Seebri Breezhaler

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Seebri Breezhaler (Glycopyrronium-bromide-inh). If you are concerned about side effects, discuss the risks and benefits of Seebri Breezhaler (Glycopyrronium-bromide-inh) with your doctor.

The following side effects have been reported by at least 1% of people taking Seebri Breezhaler (Glycopyrronium-bromide-inh). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cavities
• difficulty sleeping
• Dry Mouth
• feeling of pressure or pain in the cheeks and forehead (possible symptoms of sinus congestion)
• itchiness
• nausea, vomiting, Diarrhea, and abdominal pain (possible symptoms of gastroenteritis)
• nose bleeds
• pain in arms or legs
• pain in muscles, bones, or joints
• rash
• symptoms of common cold (runny or stuffy nose, cough, sore throat, sneezing)
• tiredness
• throat irritation
• tingling or numbness
• upset stomach or indigestion
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• difficulty and pain when passing urine, urinating frequently, urination in a weak stream or drips
• signs of Glaucoma (an eye problem that causes increased eye pressure), such as new or worsened pressure in your eyes, eye pain or discomfort, blurred vision, seeing halos of bright colours around lights, red eyes
• signs of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• new occurrence of irregular heart beat
• signs of a serious allergic reaction (e.g., rash; Hives; swelling of the face, mouth, lips, throat, and tongue; difficulty swallowing or breathing)
• signs of bronchospasm (narrowing airways), such as chest tightness, coughing, wheezing or breathlessness immediately after using Seebri Breezhaler (Glycopyrronium-bromide-inh)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Seebri Breezhaler (Glycopyrronium-bromide-inh).

Capsules
Each transparent orange capsule printed "GPL50" in black above a black bar on one side and the Novartis company logo printed under a black bar on the other side contains 50 µg of glycopyrronium. Nonmedicinal ingredients: lactose and magnesium stearate. Capsule shells are made of hypromellose, purified water, carrageenan, potassium chloride and FDC Yellow 6 (110 Sunset Yellow FCF).

Inhalation device
The Breezhaler® inhalation device is a plastic device that is especially designed for administering Seebri® capsules.

Do not use glycopyrronium if you:

• are allergic to glycopyrronium or any ingredients of Seebri Breezhaler (Glycopyrronium-bromide-inh)
• are severely allergic to lactose or milk proteins

There may be an interaction between glycopyrronium and any of the following:

• aclidinium
• antihistamines (e.g., Chlorpheniramine, Diphenhydramine, doxylamine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• atropine
• azelastine
• belladonna
• Benztropine
• beta-2 agonists (e.g., salbutamol, formoterol, terbutaline)
• botulinum toxin
• cannabis
• Cyclobenzaprine
• Darifenacin
• Disopyramide
• Domperidone
• Donepezil
• dronabinol
• Flavoxate
• Galantamine
• Glucagon
• glycopyrrolate
• ipratropium
• ketotifen
• Levocabastine
• levodopa
• long-acting bronchodilators (e.g., Indacaterol, salmeterol)
• Metoclopramide
• Metformin
• mianserin
• Mirabegron
• monoamine oxidase (MAO) inhibitors (e.g., Phenelzine, Tranylcypromine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• orphenadrine
• Oxybutynin
• potassium supplements
• quinidine
• Rivastigmine
• scopolamine
• secretin
• Solifenacin
• thiazide diuretics (e.g., chlorothiazide, Hydrochlorothiazide, Indapamide)
• tiotropium
• Tolterodine
• Topiramate
• tricyclic antidepressants (e.g., Amitriptyline, Imipramine)
• Trospium
• umeclidinium

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Seebri Breezhaler (Glycopyrronium-bromide-inh). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Seebri Breezhaler (Glycopyrronium-bromide-inh).

COPD symptoms: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment stop using Seebri Breezhaler (Glycopyrronium-bromide-inh) and tell your doctor immediately.

Bladder or urinary problems: Glycopyrronium can worsen symptoms of bladder problems. If you have a history of bladder problems, discuss with your doctor how Seebri Breezhaler (Glycopyrronium-bromide-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Enlarged prostate: Glycopyrronium can worsen symptoms of an enlarged prostate, such as difficulty starting urination. If you have an enlarged prostate, discuss with your doctor how Seebri Breezhaler (Glycopyrronium-bromide-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Seebri Breezhaler (Glycopyrronium-bromide-inh), and whether any special monitoring is needed.

Glaucoma: People with eye conditions (e.g., glaucoma) are more likely to experience worsening of their conditions and symptoms such as eye pain and swelling, blurred vision, or other unusual changes in their vision. Take extra care to ensure that glycopyrronium powder does not come into contact with your eyes. If your eyes have been in contact with glycopyrronium powder or you have any of these symptoms, contact your doctor immediately.

Heart problems: If you have heart problems such as rapid or irregular heart beat, "QT prolongation" (abnormal electrical signals in the heart), or a history of Heart Attack, discuss with your doctor how Seebri Breezhaler (Glycopyrronium-bromide-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Seebri Breezhaler (Glycopyrronium-bromide-inh), and whether any special monitoring is needed.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways which make breathing difficult. If you experience this problem when using glycopyrronium, stop using Seebri Breezhaler (Glycopyrronium-bromide-inh) immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Kidney function: Kidney Disease or reduced kidney function may cause Seebri Breezhaler (Glycopyrronium-bromide-inh) to build up in the body, causing side effects. If you have severely reduced kidney function or severe kidney disease, discuss with your doctor how Seebri Breezhaler (Glycopyrronium-bromide-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Seebri Breezhaler (Glycopyrronium-bromide-inh), and whether any special monitoring is needed.

Prevention only: Glycopyrronium is not useful for treating acute symptoms (as a "rescue" medication). It is meant for prevention only. Short-acting medications such as salbutamol, terbutaline, or formoterol are required to relieve breathing symptoms as instructed by your doctor and should be available at all times.

Pregnancy: There are no studies on the use of glycopyrronium by pregnant women. Seebri Breezhaler (Glycopyrronium-bromide-inh) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if glycopyrronium passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Seebri Breezhaler (Glycopyrronium-bromide-inh) for children younger than 18 years of age have not been established.