Striverdi Respimat - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Form:||Liquid solution, Inhaler|
|Ingredients:||olodaterol hydrochloride, benzalkonium chloride, citric acid, edetate disodium, purified water|
Olodaterol Hydrochloride Inhalation Solution
About this Medication
What the medication is used for
STRIVERDI RESPIMAT is a long-acting beta2-adrenergic agonist (LABA) 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
STRIVERDI RESPIMAT helps the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness and shortness of breath.
When it should not be used
Do not use STRIVERDI RESPIMAT:
- if you have asthma;
- to treat sudden symptoms of COPD;
- if you are less than 18 years of age;
- if you are allergic (hypersensitive) to olodaterol hydrochloride or any of the non-medicinal ingredients in the formulation.
What the medicinal ingredient is
What the non-medicinal ingredients are
Benzalkonium chloride, citric acid, edetate disodium and purified water.
What dosage forms it comes in
Inhalation solution: 2.5 mcg per puff
STRIVERDI RESPIMAT is supplied in a carton containing one STRIVERDI RESPIMAT cartridge and one STRIVERDI RESPIMAT inhaler.
The STRIVERDI RESPIMAT cartridge is only intended for use with the STRIVERDI 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 STRIVERDI RESPIMAT.
STRIVERDI RESPIMAT should only be used to treat COPD.
STRIVERDI RESPIMAT should not be used to treat asthma.
BEFORE you use STRIVERDI 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 other LABA drugs;
- have been told you react strongly to sympathomimetic amines (a class of drugs that includes LABA drugs);
- are pregnant or planning to become pregnant. It is not known if STRIVERDI RESPIMAT can harm your unborn baby;
- are breastfeeding. It is not known if STRIVERDI RESPIMAT passes into your milk and if it can harm your baby.
During the treatment with STRIVERDI RESPIMAT, tell your doctor immediately if you experience any of the following symptoms:
- If you experience a tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (signs of bronchospasm).
- If you experience difficulties in breathing or swallowing, swelling of tongue, lips and face, hives or itching, skin rash (signs of hypersensitivity reaction). Do not use STRIVERDI RESPIMAT again before speaking with your doctor.
- If your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment.
STRIVERDI 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.
Get emergency medical care if:
- breathing problems worsen quickly
- you use your rescue inhaler medicine, but it does not relieve your breathing problems
Driving and using machines: Caution is required when driving a car or operating machinery as dizziness may occur with the use of STRIVERDI 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 STRIVERDI RESPIMAT:
- antidepressants, in particular tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs);
- medicines similar to STRIVERDI RESPIMAT (other LABA) 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 STRIVERDI 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 STRIVERDI RESPIMAT inhaler that is provided with each new prescription.
- STRIVERDI RESPIMAT does not relieve sudden symptoms of COPD; always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, ask your healthcare provider.
- Do not stop using STRIVERDI 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 use STRIVERDI RESPIMAT:
- more often than prescribed;
- with other medicines that contain a long-acting beta2-agonist (LABA) for any reason.
- Do not spray into eyes.
- Call your healthcare provider or get emergency medical care right away if:
- your breathing problems worsen with STRIVERDI 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 STRIVERDI RESPIMAT is 2 puffs (5 mcg olodaterol), once daily at the same time of the day.
The STRIVERDI RESPIMAT inhaler, is designed to deliver 60 puffs after preparation for use; the equivalent of 30 days medication when used according to the directions for use (one dose equals two puffs).
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 STRIVERDI RESPIMAT.
If necessary, wipe the outside of STRIVERDI RESPIMAT with a damp cloth.
STRIVERDI 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.
Questions and answers about your STRIVERDIRESPIMAT inhaler
|What if...||Reason||What to do|
|I cannot turn the base easily?||The STRIVERDI RESPIMAT inhaler is already prepared and ready to use.|
The STRIVERDI RESPIMAT inhaler is locked after 60 puffs.
|The STRIVERDI RESPIMAT inhaler can be used as it is.|
Prepare and use a new STRIVERDI 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 STRIVERDI 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 yellow cap closed, turn the clear base until it clicks (half a turn).|
|If you think you have inhaled too much STRIVERDIRESPIMAT, 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 STRIVERDI 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:
- inflammation of the throat and nasal passages;
- feeling dizzy;
- swollen painful joints;
- back pain;
- nervousness, feeling anxious;
- difficulty sleeping (insomnia);
- dry mouth;
- pain in mouth and throat;
- muscle spasms;
- muscular pain;
- feeling tired;
- feeling unwell;
- stomach/digestion problems;
- upper respiratory tract infection (common cold).
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, nurse, or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
|Common||Bronchitis: shortness of breath, cough, chest pain||✓|
|Bladder infection: pain and burning when urinating, frequent urination||✓|
|Uncommon||Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing||✓|
|Bronchospasm: wheezing or coughing and difficulty breathing||✓|
|Lower respiratory infection: shortness of breath, cough, chest pain||✓|
|High or low blood pressure: headache, ringing in the ears, lightheadedness, dizziness, fainting||✓|
|Fast or irregular heartbeat, heart palpitations, prolongation of QT interval||✓|
|Myocardial ischaemia (decreased blood flow to your heart muscle): chest pain, trouble breathing, swelling of the hands or feet, heartburn||✓|
|Low blood potassium: irregular heartbeats, muscle weakness or spasms and generally feeling unwell||✓|
|High blood sugar: frequent urination, thirst, and hunger||✓|
|Blood pH imbalance: chest pain, headache, heart palpitations, nausea, vomiting, stomach pain||✓|
|Swelling of the feet, ankles or legs||✓|
This is not a complete list of side effects. For any unexpected effects while taking STRIVERDI RESPIMAT, contact your doctor, nurse or pharmacist.
How to Store it
Store STRIVERDI RESPIMAT between 15–30°C.
Do not freeze your STRIVERDI RESPIMAT cartridge and inhaler.
Keep your STRIVERDI 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
Postage paid labels, Canada Vigilance Reporting Form 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).