Seebri Neohaler inhalation

Glycopyrrolate is an anticholinergic that works by relaxing muscles in the airways to improve breathing.

Glycopyrrolate is used as an inhaled medication to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Glycopyrrolate may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• glycopyrrolate taken in pill form (Cuvposa, Robinul);

• cold or allergy medicine that contains an antihistamine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or

• bronchodilators--aclidinium, ipratropium, tiotropium, or umeclidinium.

This list is not complete. Other drugs may interact with glycopyrrolate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Dry mouth, dry/sore throat, or runny/stuffy nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficult/painful urination, fast/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).

Rarely, glycopyrrolate may cause worsening of breathing problems (paradoxical bronchospasm) that may be severe. If this occurs, get medical attention right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Applies to glycopyrrolate: oral solution, oral tablet

Other dosage forms:

• inhalation capsule

Along with its needed effects, glycopyrrolate (the active ingredient contained in Seebri Neohaler) 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 glycopyrrolate:

• Body aches or pain
• chills
• constipation
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• difficulty with breathing
• ear congestion
• feeling of warmth
• fever
• headache
• loss of voice
• nasal congestion
• painful urination
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Abdominal or stomach discomfort or pain
• abdominal or stomach distension
• chest pain
• confusion
• convulsions
• dizziness
• dry heaves
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• pain or tenderness around the eyes and cheekbones
• rapid breathing
• shortness of breath or troubled breathing
• stuffy nose
• sunken eyes
• thirst
• tightness in the chest
• vomiting
• wheezing
• wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking glycopyrrolate:

• low blood pressure
• muscle weakness
• trouble breathing

Some side effects of glycopyrrolate 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:

• Altered mood
• anxiety
• attack, assault, or force
• bloated
• change in taste
• chapped lips
• crying
• dry skin
• dry tongue
• excess air or gas in the stomach or intestines
• full feeling
• hyperventilation
• irregular heartbeats
• irritability
• loss of taste
• moaning
• nervousness
• pain
• paleness of the skin
• passing gas
• rash
• restlessness
• shaking
• trouble with sleeping
• uncontrolled eye movements