SYMBICORT (BUDESONIDE/FORMOTEROL) TURBUHALER

How does this medication work? What will it do for me?

This combination product contains two medications: budesonide and formoterol. Budesonide belongs to the group of medications known as corticosteroids. It works by reducing the swelling in the airways of the lungs. Formoterol belongs to the group of medications known as bronchodilators. It works by relaxing the muscles surrounding the airways and allowing the airways to open.

This medication is used to treat reversible obstructive airway disease, often known as asthma. When combined, these medications help to control the symptoms of asthma and prevent asthma attacks by keeping the airways open to make breathing easier.

It is also used for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.

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.

What form(s) does this medication come in?

Symbicort 100 Turbuhaler
Each dry powder inhaler contains 100 µg of budesonide and 6 µg of formoterol fumarate dihydrate per dose. It also contains lactose, which acts as a “carrier.” The amount added does not normally cause problems for lactose-intolerant people.

Symbicort 200 Turbuhaler
Each dry powder inhaler contains 200 µg of budesonide and 6 µg of formoterol fumarate dihydrate per dose. It also contains lactose, which acts as a “carrier.” The amount added does not normally cause problems for lactose-intolerant people.

Symbicort Forte Turbuhaler
Each dry powder inhaler contains 400 µg of budesonide and 12 µg of formoterol fumarate dihydrate per dose. It also contains lactose, which acts as a “carrier.” The amount added does not normally cause problems for lactose-intolerant people.

How should I use this medication?

For asthma treatment, budesonide – formoterol can be used for reliever therapy, maintenance therapy, or for maintenance plus reliever therapy.

The starting dose of budesonide – formoterol is based on control of your symptoms. After asthma symptoms are controlled, your doctor will adjust your dose to the lowest regular dose that prevents asthma symptoms.

This medication is inhaled into the lungs through the mouth, using the device that contains the medications (Turbuhaler®). Your health care professional should show you how to use the device. If you are not sure about how to use the device, contact your doctor or pharmacist for advice.

When used as a “reliever” inhaler, the recommended dose is 200 µg inhaled once. If you still have difficulty breathing, another dose may be inhaled after several minutes. Do not inhale more than 6 doses for a single episode. No more than 8 inhalations should be used in a 24-hour period.

For maintenance therapy, the recommended dose for adults and adolescents over 12 years of age is 100 µg to 400 µg of budesonide, which is equivalent to 1 to 2 inhalations (or puffs) of Symbicort® 100 or Symbicort® 200, 1 or 2 times daily. If you need fast relief from asthma symptoms, use your fast-acting “reliever” (or “rescue”) medication such as formoterol, terbutaline, or salbutamol. The maximum recommended daily maintenance dose is 4 inhalations. When asthma is worsening, the dose can temporarily be increased to a maximum of 4 inhalations twice daily.

With the higher-strength product, Symbicort® Forte, a 400 µg dose is achieved with 1 puff, which may be inhaled 1 or 2 times a day. The maximum daily dose of this product is 2 puffs (800 µg) inhaled twice daily.

For maintenance and reliever therapy, the recommended dose for adults and adolescents over 12 years of age is 1 to 2 inhalations 2 times daily or 2 inhalations once daily. If you need fast relief from asthma symptoms, use 1 additional inhalation as needed and repeat after a few minutes (to a maximum of 6 inhalations) if symptoms persist. The maximum recommended total daily dose is 8 inhalations. Symbicort® Forte should not be used as a reliever medication.

When used as COPD maintenance therapy, the recommended dose is 400 µg of budesonide (2 inhalations of Symbicort® 200 or 1 inhalation of Symbicort® Forte), inhaled 2 times daily. The maximum recommended daily dose is 800 µg of budesonide.

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 using the medication without consulting your doctor.

When used regularly, this medication can reduce the number and severity of episodes of difficulty breathing. Regular daily use is important for its effectiveness.

Budesonide – formoterol turbuhaler should be used regularly, even when you are not experiencing any symptoms.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, use it as soon as possible and then 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 with the cover on tight, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you are allergic to budesonide, formoterol, or inhaled lactose.

What side effects are possible with this medication?

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.

• awareness of heartbeat or fast heartbeat
• cough
• dizziness
• headache
• hoarseness
• irritation of the mouth or throat
• muscle cramps
• nausea
• restlessness or nervousness
• tremor
• trouble sleeping

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
• bone pain or fractures
• chest pain
• chest tightness
• fast or irregular heartbeat
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat) that includes rash, pins and needles sensation, worsening breathing problems)
• mood or mental changes
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• skin rash or hives all over the body
• symptoms of cataracts (e.g., clouding of the lens in the eye, blurred vision, eye pain)
• symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
• 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 pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)
• symptoms of too much corticosteroid in the body (e.g., rapid weight gain, round “moon” face, excess sweating, thinning skin, easy bruising, muscle and bone weakness)
• unexplained skin bruising
• unusual colour, amount, or consistency of phlegm
• white patches in the mouth or throat (thrush)

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

• breathlessness when resting
• sudden wheezing and chest pain or tightness immediately after using the medication
• signs of a severe allergic reaction (e.g., swelling of face, lips, tongue, throat, or eyelids; difficulty swallowing, breathing, or speaking)
• worsening breathing symptoms even after using your reliever medication

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.

