Rhinocort Turbuhaler - Consumer Medicine Information
|Condition:||Allergic Rhinitis, Crohn's Disease, Polyps, Nasal (Nasal Polyps), Rhinitis|
budesonide (powder for nasal inhalation)
About this medication
What the medication is used for:
RHINOCORT TURBUHALER is used to treat:
- seasonal allergic rhinitis (hay fever)
- perennial (year-round) rhinitis
- nasal polyps and/or prevent new nasal polyps from appearing after surgery (polypectomy).
What it does:
RHINOCORT TURBUHALER reduces and prevents inflammation in the lining of the nose (rhinitis).
When it should not be used:
Do not use RHINOCORT TURBUHALER if you:
- are allergic to budesonide;
- have an untreated infection:
- fungal (yeast)
- have tuberculosis in your respiratory tract;
- are younger than 6 years old.
What the medicinal ingredient is:
What the nonmedicinal ingredients are:
RHINOCORT TURBUHALER contains no other ingredients.
What dosage form it comes in:
Powder for nasal inhalation: 100 mcg per inhalation (200 metered doses per TURBUHALER).
Warnings and precautions
BEFORE you use RHINOCORT TURBUHALER talk to your doctor or pharmacist if you:
- are allergic to budesonide;
- have had lung tuberculosis or any other recent infection;
- have asthma;
- have thyroid problems;
- have or had liver problems;
- are taking, or have previously taken steroids either as an injection or by mouth within the past several months;
- are pregnant or planning to become pregnant;
- are breastfeeding;
- about all health problems you have now or have had in the past.
You should avoid coming into contact with people who have measles or chicken pox while taking RHINOCORT TURBUHALER. If you are exposed, tell your doctor right away.
It is not recommended to use RHINOCORT TURBUHALER for continuous, long-term treatment in children.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Drugs that may interact with RHINOCORT TURBUHALER include:
- ritonavir used to treat HIV or AIDS;
- ketoconazole/ itraconazole used to treat fungal infections.
Proper use of this medication
This medicine is prescribed for you by your doctor. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
- Is for use in the nose only. Do not use it in your eyes or mouth.
- May take 2-3 days (and up to 2 weeks) to work. Take it each day without missing a dose to get the best results.
Take RHINOCORT TURBUHALER exactly as recommended by your doctor.Follow your doctor’s directions carefully. They may differ from the information in this leaflet.
Do not take more of your medicine or take it more often than your doctor tells you. Do not stop taking RHINOCORT TURBUHALER even if you feel better unless told to do so by your doctor.
For seasonal allergic rhinitis, RHINOCORT TURBUHALER works best if it is started before allergy season begins.
If your nose is blocked, decongestant nose drops may be used during the first 2-3 days of the treatment.
This drug does not relieve allergy symptoms in the eyes. If your eyes bother you, your doctor may be able to give you some additional medicine to relieve these symptoms.
Tell your doctor if:
- your symptoms have not improved after 3 weeks of taking RHINOCORT TURBUHALER
- you nose becomes irritated
- you have a yellow or green discharge from your nose
- you have repeated nose bleeds
Adults and Children (6 years and older)
Usual starting dose: 2 applications (200 mcg) into each nostril in the morning (total daily dose: 400 mcg).
Maintenance Dose: Use the lowest effective dose necessary to control symptoms.
Depending on how RHINOCORT TURBUHALER works for you, your doctor may change your dose.
Usual dose: 1 application (100 mcg) into each nostril, morning and evening (total daily dose: 400 mcg).
If you have been prescribed RHINOCORT TURBUHALER and are taking oral steroid medication, your doctor may gradually (over a period of weeks or months) reduce the dose of your tablets. If your medication is changed, you may experience the same symptoms you had earlier such as:
- Runny nose
- Muscle and joint pain
You should contact your doctor if you get symptoms such as:
- Nausea or vomiting
|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.|
If you miss a dose and remember within 12 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. If it is more than 12 hours when you remember, do not take the missed dose. Take the next dose at the usual time.
If you miss a dose 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. Take the next dose at the usual time.
