Consumer medicine information

Rhinocort Hayfever & Allergy Original

Budesonide

BRAND INFORMATION

Brand name

Rhinocort Hayfever & Allergy Original

Active ingredient

Budesonide

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Rhinocort Hayfever & Allergy Original.

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 (hayfever).

Hayfever 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 - 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.
  1. You have frequent nose bleeds.
Your condition may cause nose bleeds and still require treatment. Discuss with your doctor if you have any concerns.
  1. 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 hayfever.

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 hayfever.

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:

  • FOUR sprays into EACH nostril in the morning; or
  • TWO sprays into EACH nostril twice a day (in the morning and evening).

Do not exceed the recommended dose (total of 8 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 in the morning.

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, 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 60 or 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 Nasal Spray contains 32 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.

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 December 2019.

Australian Registration Number:

Rhinocort Hayfever & Allergy Original Nasal Spray - AUST R 77885

Published by MIMS April 2020

BRAND INFORMATION

Brand name

Rhinocort Hayfever & Allergy Original

Active ingredient

Budesonide

Schedule

S2

 

1 Name of Medicine

Budesonide.

6.7 Physicochemical Properties

The active ingredient, budesonide, is a non-halogenated glucocorticoid structurally related to 16α hydroxyprednisolone. Budesonide is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Budesonide melts between 224°C and 231.5°C with decomposition.
Chemical Name: 16α, 17α-22 R,S-propylmethylenedioxypregna -1,4-diene-11β,21 -diol-3,20-dione. MW: 430.5.

Chemical structure.


CAS number.

51333-22-3.

2 Qualitative and Quantitative Composition

Rhinocort is an aqueous nasal suspension containing 32 microgram budesonide per actuation as the active ingredient. Rhinocort also includes disodium edetate, potassium sorbate, glucose anhydrous, dispersible cellulose, polysorbate 80 and purified water as inactive ingredients. The pH of the solution may have been adjusted by hydrochloric acid, if required.

3 Pharmaceutical Form

Budesonide is formulated for intranasal administration and is available as a nasal spray.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The mechanism of action of intranasally administered budesonide has not yet been completely defined, however budesonide has been shown to counteract the mainly IgE mediated lung anaphylaxis in guinea pigs.

Clinical trials.

The therapeutic efficacy of intranasal budesonide has been evaluated in placebo controlled clinical trials of seasonal and perennial allergic rhinitis of 3-6 weeks duration.
Overall, the results of these clinical trials showed that intranasal budesonide administered once daily provides statistically significant reduction in the severity of nasal symptoms of seasonal and perennial allergic rhinitis including runny nose, sneezing, and nasal congestion. In some studies, improvement versus placebo has been shown to occur within 24 hours of initiating treatment with intranasal budesonide. Maximum benefit can take up to 2 weeks after initiation of treatment.
Studies in animals and humans have shown an advantageous ratio between topical anti-inflammatory activity and systemic glucocorticoid effect over a wide dose range.
Budesonide is approximately twice as potent as beclomethasone dipropionate as shown in the skin blanching test for anti-inflammatory activity of topical steroids in humans. Budesonide has, however, less systemic effect than beclomethasone dipropionate, as measured by depression of morning plasma cortisol and effect on differential WBC count. The improved ratio of topical anti-inflammatory activity to systemic effect of budesonide is due to high glucocorticoid receptor affinity combined with a high first-pass metabolism and a short half-life.
Pretreatment for one week with intranasal budesonide 400 microgram daily in asymptomatic patients with seasonal rhinitis significantly inhibited the immediate reaction to allergen challenge.

5.2 Pharmacokinetic Properties

The systemic availability of budesonide from Rhinocort, with reference to the metered dose, is 33%. Negligible biotransformation occurs in human nasal mucosa.

Absorption.

After nasal application of 256 microgram budesonide peak plasma concentrations of approximately 0.63 nanomol/L in adults and 1.53 nanomol/L in children were observed within 45 minutes. The area under the curve (AUC) after administration of 256 microgram budesonide from Rhinocort is 2.7 nanomol.hour/L in adults and 5.5 nanomol.hour/L in children.

Distribution.

Budesonide has a volume of distribution of approximately 3 L/kg. Plasma protein binding averages 85-90%.

Metabolism.

