Striverdi Respimat: Uses, Side Effects and Dosage

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:

Olodaterol Hydrochloride

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

BEFORE you use STRIVERDI RESPIMAT talk to your doctor, nurse or pharmacist if you:

• have heart problems, such as rapid or irregular heartbeat 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.

Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.

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 2 puffs).

Overdose:

Missed Dose:

If you miss a dose of STRIVERDI RESPIMAT, take it as soon as you remember. Do not take more than one dose (2 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;
• rash;
• swollen painful joints;
• back pain;
• tremor;
• headache;
• nervousness, feeling anxious;
• difficulty sleeping (insomnia);
• dry mouth;
• pain in mouth and throat;
• nausea;
• muscle spasms;
• muscular pain;
• feeling tired;
• feeling unwell;
• cough;
• diarrhea;
• stomach/digestion problems;
• upper respiratory tract infection (common cold).

If any of these affects you severely, tell your doctor, nurse or pharmacist.

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 Side Effects

MORE INFORMATION

If you want more information about STRIVERDI 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, ext. 84633.

Last revised: May 13, 2019

INSTRUCTIONS FOR USE 2 PUFFS ONCE A DAY

Introduction Read these Instructions for Use before you start using STRIVERDI RESPIMAT. You will need to use this inhaler only ONCE A DAY. Each time you use it take 2 PUFFS. Each box contains: 1 RESPIMAT inhaler 1 cartridge Each cartridge provides 60 puffs (30 doses). The colour of the cap of the RESPIMAT inhaler is colour coded to match the cartridge. How to store my STRIVERDI RESPIMAT inhaler Store STRIVERDI 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: 7 days: release 1 puff towards the ground 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 STRIVERDI 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 STRIVERDI RESPIMAT works.

When to get a new STRIVERDI RESPIMAT Your STRIVERDI RESPIMAT inhaler contains 60 puffs (30 doses) if you use it as directed (2 puffs/once a day). The dose indicator shows you about how much medication is left. When the dose indicator enters the red area of the scale, there is about 7 days of medication left. You need to get a new prescription or refill your prescription. Once the dose indicator reaches the end of the red scale: Your STRIVERDI RESPIMAT locks automatically. No more doses can be released. At this point, the clear base cannot be turned any further. You should throw out STRIVERDI RESPIMAT when one of the following happens first: 3 months after first use, even if all the medication has not been used, or it locks automatically.

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.
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. To take your second puff, repeat the 3 steps, TURN, OPEN and PRESS (TOP) one more time. Close the cap.