What Symbicort Turbuhaler is used for and how to use it
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Symbicort Turbuhaler - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Asthma, Maintenance, COPD, Maintenance, COPD
Class: Bronchodilator combinations
Form: Inhaler, Powder
Ingredients: formoterol fumarate dihydrate, budesonide, lactose (may contain milk protein)

budesonide/formoterol fumarate dihydrate powder for inhalation

About this medication

This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

What the medication is used for

SYMBICORT TURBUHALER contains a mixture of the medicines budesonide and formoterol to treat asthma in adults and children (i.e. 12 years and older) and Chronic Obstructive Pulmonary Disease (COPD) in adults (i.e. 18 years and older).

Asthma

Asthma is a chronic disease of the lungs caused by inflammation which causes narrowing of the airways and increased mucus production. Symptoms such as chest tightness, wheezing, coughing and difficulty in breathing are common. These symptoms become more pronounced during periods of disease worsening or an asthma attack due to the narrowing of the airways.

SYMBICORT TURBUHALER should only be used when your doctor decides that other asthma medications (i.e. inhaled glucocorticosteroids along with an as needed relief medication) are not helping you enough, or that you need two maintenance medications to control your asthma. SYMBICORT TURBUHALER should not be the first medication you use, unless advised by your doctor.

COPD

Chronic Obstructive Pulmonary Disease (COPD) is also referred to as chronic bronchitis and emphysema. COPD is a chronic lung disease largely caused by cigarette smoking. COPD leads to a narrowing and persistent inflammation of the airways, increased mucous production and damage to the lungs. This results in breathing difficulties and a feeling of breathlessness. Symptoms such as coughing, breathlessness, mucous production and coughing and wheezing can become intense during periods of disease worsening.

What it does

Budesonide is a corticosteroid that reduces and prevents this airway inflammation. Formoterol widens your airways by relaxing the airway muscles, making it easier for you to breathe. This effect starts within 1-3 minutes after you have inhaled the medicine and lasts for up to 12 hours. When you breathe in through the mouthpiece of the inhaler, the medicine follows your breath to your lungs.

Regular use of SYMBICORT TURBUHALER gives 24-hour relief or prevention of symptoms such as shortness of breath in patients with asthma, COPD and other similar conditions (see PROPER USE OF THIS MEDICATION).

When it should not be used

  • If you are allergic to budesonide, formoterol or inhaled lactose
  • Asthma: if you are under 12 years old
  • COPD: if you are under 18 years old

What the medicinal ingredient is

SYMBICORT TURBUHALER is a dry powder inhalation device that contains formoterol fumarate dihydrate and budesonide.

What the nonmedicinal ingredients are

Lactose (may contain milk protein).

What dosage forms it comes in

SYMBICORT TURBUHALER is supplied in three strengths:

SYMBICORT 100 TURBUHALER (100/6 μg
budesonide/formoterol fumarate dihydrate per dose) (120 doses),

SYMBICORT 200 TURBUHALER (200/6 μg
budesonide/formoterol fumarate dihydrate per dose) (60 and 120 doses), and

SYMBICORT FORTE TURBUHALER (400/12 μg
budesonide/formoterol fumarate dihydrate per dose) (60 doses).

Warnings and precautions

Serious Warnings for Asthma Patients
Formoterol, one of the medicines in SYMBICORT TURBUHALER, may increase the risk of asthma-related death. It may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Therefore,
     — Your doctor will assess your asthma control at regular intervals. SYMBICORT     TURBUHALER should only be used when your doctor decides that other asthma     medications (e.g. inhaled glucocorticosteroids along with an as needed relief medication)     are not helping you enough, or that you need two maintenance medications to control     your asthma.
     — SYMBICORT TURBUHALER should not be the first medication you use, unless     advised by your doctor.
For any concerns regarding the use of SYMBICORT TURBUHALER, consult your doctor.
BEFORE you use SYMBICORT TURBUHALER talk to your doctor or pharmacist if:
  • You have health problems now or have had in the past, especially if you have any problems with your heart, high blood sugar (diabetes), low blood potassium or any problems with your thyroid gland, or if you suffer from seizures (epilepsy).
  • You suffer from severe liver problems (e.g. cirrhosis).
  • You take other medicines, including those you have bought without a prescription. Certain types of medicines, for example beta-blockers [some medicines for heart conditions (propranolol), high blood pressure (atenolol) or eye drops (timolol)] may reduce or block the effect of SYMBICORT TURBUHALER when taken at the same time. As well, some medicines used to treat fungal infections (ketoconazole, itraconazole) or ritonavir (medication used to treat HIV infection or AIDS) may alter the effect of SYMBICORT TURBUHALER.
  • You take, or have taken steroid medicines within the past several months.
  • You have ever had a bad, unusual or allergic reaction to budesonide, formoterol or lactose or to other medicines for breathing problems.
  • You are pregnant, plan to become pregnant or are breast feeding.
  • You have weak bones (osteoporosis).