Budesonide is metabolised in the liver by cytochrome P450 3A to more polar metabolites with low glucocorticoid activity (i.e. 100-fold lower than the parent compound). The metabolites are inactive and excreted mainly via the kidneys. No intact budesonide has been detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 L/minute) and the plasma half-life after intravenous dosing averages 2-3 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

The carcinogenic potential of budesonide has been evaluated in mouse and rat at oral doses up to 200 and 50 microgram/kg/day, respectively. No oncogenic effect was noted in the mouse. One study indicated an increased incidence of brain gliomas in male Sprague-Dawley rats given budesonide, however the results were considered equivocal.
Further studies performed in male Sprague-Dawley and Fischer rats showed that the incidence of gliomas in the budesonide treated rats was low and did not differ from that in the reference glucocorticoid groups or the controls. It was concluded that treatment with budesonide does not increase the incidence of brain tumours in the rat.
In male rats dosed with 10, 25 and 50 microgram/kg/day, those receiving 25 and 50 microgram/kg/day showed an increased incidence of primary hepatocellular tumours. This was observed in all three steroid groups (budesonide, prednisolone, triamcinolone acetonide) in a repeat study in male Sprague-Dawley rats thus indicating a class effect of corticosteroids.
The mutagenic potential of budesonide was evaluated in 6 different test systems. No mutagenic or clastogenic effects of budesonide were found.

4 Clinical Particulars

4.1 Therapeutic Indications

For short-term (3-6 months) prophylaxis or treatment of seasonal allergic rhinitis in adults and children aged 12 years and over, and perennial allergic rhinitis in adults 18 years and over.

4.3 Contraindications

1. Hypersensitivity to any ingredient.
2. Hypersensitivity to other corticosteroids.
3. Severe nasal infections, especially candidiasis.
4. Persons with haemorrhagic diatheses or with a history of recurrent nasal bleeding.

4.4 Special Warnings and Precautions for Use

Clinical response.

The full effect of Rhinocort in allergic rhinitis is not achieved until after 2 to 3 days of treatment (in rare cases not until after 2 weeks).

Concomitant treatment.

Concomitant treatment may sometimes be necessary to counteract potential eye symptoms caused by the allergy.

Concomitant corticosteroid therapy.

If Rhinocort is administered to patients already using corticosteroids, care should be taken to ensure that the daily dosage of Rhinocort is included when determining total daily corticosteroid dose.

Severe nasal obstruction/congestion.

In some patients with severe nasal obstruction and congestion, concomitant treatment with local decongestants should be considered for 2-3 days only. The decongestant should be administered a few minutes before budesonide. Nasal polypectomy may be indicated initially for patients with nasal obstruction due to nasal polyposis.

Tuberculosis.

Whenever corticosteroid administration is required in patients with quiescent or active tuberculosis, the therapeutic advantages should be weighed against possible undesirable effects.

Infection.

If infection of the respiratory tract, nasal passages or paranasal sinuses is present or occurs during administration of Rhinocort, adequate antibacterial therapy should be promptly instituted (see Section 4.3 Contraindications).

Wound healing.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.

Adrenocortical function.

Dose related suppression of plasma and urinary cortisol has been observed in healthy volunteers after short-term administration of Rhinocort. However, at recommended doses, Rhinocort does not cause any clinically important changes in basal cortisol levels nor in the response to stimulation with ACTH in patients with rhinitis.

Use in hepatic impairment.

Reduced liver function may affect the elimination of glucocorticosteroids. The pharmacokinetics after oral ingestion of budesonide were affected by compromised liver function as evidenced by a doubled systemic availability. The relevance of this finding to intranasally administered budesonide has not been established.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

No data available.

Paediatric use.

Rhinocort is not recommended for use in children below 12 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The metabolism of budesonide is primarily mediated by CYP3A, a subfamily of cytochrome P450. After oral administration of ketoconazole, a potent inhibitor of cytochrome P450 3A, the mean plasma concentration of budesonide increased by more than sevenfold. Concomitant administration of other known inhibitors of this enzyme (e.g. itraconazole, clarithromycin, erythromycin) may inhibit the metabolism of, and increase the systemic exposure to, budesonide.
Cimetidine, primarily an inhibitor of cytochrome P450 1A2, caused a slight decrease in budesonide clearance and corresponding increase in its oral bioavailability.

