Rhinocort Hayfever & Allergy Extra Strength

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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 pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or 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 pharmacist or doctor.

Keep this leaflet with your Rhinocort.

You may need to read it again.

What RHINOCORT is used for

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).

While hayfever is the name most commonly used for these allergic conditions, the medical names are "seasonal allergic rhinitis" and "perennial allergic rhinitis".

Seasonal allergic rhinitis (hayfever) - generally triggered by pollens (eg grass, weeds and sometimes trees) in the air and is most common during Spring and Summer months.

Perennial allergic rhinitis - may be triggered by dust mites, animal dander (particularly cats) or mould spores and can occur throughout the year.

Rhinocort contains budesonide. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation.

Ask your pharmacist or doctor if you have any questions about why Rhinocort has been recommended for you.

Rhinocort is not addictive.

Rhinocort is available from pharmacists without a 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 infections in the nose especially candidiasis (thrush).

Do not give Rhinocort to a child under the age of 12 years.

If necessary, your doctor will prescribe a suitable medicine for children less than 12 years of age who have allergic rhinitis.

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 pharmacist or doctor, if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your pharmacist or 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 pharmacist or 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 pharmacist or doctor about any of the above, tell them before you start using Rhinocort.

Taking other medicines

Tell your pharmacist or doctor 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 symptoms.

If you start using Rhinocort early, it will help reduce the severity of your symptoms.

Follow all directions given to you by your pharmacist or doctor 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 pharmacist or doctor for help.

Gently blow your nose before using Rhinocort.

Use only in your nose.

How much to use

When you first start using Rhinocort:

The usual starting dose is:

TWO sprays into EACH nostril once daily

Do not exceed the recommended dose (total of 4 sprays each day).

It may take a few days of using Rhinocort before you notice any improvement in your symptoms.

Once your symptoms improve:

After your symptoms have improved, you should gradually reduce the number of sprays you put into each nostril to the lowest number that controls your symptoms. This might be ONE spray into EACH nostril daily.

How long to use it

See your doctor or pharmacist if your symptoms are not relieved within 7 days.

It generally takes a few days before you notice any improvement in your symptoms.

Do not use for more than 6 months without the advice of your doctor or pharmacist.

If symptoms persist or worsen, or if new symptoms occur, stop use and consult a physician.

If you forget to use it

If you miss a dose of Rhinocort Extra Strength, 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 pharmacist or doctor.

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

See your pharmacist or doctor if your symptoms are not relieved within 7 days.

It generally takes a few days before you notice any improvement in your symptoms.

Ask your doctor to examine your nose if you have been using Rhinocort for several months without a break.

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 your Rhinocort to anyone else, even if they have the same condition as you.

Side effects

Tell your pharmacist or doctor 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 pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor 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 pharmacist or doctor 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.

change in vision or 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.

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 you stop using Rhinocort or it has passed its expiry date, ask your pharmacist what to do with any you have left.

Product description

Rhinocort contains approximately 120 sprays in a 10 mL brown glass bottle, with pump spray equipment and nasal adaptor.

Rhinocort bottle contains an overfill to allow for the small amount of liquid that cannot be pumped out of the bottle.

Rhinocort Hayfever & Allergy Extra Strength Nasal Spray contains 64 micrograms of budesonide as the active ingredient per spray, 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.