This product is a combination of two medications: aclidinium and formoterol. Aclidinium belongs to the class of medications called long-acting muscarinic antagonists. Formoterol belongs to the class of medications called long-acting beta2-agonists. Aclidinium - formoterol is used as long-term maintenance to keep the airways open for people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Aclidinium and formoterol work by different means to relax the muscles that surround the airways. This opens the air passages, allowing more air to get to the lungs, and makes breathing easier.

Aclidinium - formoterol should not be used as a rescue medication to relieve sudden attacks of COPD symptoms such as wheezing or shortness of breath. Consult your doctor or pharmacist for advice about rescue medications that are appropriate for you.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of aclidinium - formoterol is one inhalation 2 times daily: once in the morning and once in the evening.

Have your doctor or pharmacist explain how to use the inhaler and read the instructions carefully before using the inhaler. If you have any questions about how to use the inhaler, check with your health care professional.

Do NOT use this medication to treat episodes of shortness of breath.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

To receive the most benefit from this medication, it must be used regularly. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, in the sealed pouch, until it is needed. Once opened, protect it from light and moisture. Keep it out of the sight and reach of children. Discard any remaining medication 60 days after opening the pouch.

Each inhalation dose contains 400 µg of aclidinium bromide and 12 µg of formoterol fumarate dihydrate, which corresponds to a delivered dose (the dose leaving the mouthpiece) of 396 µg of aclidinium bromide equivalent to 340 µg of aclidinium and 12 µg of formoterol fumarate dihydrate. Nonmedicinal ingredients: lactose monohydrate.

Do not use this medication if you:

• are allergic to aclidinium, formoterol, or any ingredients of the medication
• have been prescribed this medication to treat asthma and do not have a long-term control medication (corticosteroid)

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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.

• changed sense of taste
• cough
• diarrhea
• difficulty sleeping
• dizziness
• dry mouth
• headache
• hoarseness
• irritation of the nose or throat
• itchy skin
• mouth inflammation
• muscle pain, cramps or spasms
• nausea
• rash
• tremor, shakiness

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:

• agitation
• anxiety
• flu-like symptoms (e.g., fever, chills, headache, sudden lack of energy)
• increased blood pressure
• pounding, rapid, or irregular heartbeat
• swelling of the hands or feet
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of reduced potassium in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• symptoms of urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• throat pain
• tooth infection

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

• chest pain
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using this medication
• symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)

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 this medication.

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 this medication.

Allergy: In rare cases, immediate allergic reactions may occur after using aclidinium - formoterol, causing hives, swelling around the throat and tongue, rash, and worsening of breathing problems. If this occurs, seek emergency medical help at once.

Asthma: This medication has not been studied for the treatment of asthma. The use of medications similar to formoterol to treat asthma, without a long-term control medication such as a corticosteroid increases the risk of asthma-related death.

Diabetes: This medication may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

Glaucoma: Aclidinium may cause symptoms of glaucoma (increased pressure in the eyes), such as blurred vision or eye pain or pressure to become worse. If you have glaucoma, discuss with your doctor how this medication 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.

Heart conditions: Medications like aclidinium and formoterol may have effects on the cardiovascular system (heart and blood vessels). Effects such as chest pain, rapid or pounding heartbeat and changes to blood pressure have been linked to these medications. If you have a history of heart attack, angina or high blood pressure, discuss with your doctor how this medication 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.

Heart rhythm: Aclidinium - formoterol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication 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.

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

Smoking: If you smoke, discuss with your doctor or pharmacist the benefits of stopping smoking. Smoking contributes to the symptoms of COPD. People who stop smoking often see a significant improvement in their breathing symptoms.

Urinary tract problems: This medication can cause the symptoms of some urinary tract problems to become worse. If you have an enlarged prostate or another condition that causes urination to be difficult, discuss with your doctor how this medication 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.

Pregnancy: This medication 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 aclidinium or formoterol pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 18 years.

There may be an interaction between aclidinium - formoterol and any of the following:

• amantadine
• amiodarone
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• atomoxetine
• atropine
• benztropine
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• botulinum toxin
• fast acting bronchodilators (beta2-agonists; e.g., salbutamol, terbutaline)
• other long-acting bronchodilators (beta2-agonists; e.g., indacaterol, salmeterol)
• caffeine and products that contain caffeine
• cannabis
• cyclobenzaprine
• cyclopentolate
• darifenacin
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• dicyclomine
• disopyramide
• domperidone
• donepezil
• dopamine
• dronedarone
• epinephrine
• fesoterodine
• flecainide
• galantamine
• glucagon
• glycopyrrolate
• inhaled anesthetics (medications to put you to sleep for surgery)
• ipratropium
• ketotifen
• loop diuretics (water pills; bumetanide, furosemide)
• metoclopramide
• methadone
• methylphenidate
• midodrine
• mirabegron
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• nabilone
• narcotics (e.g., codeine, morphine, oxycodone)
• neostigmine
• nitroglycerin
• orphenadrine
• oxybutynin
• ozanimod
• pizotifen
• potassium chloride
• procainamide
• propiverine
• protein kinase inhibitors (e.g., lenvatinib, selpercatinib, vandetanib)
• prucalopride
• pyridostigmine
• quinidine
• rilpivirine
• rivastigmine
• saquinavir
• scopolamine
• solifenacin
• solriamfetol
• theophyllines (e.g., aminophylline, theophylline)
• thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
• tiotropium
• tolterodine
• topiramate
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• trihexyphenidyl
• 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 this medication. 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.