Inspiolto Respimat - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||COPD, Maintenance, COPD|
|Class:||Bronchodilator combinations, Bronchodilators|
|Form:||Liquid solution, Inhaler|
|Ingredients:||tiotropium bromide monohydrate, olodaterol hydrochloride, benzalkonium chloride, disodium edetate, hydrochloric acid and purified water|
Tiotropium (as Tiotropium Bromide Monohydrate) / Olodaterol (as Olodaterol Hydrochloride) Inhalation Solution
About this medication
What the medication is used for
INSPIOLTO RESPIMAT is a combination of two medicines that are used to make breathing easier for people who experience breathing difficulties due to a lung disease called Chronic Obstructive Pulmonary Disease or COPD (including chronic bronchitis and emphysema).
What it does
INSPIOLTO RESPIMAT contains two active ingredients: Tiotropium, a long-acting muscarinic antagonist (LAMA), and Olodaterol, a long-acting beta2-adrenergic agonist (LABA).
Tiotropium and olodaterol relax the muscles in the walls of small airways in the lungs. Both of these medicines work together to help open the airways and make it easier for air to get in and out of the lungs. When taken as prescribed, tiotropium and olodaterol help keep the airways open, which can help prevent shortness of breath and wheezing.
When it should not be used
Do not use INSPIOLTO RESPIMAT:
- if you have asthma;
- to treat sudden symptoms of COPD;
- if you are allergic to tiotropium bromide, ipratropium bromide or other anticholinergic drugs (containing atropine or its derivatives);
- if you are allergic to olodaterol hydrochloride or other drugs containing a beta agonist;
- if you are allergic to any of the non-medicinal ingredients in the formulation;
- if you are less than 18 years of age.
What the medicinal ingredients are
Tiotropium Bromide Monohydrate and Olodaterol Hydrochloride
What the non-medicinal ingredients are
Benzalkonium chloride, disodium edetate, hydrochloric acid and purified water.
What dosage forms it comes in
Each puff delivers 2.5 mcg tiotropium (as tiotropium bromide monohydrate) and 2.5 mcg olodaterol (as olodaterol hydrochloride) from the mouthpiece.
INSPIOLTO RESPIMAT is supplied in a carton containing one INSPIOLTO RESPIMAT cartridge and one INSPIOLTO RESPIMAT inhaler.
The INSPIOLTO RESPIMAT cartridge is only intended for use with the INSPIOLTO RESPIMAT inhaler.
Warnings and precautions
|Warnings – Asthma-Related Death|
You are advised that in patients with asthma, long -acting beta 2-agonist (LABA) medicines increase the chance of death from asthma problems. In a large asthma study, more patients who used another LABA medicine (salmeterol) died from asthma problems compared with patients who did not use that LABA medicine. This finding may also apply to INSPIOLTO RESPIMAT.
INSPIOLTO RESPIMAT should only be used to treat COPD.
INSPIOLTO RESPIMAT should not be used to treat asthma.
BEFORE you use INSPIOLTO RESPIMAT talk to your doctor, nurse or pharmacist if you:
- have heart problems, such as rapid or irregular heart beat or abnormal electrical signal called “prolongation of the QT interval”;
- have high blood pressure;
- have seizures;
- have thyroid problems;
- have diabetes;
- are taking similar medicines for your lung disease;
- have been told you react strongly to sympathomimetic amines (a class of drugs that includes LABA drugs) or if you are allergic to ipratropium bromide or other drugs which are anticholinergic (contain atropine or its derivatives);
- are taking any medications including eye drops, this includes those you can buy without a prescription;
- have any other medical problems such as difficulty with urination or enlarged prostate;
- have eye problems, such as glaucoma, or eye pain;
- have any allergies to food or drugs;
- have kidney disease;
- are pregnant or planning to become pregnant. It is not known if INSPIOLTO RESPIMAT can harm your unborn baby;
- are breastfeeding. It is not known if INSPIOLTO RESPIMAT passes into your milk and if it can harm your baby.
During the treatment with INSPIOLTO RESPIMAT, tell your doctor immediately or get emergency medical care if you experience any of the following symptoms:
- Tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (signs of bronchospasm).
