Rhinocort Aqueous
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
RHINOCORT®
Budesonide
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Rhinocort.
It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.Your doctor has weighed the risks of you using Rhinocort against the benefits they expect it will have for you.
If you have any concerns about using Rhinocort, ask your doctor or pharmacist.
Keep this leaflet with your Rhinocort.
You may need to read it again.
What RHINOCORT is used for
Allergic rhinitis
Rhinocort is sprayed into the nose to help prevent and treat allergic rhinitis).Allergic rhinitis is an inflammation or swelling of the nose lining (which may cause blockage, runny nose, itching and/or sneezing).This is often, but not always, due to an allergy to something in the air (eg pollen, dust mites).
You may have symptoms only during spring or summer.This type of allergy is generally due to various pollens and is commonly referred to as hayfever.Some people may experience symptoms all year round.This is usually caused by house dust mites, pets or moulds and is commonly referred to as perennial allergic rhinitis
Nasal Polyps
Rhinocort is also used to treat nasal polyps, which are small masses of tissue that grow from the nose lining.
Rhinocort contains budesonide.
This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation.
Ask your doctor if you have any questions about why Rhinocort has been prescribed for you.
Your doctor may have prescribed it for another reason.
Rhinocort is not addictive.
Rhinocort is available only with a doctor’s prescription.
Before you use RHINOCORT
When you must not use it
Do not use Rhinocort if:
1.you have an allergy to:
any medicines containing budesonide
any of the ingredients listed at the end of this leaflet.
Other corticosteroid medicines
Some of the symptoms of an allergic reaction may include:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body.
2.You have frequent nose bleeds.
Your condition may cause nose bleeds and still require treatment.Discuss with your doctor if you have any concerns.
3.You have severe nasal infections especially candidiasis (thrush).
Do not give Rhinocort to a child under the age of 6 years.
Rhinocort is not recommended for use in children under 6 years of age.
Do not use Rhinocort after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using Rhinocort, talk to your pharmacist or doctor.
Before you start to use it
Tell your doctor, if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
nasal, sinus or chest infection
recent injury that has not healed or surgery to your nose
open sores in your nose
severe nasal congestion or obstruction
tuberculosis (TB) or have been exposed to someone who has tuberculosis, chicken pox or measles
glaucoma
cataracts or have an eye infection
diabetes
It may not be safe for you to use Rhinocort if you have any of these conditions.
Tell your doctor if you are pregnant or plan to become pregnant, or breast-feeding.
Your doctor will discuss the possible risks and benefits of using Rhinocort during pregnancy and while breastfeeding.
If you have not told your doctor about any of the above, tell them before you start using Rhinocort.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Rhinocort may interfere with each other.These include:
other corticosteroid medicines for conditions such as asthma, allergies or skin rash. These may include tablets, asthma inhalers, nasal sprays, or eye/nose drops.
medicines used to treat fungal infections (eg ketoconazole, itraconazole)
cimetidine, a medicine used to treat reflux and stomach ulcers
some antibiotic medicines (including erythromycin, clarithromycin).
These medicines may be affected by Rhinocort, or may affect how well it works.You may need different amounts of Rhinocort, or you may need to use a different medicine. Your doctor or pharmacist will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Rhinocort.
How to use RHINOCORT
To prevent symptoms, start using Rhinocort:
before the hayfever season; or
before coming into contact with something you know will cause your allergic rhinitis.
If you start using Rhinocort early, it will help reduce the severity of your symptoms.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How to use it
Each pack of Rhinocort contains an instruction leaflet that tells you the correct way to use it.Please read the leaflet carefully.
If you do not understand the instruction leaflet, ask your doctor or pharmacist for help.
Gently blow your nose before using Rhinocort.
Use only in your nose.
How much to use
Your doctor may tell you to use doses that are different to those outlined below. If so, follow your doctor’s instructions.
