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

Manufacture: AstraZeneca
Country: Canada
Condition: Asthma, Maintenance
Class: Inhaled corticosteroids
Form: Inhaler, Powder
Ingredients: budesonide

PULMICORT

TURBUHALER

budesonide (powder for oral inhalation)

About this Medication

What the medication is used for

PULMICORT is a brand name for a drug called budesonide, which belongs to a group of medicines called glucocorticosteroids. PULMICORT is an inhaled form of the drug budesonide. It is used to treat asthma, which is caused by inflammation in the airways.

TURBUHALER is the brand name for a multiple-dose, drypowder inhaler. When you breathe in through the inhaler, your indrawn breath provides the necessary force to deliver the drugs to your lungs.

PULMICORT TURBUHALER is not meant to relieve an asthma attack that has already started. Other inhalers containing fast-acting bronchodilators provide rapid relief. If your doctor prescribed one of these, you should follow his or her directions when you have an acute attack of asthma.

What it does

Asthma is caused by inflammation in the airways. PULMICORT TURBUHALER reduces and prevents this inflammation. In some cases, 1-2 weeks of regular use may be needed before the full effect is seen.

When it should not be used

You should not use PULMICORT TURBUHALER:

  • if you are allergic to budesonide.
  • to treat a sudden attack of breathlessness. You will probably need a different kind of medicine (ie. a fast acting relief medication) in a different colour puffer than may already have been given to you. If you have more than one medicine, be careful not to confuse them.
  • if you have an untreated infection (fungal, bacterial, or viral) or tuberculosis in the respiratory tract.

What the medicinal ingredient is

budesonide

What are the nonmedicinal ingredients

PULMICORT TURBUHALER contains no other ingredients.

If you happen to shake the inhaler, the sound you hear is the drying agent built into the brown turning grip. This is not the medication and cannot be inhaled.

What dosage forms it comes in

Powder for oral inhalation, containing 100 µg, 200 µg, or 400 µg per inhalation (200 doses/Turbuhaler).

Warnings and Precautions

BEFORE you use PULMICORT TURBUHALER talk to yourdoctor or pharmacist:

  • about all health problems you have now or have had in the past, especially if you have had lung tuberculosis or any other recent infection or liver problems;
  • about other medicines you take, including ones you can buy without a prescription;
  • if you take, or have taken steroid medicines within the past several months;
  • if you have ever had a bad, unusual or allergic reaction to budesonide;
  • if you are pregnant, plan to become pregnant or are breast feeding;
  • if you are pregnant, plan to become pregnant or are breast feeding;

All cortisone-type medicines, especially when used for a long time, may possibly interfere with the usual growth pattern in growing adolescents. You may want to discuss this with your doctor.

If you develop an infection or a respiratory infection, contact your doctor to see if you can continue taking PULMICORT TURBUHALER.

Interactions with this Medication

Drugs that may interact with budesonide include:

  • ritonavir or some antifungals (such as ketoconazole and itratonazole.

Proper use of this Medication

The dosage of PULMICORT TURBUHALER is individual.

Follow your doctor's instructions carefully. They may differ from the information in this leaflet.

IMPORTANT: DO NOT EXCEED THE DOSE PRESCRIBED BY YOUR DOCTOR. IF DIFFICULTY IN BREATHING PERSISTS, CONTACT YOUR DOCTOR OR PHARMACIST. DO NOT STOP TAKING PULMICORT TURBUHALER ON YOUR OWN. Your doctor may want to slowly reduce your dose, especially if you have been using PULMICORT TURBUHALER for a long time.

Suggested starting doses are

Adults and children 12 years of age and older

400-2400 µg daily, divided into 2-4 administrations.

Children 6 to 12 years old

200-400 µg daily, divided into 2 administrations.

Maintenance dose

Use the lowest dose necessary to control symptoms.

Adults and Children 12 Years of Age and Older

200-400 µg daily, divided into 2 administrations.

Children 6 to 12 Years Old

Use the lowest dose necessary to control symptoms.

In adults who require 400 µg daily, PULMICORT TURBUHALER may be taken once daily, either in the morning or evening.

It is important that you use PULMICORT TURBUHALER daily at the intervals recommended by your doctor. Do not stop or change dosage without asking your doctor.

Before you start using PULMICORT 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 PULMICORT 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.



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 1 Unscrew and lift off the cover. You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.
STEP 2 Holding the inhaler upright, turn the brown grip as far as it will go in one direction (clockwise or counter-clockwise, 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 1). 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.

