BUDESONIDE AQUEOUS NASAL SPRAY 100MCG
PACKAGE LEAFLET: INFORMATION FOR THE USER
Budesonide aqueous nasal spray 100 micrograms
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
What Budesonide is and what it is used for
What you need to know before you use Budesonide
How to use Budesonide
Possible side effects
How to store Budesonide
Contents of the pack and other information
WHAT BUDESONIDE IS AND WHAT IT IS USED FOR
Budesonide belongs to a group of medicines called corticosteroids (commonly called steroids).
Corticosteroids help to prevent inflammation.
Budesonide is used to treat and prevent the effects of allergies (such as hayfever) which can cause
inflammation inside the nose (rhinitis).
Budesonide should not be confused with anabolic steroid tablets or injections, which may be misused by
WHAT YOU NEED TO KNOW BEFORE YOU USE BUDESONIDE
Do not use Budesonide if:
you are allergic (hypersensitive) to budesonide or another steroid or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before using Budesonide. You should tell your doctor before taking this
if you have been diagnosed as having a fungal or viral infection in your chest or throat
if you have tuberculosis (TB) infection in your lungs
if you have pituitary (pea shaped structure in brain) and adrenal (glands in the kidneys) dysfunction
and were receiving steroids previously, your doctor might conduct some relevant tests
if you have liver problems as this may increase the availability of Budesonide
if you are a child under 18 years of age and have received the medicine for a long time, as your
doctor might monitor your growth and reduce the dose if required.
as many undesirable effects can occur with its long term treatment with high doses like growth
retardation, kidney glands (adrenal) suppression, eye problems, and psychological problems like
anxiety, depression, aggression or sleep disorders and a disorder causing weight gain, moon face,
obesity of face and trunk and other symptoms (Cushingoid syndrome).
It may take a few days before you notice an improvement in your symptoms. It is therefore important to use
your nasal spray regularly as instructed by your doctor.
It may be necessary to take additional medicines to treat eye symptoms. Your doctor will discuss this with
you if it is necessary.
If you use Budesonide long-term your doctor will check the lining of your nose every 6 months to check that
it is in good condition.
Other medicines and Budesonide
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines,
including the following:
medicine to treat a fungal infection (e.g. ketoconazole, itraconazole) as they can increase the
concentration of budesonide and therefore this combination should be avoided. If not possible, then
the period between the intake of the two drugs should be as long as possible.
oestrogens and contraceptive steroids, because they can increase the budesonide effects
Budesonide may also have a possible effect on test for diagnosing pituitary insufficiency.
Pregnancy,breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnancy or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine. Budesonide should only be used in pregnancy if
your doctor feels the benefit of using the spray outweighs any risks.
Budesonide has been shown to pass in to breast milk, however, when used at the recommended dose it is not
expected that Budesonide will have any effect of your baby.
Driving and using machines
Budesonide will not affect your ability to drive and use machines.
HOW TO USE BUDESONIDE
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
If you are using Budesonide for hayfever you should if possible, start treatment before you are exposed to
Follow the instructions given below. Do not use your spray more often than your doctor advised. If you have
any problems tell your doctor or pharmacist. Before you use the nasal spray for the first time:
shake the bottle gently
remove the plastic cover
spray a few times in the air until a fine, even mist comes out of the nozzle.
You should also do this if you have not used the spray for a few days.
Blow your nose gently. Shake the bottle. Remove the plastic cover.
Hold the spray bottle so that you can press down the plastic applicator.
Place the applicator into one of your nostrils.
Keeping your head tilted slightly forward, spray in the recommended number of sprays. Repeat for
the other nostril. NOTE: it is not necessary to inhale at the same time as spraying.
Replace the plastic cover.
It is helpful to clean the upper plastic parts occasionally. To do this, remove the plastic cover. Pull off the
nasal applicator. Rinse the plastic cover and the applicator under lukewarm water. Let the parts dry in the air
and then put them back in place. The spray unit should be cleaned if at any time the spray of medicine is not
coming out as it should i.e. as a fine, even mist. Any blockage should be removed by washing and not with a
pin or any other sharp object.
The recommended dose is:
Adults (including the elderly)
Two sprays into each nostril every morning. In some cases, your doctor may advise one spray into
each nostril every morning and evening.
Your doctor may reduce this dose once your symptoms improve.
You will need to use the Budesonide spray regularly.
Children should not use Budesonide.
If you use more Budesonide than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You
should use only as much as your doctor recommends; using more or less may make your symptoms worse. If
you accidentally take too much of your medicine tell your doctor.
If you forget to use Budesonide
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double
dose to make up for a forgotten dose.
If you stop using Budesonide
Speak to your doctor first before stopping this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Budesonide and tell your doctor immediately:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or
other body parts, shortness of breath, wheezing or trouble breathing (anaphylaxis)
Common side effects (seen in more in 100 patients but less than 1 in 10 patients):
Uncommon side effects (seen in more than 1 in 100 patients but less than 1 in 1,000):
skin rash, hives, itching, blistering of the skin
Rare side effects (seen in more than 1 in 10,000 patients but less than 1 in 1,000 patients):
slowing of the rate of growth in children and adolescents
This medicine can affect the normal production of steroid hormones in your body, particularly if you use
high doses for a long time.
Very rare side effects (seen in less than 1 in 10,000 patients):
perforation of the membrane separating the nostrils (the nasal septum)
sores on the lining of the nose
Not known side effects (cannot be estimated from the available data)
cataract (clouding of the lens in the eye)
glaucoma (increased eye pressure)
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
HOW TO STORE BUDESONIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers
to the last day of that month.
Do not store above 25°C.
Once opened, you should not keep your medicine for longer than 2 months. After two months you should
replace it even if it has not all been used up.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Budesonide contains
The active substance is budesonide. Each individual spray will contain 100 micrograms of budesonide.
The other ingredients (excipients) are disodium edetate, anhydrous dextrose, microcrystalline cellulose,
sodium carboxymethycellulose, polysorbate 80, potassium sorbate, hydrochloric acid and purified water.
What Budesonide looks like and contents of the pack
Each nasal spray consists of a small brown glass bottle with a plastic nasal applicator. It contains enough
Budesonide for 200 sprays.
Marketing Authorisation Holder
Generics [UK] Ltd
This leaflet was last revised in: March 2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.