Drugs like SYMBICORT can cause Eye Disorders:

  • Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
  • Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss;

You should therefore have regular eye exams.

Special attention should be paid if you are an adolescent with asthma, as your growth should be monitored regularly by a physician when being treated with corticosteroids. Studies have also shown that children whose asthma is not controlled do not grow as quickly as other children.

You should avoid coming into contact with people who have measles or chicken pox while taking SYMBICORT. If you are exposed, tell your doctor right away.

Interactions with this medication

Drugs that may interact with SYMBICORT TURBUHALER include: beta-blockers (propranolol, atenolol, timolol), ketoconazole, itraconazole and ritonavir.

Proper use of this medication

The dosage of SYMBICORT TURBUHALER is individual. It should be taken regularly (every day), even when you have no symptoms.

Follow your doctor's instructions carefully. Asthma and COPD therapy will differ from person to person and therefore your prescribed treatment may be different from the information contained in this leaflet.

Patients with Asthma

Treatment with SYMBICORT should not be initiated to treat an asthma attack.

For the treatment of asthma, your doctor will instruct you to use SYMBICORT TURBUHALER in one of two ways: as SYMBICORT maintenance therapy or as SYMBICORT maintenance and reliever therapy. Each of these treatment plans is described below.

SYMBICORT Maintenance Therapy for asthma

You take a regular daily dose from SYMBICORT TURBUHALER. In addition, you use a separate inhaler, containing a fast-acting bronchodilator (airway-widening medicine) for relief of asthma symptoms. This means that you need two separate inhalers.

Adults and adolescents (12 years and older)
  • 1 - 2 inhalations SYMBICORT 100 TURBUHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations. or
  • 1 - 2 inhalations SYMBICORT 200 TURBUHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations. or
  • 1 inhalation SYMBICORT FORTE TURBUHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.

Always carry your fast-acting bronchodilator (rescue medication) with you for relief of symptoms.

During periods of worsening asthma, the dose may temporarily be increased up to a maximum of 4 inhalations of SYMBICORT 100TURBUHALER or SYMBICORT 200 TURBUHALER twice daily or 2 inhalations of SYMBICORT FORTE TURBUHALER twice daily.

Do NOT exceed the dose prescribed by your doctor.

SYMBICORT Maintenance and Reliever Therapy (SYMBICORT SMART) for Asthma

You take a regular daily maintenance dose of SYMBICORT TURBUHALER, and also use SYMBICORT TURBUHALER if you need extra doses for relief of asthma symptoms. This means that you use one inhaler (SYMBICORT TURBUHALER) for both daily maintenance and symptom relief.

Adults and adolescents (12 years and older)
  • 1 - 2 inhalations SYMBICORT 100 TURBUHALER twice daily or 2 inhalations once daily. You should take 1 additional inhalation as-needed if you feel symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. The maximum recommended daily dose is 8 inhalations.
    or
  • 1 - 2 inhalations SYMBICORT 200 TURBUHALER twice daily or 2 inhalations once daily. You should take 1 additional inhalation as-needed if you feel symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. The maximum recommended daily dose is 8 inhalations.

Always carry SYMBICORT TURBUHALER with you. You should use extra doses as needed to relieve your asthma symptoms, including periods when your asthma gets worse.

Do not exceed the maximum total number of daily inhalations (8 inhalations/day). If you exceed 8 inhalations/day please seek medical attention.

Patients with COPD

For the maintenance treatment of COPD, your doctor will instruct you to use SYMBICORT TURBUHALER as follows:

Adults (18 years and older)

  • 2 inhalations SYMBICORT 200 TURBUHALER twice daily. The maximum recommended daily dose is 4 inhalations.
    or
  • 1 inhalation SYMBICORT FORTE TURBUHALER twice daily. The maximum recommended daily dose is 2 inhalations.

Treatment with SYMBICORT should not be initiated to treat a COPD attack.

How to prepare a new inhaler for use

Before you start using SYMBICORT TURBUHALER for the first time it is important that you read the instructions below and follow them carefully. TURBUHALER is an inhaler from which very small amounts of powder are administered. When you breathe in through TURBUHALER the powder is delivered to the lungs. It is therefore important that you inhale as deeply and strongly as you can through the mouthpiece.


SYMBICORT TURBUHALER is simple to use.

A. Preparation before first use of a NEW (never been used) inhaler:

Before using your inhaler for the first time you need to prepare the inhaler for use. The preparation does not need to be repeated even if your inhaler is not used regularly.

STEP 1Unscrew and lift off the cover (Figure 1). You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.
STEP 2Holding the inhaler upright, turn the red grip as far as it will go in one direction (clockwise or counterclockwise, it does not matter which way you turn it first); then you must turn it back again as far as it will go in the opposite direction (Figure 2). Do not hold the mouthpiece when turning the grip. The click you hear is part of the loading process. Once you perform this step twice, the inhaler is ready to use.

B. Using the inhaler:

To use your TURBUHALER properly, follow these 4 steps:

STEP 1Unscrew and lift off the cover (Figure 1). You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.
STEP 2Holding the inhaler upright, turn the red grip as far as it will go in one direction (clockwise or counterclockwise, it does not matter which way you turn it first); then you must turn it back again as far as it will go in the opposite direction (Figure 2). Do not hold the mouthpiece when turning the grip. The click you hear is part of the loading process. The inhaler is now ready to use.

If you are not sure you heard the click, and you turn and click the inhaler a second time, you will not end up taking 2 doses by mistake. The TURBUHALER is designed to load only one dose at a time.
STEP 3Breathe out, with your mouth away from the mouthpiece (Figure 3). Then, place the mouthpiece gently between your teeth.
STEP 4Now close your lips over the mouthpiece. Inhale as deeply and strongly as you can (Figure 4). Before you exhale, remember to remove the inhaler from your mouth. Repeat this process from Step 1 if more than one dose has been prescribed. When you have taken the prescribed amount of maintenance doses, rinse your mouth with water, and do not swallow. Once you perform these steps, you have completed using SYMBICORT TURBUHALER.

You may not feel or taste the medication when inhaling. This is common.
Do not bite or chew the mouthpiece.


If you accidentally drop, shake or breathe out into SYMBICORT TURBUHALER after it is loaded, you will lose your dose. If this happens, you should load a new dose and inhale it.

Note: Always replace the cover properly after use. Do not try to remove the mouthpiece or to twist it unnecessarily; it is fixed to the inhaler and must not be taken off.

Stopping SYMBICORT TURBUHALER

Talk to your doctor about how to gradually stop your medication if necessary. It is important that you do not suddenly stop taking SYMBICORT TURBUHALER as it may cause unwanted side effects.

Cleaning: Clean the outside of the mouthpiece once a week with a dry tissue. Never use water or any other fluid when cleaning the mouthpiece. If fluid enters the inhaler it may not work properly.

When to start a new inhaler: SYMBICORT TURBUHALER has a dose indicator. The dose indicator tells you approximately how many doses are left in the inhaler. The dose indicator moves slowly each time you load a dose. Every 20th dose is marked with a number and every 10th dose is marked with a dash (Figure 5). When the "0" on the red background has reached the middle of the window you should discard your inhaler. The sound you hear when you shake the inhaler is produced by a drying agent, not the medication. SYMBICORT TURBUHALER cannot be re-filled with drug and should be discarded.


Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

The most common signs and symptoms that may occur after overdosage are trembling, headache and rapid heartbeat.

Missed dose

If you miss a dose of SYMBICORT TURBUHALER, take it as soon as you remember and then go back to your regular schedule. Never take a double dose of SYMBICORT TURBUHALER to make up for missed doses. If you are still unsure, check with your doctor or pharmacist to see what you should do.

Side effects and what to do about them

Like all medicines, SYMBICORT may cause unwanted reactions, so-called side effects. Most patients do not experience side effects from SYMBICORT.