4.6 Fertility, Pregnancy and Lactation

(Category A)
Results from a large prospective epidemiological study and from worldwide postmarketing experience indicate that inhaled budesonide during pregnancy has no adverse effects on the health of the foetus or newborn child. As with other drugs the administration of budesonide during pregnancy requires that the benefits for the mother be weighed against the risks for the foetus.
Inhaled glucocorticosteroids such as budesonide, should be considered because of the lower systemic effects, compared to oral glucocorticosteroids.
Budesonide is excreted in breast milk. However, due to the relatively low doses used via the intranasal route the amount of drug present in the breast milk, if any, is likely to be low.
Breastfeeding can be considered if the potential benefit outweighs any potential risks.

Effects on fertility.

No data available.

4.8 Adverse Effects (Undesirable Effects)

Adverse local reactions following intranasal budesonide use are mild and usually transient. Systemic corticosteroid side effects have not been reported during clinical studies of intranasal budesonide in adults.
Adverse events reported during studies with intranasal budesonide:

Common (more than 1%).

Nose and throat.

Nasal irritation, itching of throat and larynx, sore throat, dry mucous membranes, dry mouth, sneezing after spraying, increased sputum, haemorrhagic secretion, epistaxis (nose bleeding), nasal crust, sinusitis.

Respiratory.

Cough, dyspnoea, asthma, epistaxis, oropharyngeal pain, upper respiratory tract infection, rhinitis.

Central nervous system.

Headache, dizziness, tiredness, pyrexia.

Skin and appendages.

Rash.

Gastrointestinal.

Abdominal discomfort.

Injury, poisoning and procedural complications.

Head injury.

Uncommon (less than 1%).

Nose and throat.

Strong smell of spray, bad taste, earache.

Gastrointestinal.

Loss of appetite, stomach disorder, nausea.

Skin and appendages.

Skin itching.

Central nervous system.

Tremor, sedation.

Infection.

Urinary tract infection.

Immune system.

Immediate and delayed hypersensitivity reactions including urticaria, rash, dermatitis, angioedema and pruritus.

Injury, poisoning and procedural complications.

Injury.

Rare (less than or equal to 0.2%).

Ear itching, joint aches, sexual dysfunction.
Very rare cases of ulcerations of the mucous membrane, nasal septal perforations and anaphylactic reactions have been reported following the use of intranasal corticosteroids.

Laboratory variables.

All changes in haematology, biochemistry and urinalysis were within the normal range and were not considered clinically significant.

Postmarketing data.

Adverse drug reactions (ADRs) identified during postmarketing experience with budesonide are included in Table 1. The frequencies are provided according to the following convention: very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1,000 and < 1/100; rare ≥ 1/10,000 and < 1/1,000; very rare < 1/10,000; not known (cannot be estimated from the available data).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at: https://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Seasonal allergic rhinitis (adults and children 12 years and over) and perennial allergic rhinitis (adults 18 years and over).

There is no evidence that efficacy improves when the recommended dose is exceeded.

Initially.

Total daily dose, 256 microgram given as either a single daily application of 128 microgram into each nostril in the morning, or divided into two applications of 64 microgram into each nostril, morning and evening.

Maintenance - individualisation of dosage.

When a satisfactory therapeutic response has been achieved, the maintenance dose should be titrated to the minimum effective dose. This may be a total daily dose of 128 microgram given as 64 microgram into each nostril in the morning, however clinical trials suggest that a maintenance dose of 32 microgram in each nostril in the morning may be sufficient in some patients.
Patients should be informed that full response may not occur until after 2-3 days of treatment (in rare cases not until after 2 weeks). Ideally, in seasonal allergic rhinitis treatment should start before exposure to the allergen.

Patient instructions.

Patients should be instructed in the correct use of Rhinocort. An instruction leaflet is included in each pack of Rhinocort. Patients should also be advised to clear secretions from nasal passages prior to use and not to exceed the recommended dose.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Acute overdosage with Rhinocort, even in excessive doses, is not expected to be a clinical problem.
In the unlikely event of prolonged excessive use of Rhinocort which could possibly lead to adrenal suppression, treatment should be discontinued. Overdosage may give rise to signs of Cushing's syndrome, such as increased bodyweight, lethargy, hypertension, hirsutism, cutaneous striae, personality change, ecchymosis, oedema, polyuria and polydipsia. In severe cases, the dosage of the corticosteroid should be gradually withdrawn to prevent the possibility of adrenal failure.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S2.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Do not freeze.

6.5 Nature and Contents of Container

Rhinocort Nasal Spray is available in a brown glass bottle, with pump spray equipment and nasal adaptor. Each bottle contains either 60 or 120 actuations approximately, with 32 microgram of budesonide per actuation.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes