cap) enables you to inhale the metal part inside the mouthpiece medicine from the cartridge. with a damp cloth or tissue only, at Each pack consists of: least once a week. • one Spiolto Respimat cartridge It is important to keep your inhaler containing the solution for clean and dry. inhalation and It may not work as well if it gets • one Spiolto Respimat inhaler dirty. providing 60 puffs (equal to 30 doses of medicine). Storage Keep Spiolto Respimat in a cool Ingredients dry place where the temperature Spiolto Respimat contains 2.5 stays below 25°C. Do not freeze. micrograms tiotropium (as bromide Do not store Spiolto Respimat or monohydrate) and 2.5 micrograms any other medicine in the olodaterol (as hydrochloride) per bathroom or near a sink. Do not puff. leave it on a window sill or in the It also contains: car. • benzalkonium chloride Heat and dampness can destroy some • medicines. disodium edetate • hydrochloric acid Keep it where children cannot reach it. • purified water. A locked cupboard at least one-and- a-half metres above the ground is a Supplier good place to store medicines. Spiolto Respimat is supplied in New Discard Spiolto Respimat inhaler 3 Zealand by: months after inserting the Spiolto (NZ) Limited Respimat cartridge into the Spiolto Auckland Respimat inhaler even if it contains some unused medicine, or when the inhaler is locked (after 60 puffs), This Consumer Medicine whichever comes first. Information was updated in January 2020. Disposal ® Spiolto and Respimat are If your doctor tells you to stop registered trademarks of Boehringer using this medicine, or the expiry Ingelheim. date has passed, or it has been © Boehringer Ingelheim Pty Limited more than 3 months after its first 2020 use, or if the inhaler has locked (after 60 puffs), ask your pharmacist how to dispose of it properly.

Product Description

What it looks like Spiolto Respimat is available as a solution for inhalation contained in the cartridge. The Spiolto Respimat inhaler (with a light-green coloured

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Spiolto® Respimat®

2.5 micrograms / 2.5 micrograms Solution for Inhalation Tiotropium (as bromide monohydrate) / Olodaterol (as hydrochloride)

2. Insert cartridge When to get a new Spiolto • Respimat Insert the narrow end of the Instructions for Use cartridge into the inhaler. • Place the inhaler on a firm Introduction surface and push down firmly Read these Instructions for Use until it snaps into place. before you start using Spiolto Respimat (tiotropium bromide monohydrate and olodaterol hydrochloride).

You will need to use this inhaler only • Your Spiolto Respimat inhaler ONCE A DAY. Each time you use it contains 60 puffs (30 doses) if take TWO PUFFS. used as indicated (two puffs/once daily). 3. Replace clear base • The dose indicator shows approximately how much • Put the clear base back into medication is left. place until it clicks. • When the dose indicator enters the red area of the scale you need to get a new prescription; there is approximately medication for 7 days left (14 • If Spiolto Respimat has not been puffs). used for more than 7 days • Once the dose indicator reaches 4. Turn release one puff towards the the end of the red scale, your • Keep the cap closed. ground. Spiolto Respimat locks • Turn the clear base in the • If Spiolto Respimat has not been automatically – no more doses direction of the arrows on the used for more than 21 days can be released. At this point, label until it clicks (half a turn). repeat steps 4 to 6 under the clear base cannot be turned ‘Prepare for first use’ until a any further. cloud is visible. Then repeat • Three months after first use, the steps 4 to 6 three more times. Spiolto Respimat should be • Do not touch the piercing discarded even if it has not been element inside the clear base. used.

How to care for your Spiolto Prepare for first use 5. Open Respimat 1. Remove clear base • Open the cap until it snaps fully open. Clean the mouthpiece including the • Keep the cap closed. metal part inside the mouthpiece with • Press the safety catch while a damp cloth or tissue only, at least firmly pulling off the clear base once a week. with your other hand. Any minor discoloration in the mouthpiece does not affect your

Spiolto Respimat inhaler performance.

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6. Press dose-release button and continue • Point the inhaler toward the to breathe in. ground • Hold your breath for 10 seconds • Press the dose-release button. or for as long as comfortable. • • Close the cap. Repeat Turn, Open, Press for a total of 2 puffs. • Repeat steps 4-6 until a cloud is • visible. Close the cap until you use the inhaler again. • After a cloud is visible, repeat

steps 4-6 three more times.

Daily use TURN • Keep the cap closed. • TURN the clear base in the direction of the arrows on the label until it clicks (half a turn).

OPEN • OPEN the cap until it snaps fully open.

PRESS • Breathe out slowly and fully. • Close your lips around the mouthpiece without covering the air vents. • While taking a slow, deep breath through your mouth, PRESS the

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Answers to Common The dose indicator on the in the steps 4 to 6 under “Prepare for Questions Spiolto Respimat reaches first use”. zero too soon Is the dose indicator on the Spiolto It is difficult to insert the Did you use Spiolto Respimat as Respimat pointing to 0? cartridge deep enough indicated (two puffs/once daily)? If the dose indicator points to 0, you have used up all your medication and Spiolto Respimat will last 30 days if Did you accidentally turn the clear the inhaler is locked. base before inserting the used at two puffs once daily. Once your Spiolto Respimat is cartridge? Did you turn the clear base before assembled, do not remove the clear Open the cap, press the dose-release you inserted the cartridge? base or the cartridge. Always insert a button, then insert the cartridge. The dose indicator counts each turn new cartridge into a NEW Spiolto Did you insert the cartridge with of the clear base regardless whether a Respimat inhaler. the wide end first? cartridge has been inserted or not. Insert the cartridge with the narrow Did you spray in the air often to Supplier check whether the Spiolto end first. Spiolto Respimat inhaler is supplied Respimat is working? Did you place the inhaler on a firm in New Zealand by: Once you have prepared Spiolto surface and push down firmly until Boehringer Ingelheim (NZ) Limited the cartridge snaps into place? Respimat, no test-spraying is required if used daily. Auckland The cartridge should be pushed Did you insert the cartridge into a firmly against a firm surface to Manufacturer ensure that it has gone all the way in. used Spiolto Respimat inhaler? Spiolto Respimat inhaler is The cartridge will not be flush with Always insert a new cartridge into a manufactured by: the inhaler, you will see the silver NEW Spiolto Respimat inhaler. ring of the lower end of the cartridge. Boehringer Ingelheim Pharma GmbH My Spiolto Respimat sprays & Co. KG I cannot press the dose- automatically Binger Straße 173 release button Was the cap open when you turned D-55216 Ingelheim am Rhein Did you turn the clear base? the clear base? Germany If not, turn the clear base in a Close the cap, then turn the clear continuous movement until it clicks base. (half a turn). Did you press the dose-release Is the dose indicator on the Spiolto button when turning the clear Respimat pointing to zero? base? The Spiolto Respimat inhaler is Close the cap, so the dose-release locked after 60 puffs (30 medicinal button is covered, then turn the clear doses). Prepare and use your new base. Spiolto Respimat inhaler. Did you stop when turning the clear base before it clicked? I cannot turn the clear base Turn the clear base in a Did you turn the clear base CONTINUOUS movement until it already? clicks (half a turn). If the clear base has already been turned, follow steps “OPEN” and My Spiolto Respimat doesn’t “PRESS” under “Daily use” to get spray your medicine. Did you insert a cartridge? Is the dose indicator on the Spiolto If not, insert a cartridge. Respimat pointing to zero? Did you repeat Turn, Open, Press The Spiolto Respimat inhaler is less than three times after inserting locked after 60 puffs (30 medicinal the cartridge? doses). Prepare and use your new Spiolto Respimat inhaler. Repeat Turn, Open, Press three times after inserting the cartridge as shown SPIOLTO RESPIMAT NZ CMI V02 8