- Difficulties in breathing or swallowing, swelling of tongue, lips and face, hives or itching, skin rash (signs of hypersensitivity reaction). Do not use INSPIOLTO RESPIMAT again before speaking with your doctor.
- Your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment.
- Pain or difficulty with urination.
Other warnings you should know about
Treatment of COPD
INSPIOLTO RESPIMAT does not relieve sudden symptoms of COPD. Always have a short-acting bronchodilator medicine with you to treat acute symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.
Driving and using machines
Caution is required when driving a car or operating machinery as dizziness and blurred vision may occur with the use of INSPIOLTO RESPIMAT. If you experience dizziness, you should avoid driving or operating machinery.
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 INSPIOLTO RESPIMAT:
- antidepressants, in particular tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs);
- medicines similar to INSPIOLTO RESPIMAT used for your lung disease as it may increase the risk of experiencing possible side effects;
- medicines that decrease the level of potassium in your blood. These include diuretics (also known as “water pills” and are used to treat high blood pressure e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines (e.g. theophylline) or steroids (e.g. prednisolone);
- beta-blockers used in the treatment of high blood pressure or other heart problems (e.g. propranolol) or in the treatment of glaucoma (e.g. timolol).
Proper use of this medication
- Read the Instructions for use before using INSPIOLTO RESPIMAT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor, nurse or pharmacist about your medical condition or your treatment.
- Always use the new INSPIOLTO RESPIMAT inhaler that is provided with each new prescription.
- Do not stop using INSPIOLTO RESPIMAT or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- Do not spray into eyes.
- Call your healthcare provider or get emergency medical care right away if:
- your breathing problems worsen with INSPIOLTO RESPIMAT;
- you need to use your rescue medicine more often than usual;
- your rescue inhaler medicine does not work as well for you at relieving your symptoms.
Usual Adult Dose
The recommended dose of INSPIOLTO RESPIMAT is 2 puffs (5 mcg tiotropium and 5 mcg olodaterol), once daily at the same time of the day, every day.
INSTRUCTIONS FOR USE
Each box contains 1 RESPIMAT inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses). Physician samples provide 28 puffs (14 medicinal doses).
The colour of the cap of the RESPIMAT inhaler is colour coded to match the cartridge.
The inhaler and cartridge for INSPIOLTO RESPIMAT
Inserting the cartridge
The following steps 1-6 are necessary before first use:
With the light-green cap (A) closed, press the safety catch (E) while pulling off the clear base (G).
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.
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.
Replace the clear base (G).
Do not remove the clear bas again.
|Preparing INSPIOLTO RESPIMAT for first-time use|
Hold INSPIOLTO RESPIMAT upright, with the light-green cap (A) closed. Turn the base (G) in the direction of the black arrows on the label until it clicks (half a turn).
Open the light-green cap (A) until it snaps fully open.
Point INSPIOLTO RESPIMAT towards the ground.
Press the dose release button (D). Close the light-green cap (A).
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.
INSPIOLTO RESPIMAT is now ready to use.
These steps will not affect the number of doses available. After preparation INSPIOLTO RESPIMAT will deliver 60 puffs (30 medicinal doses) or 28 puffs (14 medicinal doses).
Daily use of INSPIOLTO RESPIMAT
You will need to use this inhaler ONLY ONCE A DAY. Each time you use it take TWO PUFFS by repeating steps I and II below so that you get the full dose (1 dose equals 2 puffs).
Hold INSPIOLTO RESPIMAT upright, with the light-green cap (A) closed, to avoid accidental release of dose. Turn the base (G) in the direction of the black arrows on the label until it clicks (half a turn).
Open the light-green 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 INSPIOLTO 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.
Close the light-green cap after you have inhaled 2 puffs. Keep INSPIOLTO RESPIMAT closed until you are ready to use the inhaler again.
If INSPIOLTO RESPIMAT has not been used for more than 7 days, release one puff towards the ground.
If INSPIOLTO RESPIMAT has not been used for more than 21days, you will need to prepare your inhaler for use again. Start by following steps 4 to 6 again until a cloud is visible. Then repeat steps 4 to 6 three more times.
When to get a new inhaler
The dose indicator shows approximately how much medication is left. When the pointer enters the red area of the scale, there is about 7 days of medication left for the 60 puff product or about 3 days for the 28 puff sample product. This is when you need to get a new INSPIOLTO RESPIMAT prescription
Once the dose indicator has reached the end of the red scale all puffs have been used and the RESPIMAT inhaler locks automatically. At this point, the base cannot be turned any further.
INSPIOLTO RESPIMAT should be discarded either 3 months after first use (even if all the medication has not been used) or when the locking mechanism is engaged, whichever comes first.
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 INSPIOLTO RESPIMAT.
If necessary, wipe the outside of INSPIOLTO RESPIMAT with a damp cloth.
Do not touch the piercing element inside the bottom of the clear base.
Questions and answers about your INSPIOLTO RESPIMAT inhaler
|What if...||Reason||What to do|
|I cannot turn the base easily?||The INSPIOLTORESPIMAT inhaler is already prepared and ready to use.The INSPIOLTO RESPIMAT inhaler is locked after 60 or 28 puffs.||The INSPIOLTO RESPIMAT inhaler can be used as it is. Prepare and use a new INSPIOLTO 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 INSPIOLTO 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 light-green cap closed, turn the clear base until it clicks (half a turn).|
|If you think you have inhaled too much INSPIOLTO RESPIMAT, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you miss a dose of INSPIOLTO RESPIMAT, take it as soon as you remember. Do not take more than one dose (two puffs) per day. Then take your next dose as usual.
Side effects and what to do about them
Side effects may include:
- increase of the measured eye pressure;
- seeing halos around lights or coloured images in association with red eyes;
- blurred vision;
- dry mouth;
- inflammation of the mouth, gums and tongue;
- difficulty in swallowing;
- feeling tired;
- general weakness;
- inflammation of the throat, nasal passages and sinuses;
- common cold;
- fungal infections of the oral cavity and throat;
- depletion of body water;
- back pain;
- swollen and painful joints;
- muscular pain;
- muscle spasms;
- feeling dizzy;
- difficulty sleeping;
- pain in mouth and throat;
- sore throat and discomfort when swallowing;
- inflammation/irritation of the vocal chords;
- pain when passing urine;
- inability to empty the bladder ;
- nettle rash;
- infections or ulcerations of the skin;
- dryness of the skin.
If any of these affects you severely, tell your doctor, nurse or pharmacist.
Serious side effects, how often they happen and what to do about them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Uncommon||High or low blood pressure: headache, ringing in the ears, lightheadedness, dizziness, fainting||√|
|Fast or irregular heartbeat,heart palpitations, prolongation of QT interval||√|
|Blockage of intestines or absence of bowel movements (intestinal obstruction , including ileus paralytic)||√|
|Blurred vision or pain in the eyes||√|
|Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing||√|
|Bronchospasm: wheezing or coughing and difficulty breathing||√|
|Urinary tract infection: pain and burning when urinating, frequent urination||√|
|Rare||Swelling of the feet, ankles or legs (edema peripheral)||√|
|Bronchitis: shortness of breath, cough, chest pain||√|
|Lower respiratory infection: shortness of breath, cough, chest pain||√|
|Myocardial ischaemia (decreased blood flow to your heart muscle): chest pain, trouble breathing, swelling of the hands or feet, heartburn||√|
|Not Known||Chest pain||√|
|High blood sugar: frequent urination, thirst, and hunger||√|
|Blood pH imbalance (metabolic acidosis): chest pain, headache, heart palpitations, nausea, vomiting, stomach pain||√|
|Low blood potassium: irregular heartbeats, muscle weakness or spasms and generally feeling unwell||√|
This is not a complete list of side effects. For any unexpected effects while taking INSPIOLTO RESPIMAT, contact your doctor, nurse or pharmacist.
How to store it
Store INSPIOLTO RESPIMAT between 15–30°C.
Do not freeze your INSPIOLTO RESPIMAT cartridge and inhaler.
Keep your INSPIOLTO RESPIMAT cartridge and inhaler out of the reach and sight of children.
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
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
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).