Consumer medicine information

APOHealth Budesonide Hayfever Nasal inhalation

Budesonide

BRAND INFORMATION

Brand name

APOHealth Budesonide Hayfever Nasal inhalation

Active ingredient

Budesonide

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHealth Budesonide Hayfever Nasal inhalation.

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about APOHEALTH Budesonide Hayfever. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

All medicines have risks and benefits.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APOHEALTH Budesonide Hayfever. It contains the active ingredient Budesonide.

It is used for the prevention or treatment of seasonal allergic rhinitis (eg due to pollen) for up to six months in adults and children 12 years of age and over and perennial (non-seasonal) allergic rhinitis (eg due to cats, dust mites) in adults 18 years and over.

Symptoms of Allergic Rhinitis can include:

  • stuffiness (congestion) in the nose
  • discharge, itching and sneezing

This medicine is available only from a pharmacy.

How it works

Budesonide belongs to a family of medicines called corticosteroids.

These medicines work by helping to reduce inflammation.

There is no evidence that this medicine is addictive.

It may take a few days of use before you feel the full effects of the medicine. In rare cases it may take up to 2 weeks

If you suffer moderate to severe symptoms, you may wish to start treatment before the beginning of the ‘pollen’ season.

Use in children

Do not use in children under 12 years of age.

Do not use in children under 18 years of age for non-seasonal hayfever

Before you use this medicine

When you must not use it

Do not use this medicine if:

  • You have or have had any of the following:
    - a tendency to bleed or recurrent nose bleeding
    - a severe nose infection, especially fungal infection.
  • You are hypersensitive to, or have had an allergic reaction to, budesonide or any of the ingredients listed at the end of this leaflet.
  • Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Do not continue using this medicine if you have already used it, or a similar corticosteroid nasal spray, for 6 months or longer.

Do not use if the expiry date (EXP) printed on the pack has passed.

Do not use if the packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your pharmacist or doctor if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
    - tuberculosis
    - infection of the nose, sinus, mouth, throat, lungs or eye
    - sores in the nose, including open sores
    - recent injury or surgery to your nose.
    Tell your pharmacist or doctor if you are taking other corticosteroid medicines, either by mouth, as eye drops, as an asthma inhaler or by injection.
  2. You are currently pregnant or you plan to become pregnant.
    Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
  3. You are currently breastfeeding or you plan to breastfeed.
    Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
  4. You are currently receiving or are planning to receive dental treatment.
  5. You are planning to have surgery or an anaesthetic.
  6. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

How to use this medicine

Follow carefully all the directions provided to you on the product packaging, the package insert and in this information leaflet. If you do not understand the instructions, ask your pharmacist or doctor for help.

Administration to children 12 years and over should be aided by an adult to ensure correct use.

How much to use

Adults and Children 12 years and over (adults 18 years and over for non-seasonal hayfever):
The initial dose is four sprays into each nostril once a day or two sprays into each nostril twice a day. Once your symptoms have improved, you may be able to lower the dose to as little as one spray into each nostril once a day. If symptoms get worse again, the dosage may be increased back to four sprays into each nostril once a day.

Always use the lowest dose which controls your symptoms.

Do not use in children under 12 years of age.

When to use it

It may take a few days to significantly improve symptoms, therefore, to prevent the onset of symptoms, start to use APOHEALTH Budesonide Hayfever a few days before expected exposure to one of your usual 'triggers'.

If you suffer moderate to severe symptoms, you may wish to start treatment before the beginning of the 'pollen' season.

It is very important that you use APOHEALTH Budesonide Hayfever regularly. If you stop the treatment when you feel better, your symptoms may return as the medication wears off.

How long to use it

If you have used the spray for 7 days and the symptoms have not improved, or not improved enough, see your pharmacist or doctor for advice.

Do not use a larger dose or use your nasal spray more often than recommended. Do not use more than 4 sprays in each nostril daily.

If symptoms worsen during treatment, see your pharmacist or doctor immediately.

Do not use for more than 6 months continuously without the advice of a doctor. If you have already used a similar nasal spray for 6 months, or are currently using a similar nasal spray, seek the advice of your pharmacist or doctor before using this medicine.

This medicine must be discarded 60 days after you first open it.

If you have the 120 spray pack, depending on the dose you use, you may have some left over medicine.

The medicine must be discarded 60 days after opening, regardless of whether there are sprays remaining.

About your nasal spray

Your nasal spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray and to replace it after use. Do not pierce the nasal applicator.

If you are using the spray for the first time, prime the pump by pumping the spray 8 times until a fine mist is produced. If you have not used the pump for 14 days or more reprime by pumping 2 or more times until a fine spray appears.

It is important to clean the nozzle regularly; otherwise, it may not work properly. Remove the dust cap and gently pull off the nozzle. Wash the nozzle and dust cap in warm water and then rinse under a running tap. Allow the nozzle to dry. Push the nozzle back onto the bottle and replace the dust cap. The pump will need to be reprimed when first used after cleaning.

How to use it

  1. Gently blow your nose to clear your nostrils, if necessary.
  2. Shake the bottle gently for a few seconds and remove the protective cap.
  3. Hold the bottle firmly with your index and middle finger on either side of the spray tip and your thumb underneath the bottle
  4. Insert the spray tip into your nostril (the tip should not reach far into your nose). Close the other nostril with a finger and lean your head slightly forward so the spray will aim toward the back of your nose.
  5. For each spray, activate the pump by quickly and firmly pressing down on the white collar while holding the base of the bottle with your thumb. Breathe gently inward through the nostril.
  6. After spraying into your nostril, lean your head backward for a few seconds.
  7. If a second spray is needed in the same nostril, repeat steps 3 through 6.
  8. Repeat steps 3 through 7 for your other nostril.
  9. Avoid blowing your nose for 15 minutes after you use budesonide nasal spray.
  10. Wipe the spray tip with a clean tissue, and replace the protective cap. Store the bottle in an upright position.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time.

Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breast-feed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.
  • Go to your doctor immediately if you notice symptoms of a bacterial infection. These symptoms may include fever, persistent face/tooth pain on one side of the face, swelling around the eye area, or worsening of symptoms after an initial improvement.

Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Take your medicine for a longer than 6 months continuously without the advice of a doctor.
  • Stop taking your medicine suddenly, or change the dosage, unless advised to do so by your doctor.
  • Take this medicine if you are already taking a similar nasal spray, or have used a similar nasal spray continuously over the last 6 months without the advice of a pharmacist or doctor.

Things to be careful of

This medicine generally does not cause any problems with your ability to drive a car or operate machinery.

If you have a lower resistance to infection, avoid coming into contact with anyone who has measles or chickenpox, especially while you are using cortisone-type medicines. Tell your doctor if you do.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking budesonide or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

  • headache
  • nausea
  • sneezing
  • nasal irritation
  • nosebleeds
  • nasal crust
  • dry mouth or nose
  • sore throat
  • cough
  • disturbances of taste or smell
  • diarrhoea
  • abdominal pain.

There is evidence that corticosteroid nasal sprays may reduce the speed of growth in children. The growth of children receiving corticosteroid nasal sprays should be monitored routinely.

If you have eye pain or visual disturbances, stop treatment and see your doctor.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to budesonide, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms.

Storage and Disposal

Storage

Keep your nasal spray upright in a cool dry place where the temperature will stay below 25°C. Do not freeze.

After opening, please discard product after 60 days.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine 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 or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APOHEALTH Budesonide Hayfever looks like

APOHEALTH Budesonide Hayfever is a white suspension contained in an amber glass bottle with a metered-dose, manual spray pump for intranasal administration.

Ingredients

Each actuated spray contains 32 µg of the active ingredient budesonide.

It also contains the following inactive ingredients:

  • potassium sorbate
  • glucose
  • disodium edetate,
  • microcrystalline cellulose
  • sodium carboxymethyl cellulose
  • polysorbate 80
  • hydrochloric acid
  • purified water

This medicine is gluten-free, lactose-free, tartrazine-free and free of other azo dyes.

APOHEALTH Budesonide Hayfever is available in bottles of 120 sprays.

Australian Registration Numbers

APOHEALTH Budesonide Hayfever: AUST R 259935

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

The APOTEX and APOHEALTH trade marks are used under licence.

This leaflet was prepared in September 2016.

BRAND INFORMATION

Brand name

APOHealth Budesonide Hayfever Nasal inhalation

Active ingredient

Budesonide

Schedule

S2

 

Name of the medicine

Budesonide.

Excipients.

Glucose, disodium edetate, potassium sorbate, microcrystalline cellulose, sodium carboxymethyl cellulose, polysorbate 80, hydrochloric acid, purified water.

Description

Chemical Name: 16α, 17α - 22 R, S-propylmethylenedioxypregna - 1, 4 - diene - 11β, 21-diol-3, 20-dione. Molecular Formula: C25H34O6. Molecular Weight: 430.5. CAS Registry Number: 51333-22-3.
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.
Budesonide Hayfever is an aqueous nasal suspension, containing 32 microgram budesonide per actuation as the active ingredient.
In addition, each vial contains the following inactive ingredients: glucose, disodium edetate, potassium sorbate, microcrystalline cellulose, sodium carboxymethyl cellulose, polysorbate 80, hydrochloric acid, purified water.

Pharmacology

Pharmacological actions.

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.
Pre-treatment for one week with intranasal budesonide 400 microgram daily in asymptomatic patients with seasonal rhinitis, significantly inhibited the immediate reaction to allergen challenge.
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.

Pharmacokinetics.

The systemic availability of budesonide from Budesonide Hayfever, with reference to the metered dose, is 33%. Negligible biotransformation occurs in human nasal mucosa.
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 Budesonide Hayfever is 2.7 nanomol.h/L in adults and 5.5 nanomol.h/L in children.
Budesonide has a volume of distribution of approximately 3 L/kg. Plasma protein binding averages 85-90%.
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/min) and the plasma half-life after i.v. dosing averages 2-3 hours.

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.

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.

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.

Precautions

Clinical response.

The full effect of Budesonide Hayfever 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 Budesonide Hayfever is administered to patients already using corticosteroids, care should be taken to ensure that the daily dosage of Budesonide Hayfever 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 Budesonide Hayfever, adequate antibacterial therapy should be promptly instituted (see also Contraindications, 2).

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.

Reduced liver function.

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.

Adrenocortical function.

Dose-related suppression of plasma and urinary cortisol has been observed in healthy volunteers after short-term administration of Budesonide Hayfever. However, at recommended doses, Budesonide Hayfever 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 pregnancy.

(Category A)
Results from a large prospective epidemiological study and from world-wide post marketing experience indicate that inhaled budesonide during pregnancy has no adverse effects on the health of the foetus or new born 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.

Use in lactation.

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.

Paediatric use.

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

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.

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 seven fold. 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.

Adverse 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.

Central nervous system.

Headache, dizziness, tiredness.

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.

Immune system.

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

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.

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

Overdosage

Symptoms.

Acute overdosage with Budesonide Hayfever, even in excessive doses, is not expected to be a clinical problem.
In the unlikely event of prolonged excessive use of Budesonide Hayfever 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 131 126 (Australia).

Presentation

APOHealth Budesonide Hayfever is intended for nasal inhalation.
Each bottle contains budesonide 32 microgram per actuation, as the active ingredient 120 doses per bottle.
White to off-white suspension contained in an amber glass bottle with a metered-dose, manual spray pump for intranasal administration (AUST R 259935).

Storage

Store below 25°C.
Store upright. Do not freeze.

Poison Schedule

S2.