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Management and Staff
Medix Pharmacy

Stiolto Respimat
(Tiotropium Bromide/Olodaterol)

Prescription Settings Edit

Brand Name Choices

Stiolto Respimat 2.5/2.5mcg/Inh
Stiolto Respimat 2.5/2.5mcg/Inh Metered-Dose Inhaler

Marketed as Inspiolto Respimat in Canada

Tiotropium Bromide/Olodaterol

Manufactured by Boehringer Ingelheim Ltd

Product of Canada

Dispensed by an approved Canadian pharmacy partner

* Each normal medicinal dose consists of two sprays from the inhalation device. Each inhaler unit contains 60 sprays or 30 medicinal doses.

Prescription Required

Stiolto Respimat 2.5/2.5mcg/Inh
Stiolto Respimat 2.5/2.5mcg/Inh Metered-Dose Inhaler

Marketed as Spiolto Respimat in United Kingdom

Tiotropium Bromide/Olodaterol

Manufactured by Boehringer Ingelheim Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

* Each normal medicinal dose consists of two sprays from the inhalation device. Each inhaler unit contains 60 sprays or 30 medicinal doses.

Prescription Required

Parallel Import

More Brand Name Choices

Generic Choices

No generic medication is available for Stiolto Respimat (Tiotropium Bromide/Olodaterol)

What Stiolto Respimat is and what it is used for

Spiolto Respimat contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta2 agonists. What Spiolto Respimat is used for Spiolto Respimat helps adult patients who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Spiolto Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Spiolto Respimat can also help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life. As COPD is a long-term disease you should take Spiolto Respimat every day and not only when you have breathing problems or other symptoms of COPD.

How to take Stiolto Respimat

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Spiolto Respimat is for inhalation use only. Dosage The recommended dose is: Spiolto Respimat is effective for 24 hours so you will need to use Spiolto Respimat only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS. As COPD is a long-term disease take Spiolto Respimat every day and not only when you experience breathing problems. Do not take more than the recommended dose. Use in children and adolescents There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years). Make sure that you know how to use your Spiolto Respimat inhaler properly. The instructions for use of the Spiolto Respimat inhaler are provided on the other side of this leaflet. If you take more Spiolto Respimat than you should You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, blurred vision, chest pain, high or low blood pressure, faster or irregular heartbeat or feeling of heart beat, dizziness, nervousness, difficulty in sleeping, anxiety, headache, shaking, muscle cramps, nausea, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing). If you forget to take Spiolto Respimat If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not take a double dose to make up for a forgotten dose. If you stop using Spiolto Respimat Before you stop taking Spiolto Respimat, you should talk to your doctor or your pharmacist. If you stop taking Spiolto Respimat the signs and symptoms of COPD may worsen. 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. If any of the following occurs, please stop using this medicine and consult your doctor immediately.
• Immediate allergic reactions to Spiolto Respimat are rare (they may affect up to 1 in 1,000 people). These reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of Spiolto Respimat. These include rash, nettle rash (urticaria), swelling of the mouth and face, sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or light headedness).
• As with all inhaled medications , tightness of the chest, associated with coughing, wheezing or breathlessness may occur immediately after inhalation (paradoxical bronchospasm).
• seeing halos around lights or coloured images in association with red eyes (glaucoma). The frequency cannot be estimated from the available data.
• blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic). The frequency cannot be estimated from the available data. Other possible side effects:

Common (may affect up to 1 in 10 people)
•dry mouth

Uncommon (may affect up to 1 in 100 people)
•dizziness
•difficulty in sleeping (insomnia)
•headache
•high blood pressure (hypertension)
•irregular heart beat (atrial fibrillation)
•faster heart beat (tachycardia)
•feeling your heartbeat (palpitations)
•cough
•hoarseness (dysphonia)
•constipation

Rare (may affect up to 1 in 1,000 people)
•nasopharyngitis
•blurred vision
•rapid heartbeat (supraventricular tachycardia)
•inflammation of the larynx (laryngitis)
•sore throat (pharyngitis)
•nosebleed (epistaxis)
•fungal infections of the mouth and throat (oropharyngeal candidiasis)
•inflammation of the gums (gingivitis)
•feeling sick (nausea)
•itching (pruritus)
•joint pain (arthralgia)
•back pain
•difficulties passing urine (urinary retention)
•infections of the urinary tract
•painful urination (dysuria)

