Patient information: uses, side effects, how to take - Striverdi Respimat

What is STRIVERDI RESPIMAT?

STRIVERDI RESPIMAT is a long-acting beta₂-adrenergic agonist (LABA) medicine, olodaterol.
LABA medicines such as STRIVERDI RESPIMAT help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
STRIVERDI RESPIMAT is for long-term use and should be taken as 2 puffs 1 time each day to improve the symptoms of COPD for better breathing.
STRIVERDI RESPIMAT is a prescription medicine used to control the symptoms of COPD in adults with COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
STRIVERDI RESPIMAT is not used to treat sudden symptoms of COPD. Always have a beta₂-agonist inhaler medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler medicine, contact your healthcare provider to have one prescribed for you.
STRIVERDI RESPIMAT is not for the treatment of asthma. It is not known if STRIVERDI RESPIMAT is safe and effective in people with asthma.
STRIVERDI RESPIMAT should not be used in children. It is not known if STRIVERDI RESPIMAT is safe and effective in children.

Do not use STRIVERDI RESPIMAT if you have asthma.

Before you use STRIVERDI RESPIMAT, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems.
have high blood pressure.
have seizures.
have thyroid problems.
have diabetes.
are pregnant or plan to become pregnant. It is not known if the medicine olodaterol in STRIVERDI RESPIMAT can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if the medicine olodaterol in STRIVERDI RESPIMAT passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will take STRIVERDI RESPIMAT while breastfeeding.
are allergic to any of the ingredients in STRIVERDI RESPIMAT, any other medicines, or food products.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. STRIVERDI RESPIMAT and certain other medicines may affect each other. This may cause serious side effects.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use STRIVERDI RESPIMAT?

Read the step-by-step instructions for using STRIVERDI RESPIMAT at the end of this Patient Information leaflet.

Do not use STRIVERDI RESPIMAT unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Ask your healthcare provider or pharmacist if you have any questions.
The STRIVERDI RESPIMAT inhaler has a slow-moving mist that helps you inhale the medicine.
Use STRIVERDI RESPIMAT exactly as your healthcare provider tells you to use it. Do not use STRIVERDI RESPIMAT more often than prescribed.
Use 1 dose (2 puffs) of STRIVERDI RESPIMAT, 1 time each day, at the same time of the day.
If you miss a dose of STRIVERDI RESPIMAT, take it as soon as you remember. Do not take more than 1 dose (2 puffs) in 24 hours.
If you take too much STRIVERDI RESPIMAT, call your healthcare provider or go to the nearest hospital emergency room right away.
Do not spray STRIVERDI RESPIMAT in your eyes.
STRIVERDI RESPIMAT Inhalation Spray should only be given using the STRIVERDI RESPIMAT inhaler. The STRIVERDI RESPIMAT inhaler should not be used to give other medicines.
Always use the new STRIVERDI RESPIMAT inhaler that is provided with each new prescription.
STRIVERDI RESPIMAT does not relieve sudden symptoms of COPD. You should not take extra doses of STRIVERDI RESPIMAT to 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, call your healthcare provider to have one prescribed for you.
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.
If your COPD symptoms worsen over time do not increase your dose of STRIVERDI RESPIMAT, instead call your healthcare provider.
Do not use STRIVERDI RESPIMAT:
- more often than prescribed for you,
- at a higher dose than prescribed for you, or
- with other LABA medicines. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
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 inhaler medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.

What are the possible side effects of STRIVERDI RESPIMAT?

STRIVERDI RESPIMAT can cause serious side effects, including:

serious problems from asthma. People with asthma who take long-acting beta₂-adrenergic agonist (LABA) medicines, such as STRIVERDI RESPIMAT, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
call your healthcare provider if breathing problems worsen over time while using STRIVERDI RESPIMAT. You may need a different treatment.
Get emergency medical care if:
- your breathing problems worsen quickly
- you use your rescue inhaler medicine, but it does not relieve your breathing problems.

using too much of a LABA medicine may cause:

chest pain
fast and irregular heartbeat
tremor

increased blood pressure
headache
nervousness

COPD symptoms can get worse over time. If your COPD symptoms worsen over time, do not increase your dose of STRIVERDI RESPIMAT, instead call your healthcare provider.
sudden shortness of breath can happen immediately after using STRIVERDI RESPIMAT. Sudden shortness of breath may be life-threatening. Stop taking STRIVERDI RESPIMAT and call your healthcare provider or get emergency medical help right away if you get sudden shortness of breath after using STRIVERDI RESPIMAT.
effects on your heart, including fast or irregular heartbeat, palpitations, chest pain or increased blood pressure.
changes in laboratory blood levels including high blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle weakness or abnormal heart rhythm.
serious allergic reactions including rash, hives, itching, swelling of the face, lips, tongue, throat, difficulties in breathing or swallowing. Stop taking STRIVERDI RESPIMAT and get emergency medical help right away if you get any symptoms of a serious allergic reaction after using STRIVERDI RESPIMAT.

Common side effects of STRIVERDI RESPIMAT include: runny nose, sore throat, upper respiratory infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint pain.

These are not all the side effects of STRIVERDI RESPIMAT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store STRIVERDI RESPIMAT?

Store STRIVERDI RESPIMAT at room temperature, between 68°F to 77°F (20°C to 25°C).
Do not freeze your STRIVERDI cartridge or RESPIMAT inhaler.
Keep STRIVERDI RESPIMAT inhaler, cartridge, and all medicines out of the reach of children.

General information about safe and effective use of STRIVERDI RESPIMAT.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use STRIVERDI RESPIMAT for a condition for which it was not prescribed. Do not give STRIVERDI RESPIMAT to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about STRIVERDI RESPIMAT that is written for health professionals.

Active ingredient: olodaterol

Inactive ingredients: anhydrous citric acid, benzalkonium chloride, edetate disodium, and water for injection

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877 USA

Licensed from:

Boehringer Ingelheim International GmbH

STRIVERDI^®and RESPIMAT^®are registered trademarks of and are used under license from Boehringer Ingelheim International GmbH

COL10540BA022025

This product's label may have been updated. For current full prescribing information for STRIVERDI RESPIMAT, go to www.STRIVERDI.com or to view a video demonstration on how to use your STRIVERDI RESPIMAT inhaler, scan the code or visit www.themist.com. You may also call 1-800-542-6257 for further information about STRIVERDI RESPIMAT.

Instructions for Use

STRIVERDI^®RESPIMAT^®(STRIH ver dee- RES peh mat)

(olodaterol inhalation spray), for oral inhalation use

For Oral Inhalation Only

Do not spray STRIVERDI RESPIMAT into your eyes.

Read these Instructions for Use before you start using STRIVERDI RESPIMAT and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

You will need to use this inhaler 1 time each day, at the same time each day. Each time you use it take 2 puffs.

Do not turn the clear base before inserting the cartridge.

How to store your STRIVERDI RESPIMAT inhaler

Store STRIVERDI RESPIMAT at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze your STRIVERDI RESPIMAT cartridge and inhaler.
If STRIVERDI RESPIMAT has not been used for more than 3 days, release 1 puff towards the ground.
If STRIVERDI RESPIMAT has not been used for more than 21 days, repeat steps 4 to 6 under the "Prepare for first use" until a mist is visible. Then repeat steps 4 to 6 three more times.
Keep your STRIVERDI RESPIMAT cartridge and inhaler out of the reach of children.

How to care for your STRIVERDI RESPIMAT 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 your STRIVERDI RESPIMAT inhaler.

When to get a new STRIVERDI RESPIMAT inhaler

Your inhaler contains 60 puffs (30 doses) if used as indicated (2 puffs once daily). If you have a sample, your inhaler contains 28 puffs (14 doses) if used as indicated (2 puffs once daily).
The dose indicator shows approximately how much medicine is left.
When the dose indicator enters the red area of the scale you need to get a refill; there is approximately medicine for 7 days left (if you have a sample, there is approximately medicine for 3 days left).
When the dose indicator reaches the end of the red scale, your STRIVERDI RESPIMAT is empty and automatically locks. At this point, the clear base cannot be turned any further.
Three months after insertion of cartridge, throw away the STRIVERDI RESPIMAT even if it has not been used, or when the inhaler is locked, or when it expires, whichever comes first.

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. Be careful not to touch the piercing element. Write the discard by date on the label (3 months from the date the cartridge is inserted).
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 clicks into place.
3. Replace clear base Put the clear base back into place until it clicks. Do not remove the clear base or the cartridge after it has been put together.
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. If you do not see a mist, repeat steps 4 to 6 until a mist is seen. After a mist is seen, repeat steps 4 to 6 three more times. After complete preparation of your inhaler, it will be ready to deliver the number of puffs on the label.

Daily use (T O P)

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.
Point the inhaler to the back of your throat.
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 comfortable.
Repeat Turn, Open, Press (TOP) for a total of 2 puffs.
Close the cap until you use your inhaler again.

Answers to Common Questions

It is difficult to insert the cartridge deep enough:

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 insert the cartridge with the wide end first? Insert the cartridge with the narrow end first.

I cannot press the dose-release button:

Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half a turn).

Is the dose indicator on the STRIVERDI RESPIMAT pointing to zero? The STRIVERDI RESPIMAT inhaler is locked after 60 puffs (30 doses). If you have a sample, the STRIVERDI RESPIMAT inhaler is locked after 28 puffs (14 doses). Prepare and use your new STRIVERDI RESPIMAT inhaler.

I cannot turn the clear base:

Did you turn the clear base already? If the clear base has already been turned, follow steps "Open" and "Press" under "Daily use" to get your medicine.

The dose indicator on the STRIVERDI RESPIMAT reaches zero too soon:

Did you use STRIVERDI RESPIMAT as indicated (2 puffs once daily)? STRIVERDI RESPIMAT will deliver 60 puffs and last 30 days if used at 2 puffs once daily. If you have a sample, STRIVERDI RESPIMAT will deliver 28 puffs and last 14 days if used at 2 puffs once daily.

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 STRIVERDI RESPIMAT is working? Once you have prepared STRIVERDI RESPIMAT, no test-spraying is required if used daily.

Did you insert the cartridge into a used STRIVERDI RESPIMAT? Always insert a new cartridge into a NEW STRIVERDI RESPIMAT.

My STRIVERDI RESPIMAT sprays automatically:

Was the cap open when you turned the clear base? Close the cap, then turn the clear base.

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).

My STRIVERDI RESPIMAT doesn't spray:

Did you insert a cartridge? If not, insert a cartridge.

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 STRIVERDI RESPIMAT pointing to 0? You have used up all your medicine and the inhaler is locked.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH