This combination product contains two medications: olodaterol and tiotropium. Both medications are bronchodilators. Olodaterol is a long-acting beta agonist (LABA), while tiotropium is a long-acting muscarinic antagonist (LAMA). They work in different ways to open the airways to make breathing easier. Olodaterol – tiotropium is used for the long-term relief of symptoms such as shortness of breath and wheezing associated with the lung disease known as COPD (Chronic Obstructive Pulmonary Disease) (COPD), which includes chronic Bronchitis and emphysema.

Olodaterol - tiotropium should not be used as a rescue medication to relieve sudden attacks of COPD symptoms such as wheezing or shortness of breath. It also should not be used to treat Asthma. Consult your doctor or pharmacist for advice about rescue medications that are appropriate for you.

Inspiolto Respimat may be available under multiple brand names and/or in several different forms. Any specific brand name of Inspiolto Respimat may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Inspiolto Respimat may not be used for all of the conditions discussed here.

Your doctor may have suggested Inspiolto Respimat for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Inspiolto Respimat, speak to your doctor. Do not stop taking Inspiolto Respimat without consulting your doctor.

Do not give Inspiolto Respimat to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Inspiolto Respimat if their doctor has not prescribed it.

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The recommended adult dose of olodaterol - tiotropium using the Respimat® inhalation device is 2 actuations of 2.5 µg of each medication, inhaled once daily. This provides a total daily dose of 5 µg of each medication.

To use the Respima® inhaler, the Respimat® cartridge is inserted into the inhaler device.  After the cartridge has been inserted into the inhaler, the device must be primed. To prime the device, load a dose and press the dose release button with the inhaler pointed towards the ground. Continue until a cloud of medication is released. Repeat 3 more times to ensure that the inhaler is ready for use. When the device is used regularly, the inhaler does not need to be re-primed. If more than 7 days have passed since last using the inhaler, it must be re-primed by actuating the inhaler once. If more than 21 days have passed since last using the inhaler, it should be primed as though it were new.

Your doctor or another health care professional, such as your pharmacist, should teach you how to use the Respimat® inhalation device. If you are unsure of how to use the device, contact your doctor or pharmacist.

After 3 months of use, safely discard the device and canister, even if there is still medication remaining in the canister.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use Inspiolto Respimat exactly as prescribed by your doctor. To obtain the most benefit from Inspiolto Respimat, it must be used regularly, even if you do not have any symptoms of illness.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Inspiolto Respimat at room temperature, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does Inspiolto Respimat come in?

Each actuation of aqueous solution contains 2.5 µg of tiotropium and 2.5 µg of olodaterol. Nonmedicinal ingredients: purified water, benzalkonium chloride, disodium edetate, and hydrochloric acid.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Inspiolto Respimat. If you are concerned about side effects, discuss the risks and benefits of Inspiolto Respimat with your doctor.

The following side effects have been reported by at least 1% of people taking Inspiolto Respimat. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cold symptoms (e.g., runny nose, stuffy nose, sore throat)
• Constipation
• cough
• dehydration
• Diarrhea
• difficulty swallowing
• dizziness
• Dry Mouth
• dry skin
• feeling tired
• heartburn
• hoarseness
• inflammation or pain of the gums, tongue, mouth, or throat
• muscle pain or spasms
• nosebleeds
• rash
• swollen and painful joints
• trouble sleeping
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bronchitis (e.g., shortness of breath, cough, chest pain)
• change in blood pressure (increase or decrease)
• fungal infections in the mouth and throat
• lack of bowel movements
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
• signs of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• skin infection or sores
• swelling of the feet, ankles or legs
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
• symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
• symptoms of a lung infection (shortness of breath, cough and chest pain)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of metabolic acidosis (e.g., chest pain, headache, heart palpitations, nausea, vomiting, stomach pain)
• wheezing or coughing, difficulty breathing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Inspiolto Respimat.

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Each actuation of aqueous solution contains 2.5 µg of tiotropium and 2.5 µg of olodaterol. Nonmedicinal ingredients: purified water, benzalkonium chloride, disodium edetate, and hydrochloric acid.