Not known (frequency cannot be estimated from the available data)
•tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
•seeing halos around lights or coloured images in association with red eyes (glaucoma)
•increase of the measured eye pressure
•inflammation in sinuses (sinusitis)
•blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic)
•heart burn (gastrooesophageal reflux disease)
•difficulties swallowing (dysphagia)
•inflammation of the tongue (glossitis)
•inflammation of the mouth (stomatitis)
•dental caries
•infections or ulcerations of the skin
•dryness of the skin
•swelling of joint
•depletion of body water (dehydration) You may also experience side effects which are known to occur with certain medicines for breathing problems similar to Spiolto Respimat (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, muscle cramps, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal 5. How to store Spiolto Respimat Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label after EXP. The expiry date refers to the last day of the month. Do not freeze. Spiolto Respimat inhaler should be discarded at the latest 3 months after first use. 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 Spiolto Respimat contains The active substances are tiotropium and olodaterol. The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. The delivered dose is the dose which is available for the patient after passing the mouthpiece. The other ingredients are: Benzalkonium chloride, disodium edetate, purified water and hydrochloric acid for pH adjustment. What Spiolto Respimat looks like and contents of the pack Spiolto Respimat is composed of one cartridge with inhalation solution and one Respimat inhaler. The cartridge has to be inserted into the inhaler before the first use. Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Double pack: 2 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Triple pack: 3 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Eight pack: 8 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing authorisation holder for Spiolto Respimat is: Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein Germany The manufacturer for Spiolto Respimat is: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Straße 173 D-55216 Ingelheim am Rhein Germany This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Liechtenstein: Spiolto Respimat 2,5 Mikrogramm/ 2,5 Mikrogramm – Lösung zur Inhalation Belgium, Luxembourg: Spiolto Respimat 2,5 microgrammes/ 2,5 microgrammes/inhalation, solution à inhaler Bulgaria: Spiolto Respimat Спиолто Респимат Cyprus, Greece: Spiolto Respimat Croatia: Spiolto Respimat 2,5 mikrograma/ 2,5 mikrograma, otopina inhalata Czech Republic: Spiolto Respimat 2,5 mikrogramů/ 2,5 mikrogramů Denmark: Spiolto Respimat Estonia: Spiolto Respimat Finland: Inspiolto Respimat 2.5 mikrog/ 2.5 mikrog inhalaationeste, liuos France: Spiolto Respimat 2,5 microgrammes/ 2,5 microgrammes/dose, solution à inhaler Germany: Spiolto Respimat 2,5 Mikrogramm/ 2,5 Mikrogramm pro Hub, Lösung zur Inhalation Hungary: Spiolto Respimat 2,5 mikrogramm/ 2,5 mikrogramm inhalációs oldat Iceland: Spiolto Respimat Ireland, Malta, UK: Spiolto Respimat Italy: Spiolto Respimat 2,5 microgrammi/ 2,5 microgrammi, soluzione per inalazione Latvia: Spiolto Respimat 2,5 mikrogrami/ 2,5 mikrogrami šķīdums inhalācijām Lithuania: Spiolto Respimat 2,5 mikrogramo/ 2,5 mikrogramo/išpurškime įkvepiamasis tirpalas Netherlands: Spiolto Respimat 2,5 microgram/ 2,5 microgram, inhalatieoplossing Norway: Spiolto Respimat Poland: Spiolto Respimat Portugal: Spiolto Respimat Romania: Spiolto Respimat 2,5 micrograme/ 2,5 micrograme soluţie de inhalat Slovakia: Spiolto Respimat Slovenia: Spiolto Respimat 2,5 mikrogramov/ 2,5 mikrogramov/vdih raztopina za inhaliranje Spain: Spiolto Respimat 2,5 microgramos/ 2,5 microgramos solución para inhalación Sweden: Spiolto Respimat This leaflet was last revised in 02/2017. Spiolto® Respimat® 2.5 microgram/2.5 microgram, inhalation solution tiotropium/olodaterol ® Respimat ® Spiolto 2.5 microgram/2.5 microgram, inhalation solution tiotropium/olodaterol 309838-04 File information Issue date of TD: PPM SKU: PPM SKU version: Issue date of artwork: Print colors: Black 15.03.2017 004 P033604 17.12.2015 Yes Yes No Yes No Yes No Yes No No Yes Yes TD Printfile Mandatory in Cyan Magenta Yellow Mat. No. Pack. Site: 309838-04 Legend case version: a = Batch No. b = Expiry date c = Manufacturing date d = Price/Sample/Clinic Technical colors BI-Diecut-Legendcase Free area Gluepoints Technical information Template name: TD-PI_710x274_90x35 Index: a Additional Requirements of Packaging site Example Technical information Control Code Type: Laetus mini MASS D: 0,35 mm MASS E: 1,0 mm MASS G: 0,65 mm Min. font size: 10pt V4.0 01/OCT/2012 (please do not change or remove it) Only for BI-internal use, Template according to Drawing no.: SP-14-0090-001-B_Index_ PACKAGE LEAFLET: INFORMATION FOR THE USER Spiolto® Respimat® 2.5 microgram/2.5 microgram, inhalation solution tiotropium/olodaterol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Spiolto Respimat is and what it is used for 2. What you need to know before you take Spiolto Respimat 3. How to take Spiolto Respimat 4. Possible side effects 5. How to store Spiolto Respimat 6. Contents of the pack and other information 1. What Spiolto Respimat is and what it is used for What Spiolto Respimat is Spiolto Respimat contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta2 agonists. What Spiolto Respimat is used for Spiolto Respimat helps adult patients who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Spiolto Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Spiolto Respimat can also help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life. As COPD is a long-term disease you should take Spiolto Respimat every day and not only when you have breathing problems or other symptoms of COPD. 2. What you need to know before you take Spiolto Respimat Do not use Spiolto Respimat – if you are allergic to tiotropium or olodaterol or any of the other ingredients of this medicine (listed in section 6) – if you are allergic to atropine or substances related to it, e.g. ipratropium or oxitropium Warnings and precautions Talk to your