Combivent Respimat: Uses, Side Effects and Dosage

What COMBIVENT RESPIMAT is used for:

COMBIVENT RESPIMAT is used in adults to treat the wheezing or shortness of breath (bronchospasm) caused by chronic obstructive pulmonary disease (COPD).

How COMBIVENT RESPIMAT works:

COMBIVENT RESPIMAT contains 2 medicinal ingredients:

• ipratropium bromide (an anticholinergic)
• salbutamol (a beta-agonist)

Both ingredients belong to a group of medicines called bronchodilators. Bronchodilators help to open and relax the muscles of the airways. This allows more air to get in and out of the lungs. This makes it easier to breathe and helps prevent shortness of breath and wheezing.

The ingredients in COMBIVENT RESPIMAT are:

Medicinal ingredients: Ipratropium bromide monohydrate and salbutamol sulfate.

Non-medicinal ingredients: Benzalkonium chloride, edetate disodium, hydrochloric acid and purified water.

COMBIVENT RESPIMAT comes in the following dosage forms:

Solution for oral inhalation delivered by the COMBIVENT RESPIMAT inhaler. Each dose contains 20 mcg ipratropium bromide (monohydrate) and 100 mcg salbutamol (as salbutamol sulfate).

Do not use COMBIVENT RESPIMAT if:

• you are allergic to ipratropium bromide or other drugs which are anticholinergic (contain atropine or its derivatives), salbutamol sulfate, or to any other ingredients COMBIVENT RESPIMAT
• you have a fast or irregular heart beat or have a thickened heart muscle due to various conditions.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take COMBIVENT RESPIMAT. Talk about any health conditions or problems you may have, including if you:

• have thyroid or adrenal gland problems;
• have high blood pressure;
• have heart or blood vessel problems such as heart disease and problems with how your heart beats;
• have diabetes;

• have low levels of potassium in your blood (hypokalemia), especially if you are taking:

  • drugs known as xanthine derivatives (such as theophylline);
  • steroids to treat asthma;
  • water pills (diuretics);
• have eye problems, such as glaucoma, or eye pain;
• are taking any other medications including eye drops or any medications you can buy without a prescription;
• have problems passing urine;
• have prostate problems;

• have ever had to stop taking other medications for this illness because you were allergic to them

  or they caused problems;

• have low oxygen levels in your body (hypoxia);
• have or have a history of seizures;
• have cystic fibrosis, a genetic disorder that affects the lungs, pancreas and other organs;

• are pregnant or planning to become pregnant. Talk to your healthcare professional if you become pregnant while taking COMBIVENT RESPIMAT. Your healthcare professional will consider the benefit to you and the risk to your unborn baby;

• are breastfeeding. It is not known if COMBIVENT RESPIMAT can pass into breastmilk

Other warnings you should know about:

Driving and Using Machines: If you experience side effects such as dizziness, dilated pupils, or blurred vision, you should avoid driving or operating machinery.

Paradoxical bronchospasm: If you feel tightness of the chest, coughing, wheezing or breathlessness right after using COMBIVENT RESPIMAT, you may have a serious condition called “paradoxical bronchospasm” (an unexpected closing of your airways). Stop using COMBIVENT RESPIMAT and seek medical help right away.

Monitoring and Laboratory Tests: COMBIVENT RESPIMAT can cause abnormal blood test results such as high blood levels of ketones, low blood levels of potassium and high blood sugar. Your healthcare professional will decide when to perform blood tests and will interpret the results.

COMBIVENT RESPIMAT may cause positive tests for performance enhancement (doping) in athletic competitions.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with COMBIVENT RESPIMAT:

• other bronchodilators, medicines used to open the airway;

• beta blockers, medicines used to treat high blood pressure or other heart problems such as

  propranolol;

• xanthine derivatives such as theophylline;

• anti-depressants, medicines used to treat depression (such as monoamine oxidase inhibitors, and

  tricyclic antidepressants);

• epinephrine, a medicine that can be used to treat allergic reactions or sudden asthma attacks;

• certain diuretics or “water pills”, medicines used to lower fluid levels and treat high blood

  pressure such asfurosemide, hydrochlorothiazide;

• medicines used to treat allergies;
• digoxin, a medicine used to treat certain heart problems;
• glucocorticosteroids, medicines used to treat autoimmune diseases, severe allergies and asthma;
• halothane or halogenated anesthesia.

How to take COMBIVENT RESPIMAT:

• Take COMBIVENT RESPIMAT as directed by your healthcare professional.
• Before using COMBIVENT RESPIMAT, read the Instructions for Use at the end of this Patient Medication Information and follow the instructions carefully. Make sure you understand and can follow these instructions. Talk to your healthcare professional if you are unsure.
• COMBIVENT RESPIMAT should only be inhaled. Do not spray into your eyes.
• COMBIVENT RESPIMAT has been prescribed for you and should not be given to other people.
• If you have to go into hospital for an operation, take your inhaler with you and tell the healthcare professional what medicine(s) you are taking.

See a healthcare professional right away if:

• your breathing condition gets worse (breathlessness, wheezing or tight chest);
• your usual dose does not provide relief of wheezing or chest tightness.

Usual dose:

Your healthcare professional will decide your dose of COMBIVENT RESPIMAT. This may depend on your condition and how you react to COMBIVENT RESPIMAT.

The recommended dose is 1 puff four times a day.

The maximum dose is 6 puffs in 24 hours.

Overdose:

If you accidentally take more COMBIVENT RESPIMAT than recommended by your healthcare professional, you may feel shaky, have chest pain, dry mouth, blurred vision, or feel like your heart is beating faster than usual. Talk to your healthcare professional right away if this occurs.

Possible side effects from using COMBIVENT RESPIMAT:

These are not all the possible side effects you may have when taking COMBIVENT RESPIMAT. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• wheezing after inhalation;
• headache, dizziness, drowsiness;
• nausea (feeling sick), digestive problems like constipation, diarrhoea and vomiting;
• muscle problems such as cramps, spasms, weakness, pain, feeling weak, tremor (shaking);
• feeling nervous;
• mental disorder;
• voice sounds raspy or strained;
• increased sweating;
• bronchitis and upper respiratory tract infection (a cold);
• throat irritation, cough, dry mouth or throat, bad taste - sucking on a sour candy or rinsing your mouth may help.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15- 30^oC). Do not freeze.

Keep out of reach and sight of children.

COMBIVENT RESPIMAT should be discarded when:

• three months have passed since you first used it (even if not all the medication has been used) or;
• when the locking mechanism is engaged and no more medication can be dispensed.

If you want more information about COMBIVENT RESPIMAT:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html ); the manufacturer’s website (https://www.boehringer-ingelheim.ca), or by calling the manufacturer, Boehringer Ingelheim (Canada) Ltd., at 1-800-263-5103, extension 84633.

The information in this leaflet is current up to the time of the last authorization date shown below, but more current information may be available from the manufacturer.

Date of Authorization: 2026-07-22

INTRODUCTION

Read these Instructions for Use before you start using COMBIVENT RESPIMAT.

You will need to use this inhaler FOUR TIMES A DAY. Each time you use it take 1 PUFF.

Each box contains:

• 1 RESPIMAT inhaler
• 1 cartridge

Each cartridge provides 120 puffs (120 doses).

The colour of the cap of the RESPIMAT inhaler is the same colour as the cartridge.

HOW TO STORE MY COMBIVENT RESPIMAT INHALER

• Store COMBIVENT RESPIMAT (the cartridge and inhaler) between 15-30^oC. Do not freeze.
• Keep out of the sight and reach of children. Do not use your inhaler after the expiry date.
• Do not touch the piercing element inside the clear base.
• If COMBIVENT RESPIMAT has not been used for more than 3 days, release 1 puff towards the ground.
• If COMBIVENT RESPIMAT has not been used for more than 21 days, repeat steps 4 to 6 under “Prepare for First Use” until a cloud is visible. Then repeat steps 4 to 6 three more times.

HOW TO CARE FOR YOUR COMBIVENT RESPIMAT

Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only. You should do this at least once a week. Any minor changes in the colour of the mouthpiece will not affect how your COMBIVENT RESPIMAT inhaler works.

WHEN TO GET A NEW COMBIVENT RESPIMAT

• Your COMBIVENT RESPIMAT inhaler contains 120 puffs (120 doses).
• The dose indicator shows you about how much medication is left.

• When the dose indicator enters the red area of the scale you need to get a refill or a new prescription. There is about:

  • 7 days of medication left for the 120 puff product.
• When the dose indicator reaches the end of the red scale, your COMBIVENT RESPIMAT is empty and locks automatically. At this point, the clear base cannot be turned any further.

• Throw out the COMBIVENT RESPIMAT when:

  • Three months have passed since you first used it or, even if all the medication has not bee used
  • When the locking mechanism is engaged and no more medication can be dispensed.

INSTRUCTIONS FOR USE

1 PUFF FOUR TIMES A DAY

Prepare for First Use
1	Remove clear base Keep the cap closed. Press the safety catch while firmly pulling off the clear base with your other hand. Be careful not to touch the piercing element.
2	Insert cartridge Insert the narrow end of the cartridge into the inhaler. Place the inhaler on a firm surface and push down firmly until it snaps into place. You should hear a “click” when it has gone in all the way.
3	Replace clear base Put the clear base back into place until it “clicks”. Do not remove the clear base again.
4	Turn Keep the cap closed. Turn the clear base in the direction of the arrows on the label until it “clicks” (half a turn).
5	Open Open the cap until it snaps fully open.
6	Press Point the inhaler toward the ground. Press the dose-release button. Close the cap. Repeat steps 4 to 6 until a cloud is visible. After a cloud is visible, repeat steps 4 to 6 three more times. Your inhaler is now ready to use.

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 dose-release button and continue to breathe in. Hold your breath for 10 seconds or for as long as you feel comfortable. Close the cap.