Do NOT double the dose of RHINOCORT TURBUHALER to make up for a missed dose. If you are still unsure, check with your doctor or pharmacist to see what you should do.
How to use your RHINOCORT TURBUHALER:
Before you start using RHINOCORT TURBUHALER for the first time, it is important that you read the instructions below and follow them carefully.
Parts of the TURBUHALER:
A. How to prepare a new TURBUHALER for use:
Before using your inhaler for the first time you need to prepare the TURBUHALER for use.
You may hear a rattling sound. This is normal. This is the sound of the drying agent, not the medication.
|STEP 1||Unscrew and lift off the cover.|
|STEP 2||Holding the inhaler upright, turn the grey grip as far as it will go in one direction. Then turn it as far as it will go in the other direction. It does not matter which way you turn it first. You should hear a “click” sound (Figure 1). Do not hold the nasal adapter when turning the grip. Perform STEP 2 twice.
The TURBUHALER is now ready to use.
B. To take a dose:
|STEP 1||Blow your nose.|
|STEP 2||Unscrew and lift off the cover.|
|STEP 3||Hold the inhaler upright.|
|STEP 4||Do not hold the nasal adaptor when you load the TURBUHALER. To load your TURBUHALER with a dose, turn the grey grip as far as it will go in one direction. Then turn it as far as it will go in the other direction. It does not matter which way you turn it first. You should hear a “click” sound. (Figure 1)
|STEP 5||Breathe out, with your nose away from the nasal adapter. Then, place the nasal adapter so that your nostril fits tightly around the adapter. Block the opposite nostril with your finger.|
|STEP 6||Breathe in (sniff) quickly and hard through your nose. (Figure 2) When you breathe in, your indrawn breath provides the force needed to bring the drug to your nasal passages. When you breathe out, do not breathe into your TURBUHALER.
|STEP 7||Replace the cover by screwing it back on tightly after use.|
If you accidentally drop, shake or breathe out into RHINOCORT TURBUHALER after it is loaded, you will lose your dose. If this happens, you should load a new dose and inhale it.
Cleaning your TURBUHALER: Wipe the outside of the nasal adapter once a week with a dry tissue. Do not use water or liquids.
When to start a new TURBUHALER:
- The TURBUHALER contains 200 doses when full.
- There is a small window underneath the nasal adaptor. When you see a red mark at the top of the window, there are about 20 doses left.
- When the red mark reaches the bottom of the window, you should start using a new TURBUHALER and throw out the old one.
Note: The grip will still twist and “click” even when your TURBUHALER is empty.
Side effects and what to do about them
Side effects may include:
- nose and throat irritation
- nosebleeds and crusting
- itchy and sore throat
- skin rash
Side effects that may occur with the use of local corticosteroids are:
- itching and swelling in the face
- slower healing of wounds. Do not use RHINOCORT TURBUHALER until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
- slower growth in children. Your physician should monitor growth regularly for children.
- worsening of the symptoms of infections such as existing tuberculosis, fungal, bacterial or viral infections.
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and immediately seek emergency medical attention|
|Only if severe||In all cases|
|Very rare||small holes or ulcers in the skin inside the nose||√|
such as swelling of the face, lips, tongue, and/or throat (which may cause difficulty in breathing or swallowing), hives, rash and itching
(hypercorticism) Rapid weight gain especially around the body and face; round "moon" face, excess sweating;thinning of the skin with easy bruising and dryness; muscleand bone weakness.
This is not a complete list of side effects. For any unexpected effects while taking RHINOCORT TURBUHALER, contact your doctor or pharmacist.
How to store it
Keep RHINOCORT TURBUHALER out of the reach and sight of children.
Store the inhaler at room temperature (15-30°C) in a dry place, away from moisture.
Always replace the cover after using RHINOCORT TURBUHALER.
Do not keep or use RHINOCORT TURBUHALER after the expiry date indicated on the label.
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
Postal Locator 0701E
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.
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:
- by contacting the sponsor, AstraZeneca Canada Inc. at:
Customer inquiries – 1 (800) 668-6000,
Renseignements – 1 (800) 461-3787.