doctor or pharmacist before using Spiolto Respimat – if you have asthma (you should not use Spiolto Respimat for the treatment of asthma). – if you have diseases of the heart. – if you have high blood pressure. – if you have epilepsy. – if you have a specific thyroid gland problem called thyrotoxicosis. – if you have an abnormal widening of an artery called aneurysm. – if you have diabetes. – if you have severe hepatic impairment. – if you have renal impairment. – in case of a planned surgery. – if you have an eye problem called narrow-angle glaucoma. – if you have prostate problems or have difficulty passing urine. During treatment with Spiolto Respimat – Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm (see section 4). – If your breathing has got worse or if you experience rash, swelling or itching directly after using your inhaler, stop using it and tell your doctor immediately (see section 4). – If you experience any side effects affecting your heart (increase in pulse rate, increase in blood pressure and/or increase in symptoms like chest pain), tell your doctor immediately (see section 4). – If you experience muscle spasm, muscle weakness or abnormal heart rhythm, consult your doctor as these may be related to low blood levels of potassium (see section 4). When taking Spiolto Respimat take care not to let any spray enter your eyes. This may result in eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes (i.e. narrow angle glaucoma). Eye symptoms may be accompanied by headache, nausea or vomiting. Wash your eyes in warm water, stop using Spiolto Respimat and immediately consult your doctor for further advice. Spiolto Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease. It should not be used to treat a sudden attack of breathlessness or wheezing. Do not use Spiolto Respimat together with certain medicines containing long-acting β-adrenergic agonists, like salmeterol or formoterol. If you regularly take certain medicines called short-acting β-adrenergic agents, like salbutamol, continue to use these only to relieve acute symptoms like breathlessness. Dry mouth which has been observed with anti-cholinergic treatment may in the long term be associated with dental caries. Therefore, please remember to pay attention to oral hygiene. Do not take Spiolto Respimat more frequently than once daily. Children and adolescents Spiolto Respimat should not be given to children or adolescents (below the age of 18 years). Other medicines and Spiolto Respimat Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. In particular, please tell your doctor if you are using: – any medicines that may be similar to Spiolto Respimat (contain similar active substances, such as anticholinergic drugs or β-adrenergic agents). You may be more likely to get side effects. – medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). This may result in loss of the effect of Spiolto Respimat – medicines that lower the amount of potassium in your blood. These include: –steroids (e.g. prednisolone), –diuretics (water tablets), –medicines for breathing problems such as theophylline. If you use these medicines together with Spiolto Respimat you may experience symptoms of muscle spasm, muscle weakness or abnormal heart rhythm. – medicines called tricyclic antidepressants or monoamine oxidase (MAO) inhibitors (like selegiline or moclobemide), that are used to treat neurological or psychiatric disorders like Parkinson’s disease or depression; the use of these drugs will increase the likelihood that you get side effects affecting your heart. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine unless specifically recommended by your doctor. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. If you feel dizzy or if blurred vision occurs while taking Spiolto Respimat, do not drive or use any tools or machines. 3. How to take Spiolto Respimat Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Spiolto Respimat is for inhalation use only. Dosage The recommended dose is: Spiolto Respimat is effective for 24 hours so you will need to use Spiolto Respimat only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS. As COPD is a long-term disease take Spiolto Respimat every day and not only when you experience breathing problems. Do not take more than the recommended dose. Use in children and adolescents There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years). Make sure that you know how to use your Spiolto Respimat inhaler properly. The instructions for use of the Spiolto Respimat inhaler are provided on the other side of this leaflet. If you take more Spiolto Respimat than you should You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, blurred vision, chest pain, high or low blood pressure, faster or irregular heartbeat or feeling of heart beat, dizziness, nervousness, difficulty in sleeping, anxiety, headache, shaking, muscle cramps, nausea, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing). If you forget to take Spiolto Respimat If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not take a double dose to make up for a forgotten dose. If you stop using Spiolto Respimat Before you stop taking Spiolto Respimat, you should talk to your doctor or your pharmacist. If you stop taking Spiolto Respimat the signs and symptoms of COPD may worsen. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following occurs, please stop using this medicine and consult your doctor immediately.
• Immediate allergic reactions to Spiolto Respimat are rare (they may affect up to 1 in 1,000 people). These reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of Spiolto Respimat. These include rash, nettle rash (urticaria), swelling of the mouth and face, sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or light headedness).
• As with all inhaled medications , tightness of the chest, associated with coughing, wheezing or breathlessness may occur immediately after inhalation (paradoxical bronchospasm).
• seeing halos around lights or coloured images in association with red eyes (glaucoma). The frequency cannot be estimated from the available data.
• blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic). The frequency cannot be estimated from the available data. Other possible side effects:

Common (may affect up to 1 in 10 people)
•dry mouth

Uncommon (may affect up to 1 in 100 people)
•dizziness
•difficulty in sleeping (insomnia)
•headache
•high blood pressure (hypertension)
•irregular heart beat (atrial fibrillation)
•faster heart beat (tachycardia)
•feeling your heartbeat (palpitations)
•cough
•hoarseness (dysphonia)
•constipation

Rare (may affect up to 1 in 1,000 people)
•nasopharyngitis
•blurred vision
•rapid heartbeat (supraventricular tachycardia)
•inflammation of the larynx (laryngitis)
•sore throat (pharyngitis)
•nosebleed (epistaxis)
•fungal infections of the mouth and throat (oropharyngeal candidiasis)
•inflammation of the gums (gingivitis)
•feeling sick (nausea)
•itching (pruritus)
•joint pain (arthralgia)
•back pain
•difficulties passing urine (urinary retention)
•infections of the urinary tract
•painful urination (dysuria)

Not known (frequency cannot be estimated from the available data)
•tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
•seeing halos around lights or coloured images in association with red eyes (glaucoma)
•increase of the measured eye pressure
•inflammation in sinuses (sinusitis)
•blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic)
•heart burn (gastrooesophageal reflux disease)
•difficulties swallowing (dysphagia)
•inflammation of the tongue (glossitis)
•inflammation of the mouth (stomatitis)
•dental caries
•infections or ulcerations of the skin
•dryness of the skin
•swelling of joint
•depletion of body water (dehydration) You may also experience side effects which are known to occur with certain medicines for breathing problems similar to Spiolto Respimat (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, muscle cramps, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal 5. How to store Spiolto Respimat Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label after EXP. The expiry date refers to the last day of the month. Do not freeze. Spiolto Respimat inhaler should be discarded at the latest 3 months after first use. 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 Spiolto Respimat contains The active substances are tiotropium and olodaterol. The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. The delivered dose is the dose which is available for the patient after passing the mouthpiece. The other ingredients are: Benzalkonium chloride, disodium edetate, purified water and hydrochloric acid for pH adjustment. What Spiolto Respimat looks like and contents of the pack Spiolto Respimat is composed of one cartridge with inhalation solution and one Respimat inhaler. The cartridge has to be inserted into the inhaler before the first use. Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Double pack: 2 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Triple pack: 3 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Eight pack: 8 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing authorisation holder for Spiolto Respimat is: Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein Germany The manufacturer for Spiolto Respimat is: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Straße 173 D-55216 Ingelheim am Rhein Germany This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Liechtenstein: Spiolto Respimat 2,5 Mikrogramm/ 2,5 Mikrogramm – Lösung zur Inhalation Belgium, Luxembourg: Spiolto Respimat 2,5 microgrammes/ 2,5 microgrammes/inhalation, solution à inhaler Bulgaria: Spiolto Respimat Спиолто Респимат Cyprus, Greece: Spiolto Respimat Croatia: Spiolto Respimat 2,5 mikrograma/ 2,5 mikrograma, otopina inhalata Czech Republic: Spiolto Respimat 2,5 mikrogramů/ 2,5 mikrogramů Denmark: Spiolto Respimat Estonia: Spiolto Respimat Finland: Inspiolto Respimat 2.5 mikrog/ 2.5 mikrog inhalaationeste, liuos France: Spiolto Respimat 2,5 microgrammes/ 2,5 microgrammes/dose, solution à inhaler Germany: Spiolto Respimat 2,5 Mikrogramm/ 2,5 Mikrogramm pro Hub, Lösung zur Inhalation Hungary: Spiolto Respimat 2,5 mikrogramm/ 2,5 mikrogramm inhalációs oldat Iceland: Spiolto Respimat Ireland, Malta, UK: Spiolto Respimat Italy: Spiolto Respimat 2,5 microgrammi/ 2,5 microgrammi, soluzione per inalazione Latvia: Spiolto Respimat 2,5 mikrogrami/ 2,5 mikrogrami šķīdums inhalācijām Lithuania: Spiolto Respimat 2,5 mikrogramo/ 2,5 mikrogramo/išpurškime įkvepiamasis tirpalas Netherlands: Spiolto Respimat 2,5 microgram/ 2,5 microgram, inhalatieoplossing Norway: Spiolto Respimat Poland: Spiolto Respimat Portugal: Spiolto Respimat Romania: Spiolto Respimat 2,5 micrograme/ 2,5 micrograme soluţie de inhalat Slovakia: Spiolto Respimat Slovenia: Spiolto Respimat 2,5 mikrogramov/ 2,5 mikrogramov/vdih raztopina za inhaliranje Spain: Spiolto Respimat 2,5 microgramos/ 2,5 microgramos solución para inhalación Sweden: Spiolto Respimat This leaflet was last revised in 02/2017. Spiolto® Respimat® 2.5 microgram/2.5 microgram, inhalation solution tiotropium/olodaterol ® Respimat ® Spiolto 2.5 microgram/2.5 microgram, inhalation solution tiotropium/olodaterol 309838-04 File information Issue date of TD: PPM SKU: PPM SKU version: Issue date of artwork: Print colors: Black 15.03.2017 004 P033604 17.12.2015 Yes Yes No Yes No Yes No Yes No No Yes Yes TD Printfile Mandatory in Cyan Magenta Yellow Mat. No. Pack. Site: 309838-04 Legend case version: a = Batch No. b = Expiry date c = Manufacturing date d = Price/Sample/Clinic Technical colors BI-Diecut-Legendcase Free area Gluepoints Technical information Template name: TD-PI_710x274_90x35 Index: a Additional Requirements of Packaging site Example Technical information Control Code Type: Laetus mini MASS D: 0,35 mm MASS E: 1,0 mm MASS G: 0,65 mm Min. font size: 10pt V4.0 01/OCT/2012 (please do not change or remove it) Only for BI-internal use, Template according to Drawing no.: SP-14-0090-001-B_Index_ PACKAGE LEAFLET: INFORMATION FOR THE USER Spiolto® Respimat® 2.5 microgram/2.5 microgram, inhalation solution tiotropium/olodaterol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Spiolto Respimat is and what it is used for 2. What you need to know before you take Spiolto Respimat 3. How to take Spiolto Respimat 4. Possible side effects 5. How to store Spiolto Respimat 6. Contents of the pack and other information 1. What Spiolto Respimat is and what it is used for What Spiolto Respimat is Spiolto Respimat contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta2 agonists. What Spiolto Respimat is used for Spiolto Respimat helps adult patients who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Spiolto Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Spiolto Respimat can also help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life. As COPD is a long-term disease you should take Spiolto Respimat every day and not only when you have breathing problems or other symptoms of COPD. 2. What you need to know before you take Spiolto Respimat Do not use Spiolto Respimat – if you are allergic to tiotropium or olodaterol or any of the other ingredients of this medicine (listed in section 6) – if you are allergic to atropine or substances related to it, e.g. ipratropium or oxitropium Warnings and precautions Talk to your doctor or pharmacist before using Spiolto Respimat – if you have asthma (you should not use Spiolto Respimat for the treatment of asthma). – if you have diseases of the heart. – if you have high blood pressure. – if you have epilepsy. – if you have a specific thyroid gland problem called thyrotoxicosis. – if you have an abnormal widening of an artery called aneurysm. – if you have diabetes. – if you have severe hepatic impairment. – if you have renal impairment. – in case of a planned surgery. – if you have an eye problem called narrow-angle glaucoma. – if you have prostate problems or have difficulty passing urine. During treatment with Spiolto Respimat – Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm (see section 4). – If your breathing has got worse or if you experience rash, swelling or itching directly after using your inhaler, stop using it and tell your doctor immediately (see section 4). – If you experience any side effects affecting your heart (increase in pulse rate, increase in blood pressure and/or increase in symptoms like chest pain), tell your doctor immediately (see section 4). – If you experience muscle spasm, muscle weakness or abnormal heart rhythm, consult your doctor as these may be related to low blood levels of potassium (see section 4). When taking Spiolto Respimat take care not to let any spray enter your eyes. This may result in eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes (i.e. narrow angle glaucoma). Eye symptoms may be accompanied by headache, nausea or vomiting. Wash your eyes in warm water, stop using Spiolto Respimat and immediately consult your doctor for further advice. Spiolto Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease. It should not be used to treat a sudden attack of breathlessness or wheezing. Do not use Spiolto Respimat together with certain medicines containing long-acting β-adrenergic agonists, like salmeterol or formoterol. If you regularly take certain medicines called short-acting β-adrenergic agents, like salbutamol, continue to use these only to relieve acute symptoms like breathlessness. Dry mouth which has been observed with anti-cholinergic treatment may in the long term be associated with dental caries. Therefore, please remember to pay attention to oral hygiene. Do not take Spiolto Respimat more frequently than once daily. Children and adolescents Spiolto Respimat should not be given to children or adolescents (below the age of 18 years). Other medicines and Spiolto Respimat Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. In particular, please tell your doctor if you are using: – any medicines that may be similar to Spiolto Respimat (contain similar active substances, such as anticholinergic drugs or β-adrenergic agents). You may be more likely to get side effects. – medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). This may result in loss of the effect of Spiolto Respimat – medicines that lower the amount of potassium in your blood. These include: –steroids (e.g. prednisolone), –diuretics (water tablets), –medicines for breathing problems such as theophylline. If you use these medicines together with Spiolto Respimat you may experience symptoms of muscle spasm, muscle weakness or abnormal heart rhythm. – medicines called tricyclic antidepressants or monoamine oxidase (MAO) inhibitors (like selegiline or moclobemide), that are used to treat neurological or psychiatric disorders like Parkinson’s disease or depression; the use of these drugs will increase the likelihood that you get side effects affecting your heart. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine unless specifically recommended by your doctor. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. If you feel dizzy or if blurred vision occurs while taking Spiolto Respimat, do not drive or use any tools or machines. 3. How to take Spiolto Respimat Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Spiolto Respimat is for inhalation use only. Dosage The recommended dose is: Spiolto Respimat is effective for 24 hours so you will need to use Spiolto Respimat only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS. As COPD is a long-term disease take Spiolto Respimat every day and not only when you experience breathing problems. Do not take more than the recommended dose. Use in children and adolescents There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years). Make sure that you know how to use your Spiolto Respimat inhaler properly. The instructions for use of the Spiolto Respimat inhaler are provided on the other side of this leaflet. If you take more Spiolto Respimat than you should You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, blurred vision, chest pain, high or low blood pressure, faster or irregular heartbeat or feeling of heart beat, dizziness, nervousness, difficulty in sleeping, anxiety, headache, shaking, muscle cramps, nausea, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing). If you forget to take Spiolto Respimat If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not take a double dose to make up for a forgotten dose. If you stop using Spiolto Respimat Before you stop taking Spiolto Respimat, you should talk to your doctor or your pharmacist. If you stop taking Spiolto Respimat the signs and symptoms of COPD may worsen. 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. If any of the following occurs, please stop using this medicine and consult your doctor immediately.
• Immediate allergic reactions to Spiolto Respimat are rare (they may affect up to 1 in 1,000 people). These reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of Spiolto Respimat. These include rash, nettle rash (urticaria), swelling of the mouth and face, sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or light headedness).
• As with all inhaled medications , tightness of the chest, associated with coughing, wheezing or breathlessness may occur immediately after inhalation (paradoxical bronchospasm).
• seeing halos around lights or coloured images in association with red eyes (glaucoma). The frequency cannot be estimated from the available data.
• blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic). The frequency cannot be estimated from the available data. Other possible side effects:

Common (may affect up to 1 in 10 people)
•dry mouth

Uncommon (may affect up to 1 in 100 people)
•dizziness
•difficulty in sleeping (insomnia)
•headache
•high blood pressure (hypertension)
•irregular heart beat (atrial fibrillation)
•faster heart beat (tachycardia)
•feeling your heartbeat (palpitations)
•cough
•hoarseness (dysphonia)
•constipation

Rare (may affect up to 1 in 1,000 people)
•nasopharyngitis
•blurred vision
•rapid heartbeat (supraventricular tachycardia)
•inflammation of the larynx (laryngitis)
•sore throat (pharyngitis)
•nosebleed (epistaxis)
•fungal infections of the mouth and throat (oropharyngeal candidiasis)
•inflammation of the gums (gingivitis)
•feeling sick (nausea)
•itching (pruritus)
•joint pain (arthralgia)
•back pain
•difficulties passing urine (urinary retention)
•infections of the urinary tract
•painful urination (dysuria)

Not known (frequency cannot be estimated from the available data)
•tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
•seeing halos around lights or coloured images in association with red eyes (glaucoma)
•increase of the measured eye pressure
•inflammation in sinuses (sinusitis)
•blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic)
•heart burn (gastrooesophageal reflux disease)
•difficulties swallowing (dysphagia)
•inflammation of the tongue (glossitis)
•inflammation of the mouth (stomatitis)
•dental caries
•infections or ulcerations of the skin
•dryness of the skin
•swelling of joint
•depletion of body water (dehydration) You may also experience side effects which are known to occur with certain medicines for breathing problems similar to Spiolto Respimat (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, muscle cramps, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store Stiolto Respimat

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label after EXP. The expiry date refers to the last day of the month. Do not freeze. Spiolto Respimat inhaler should be discarded at the latest 3 months after first use. 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.

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