budesonide, formoterol, and glycopyrrolate

What is the most important information I should know about this medicine?

What is budesonide, formoterol, and glycopyrrolate?

Budesonide is a steroid. Formoterol is a long-acting bronchodilator. Glycopyrrolate is an anticholinergic.

Budesonide, formoterol, and glycopyrrolate is a combination medicine used in adults to help control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

This medicine is not for use in treating asthma or a bronchospasm attack.

Budesonide, formoterol, and glycopyrrolate may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

Budesonide can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• a weak immune system;
• liver or kidney disease;
• osteoporosis;
• glaucoma, cataracts, or other vision problems;
• enlarged prostate, urination problems;
• diabetes;
• tuberculosis;
• a weak immune system;
• a thyroid disorder; or
• any type of bacterial, fungal, or viral infection.

Tell your doctor if you are pregnant or breastfeeding.

How should I take this medicine?

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water after each use of your inhaler.

Your medication needs may change if you have surgery, are ill, are under stress, or have worsening COPD symptoms. Do not change your medication dose or stop using this medicine without your doctor's advice.

Do not open the foil pouch until you are ready to use the medicine.

Throw the canister away when the inhalations counter shows a 0, or 3 months after you first removed the 120-inhalation canister from its foil pouch (3 weeks after if you are using the 28-inhalation canister), whichever comes first.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include chest pain, fast heartbeats, and feeling shaky or short of breath.

What should I avoid while taking this medicine?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as budesonide.

What are the possible side effects of this medicine?

• worsened breathing problems;
• wheezing, choking, or other breathing problems after using this medication;
• tremors, nervousness, chest pain, fast or pounding heartbeats;
• sores or white patches in your mouth and throat, pain when swallowing;
• flu symptoms, body aches, unusual tiredness;
• painful or burning when you urinate, little or no urination;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• signs of a lung infection --fever, chills, cough with mucus, chest pain, feeling short of breath; or
• signs of a hormonal disorder --tiredness or weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

• throat pain or irritation;
• white patches in your mouth or throat;
• headache, joint pain, muscle spasms;
• pounding heartbeats, feeling anxious;
• high blood sugar levels;
• painful or difficult urination;
• nausea, diarrhea;
• cough, hoarse voice;
• flu symptoms; or
• cold symptoms such as stuffy or runny nose, sneezing, sinus pain, sore throat.

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.

What other drugs will affect budesonide, formoterol, and glycopyrrolate?

Tell your doctor about all your current medicines. Do not use any of the following medicines without first asking your doctor:

• atropine;
• antiviral or antifungal medication;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder;
• bronchodilator asthma medication (such as aclidinium, ipratropium, tiotropium, or umeclidinium).

This list is not complete and many other drugs may affect budesonide, formoterol, and glycopyrrolate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about budesonide, formoterol, and glycopyrrolate.