Stiolto Respimat - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||COPD, Maintenance, COPD|
|Ingredients:||tiotropium bromide, olodaterol, water for injection, benzalkonium chloride, edetate disodium, and hydrochloric acid|
(sti-OL-to– RES peh mat)
(tiotropium bromide and olodaterol) Inhalation Spray
What is the most important information I should know about STIOLTO RESPIMAT
STIOLTO RESPIMAT has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO RESPIMAT is not to be used in asthma.
STIOLTO RESPIMAT can cause serious side effects, including:
- People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as olodaterol (one of the medicines in STIOLTO RESPIMAT), have an increased risk of death from asthma problems.
- It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO RESPIMAT), increase the risk of death in people with COPD.
- Get emergency medical care if:
- breathing problems worsen quickly
- you use your rescue inhaler medicine, but it does not relieve your breathing problems breathing problems worsen quickly
What is STIOLTO RESPIMAT
STIOLTO RESPIMAT contains the anticholinergic tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol.
STIOLTO RESPIMAT is used long term, 2 puffs once each day, in controlling symptoms of COPD in adults with COPD.
Anticholinergic and LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
STIOLTO RESPIMAT is not for use to treat sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
It is not known if STIOLTO RESPIMAT is safe and effective in people with asthma.
STIOLTO RESPIMAT should not be used in children. It is not known if STIOLTO RESPIMAT is safe and effective in children.
Who should not use STIOLTO RESPIMAT
Do not use STIOLTO RESPIMAT if:
- you have asthma.
- you are allergic to tiotropium, ipratropium, olodaterol, or any of the ingredients in STIOLTO RESPIMAT. See the end of this Medication Guide for a complete list of ingredients in STIOLTO RESPIMAT.
What should I tell my healthcare provider before using STIOLTO RESPIMAT
Tell your healthcare provider about all of your health conditions, including if you:
- have heart problems
- have high blood pressure have seizures
- have thyroid problems have diabetes
- have eye problems, such as glaucoma. STIOLTO RESPIMAT can make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. STIOLTO RESPIMAT can make these problems worse.
- have any other medical conditions
- are pregnant or planning to become pregnant. It is not known if STIOLTO RESPIMAT can harm your unborn baby.
- are breastfeeding. It is not known if STIOLTO RESPIMAT passes into your breast milk and if it can harm your baby.
- are allergic to STIOLTO RESPIMAT or any of its ingredients, any other medicines, or food products.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO RESPIMAT and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
- anticholinergics (including ipratropium, aclidinium, umeclidinium or another tiotropium-containing product such as SPIRIVA RESPIMAT or SPIRIVA HandiHaler)
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 STIOLTO RESPIMAT
- Read the step-by-step instructions for using STIOLTO RESPIMAT at the end of this Medication Guide. STIOLTO RESPIMAT inhaler has a slow-moving mist that helps you inhale the medicine.
- Use STIOLTO RESPIMAT exactly as your healthcare provider tells you to use it.
- Use 1 dose (2 puffs) of STIOLTO RESPIMAT, 1 time each day, at the same time of the day.
- If you miss a dose of STIOLTO RESPIMAT, take it as soon as you remember. Do not take more than 1 dose (2 puffs) in 24 hours.
- Do not spray STIOLTO RESPIMAT in your eyes.
- Always use the new STIOLTO RESPIMAT inhaler that is provided with each new prescription.
- STIOLTO 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, call your healthcare provider to have one prescribed for you.
- Do not stop using STIOLTO 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 STIOLTO RESPIMAT:
- more often than prescribed for you, or
- with other medicines that contain LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
- Call your healthcare provider or get emergency medical care right away if:
- your breathing problems worsen with STIOLTO 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
What are the possible side effects with STIOLTO RESPIMAT
STIOLTO RESPIMAT can cause serious side effects, including:
- See “What is the most important information I should know about STIOLTO RESPIMAT?”
- If your COPD symptoms worsen over time do not increase your dose of STIOLTO RESPIMAT, instead call your healthcare provider.
- sudden shortness of breath that may be life-threatening
- serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
- heart problems including fast or irregular heartbeat, palpitations, chest pain, increased blood pressure
- new or worsening eye problems including acute narrow-angle glaucoma. Symptoms of acute narrow-angle glaucoma include eye pain or discomfort, blurred vision, seeing halos or colored images around lights, and red eyes. Call your healthcare provider right away if you have any of these symptoms. Use caution as some of these eye problems can affect your ability to drive and operate appliances and machinery.
- new or worsening urinary retention. Symptoms of urinary retention may include difficulty urinating, painful urination, urinating frequently, or urinating in a weak stream or drips. Call your healthcare provider right away if you have any of these symptoms.
- low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
- high blood sugar
Common side effects of STIOLTO RESPIMAT include runny nose, cough, and back pain. Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the side effects with STIOLTO RESPIMAT. Ask your healthcare provider or pharmacist for more information.
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 STIOLTO RESPIMAT
- Store STIOLTO RESPIMAT at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze your STIOLTO cartridge or RESPIMAT inhaler.
- Keep your STIOLTO RESPIMAT and all medicines out of the reach of children.
General Information about the safe and effective use of STIOLTO RESPIMAT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STIOLTO RESPIMAT for a condition for which it was not prescribed. Do not give STIOLTO RESPIMAT to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about STIOLTO RESPIMAT. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about STIOLTO RESPIMAT that was written for healthcare professionals.
For more information about STIOLTO RESPIMAT or a video demonstration on how to use STIOLTO RESPIMAT, go to www.STIOLTO.com, or scan the code below. You may also call 1-800-542-6257 or (TTY) 1-800-459-9906 for further information about STIOLTO RESPIMAT.
What are the ingredients in STIOLTO RESPIMAT
Active ingredients: Tiotropium bromide and olodaterol
Inactive ingredients: water for injection, benzalkonium chloride, edetate disodium, and hydrochloric acid