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.

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

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.