Are there any other precautions or warnings for 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 breastfeeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Asthma attacks: This medication works by decreasing the frequency and severity of asthma attacks, and it can be used as a “reliever” medication. If you start developing asthma symptoms, be sure to use your “reliever” medication or an additional inhalation (or puff) of this medication for rapid relief of your asthma symptoms. It is very important that you have your “reliever” medication available with you at all times, whether you’re using this medication or another rescue medication. If you persistently use more of your “reliever” medication, contact your doctor.

Budesonide – formoterol is not intended to be used before exercise to prevent difficulty breathing as a result of exercise.

Asthma-related deaths: Formoterol, like other long-acting bronchodilators, may increase the risk of hospitalization and asthma-related deaths when used alone. Studies have shown that when long-acting bronchodilators are used in combination with an inhaled corticosteroid, the risk of serious asthma related complications is not increased. If you have any concerns, speak with your doctor.

Bone health: Long-term use of inhaled corticosteroids has been associated with a decrease in bone density. This may lead to brittle bones or osteoporosis. If you have risk factors for thinning or brittle bones, such as a slight build; long-term, regular alcohol use; poor nutrition; or a family history of osteoporosis, you may be at a greater risk of thinning bones. 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.

Diabetes: Budesonide – formoterol may cause changes 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.

If you have diabetes or are at risk for developing diabetes, 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.

Eye problems: Budesonide may increase the risk of developing cataracts or glaucoma. If you are at risk of developing either of these conditions, have your eyes checked by your doctor before starting long-term treatment with this medication. You should have your eyes monitored at regular intervals while using this medication. Report any changes in vision to your doctor as soon as possible while you are taking this medication.

Heart disease: If you have heart disease 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.

Infections: Thrush infections of the inside of the mouth and throat may occur with use of this medication. If an infection develops, call your doctor. You can reduce the risk of infection by rinsing your mouth out with water after each dose and by practicing good oral hygiene. Also, tell your doctor if you are exposed to chickenpox or measles while using this medication, as you may be more prone to infection.

People using budesonide-formoterol to treat COPD may be more likely to develop lung infections, such as pneumonia. If you experience new or worsening shortness of breath or cough, fever, or other symptoms of infection at any time while you are taking this medication, contact your doctor as soon as possible.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, 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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medical conditions: If you have epilepsy or low blood potassium, 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.

Steroid medication use: If you are taking steroid medication or have taken steroid medication over the last several months, talk to your doctor before using this medication. In times of stress or during a severe asthma attack, your doctor may want you to start your steroid medication again.

Stopping the medication: Do not stop this medication abruptly, as this may cause your condition to get worse. When this medication is stopped, it should be stopped gradually as directed by your doctor.

Thyroid disease: People with decreased thyroid function (hypothyroid) may experience an increased effect from corticosteroids. If you have thyroid disease, 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: Budesonide passes into breast milk. It is not known if formoterol passes into breast milk. If you are breastfeeding and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breastfeeding.

Children: The safety and effectiveness of this medication for the treatment of asthma have not been established for children younger than 12 years of age. Adolescents may experience slowing growth while using this medication. Your doctor will monitor this. Talk to your doctor if you have any concerns.

This medication should not be used to treat chronic bronchitis or emphysema for anyone younger than 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between budesonide – formoterol turbuhaler and any of the following:

• aldesleukin
• amiodarone
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, loxapine, olanzapine, quetiapine, risperidone)
• aprepitant
• atomoxetine
• azole antifungals (e.g., ketoconazole, itraconazole, fluconazole, voriconazole)
• beta-blockers, including eye drops (e.g., carvedilol, labetalol, metoprolol, propranolol, timolol eye drops)
• betahistine
• caffeine
• cannabinoid-containing medications (e.g., cannabis, nabilone)
• cobicistat
• conivaptan
• other corticosteroids (e.g., fluticasone, prednisone)
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• desmopressin
• dexmethylphenidate
• diltiazem
• disopyramide
• diuretics (e.g., furosemide, hydrochlorothiazide, spironolactone)
• dronedarone
• epinephrine
• fast-acting bronchodilators (e.g., salbutamol, terbutaline)
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• levothyroxine
• linezolid
• long-acting bronchodilators (e.g., indacaterol, salmeterol)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• methadone
• methylphenidate
• mifepristone
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• modafinil
• ozanimod
• procainamide
• quinidine
• quinine
• sotalol
• theophylline (e.g., aminophylline, oxtriphylline, theophylline)
• tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline)
• tyrosine kinase inhibitors (e.g., ceritinib, crizotinib, idelalisib, imatinib, nilotinib)
• verapamil

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, nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.