Using the inhaler

To use your TURBUHALER properly, follow these 4 steps:

STEP 1 Unscrew and lift off the cover. You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.
STEP 2 Holding the inhaler upright, turn the brown grip as far as it will go in one direction (clockwise or counter-clockwise, 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 1). 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 do not hear the "click" sound when the turning grip is rotated, you will not receive any medication. If this problem persists, you need to replace PULMICORT TURBUHALER.
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 design of the PULMICORT TURBUHALER makes it impossible to load more than one dose at a time, even if the inhaler is clicked several times.
STEP 3 Breathe out, with your mouth away from the mouthpiece. Then, place the mouthpiece gently between your teeth.
STEP 4 Now close your lips over the mouthpiece. Inhale as deeply and strongly as you can ( figure 2). Before you exhale, remember to remove the inhaler from your outh. Repeat this process from Step 1 if more than one dose has been prescribed. Once you perform these steps, you have completed using PULMICORT TURBUHALER. Replace the cover and screw it shut.

You may not feel or taste the medication when inhaling. This is common.
Do not bite or chew the mouthpiece.
Do not use PULMICORT TURBUHALER if it has been damaged or if the mouthpiece has become detached.



With each inhalation some medication may stick to the inside of your mouth and throat. To reduce the risk of side effects it is advised that you, when possible, rinse your mouth with water after using PULMICORT TURBUHALER.

If you accidentally drop, shake or breathe out into PULMICORT 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.

Cleaning

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

When to start a new inhaler

PULMICORT TURBUHALER has a dose indicator. When a red mark first appears in the little window underneath the mouthpiece, there are approximately 20 doses left. Now is the time to obtain your next inhaler.

When the red mark reaches the bottom of the window, you should discard your inhaler. The sound you hear when you shake the inhaler is produced by a drying agent, not medication. PULMICORT TURBUHALER cannot be refilled 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.

Missed dose

If you miss a dose of PULMICORT TURBUHALER and remember within 6 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. If it is more than 6 hours when you remember, do not take the missed dose. Just take the next dose on time.

Never take a double dose of PULMICORT TURBUHALER to make up for missed doses. If you are still unsure, check with your doctor or pharmacist to see what you should do.

You may notice that your symptoms improve after the first dose of PULMICORT TURBUHALER. However, 1 - 2 weeks may pass before the full effect is achieved. Don't forget to take it even when you feel well.

Treatment with PULMICORT TURBUHALER should not be stopped abruptly, but tapered off gradually. Follow your doctor's directions.

If you have been prescribed PULMICORT TURBUHALER and are still using "cortisone" tablets, your doctor may gradually (over a period of weeks or months) reduce your dose of tablets. You may even be able to eventually stop using the tablets.

NOTE: If your medication is changed from "cortisone" tablets to PULMICORT TURBUHALER, you may temporarily regain symptoms which may have bothered you earlier, e.g. runny nose, rash, pain in muscle and joints. If any of these symptoms bothers you, or if you get symptoms such as headache, tiredness, nausea or vomiting, please contact your doctor.

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

Like any medication, PULMICORT TURBUHALER may cause side effects in some people.

The most common side effects are cough, throat irritation, thrush (fungal infection) in the mouth and hoarseness.

Other side effects include bad taste, headache, nausea, and dryness of the throat. There have been occasional reports of tiredness, thirst, and diarrhea.

Occasionally, throat or mouth infections may occur. Rare side effects include skin reactions like rash, skin bruising, and increase in chest tightness, nervousness, restlessness, depression, and behavioural disturbances in children. These may not be caused by PULMICORT TURBUHALER in your case, but only a doctor can tell this. In rare cases, severe allergic reactions may occur following the use of PULMICORT TURBUHALER.

If you take PULMICORT for a long period and at higher doses you may develop symptoms of adrenal insufficiency. If you develop symptoms such as tiredness, headache, nausea, vomiting, pain in muscles and joints, please contact your doctor.

Slowed growth in children and adolescents may occur. It is recommended that children being treated with steroids, including PULMICORT TURBUHALER have their height checked regularly by their doctor.

Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. If any side effects bother you, please contact your doctor.

If you have to go into the hospital for an operation, take your PULMICORT TURBUHALER with you and tell your doctor what medicines(s) you are taking.

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
immediately
seek
emergency
medical
attention
Only
if
severe
In all
cases
Rarebronchospasm
(shortness of
breath, chest
tightness
which causes
wheezing)
X
severe allergic
reactions such
as swelling of
the face, lips,
tongue, and/or
throat (which
may cause
difficulty in
breathing or
swallowing),
hives, rash and
itching
X

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

How to Store it

Keep PULMICORT TURBUHALER out of the reach and sight of children.

Always replace the cover after using PULMICORT TURBUHALER. Store the inhaler at room temperature (15-30°C) in a dry place, away from moisture.

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, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form 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