Umeclidinium

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Umeclidinium falls into category C. In animal studies, pregnant animals were given this medication and there was no evidence of problems for the mother or offspring. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose/dose range of umeclidinium for the long-term control of symptoms of chronic obstructive pulmonary disease is 1 oral inhalation (62.5 mcg) daily. The dose should be taken at the same time each day.

Store umeclidinium at room temperature.

Store this medication in the foil tray in which it is dispensed.

Keep this and all medicines out of the reach of children.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• rapid heartbeats;

• painful or difficult urination; or

• little or no urinating.

Common side effects may include:

• stuffy or runny nose, sinus pain, sneezing;

• sore throat, cough;

• bruising or skin discoloration;

• mouth pain, tooth pain;

• joint pain;

• stomach pain; or

• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• 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 give to a child. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using umeclidinium while you are pregnant.

• Store at room temperature.
• Protect from heat.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• After opening, throw away any part not used after 6 weeks or when the indicator reads zero, whichever comes first.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to umeclidinium: inhalation powder

Along with its needed effects, umeclidinium may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking umeclidinium:

• Bladder pain
• bloody or cloudy urine
• cough or hoarseness
• difficulty with breathing
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• loss of voice
• lower back or side pain
• painful or difficult urination
• sore throat
• unusual tiredness or weakness

• Blurred vision
• decreased urination
• difficulty in passing urine (dribbling)
• eye pain or discomfort

Some side effects of umeclidinium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• body aches or pain
• depression
• diarrhea
• dizziness or lightheadedness
• joint pain
• nausea
• rash
• sensation of spinning
• upper abdominal or stomach pain

1 inhalation (62.5 mcg) orally once a day
Maximum dose: 1 inhalation every 24 hours

Use: Treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

No adjustment recommended.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.