ALLERGIC RHINITIS/HAYFEVER:
When you first start using Rhinocort:
The usual starting dose is:
TWO sprays into EACH nostril in the morning; or
ONE spray into EACH nostril twice a day (in the morning and evening).
Do not exceed the recommended dose.
It may take a few days (in rare cases after 2 weeks) of using Rhinocort before you notice any improvement in your symptoms.
Once your symptoms improve:
After your allergies have improved, your doctor may tell you to reduce the dose of Rhinocort.This may be ONE spray into EACH nostril in the morning.
NASAL POLYPS
(Adults 18 years and older):
The usual dose is:
ONE spray into EACH nostril twice a day (in the morning and evening).
How long to use it
Adults and children 12 years and older
Continue using your Rhinocort for as long as your doctor tells you to.
Children 6-12 years of age
Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.
If you forget to use it
If you miss a dose of Rhinocort, use it as soon as you remember.
Do not use a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some hints.
If you use too much (overdose)
Immediately telephone your doctor, pharmacist or the Poisons Information Centre (telephone 131 126) if you think you or anyone else may have used too much Rhinocort.
Do this even if there are no signs of discomfort or poisoning.
While you are using RHINOCORT
Things you must do
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Keep all of your doctor’s appointments so that your progress can be checked.
If symptoms persist or worsen, or if new symptoms occur, stop use and see your doctor
Ask your doctor to examine your nose from time to time to make sure the medicine is working and to prevent unwanted side effects.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Rhinocort.
Tell any other doctors, dentists, and pharmacists who treat you that you are using Rhinocort.
If you become pregnant while using Rhinocort, tell your doctor.
Things you must not do
Do not use Rhinocort to treat any other complaints unless your doctor tells you to.
Do not give Rhinocort to anyone else, even if they have the same condition as you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Rhinocort.
All medicines can have side effects.Sometimes they are serious, most of the time they are not.You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
headache
dizziness
tiredness
sneezing after spraying or irritated nose
nose bleeds
nasal crust
dry nose or mouth
itching or sore throat
cough
increased amount of sputum
The above list includes the more common side effects of your medicine. They are usually mild and only last for a short time.
Tell your doctor or pharmacist immediately if you notice any of the following:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
severe rash
an ulcer (open wound) in your nose
sign or symptoms of a nasal or sinus infection such as a persistent fever, pain or swelling, or discoloured nasal discharges.
If you have any change in vision or have blurred vision.
These may be serious side effects.You may need urgent medical attention.Serious side effects are rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Corticosteroids taken through the nose for long periods may affect how children grow. In rare cases, some children may be sensitive to the growth effects of corticosteroids, so the doctor may monitor a child’s height.
Ask your doctor to answer any questions you may have.
After using RHINOCORT
Storage
Keep your Rhinocort in a cool dry place where the temperature stays below 30 C.Do not freeze.
Do not store Rhinocort or any other medicine in the bathroom or near a sink.Do not leave it on window sills or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop using Rhinocort or it has passed its expiry date, ask your pharmacist what to do with any you have left.
Product description
Rhinocort comes in a brown glass bottle containing approximately 50 (sample pack) or 120 doses, with metered pump spray equipment and nasal adaptor.The 120 dose bottle is available as a 1 (120 doses) or 2 bottle (240 dose) pack (2 bottles).
Rhinocort contains 64 micrograms of budesonide per dose as the active ingredient, and the following inactive ingredients:
disodium edetate
potassium sorbate (E202)
glucose
dispersible cellulose
polysorbate 80 (E433)
purified water.
Hydrochloric acid (E507) may have been added to adjust pH of the solution.
Sponsor
Johnson & Johnson Pacific
AUSTRALIA · NEW ZEALAND
45 Jones Street, Ultimo NSW 2007
® Registered Trademark
Consumer Care Centre
Australia: 1800 029 979
New Zealand: 0800 446 147
Overseas Customers: +61 2 8260 8366
This leaflet was prepared in March 2019.
Australian Registration Number:
Rhinocort 64 micrograms Nasal Spray – AUST R 75658
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