Tiotropium, Olodaterol Respiratory spray, solution

What is this medicine?

TIOTROPIUM; OLODATEROL (tee oh TRO pee um; OH loe DA ter ol) inhalation is a combination of two medicines that help to open up the airways of your lungs. It is for chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema. Do NOT use for asthma or an acute asthma attack. Do NOT use for a COPD attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• asthma

• bladder problems or difficulty passing urine

• diabetes

• glaucoma

• heart disease or irregular heartbeat

• high blood pressure

• kidney disease

• pheochromocytoma

• prostate disease

• seizures

• thyroid disease

• an unusual or allergic reaction to tiotropium, olodaterol, ipratropium, atropine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is inhaled through the mouth. It is used once per day. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose and continue with your regular schedule. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• atropine

• certain medicines for allergy, cough and cold

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• diuretics

• ipratropium

• medicines for depression, anxiety, or psychotic disturbances

• medicines for fungal infections like ketoconazole

• medicines for weight loss including some herbal products

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• procarbazine

• ritonavir

• some antibiotics like clarithromycin, erythromycin, levofloxacin, linezolid, and telithromycin

• some heart medicines

• steroid medicines like prednisone or cortisone

• stimulant medicines for attention disorders, weight loss, or to stay awake

• theophylline

• thyroid hormones

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checkups. Tell your doctor or health care professional if your symptoms do not get better.

If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not use this medicine more than once every 24 hours.

Do not get the this medicine in your eyes. It can cause irritation, pain, or blurred vision.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Clean the inhaler as directed in the patient information sheet that comes with this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue

• breathing problems right after inhaling your medicine

• changes in vision

• chest pain

• difficulty breathing or wheezing that increases or does not go away

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• general ill feeling or flu-like symptoms

• stomach pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• back pain

• constipation

• cough

• dry mouth

• nervousness

• runny nose

• sore throat

• tremor

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. The inhaler should be discarded after 3 months or when the inhaler becomes locked, whichever comes first. Throw away any unopened packages after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.