The most commonly reported side effects of SYMBICORT are: headache, trembling, sensation of heart beat, cough, irritation of mouth and/or throat and hoarseness.

Less commonly reported side effects of SYMBICORT include: nausea, sleep difficulties, agitation, restlessness or nervousness, dizziness and muscle cramps.

If any of these side effects concern you, do not stop treatment, but tell your doctor about them.

Additional side effects including skin rash and bruising, itching, facial swelling, increase in chest tightness, chest pain, depression or behavioural disturbances and high blood sugar levels were also reported rarely.

If you had been taking oral corticosteroids to treat your asthma and you suddenly have a severe asthma attack when starting SYMBICORT TURBUHALER, contact your doctor immediately.

In patients with asthma, you should TELL YOUR DOCTOR if:

  • The relief of your asthma is not as good as usual or does not last as long as usual. A change from “usual” includes more wheezing, coughing, tightness or shortness of breath.
  • You exceed the maximum total number of daily inhalations (8 inhalations/day).
  • There is a persistent increase in your use of fast-acting reliever medication.
  • Your symptoms are waking you up at night.
  • Measurement from your peak flow meter indicates a value between 60% and 80% of predicted or personal best.

These may be signs that your asthma is getting worse. Your doctor may adjust your treatment.

You should TELL YOUR DOCTOR RIGHT AWAY or go to the nearest hospital if you notice the following warning signs:

  • A sudden worsening of your shortness of breath and wheezing shortly after using your fast-acting medication.
  • You do not feel relief from additional doses of your fast-acting reliever medication.
  • Measurement from your peak flow meter indicates a value less than 60 percent of predicted or personal best.
  • You are breathless at rest.
  • Your pulse is more than 120 beats per minute.

In patients with COPD, you should TELL YOUR DOCTOR RIGHT AWAY if you notice the following warning signs, which indicate your condition is worsening:

  • Unusual increase in the severity of the breathlessness, cough, tiredness or wheeze.
  • Unusual colour, level, consistency or stickiness of phlegm.
  • Symptoms of a chest cold and/or chest tightness (e.g. indicating a chest infection).
  • Unexplained swelling.
  • Unexplained fever.

Serious side effects, how often they happen and what to do about them

Symptom / effectTalk with you doctor or pharmacistStop taking drug and seek emergency medical attention
Only if severeIn all cases
RareBronchospasm: Increased wheezing or tightness in the chest or difficulty in breathing immediately after inhalation of SYMBICORT  
Hypersensitivity reactions: Skin rash, skin eruption or other effect on the skin or eyes, itching or fever  
Allergic reactions Swelling of the lips, face or neck, accompanied by difficulty in breathing, speaking or swallowing (angioedema) and anaphylactic reaction.  
Fast or irregular heart beat  
Very RareCushing's Syndrome: (hypercorticism) rapid weight gain especially around the body and face; round "moon" face, excess sweating; thinning of the skin with easy bruising and dryness; muscle and bone weakness  
Increased blood sugar: frequent urination, thirst and hunger  
UnknownChurg-Strauss syndrome: A flu-like illness, rash, pins and needles or numbness of arms or legs, severe sinusitis and worsening lung or breathing problems  
Glaucoma: Increased pressure in your eyes, and/or eye pain.  
Cataract: Clouding of the lens in the eye, blurry vision, and/or eye pain.  
Bone Fractures or Osteoporosis: In situations where healthy people would not normally break a bone you may have sudden pain in any location and especially in the wrist, spine or hip. This may be a fracture.  
Pneumonia (an infection of the lungs): Fever, chills, increase in sputum production, change in sputum colour, increased cough or an increase in breathing difficulties.  

This is not a complete list of side effects. For any unexpected effects while taking SYMBICORT TURBUHALER, contact your doctor or pharmacist.

How to store it

Remember to keep SYMBICORT TURBUHALER out of the reach of children.

Always replace the cover after using SYMBICORT TURBUHALER. Store the inhaler at room temperature (15-30°C).

Reporting suspected side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701E
                     Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.

The Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at:

www.astrazeneca.ca

or by contacting the sponsor, AstraZeneca Canada Inc. at:

Customer Inquiries – 1 (800) 668-6000
Renseignements – 1 (800) 461-3787.