Patient Medication Information: uses, side effects, how to take - Spiriva Respimat
ABOUT THIS MEDICATION
What the medication is used for:
COPD
SPIRIVA RESPIMAT is used long term to help open the airways of people with breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). It is also used to reduce the likelihood of “flare-ups” in people with COPD. In COPD, a “flare-up” is when your condition is getting worse. You will know you are having a “flare-up” if two of the following symptoms get worse for more than two days:
- Unusual increase in the severity of breathlessness; cough, wheezing, or fatigue;
- Unusual colour, amount or thickness of mucus;
- Tightness in the chest or symptoms of a cold.
Asthma
SPIRIVA RESPIMAT is used only as add-on therapy to an inhaled corticosteroid and a long-acting beta agonist when those medications are not adequate to control your asthma.
When used to treat asthma, you should use SPIRIVA RESPIMAT in addition to another anti-asthma inhaler as prescribed by your doctor.
What it does:
SPIRIVA RESPIMAT contains tiotropium which belongs to a group of medicines called bronchodilators. SPIRIVA RESPIMAT helps the muscles around the airways in your lungs stay relaxed making it easier for air to get in and out of the lungs. When you inhale it, it helps you breathe more easily.
In COPD patients, it also helps to prevent flare-up symptoms, such as wheezing, cough, chest tightness and shortness of breath.
When it should not be used:
Do not take SPIRIVA RESPIMAT:
- if you are allergic to ipratropium bromide or other drugs which are anticholinergic (contain atropine or its derivatives) or to any component of SPIRIVA RESPIMAT;
- without also taking an inhaled corticosteroid and a long-acting beta-agonist if you are being treated for asthma;
- if you are under 18 years of age.
SPIRIVA RESPIMAT is not a rescue medicine and should not be used on as needed basis for treating sudden breathing problems during exacerbations (flare-ups or asthma attack) of the disease. Your doctor may give you other medicine to use for sudden breathing problems.
What the medicinal ingredient is:
Tiotropium bromide monohydrate
What the non-medicinal ingredients are:
Benzalkonium chloride, disodium edetate, hydrochloric acid and purified water.
What dosage forms it comes in:
Inhalation Solution
Each puff delivers 2.5 mcg tiotropium from the mouthpiece (as tiotropium bromide monohydrate).
WARNINGS AND PRECAUTIONS
The solution is intended for inhalation only. Avoid getting the mist 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 SPIRIVA RESPIMAT talk to your doctor or pharmacist if:
you are pregnant or intend to become pregnant;
- you are breast-feeding;
- you are using any medications including eye drops, other bronchodilators or medications you can buy without a prescription;
- you have any other medical problems such as difficult urination or enlarged prostate;
- you have eye problems, such as glaucoma, or eye
- pain;
- you have any allergies to food or drugs;
- you have kidney disease;
- you have unstable heart disease;
- you have any other medical problems.
SPIRIVA RESPIMAT is indicated for the treatment of COPD and asthma. Do not use this medicine to treat a sudden attack of breathlessness or wheezing. Your doctor should have given you another inhaler ("rescue medication") for this. Please follow the instructions your doctor has given you.
If you have been prescribed SPIRIVA RESPIMAT for your asthma, it should be added on to your inhaled corticosteroid and a long-acting beta-agonist medications. Continue taking your other medications as prescribed by your doctor, even if you feel better.
Your doctor will recommend when and how you should use SPIRIVA RESPIMAT. You must follow any other direction that your doctor has given you for the treatment and/or monitoring of your condition.
Contact your doctor immediately if:
- you require more than one dose (2 actuations) per day to relieve your breathing problems;
- 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.
SPIRIVA RESPIMAT may cause dizziness, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.
Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.
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.
SPIRIVA RESPIMAT should not be used together with other medicines containing a short- or long-acting muscarinic blocker as an overdose may result. For example, these other medicines include ipratropium, tiotropium, glycopyrronium, aclidinium, umeclidinium.
PROPER USE OF THIS MEDICATION
SPIRIVA RESPIMAT has been prescribed to treat your current condition. DO NOT give it to other people. Always use SPIRIVA RESPIMAT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Appropriate use of SPIRIVA 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 SPIRIVA RESPIMAT therapy.
It is very important that you use SPIRIVA RESPIMAT regularly every day. Do not stop taking SPIRIVA RESPIMAT suddenly even if you feel better.
FOR ORAL INHALATION ONLY
Take care to avoid spraying SPIRIVA RESPIMAT into your eyes.
Usual Adult Dose:
COPD
Take 2 puffs once a day, if possible at the same time of the day, every day.
Asthma
Take 2 puffs once a day, if possible at the same time of the day, every day.
In the treatment of asthma, the full benefits will be seen after several doses of SPIRIVA RESPIMAT.
Overdose:
| If you think you have taken too much SPIRIVA RESPIMAT, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed dose:
If you forget to inhale a dose, inhale the next dose as soon as possible but do not inhale two doses on the same day. Then inhale the next dose as usual.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- Cough, dry mouth or throat, bad taste;
- Dizziness;
- Hoarse voice;
- Rash, itching;
- Difficulty in sleeping;
- Heartburn;
- Constipation;
- Sore throat;
- Sinus infection;
- Inflammation of the mouth, gums and/or tongue;
- Nosebleed;
- Infections or ulcerations of the skin;
- Dry skin.
