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 Combivent Respimat. If you are concerned about side effects, discuss the risks and benefits of Combivent Respimat with your doctor.

The following side effects have been reported by at least 1% of people taking Combivent 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.

• change in taste sensation
• common cold (runny nose, nasal congestion, sore throat)
• Constipation
• coughing
• Diarrhea
• dizziness
• Dry Mouth
• headache
• nausea
• nervousness
• sweating
• throat irritation
• tremor
• voice changes
• vomiting

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

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

• changes in blood pressure (e.g., dizziness, fainting, lightheadedness)
• difficult or painful urination
• fainting
• feeling nervous
• muscle pain, weakness, or spasms
• severe dizziness
• symptoms of Glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• symptoms of a respiratory infection (e.g., shortness of breath, cough, chest pain)
• wheezing after inhalation

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

• sudden blurred vision or eye pain
• fast or irregular heartbeat
• increased shortness of breath or wheezing
• signs of Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• chest pain
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• skin rash or Hives

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 Combivent Respimat.

Cartridge

Each actuation of aqueous solution contains 20 µg of ipratropium and 100 µg of salbutamol. Nonmedicinal ingredients: benzalkonium chloride, disodium edetate, hydrochloric acid, and purified water.

Inhalation device

The Respimat® inhalation device is a grey reusable plastic device with an orange cap that is specially designed for administering Combivent solution via oral inhalation.

Do not use ipratropium - salbutamol inhalation solution if you:

• are allergic to salbutamol, ipratropium, or any ingredients of Combivent Respimat
• are allergic to atropine or related medications
• have certain types of abnormal heart rhythms (tachyarrhythmias)
• have certain types of heart disease (hypertrophic obstructive cardiomyopathy)

There may be an interaction between ipratropium – salbutamol inhalation solution and any of the following:

• aclidinium
• 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-blockers (e.g., Propranolol, Nadolol)
• Betahistine
• botulinum toxin
• fast acting bronchodilators (e.g., salbutamol, terbutaline)
• long acting bronchodilators (e.g., formoterol, salmeterol)
• caffeine
• cannabis
• chloroquine
• corticosteroids (e.g., cortisone, Prednisone)
• Cyclobenzaprine
• Darifenacin
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• dipivefrin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Domperidone
• Donepezil
• efavirenz
• Epinephrine
• Flavoxate
• Galantamine
• glycopyrrolate
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
• ketotifen
• Linezolid
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methylphenidate
• Metoclopramide
• Midodrine
• mifepristone
• Mirabegron
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, Tranylcypromine)
• narcotics (e.g., Codeine, Morphine, Oxycodone)
• orphenadrine
• Oxybutynin
• potassium chloride
• Primaquine
• quinidine
• quinine
• quinolone antibiotics (e.g., levofloxacin, moxifloxacin, Ofloxacin)
• Rivastigmine
• scopolamine
• secretin
• selective serotonin reuptake inhibitors (SSRI; e.g., Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Solifenacin
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tiotropium
• Tolterodine
• Topiramate
• 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 Combivent 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 Combivent Respimat.

Cystic Fibrosis: People with cystic fibrosis may be more likely to have stomach discomfort (due to changes in how quickly food moves through the stomach and intestines) while using Combivent Respimat.

Diabetes: Ipratropium – salbutamol inhalation solution 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 Combivent Respimat.

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

Dizziness/blurred vision: Ipratropium - salbutamol 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 Combivent Respimat affects you.

Heart conditions: Combivent Respimat can cause increased heart rate and blood pressure, making certain heart conditions worse. If you have heart disease, high blood pressure, irregular heart beat, heart failure, or have had a recent heart attack, discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent 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 ipratropium - salbutamol, stop using Combivent Respimat immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medications.

Pheochromocytoma: If you have been diagnosed with pheochromocytoma (a tumour of the adrenal gland), discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Potassium levels: Decreases in blood levels of potassium may occur with the use of Combivent Respimat. This rarely causes problems, but potassium levels should be monitored by your doctor. If you experience unexplained muscle cramps, weakness, fatigue, or constipation, contact your doctor.

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

Urinary tract problems: Ipratropium – salbutamol inhalation solution can cause difficulty with starting urine flow. If you have an enlarged prostate or bladder retention, discuss with your doctor how Combivent Respimat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Combivent Respimat, and whether any special monitoring is needed.

Vision concerns: Combivent Respimat may cause symptoms of glaucoma or cause existing glaucoma to become worse. Avoid spraying Combivent Respimat into your eyes. If this happens, rinse your eyes with clear water immediately. Report any changes in your vision, including blurred vision, halos, and eye pain, to your doctor immediately.

Worsening symptoms: If Combivent Respimat does not begin to help your symptoms quickly, or you find that you have increased difficulty breathing, or you need to use Combivent Respimat more frequently, contact your doctor immediately.

Pregnancy: The safety of ipratropium – salbutamol inhalation solution use during pregnancy has not been determined. Although Combivent Respimat should not be used during pregnancy unless the benefits outweigh the risks, sometimes the benefit to the mother does outweigh risks to the developing baby. If you become pregnant while taking Combivent Respimat, contact your doctor immediately.

Breast-feeding: It is not known if ipratropium – salbutamol inhalation solution passes into breast milk. If you are a breast-feeding mother and are taking Combivent Respimat, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.