Glycopyrrolate; Formoterol inhalation aerosol

What is this medicine?

GLYCOPYRROLATE; FORMOTEROL (glye koe PYE roe late; for MOH te rol) inhalation is a combination of 2 medicines that help to open up the airways of your lungs. This medicine is used to treat chronic obstructive pulmonary disease (COPD). Do NOT use for an acute COPD attack.

How should I use this medicine?

This medicine is inhaled through the mouth. Follow the directions on the prescription label. Shake well before each use. 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.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

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, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision, eye pain

• muscle cramps or muscle pain

• nervousness

• pain or difficulty passing urine or change in the amount of urine

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heart beat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• tremor

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

• cough

• runny nose

• sore throat

What may interact with this medicine?

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

• cisapride

• dofetilide

• dronedarone

• other medicines that contain long-acting beta-2 agonists (LABAs) like formoterol, indacaterol, olodaterol, salmeterol, vilanterol

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antihistamines for allergy, cough, and cold

• certain medicines for bladder problems like oxybutyin and tolterodine

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression, anxiety, or psychotic disturbances

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

• other medicines that contain an anticholinergic like aclidinium, ipratropium, glycopyrrolate, tiotropium, umeclidinium

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

• steroid medicines like prednisone or cortisone

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

• theophylline

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. Do not use double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a dry place at room temperature between 20 and 25 degrees C (68 and 77 degrees F). The contents are under pressure and may burst when exposed to heat or flame. Do not get the canister of the inhaler wet. Do not freeze. Inhalers need to be thrown away after the labeled number of puffs have been used or by the expiration date, whichever comes first. This inhaler should be thrown away 3 months after removing from foil pouch.

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

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

• bladder problems or difficulty passing urine

• diabetes

• glaucoma

• heart disease

• high blood pressure

• history of an irregular heartbeat

• kidney disease

• liver disease

• prostate trouble

• seizures

• thyroid disease

• an unusual or allergic reaction to glycopyrrolate, formoterol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor for regular check ups. If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not take more medicine than directed.

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.