Do not take Inspiolto Respimat if you:

• are allergic to olodaterol, tiotropium or any ingredients of the medication
• are allergic to atropine or atropine-like medications
• have been prescribed Inspiolto Respimat for asthma symptoms

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There may be an interaction between olodaterol-tiotropium and any of the following:

• acetylcholinesterase inhibitors (e.g., Donepezil, Galantamine, Rivastigmine)
• aclidinium
• Alfuzosin
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• atropine
• azelastine
• belladonna
• Benztropine
• beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)
• long-acting beta 2 agonists (e.g., Indacaterol, salmeterol)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Betahistine
• botulinum toxin
• caffeine
• cannabis
• chloroquine
• Citalopram
• Crizotinib
• Cyclobenzaprine
• Darifenacin
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• Degarelix
• dipivefrin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, hydrochlorthiazide)
• dofetilide
• Domperidone
• Dronedarone
• efavirenz
• Epinephrine
• Escitalopram
• Flecainide
• Flavoxate
• Fingolimod
• Glucagon
• glycopyrrolate
• ipratropium
• ketotifen
• Linezolid
• lopinavir
• macrolide antibiotics (e.g., clarithromycin, erythromycin,)
• Methadone
• Methylphenidate
• Metoclopramide
• mifepristone
• Mirabegron
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Nabilone
• narcotics (e.g., Codeine, Morphine, Oxycodone)
• Nilotinib
• Nitroglycerin
• orphenadrine
• Oxybutynin
• Pimozide
• potassium chloride
• Primaquine
• procainamide
• Propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., levofloxacin moxifloxacin Ofloxacin)
• saquinavir
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• scopolamine
• Solifenacin
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Metolazone)
• Tolterodine
• Topiramate
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• umeclidinium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Inspiolto Respimat. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Inspiolto Respimat.

Asthma-related death: The safety and effectiveness of using Inspiolto Respimat to treat asthma symptoms have not been determined. Studies have shown an increase in deaths caused by severe asthma symptoms when LABA medications have been used without a corticosteroid. Inspiolto Respimat should not be used by people with asthma.

Bladder or urinary problems: Tiotropium can worsen symptoms of bladder problems. If you have a history of bladder problems, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Diabetes: Olodaterol, like other beta-agonists, may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Inspiolto Respimat.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Dizziness/blurred vision: Olodaterol - tiotropium may cause dizziness or blurred vision, affecting your ability to safely drive or operate machinery. Avoid these and other hazardous tasks until you know how Inspiolto Respimat affects you.

Enlarged prostate: Tiotropium can worsen symptoms of an enlarged prostate, such as difficulty starting urination. If you have an enlarged prostate, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Glaucoma: People with eye conditions (e.g., glaucoma) are more likely to experience worsening of their conditions and symptoms such as eye pain and swelling, blurred vision, or other unusual changes in their vision. Take extra care to ensure that olodaterol - tiotropium does not come into contact with your eyes. If your eyes have been in contact with olodaterol - tiotropium or you have any of these symptoms, contact your doctor immediately.

Heart rhythm: Beta-agonists such as olodaterol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death.

Both olodaterol and tiotropium can cause a fluttering of the heartbeat (atrial fibrillation) or rapid heartbeat, increased blood pressure, chest pain and decreased oxygen reaching the heart muscle.

If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using olodaterol - tiotropium, stop using Inspiolto Respimat immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Kidney function: Kidney Disease or reduced kidney function may cause Inspiolto Respimat to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Inspiolto Respimat to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Seizures: If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Thyroid disease: People who have an over-active thyroid gland may be more sensitive to the effects of olodaterol - tiotropium. If you have thyroid disease, discuss with your doctor how Inspiolto Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inspiolto Respimat, and whether any special monitoring is needed.

Pregnancy: Inspiolto Respimat should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Inspiolto Respimat, contact your doctor immediately.

Breast-feeding: It is not known if olodaterol - tiotropium passes into breast milk. If you are a breast-feeding mother and are taking Inspiolto Respimat, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Inspiolto Respimat have not been established for children.

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