Tiotropium Monohydrate

Tiotropium Capsules for Inhalation

(ty oh TRO pee um)

Spiriva Handihaler

It is used to treat COPD (chronic obstructive pulmonary disease). This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you take other drugs called anticholinergics, like ipratropium or oxybutynin. Ask your doctor if you are not sure if any of your drugs are anticholinergic. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this drug affects you. Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often. Do not get this drug in your eyes. If you get it in your eyes, it may cause large pupils and blurred eyesight. Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects. If you are 65 or older, use this drug with care. You could have more side effects. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Change in eyesight, eye pain, or very bad eye irritation. Eye redness. Seeing halos or bright colors around lights. Trouble passing urine, pain when passing urine, passing urine in a weak stream or drips, or passing urine more often. Chest pain or pressure. This drug can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this drug, use a rescue inhaler and get medical help right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Dry mouth. Upset stomach. Nose or throat irritation. Runny or stuffy nose. Cough. Stomach pain. Dizziness. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well. Keep out of your eyes. If you are using more than 1 inhaled drug, ask the doctor which drug to use first. Do not use a spacer with the inhaler. Use new inhaler with each refill. Put the cap back on after you are done using your dose. Do not swallow capsule. The contents of the capsule will be breathed into the lungs. Only use the device that comes with this drug. Do not use any other devices.

Take a missed dose as soon as you think about it. If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time. Do not take more than 1 dose of this drug in the same day.

Store at room temperature. Store in a dry place. Do not store in a bathroom. Store capsules in the original container. Use right after opening. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.