Check with your doctor if the dry mouth or bad taste persists or if you experience constipation for a prolonged period of time.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||
|---|---|---|---|---|---|---|---|
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate medical help | |||||
| Only if severe | In all cases | ||||||
| Uncommon (<1/100 patients) | Urinary Retention: difficulty and pain when passing urine, urinating frequently, urination in a weak stream or drips | ✓ | |||||
| Oropharyngeal Candidiasis: fungal infection of the oral cavity and throat | ✓ | ||||||
| Skin rash/hives | ✓ | ||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Paradoxical Bronchospasm: tightness of the chest associated with coughing, wheezing, or breathlessness immediately after inhalation | ✓ | ||
| Rare (<1/1000 patients) | |||
| Serious Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||
| Urinary tract infection | ✓ | ||
| Difficulty in swallowing | ✓ | ||
| Fast or irregular heart beat | ✓ | ||
| Eye disorders: new or worsened pressure in your eyes, eye pain or discomfort, blurred vision, seeing halos or rainbows around items or red eyes | ✓ | ||
| Not Known | |||
| Swelling of joints | ✓ | ||
| Dehydration | ✓ | ||
| Intestinal Obstruction: absence of bowel movements | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking SPIRIVA RESPIMAT, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Store SPIRIVA RESPIMAT between 15-30°C.
Do not freeze your SPIRIVA RESPIMAT cartridge and inhaler.
Keep your SPIRIVA RESPIMAT cartridge and inhaler out of the sight and reach of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
If you want more information about SPIRIVA RESPIMAT:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada 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.
Last revised: May 7, 2019
| INSTRUCTIONS FOR USE | |
Introduction Read these Instructions for Use before you start using SPIRIVA RESPIMAT. You will need to use the inhaler only ONCE A DAY. Each time you use it take 2 PUFFS. Each box contains:
Each cartridge provides 60 puffs (30 doses). Physician samples and hospital packs provide 28 puffs (14 doses). The colour of the cap of the RESPIMAT inhaler is colour coded to match the cartridge. | How to care for your SPIRIVA 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 SPIRIVA RESPIMAT works. When to get a new SPIRIVA RESPIMAT
You need to get a new prescription or refill your prescription.
|
How to store my SPIRIVA RESPIMAT inhaler Store SPIRIVA RESPIMAT (the cartridge and inhaler) between 15-30oC. 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 you have not used your inhaler in more than:
| |
2
PUFFS
ONCE A
DAY
| Prepare for First Use | ||
| 1 | Remove clear base
| |
| 2 | Insert cartridge
| |
| 3 | Replace clear base
| |
| 4 | Turn
| |
| 5 | Open
| |
| 6 | Press
|
| Daily Use | |
TURN
| |
OPEN
| |
PRESS
To take your second puff, repeat the 3 steps, TURN, OPEN and PRESS (TOP) one more time. Close the cap. | |
| Answers to Common Questions | |
| It is difficult to insert the cartridge deep enough: | The dose indicator on the SPIRIVA RESPIMAT reaches zero too soon: |
| Did you accidentally turn the clear base before inserting the cartridge? Open the cap, press the dose-release button, then insert the cartridge. | Did you use SPIRIVA RESPIMAT as indicated (2 puffs/once daily)? SPIRIVA RESPIMAT will last 30 days if used at 2 puffs once daily. Physician samples and hospital packs will last 14 days if used at 2 puffs once daily. |
| Did you insert the cartridge with the wide end first? Insert the cartridge with the narrow end first. | Did you turn the clear base before you inserted the cartridge? The dose indicator counts each turn of the clear base regardless whether a cartridge has been inserted or not. |
| Did you spray in the air often to check whether the SPIRIVA RESPIMAT is working? Once you have prepared SPIRIVA RESPIMAT, no test-spraying is required if used daily. | |
| Did you insert the cartridge into a used SPIRIVA RESPIMAT? Always insert a new cartridge into a NEW SPIRIVA RESPIMAT. | |
| I cannot press the dose-release button: | My SPIRIVA RESPIMAT doesn’t spray: |
| Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half a turn). | Did you insert a cartridge? If not, insert a cartridge. |
Is the dose indicator on the SPIRIVA RESPIMAT pointing to zero? The SPIRIVA RESPIMAT inhaler is locked after 60 puffs (30 doses). Physician samples and hospital packs will be locked after 28 puffs (14 doses). Prepare and use your new SPIRIVA RESPIMAT inhaler. | Did you repeat Turn, Open, Press (TOP) less than three times after inserting the cartridge? Repeat Turn, Open, Press (TOP) three times after inserting the cartridge as shown in steps 4 to 6 under “Prepare for first Use”. |
Is the dose indicator on the SPIRIVA RESPIMAT pointing to 0? If the dose indicator points to 0, you have used up all your medication and the inhaler is locked. Once your SPIRIVA RESPIMAT is assembled, do not remove the clear base or the cartridge. Always insert a new cartridge into a NEW SPIRIVA RESPIMAT. | |
| I cannot turn the clear base: | My SPIRIVA RESPIMAT sprays automatically: |
| Did you turn the clear base already? If the clear base has already been turned, follow steps “OPEN” and “PRESS” under the directions for “Daily Use” to get your dose. | Was the cap open when you turned the clear base? Close the cap, then turn the clear base. |
Is the dose indicator on the SPIRIVA RESPIMAT pointing to zero? The SPIRIVA RESPIMAT inhaler is locked after 60 puffs (30 doses). Physician samples and hospital packs will be locked after 28 puffs (14 doses). Prepare and use your new SPIRIVA RESPIMAT inhaler. | Did you press the dose-release button when turning the clear base? Close the cap so the dose-release button is covered, then turn the clear base. |
| Did you stop when turning the clear base before it clicked? Turn the clear base in a continuous movement until it clicks (half a turn). | |
