Combivent Respimat - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals Inc.|
|Ingredients:||Ipratropium bromide monohydrate, salbutamol sulfate, benzalkonium chloride, edetate disodium, hydrochloric acid, purified water|
Ipratropium Bromide (as Monohydrate)/Salbutamol
(as Salbutamol Sulfate) Inhalation Solution
About this Medication
What the medication is used for
COMBIVENT RESPIMAT is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema).
What it does
COMBIVENT RESPIMAT is a combination of two drugs that are bronchodilators: ipratropium bromide (an anticholinergic) and salbutamol (a beta-agonist). COMBIVENT RESPIMAT works by relaxing the muscle surrounding the bronchi (airways in the lungs) and therefore helps to ease breathing problems.
You may already be familiar with one or both of these bronchodilators, since they are also available separately, with a prescription as ipratropium bromide and salbutamol.
When it should not be used
Do not take 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 component of COMBIVENT RESPIMAT (see "What the non-medicinal ingredients are");
- you have a fast or irregular heart beat or have a thickened heart muscle due to various conditions;
- you are under 18 years of age.
What the medicinal ingredients are
Ipratropium bromide monohydrate and salbutamol sulfate.
What the non-medicinal ingredients are
Benzalkonium chloride, edetate disodium, hydrochloric acid and purified water.
What dosage forms it comes in
Inhalation Solution. Each puff delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg salbutamol (as salbutamol sulfate) from the mouthpiece.
The inhaler enables you to inhale the medicine contained in a cartridge. The cartridge contains 120 puffs or 60 puffs (equal to 120 doses of medicine or 60 doses of medicine) available after preparing the inhaler for first use. There is enough medicine for 30 days or 15 days when it is used as 1 puff four times a day.
Warnings and Precautions
The solution is intended for inhalation only.
Avoid getting the spray into your eyes. This may result in eye pain and/or discomfort, temporary blurring of vision, and/or coloured images in association with red eyes. Should any of these symptoms develop, consult a doctor immediately.
BEFORE you use COMBIVENT RESPIMAT talk to your doctor or pharmacist if you:
- are pregnant or intend to become pregnant;
- are breast feeding;
- are having treatment for a thyroid or adrenal gland condition;
- are having treatment for high blood pressure, angina or a heart problem;
- 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 difficulty in urination;
- have enlarged prostate;
- have any allergies or reactions to foods or drugs;
- have a history of convulsions (uncontrolled shaking or seizures);
- have liver or kidney disease.
Contact your doctor immediately if:
- you require more than 1 daily dose (4 puffs); the maximum daily dose is 6 puffs;
- your shortness of breath becomes worse;
- you don't get the same benefit from your medicine as you did before;
- you have breathing difficulties and chest pain;
- you experience difficulty with urination.
COMBIVENT RESPIMAT may cause dizziness, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.
The use of COMBIVENT RESPIMAT may test positive for performance enhancement (doping) in athletic competition.
Interactions with this Medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with COMBIVENT RESPIMAT:
- other anticholinergic drugs, such as ipratropium bromide and other beta2-adrenergic agents such as salbutamol, the individual ingredients of COMBIVENT RESPIMAT;
- beta blockers, such as propranolol.
The following may interact with COMBIVENT RESPIMAT:
- xanthine derivatives such as theophylline
- monoamine oxidase inhibitors such as isocarboxazid
- tricyclic antidepressants such as amitriptyline
- certain diuretics or "water pills" such as furosemide, hydrochlorothiazide.
Proper Use of this Medication
COMBIVENT RESPIMAT has been prescribed to treat your current condition. DO NOT give it to other people. Always use COMBIVENT RESPIMAT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Appropriate use of COMBIVENT RESPIMAT includes an understanding of the way it should be administered. Therefore, it is important that you read and understand how to use the inhaler before starting COMBIVENT RESPIMAT therapy.
Dosage should be individualized.
Not recommended for use in children and adolescents under 18 years of age.
FOR ORAL INHALATION ONLY
Take care to avoid spraying COMBIVENT RESPIMAT into your eyes.
Usual adult dose
1 puff four times a day.
Patients may take additional inhalations as required; however, the total number of inhalations should not exceed six in 24 hours.
Instructions for Use
Please read and carefully follow these instructions.
Each box contains 1 RESPIMAT inhaler and 1 cartridge, providing 120 puffs or 60 puffs. The colour of the cap of the Respimat inhaler is colour coded to match the cartridge.
Before COMBIVENT RESPIMAT is used for the first time, the cartridge provided must be inserted into the inhaler.
The inhaler and cartridge for COMBIVENT RESPIMAT
- Inserting the cartridge
The following steps 1-6 are necessary before first use:
1. With the orange cap (A) closed, press the safety catch (E) while pulling off the clear base (G). 2. Take the cartridge (H) out of the box. Push the narrow end of the cartridge into the inhaler until it clicks into place. The cartridge should be pushed firmly against a firm surface to ensure that it has gone all the way in (2b). The cartridge will not be flush with the inhaler, you will still see the silver ring of the lower end of the cartridge.
Do not remove the cartridge once it has been inserted into the inhaler.
3. Replace the clear base (G).
Do not remove the clear base again.
Preparing COMBIVENT RESPIMAT for first time use
Repeat steps 4, 5 and 6 until a cloud is visible.
Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is prepared for use.
COMBIVENT RESPIMAT is now ready to use.
These steps will not affect the number of doses available. After preparation COMBIVENT RESPIMAT will deliver 120 puffs (120 medicinal doses) or 60 puffs (60 medicinal doses).
4. Hold COMBIVENT RESPIMAT upright, with the orange cap (A) closed. Turn the clear base (G) in the direction of the white arrows on the label until it clicks (half a turn). 5. Open the orange cap (A) until it snaps fully open. 6. Point COMBIVENT RESPIMAT towards the ground. Press the dose release button (D). Close the orange cap (A).
- Daily use of COMBIVENT RESPIMAT
I. Hold COMBIVENT RESPIMAT upright, with the orange cap (A) closed, to avoid accidental release of dose. Turn the clear base (G) in the direction of the white arrows on the label until it clicks (half a turn). II. Open the orange cap (A) until it snaps fully open. Breathe out slowly and fully, and then close your lips around the end of the mouthpiece without covering the air vents (C). Point COMBIVENT RESPIMAT to the back of your throat.
While taking in a slow, deep breath through your mouth, press the dose release button (D) and continue to breathe in slowly for as long as you can. Hold your breath for 10 seconds or for as long as comfortable.
- When to get a new inhaler
COMBIVENT RESPIMAT contains 120 puffs (120 medicinal doses) or 60 puffs (60 medicinal doses). The dose indicator shows approximately how much medication is left. When the pointer enters the red area of the scale, there is enough medication for 7 days or 3 days. This is when you need to get a new COMBIVENT RESPIMAT prescription.
Once the dose indicator has reached the end of the scale, (i.e. all 120 puffs or 60 puffs have been used), COMBIVENT RESPIMAT is empty and locks automatically. At this point, the base cannot be turned any further.
At the latest, three months after you first use COMBIVENT RESPIMAT it should be discarded even if not all medication has been used, or when the locking mechanism is enacted (120 puffs or 60 puffs), whichever comes first.
Close the orange cap (A). Keep COMBIVENT RESPIMAT closed until you are ready to use the inhaler again.
Helpful hints for daily dosing
|Using the COMBIVENT RESPIMAT inhaler requires 3 simple steps. A helpful way to remember the steps for Daily Dosing is to remember TOP:
Turn the clear base
Open the cap and close your lips around the mouthpiece
Press the dose-release button and inhale
If COMBIVENT RESPIMAT has not been used for more than 3 days, release one puff towards the ground.
If COMBIVENT RESPIMAT has not been used for more than 21 days, repeat steps 4 to 6 until a cloud is visible. Then repeat steps 4 to 6 three more times.
How to care for your inhaler
Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least once a week. Any minor discoloration in the mouthpiece does not affect the performance of your COMBIVENT RESPIMAT.
If necessary, wipe the outside of COMBIVENT RESPIMAT with a damp cloth.
COMBIVENT RESPIMAT must not be disassembled after inserting the cartridge and replacing the clear base.
Do not touch the piercing element inside the bottom of the clear base.
|What if...||Reason||What to do|
|I cannot turn the base easily?||The COMBIVENT
RESPIMAT inhaler is already prepared and ready to use. The COMBIVENT RESPIMAT inhaler is locked and all the medicine has been used.
|The COMBIVENT RESPIMAT inhaler can be used as it is.
Prepare and use a new COMBIVENT RESPIMAT inhaler.
|I cannot press the dose release button?||The clear base has not been turned.||Turn the clear base until it clicks (half a turn).|
|The clear base springs back after I have turned it and a small amount of moisture is released?||The clear base was not turned far enough.||Prepare the COMBIVENT RESPIMAT inhaler for use by turning the clear base until it clicks (half a turn).|
|I can turn the clear base past the point where it clicks?||Either the dose release button has been pressed, or the clear base has been turned too far.||With the orange cap closed, turn the clear base until it clicks (half a turn).|
If a dose is missed and no symptoms occur, the regular next dose according to the dosing schedule should be taken. If a dose is missed and respiratory symptoms are experienced, the missing dose should be taken and the dosing schedule according to the recommended dosage should be resumed.
Side Effects and what to do about them
Side effects may include:
- wheezing after inhalation;
- headache, dizziness;
- nausea (feeling sick), digestive problems like constipation, diarrhoea and vomiting;
- muscle problems such as cramps, weakness, pain, feeling weak, tremor (shaking);
- feeling nervous;
- mental disorder;
- impaired voice sounds;
- 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.
Check with your doctor if the dry mouth or bad taste persists or if you experience constipation for a prolonged period of time.
COMBIVENT RESPIMAT contains a beta-agonist, and taking additional doses in the form of other single agent, beta-agonists (fenoterol, salbutamol, etc.) could cause harmful effects on the heart, lungs and circulatory system. Therefore do not take additional bronchodilators by inhalation with COMBIVENT RESPIMAT unless instructed to do so by your doctor or pharmacist.
Stop taking the medication and tell your doctor immediately if you notice any of the following:
- you are wheezy or have any other difficulties in breathing;
- you are having an allergic reaction – the signs may include skin rash, itching and nettle rash. In severe cases the signs include swelling of your tongue, lips and face, sudden difficulties in breathing and reduction of your blood pressure.
COMBIVENT RESPIMAT can cause abnormal blood test results for hypokalemia and/or ketoacidosis. Your doctor will decide when to perform blood tests and will interpret the results.
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
Increased wheezing or tightness in the chest, difficulty in breathing, coughing bouts
|Shortness of breath||✓|
|Hypotension or hypertension, changes in blood pressure: dizziness, fainting, lightheadedness||✓|
rash, hives, swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, choking due to swelling of the muscles around the voice box
|Fast or irregular heart beat / chest pain||✓|
|Eye disorders: new or worsened pressure in your eyes, eye pain or discomfort, blurred vision, seeing halos or rainbows around items or red eyes||✓|
|Urinary Retention:difficulty and pain when passing urine, urinating frequently, urination in a weak stream or drips||✓|
|Muscle pain, weakness or spasms; paralysis||✓|
|Myocardial ischaemia: decreased blood flow to the heart leading to angina (chest pain), shortness of breath, or a heart attack||✓|
|Angina: Chest pain||✓|
|Decreased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell||✓|
This is not a complete list of side effects. For any unexpected effects while taking COMBIVENT RESPIMAT, contact your doctor or pharmacist.
How to store it
Store at room temperature (25°C), excursions permitted to 15-30°C. Do not freeze.
Store out of the sight and reach of children.
COMBIVENT RESPIMAT should be discarded whenever one of the following occurs first:
- at the latest, three months after you first use it (even if not all medication has been used);
- when the locking mechanism is enacted.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada web site at
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103 Ext. 84633 (Medical Information). Please visit our website to see if more up-to-date information has been posted.