Consumer Medicine Information
BUTACORT
50 micrograms (µg) per spray
Budesonide Nasal Spray
What is in this leaflet
Please read this leaflet carefully before using butacort 50 Nasal Spray. It
answers some common questions about butacort 50. It does not contain all the
information available on this medicine. It does not take the place of talking
to your doctor or pharmacist. All medicines have risks and benefits. If you
have concerns about using this medicine ask your doctor or pharmacist.
Keep this leaflet, you may need to read it again.
What BUTACORT 50 is used for and how it works
Your butacort 50 nasal spray contains budesonide. It belongs to a group of medicines known as corticosteroids, frequently referred to as 'steroids'. They are not anabolic steroids that are sometimes misused by athletes.
Butacort 50 is normally used to prevent and treat allergic rhinitis (including hayfever), which is an inflammation or swelling of the nose lining. This is often, but not always, due to an allergy to something in the air. It works by reducing the swelling and irritation in the lining of the nose. It relieves the symptoms of blocked nose, runny nose, itchy nose and sneezing.
Your doctor or pharmacist, however, may recommend butacort 50 for another purpose.
Butacort 50 is only available at a pharmacy.
There is no evidence that butacort 50 is addictive.
Before you use BUTACORT 50
When you must not use it
Do not use butacort 50 if:
- You are allergic to budesonide or any other ingredients listed at the end of this leaflet.
- You bleed easily or have recurring nose bleeds.
- You have a severe infection, especially thrush, in your nose.
Before you start to use it
Tell your doctor or pharmacist if:
- You are allergic to other corticosteroid medicines or any other substances.
- You are taking other corticosteroids by mouth or inhalation (including some asthma prevention inhalers).
- You have tuberculosis.
- You have recently had an injury or surgery to your nose.
- You have ulceration in your nose.
- You are pregnant, might become pregnant or are breast feeding.
How to use BUTACORT 50 properly
Instructions for use
- Shake the bottle well before use. Remove the dust cap from the nasal
applicator.
- Hold the nasal spray as shown. Prime the pump by firmly pressing
downwards on the white collar. Repeat until a fine spray is produced. The
nasal spray is now ready for use. It will not require repriming unless
infrequently used or disassembled.
- Gently blow your nose to clear the nostrils. Tilt your head forward
slightly, close one nostril and carefully insert the nasal applicator into
the other nostril.
- Holding the bottle upright, press firmly downwards once or twice on the
white collar to deliver the number of sprays required. Breathe gently
inwards through the nostril.
- Then breathe out through your mouth.
- Repeat the procedure in the other nostril.
- Replace the dust cap.
Cleaning your applicator
Remove the dust cap, press gently upwards on the white collar and the nasal applicator will come free. Wash the applicator and dust cap under luke warm water. Dry and replace.
If the nasal applicator becomes blocked, remove the dust cap, unscrew the pump mechanism from the bottle and soak it in warm water for a few minutes. Rinse under luke warm water, dry and reassemble on the bottle. Do not attempt to unblock the applicator with a pin or other sharp object.
How much to use
The usual dosage for adults and children over 12 years is initially one or two sprays into each nostril twice a day (morning and night), then after 2 to 3 days, one spray into each nostril twice a day. Do not use butacort 50 for children under 12 years of age without first consulting with a doctor.
Your doctor may tell you to use different doses to these. If so, follow their instructions.
Use butacort 50 as directed. Do not use more sprays or spray more often than recommended.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
How long to use it
It usually takes 2 to 3 days before you notice any improvement in your
symptoms.
If you suffer from hayfever, you should start your treatment just before the
hayfever season to prevent symptoms from starting.
If hayfever symptoms do not improve within 7 days of treatment, see your doctor.
Do not use for more than 6 months unless instructed by your doctor or pharmacist.
If you forget a dose
If you forget a dose, just take it as soon as you remember. Do not use a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using butacort 50. Butacort 50 helps most people with rhinitis, but it may have unwanted side effects in a few people. These effects are usually mild and last only for a short time.
All medicines can have some unwanted effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Tell your doctor if you notice any of the following and they worry you:
- Nose irritation.
- Itching or sore throat.
- Dry nose or mouth.
- Sneezing after spraying.
- Increased amount of sputum.
- Cough.
- Headache.
- Dizziness.
- Tiredness.
These are all mild side effects of butacort 50.
Tell your doctor immediately if you think you have developed:
- An ulcer (open wound) in your nose
- Swelling of the face, tongue or back of the throat.
- Signs and symptoms of infection such as:
- Fever, nasal or facial pain or swelling.
- Purulent (i.e. pus-containing or discoloured nasal discharge.
- Bleeding from the nose.
- Acute eye pain or visual disturbance.
These may be rare but serious side effects. You may need urgent medical attention.
Studies have shown that budesonide may cause growth reduction in children.
The list of side effects mentioned above is not complete. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.
In case of overdose
If you accidentally use a little more butacort 50 on one occasion, it is unlikely to cause a problem.
Immediately contact your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) or go to the Emergency department at your nearest hospital, if you think that you may have used too much, or if anyone else has used any butacort 50 by mistake. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
Storage conditions
Do not use this medicine after the expiry date shown on the label or if the packaging shows signs of tampering.
Store below 25°C but do not refrigerate. Protect from light. Avoid exposure to heat and moisture.
Keep the bottle in an upright position and out of reach of children.
Once you have opened your spray, you should not use this particular bottle for more than three months. Write down the date that you opened the bottle on the label or the box.
Disposal
When you stop using butacort 50 or it is past the expiry date, ask your pharmacist what to do with any that is left over.
List of ingredients
Your medicine is in the form of a liquid nasal spray in a glass bottle, which delivers an accurate measured spray. Each spray contains 50 micrograms (µg) of the active ingredient budesonide.
The liquid also contains disodium edetate, dispersible cellulose, glucose (anhydrous), hydrochloric acid, polysorbate, purified water and the preservative potassium sorbate.
If you want to know more
Should you have any questions regarding this product, please contact your doctor or pharmacist.
Who supplies this medicine
Distributed in New Zealand by:
Mylan New Zealand Ltd,
P O Box 11183,
Ellerslie,
Auckland.
Freephone: 0800 168 169
Date of information
2 February 2009