Stiolto® Respimat® (as a combination product containing olodaterol and tiotropium)
WHY is this medicine prescribed?
Tiotropium is used to prevent wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD, a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to air sacs in the lungs). Tiotropium is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.
HOW should this medicine be used?
Tiotropium comes as a capsule to use with a specially designed inhaler. You will use the inhaler to breathe in the dry powder contained in the capsules. Tiotropium is usually inhaled once a day in the morning or evening. To help you remember to inhale tiotropium, inhale it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use tiotropium exactly as directed. Do not inhale more or less of it or inhale it more often than prescribed by your doctor.
Do not swallow tiotropium capsules.
Tiotropium will only work if you use the inhaler it comes with to inhale the powder in the capsules. Never try to inhale them using any other inhaler. Never use your tiotropium inhaler to take any other medication.
Do not use tiotropium to treat a sudden attack of wheezing or shortness of breath. Your doctor will probably prescribe a different medication to use when you have great difficulty breathing.
Tiotropium controls COPD but does not cure it. It may take a few weeks before you feel the full benefits of tiotropium. Continue to take tiotropium even if you feel well. Do not stop taking tiotropium without talking to your doctor.
Be careful not to get tiotropium powder in your eyes. If tiotropium powder gets into your eyes, your vision may become blurred and you may be sensitive to light. Call your doctor if this happens.
To use the inhaler, follow these steps:
Use the diagram in the patient information that came with your medication to help you learn the names of the parts of your inhaler. You should be able to find the dust cap, mouthpiece, base, piercing button, and center chamber.
Pick up one blister card of tiotropium capsules and tear it along the perforation. You should now have two strips that each contain three capsules.
Put away one of the strips for later. Use the tab to carefully peel back the foil on the other blister strip until the STOP line. This should fully uncover one capsule. The other two capsules on the strip should still be sealed in their packaging. Plan to use those capsules on the next 2 days.
Pull upward on the dust cap of your inhaler to open it.
Open the mouthpiece of the inhaler. Remove the tiotropium capsule from the package and place it in the center chamber of the inhaler.
Close the mouthpiece firmly until it clicks, but do not close the dust cap.
Hold the inhaler so that the mouthpiece is on top. Press the green piercing button once, then let it go.
Breathe out completely without putting any part of the inhaler in or near your mouth.
Bring the inhaler up to your mouth and close your lips tightly around the mouthpiece.
Hold your head upright and breathe in slowly and deeply. You should breathe just fast enough to hear the capsule vibrate. Continue to breathe in until your lungs are full.
Hold your breath for as long as you can comfortably do so. Take the inhaler out of your mouth while you are holding your breath.
Breathe normally for a short time.
Repeat steps 8-11 to inhale any medication that may be left in your inhaler.
Open the mouthpiece and tilt the inhaler to spill out the used capsule. Discard the used capsule out of the reach of children and pets. You may see a small amount of powder remaining in the capsule. This is normal and does not mean that you did not get your full dose.
Close the mouthpiece and dust cap and store the inhaler in a safe place.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using tiotropium,
tell your doctor and pharmacist if you are allergic to tiotropium, atropine (Atropen, Sal-Tropine, Ocu-Tropine), ipratropium (Atrovent), or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Cordarone); antihistamines; atropine (Atropen, Sal-Tropine, Ocu-Tropine); cisapride (Propulsid); disopyramide (Norpace); dofetilide (Tikosyn); erythromycin (E.E.S, E-Mycin, Erythrocin); eye drops; ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; moxifloxacin (Avelox); pimozide (Orap); procainamide (Procanbid, Pronestyl); quinidine (Quinidex); sotalol (Betapace); sparfloxacin (Zagam); and thioridazine (Mellaril). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had glaucoma (an eye disease that can cause vision loss), urinary problems, irregular heart beat, or prostate (a male reproductive organ) or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tiotropium, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tiotropium.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Tiotropium may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
painful white patches in mouth
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
sore throat, fever, chills, and other signs of infection
headaches or other signs of a sinus infection
painful or difficult urination
fast heart beat
seeing halos around lights or seeing colored images
Tiotropium may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not open the blister package surrounding a capsule until just before you are ready to use it. If you accidentally open the package of a capsule that you cannot use immediately, discard that capsule. Never store capsules inside the inhaler.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
shaking hands that you cannot control
changes in thinking
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
You will receive a new inhaler with each 30 day supply of medication. Normally, you will not need to clean your inhaler during the 30 days you use it. However, if you do need to clean your inhaler, you should open the dust cap and mouthpiece and then press the piercing button to open the base. Then rinse the entire inhaler with warm water but without any soaps or detergents. Tip out excess water and leave the inhaler to air dry for 24 hours with the dust cap, mouthpiece, and base open. Do not wash your inhaler in the dishwasher and do not use it after you wash it until it has been allowed to dry for 24 hours. You may also clean the outside of the mouthpiece with a moist (not wet) tissue.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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