Consumer medicine information

Flixonase Nasule Drops

Fluticasone propionate

BRAND INFORMATION

Brand name

Flixonase Nasule Drops

Active ingredient

Fluticasone propionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flixonase Nasule Drops.

What is in this leaflet?

Please read this leaflet carefully before taking Flixonase Nasule Drops.

This leaflet answers some common questions about Flixonase Nasule Drops. It does not contain all of 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 taking Flixonase Nasule Drops against the benefits this medicine is expected to have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Flixonase Nasule Drops are used for

Flixonase Nasule Drops contain a steroid called fluticasone propionate, which treats inflamed tissue.

Flixonase Nasule Drops work by shrinking swelling inside your nose. This makes breathing easier. You may not feel the maximum benefit for a few weeks.

Inflamed tissue inside the nose can form grape-like swellings called 'polyps'. They cause nasal blockage and discomfort. Flixonase Nasule Drops are used to relieve the symptoms caused by nasal polyps by shrinking them. Flixonase Nasule Drops have not been studied in patients under 16 years of age.

Your doctor may have prescribed Flixonase Nasule Drops for another reason.

Ask your doctor if you have any questions or if you aren't sure why Flixonase Nasule Drops has been prescribed for you.

Flixonase Nasule Drops are not addictive.

Before you use Flixonase Nasule Drops

When you must not use Flixonase Nasule Drops

  • Do not use Flixonase Nasule Drops if you have ever had an allergic reaction to fluticasone propionate or any of the ingredients listed at the end of this leaflet.
    Read the side effects section to find out the symptoms of an allergic reaction.
  • Do not use Flixonase Nasule Drops if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should.
    Your doctor will discuss the risks and benefits of using Flixonase Nasule Drops if you are pregnant or breastfeeding.
  • Do not use Flixonase Nasule Drops after the expiry date (EXP) printed on the pack.
    If you use the product after the expiry date has passed, they may not work as well.
  • Do not use Flixonase Nasule Drops if the packaging is torn or shows signs of tampering.
    If you're not sure whether you should be using Flixonase Nasule Drops, talk to your doctor.

Before you start to use Flixonase Nasule Drops

You must tell your doctor if:

  • You are pregnant or planning to become pregnant
  • You are breastfeeding
  • You have an infection in your nose or sinuses
  • You have had nasal surgery
  • You have been treated with steroid injections, or taken steroid tablets.
  • You are allergic to foods, dyes, or any other medicine
  • You are diabetic
  • You have a disease or are taking medication that could compromise your immune system
  • You have ever had thrush in your mouth.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way others work. For example, medicines like ketoconazole, used to treat fungal infection, and ritonavir used to treat HIV infection, may affect how Flixonase Nasule Drops works. If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.

Use in children

Flixonase Nasule Drops are not recommended for use in patients under 16 years of age.

How to use Flixonase Nasule Drops

How much to use

Always use Flixonase Nasule drops exactly as your doctor has told you to. Don't exceed the recommended dose. Check with your doctor or pharmacist if you're not sure.

In patients over 16 years of age, the normal dose is one container (400 micrograms contained in 400 microlitres) once or twice every day, unless your doctor tells you otherwise.

The medicine should be divided equally between both affected nostrils.

Your doctor will advise you what to do if only one nostril is affected.

You may not feel the maximum benefit from your medicine straight away, but it is important that you continue to use the drops regularly.

Your doctor will assess your polyps regularly to decide on the best treatment.

How to use the product

Note: It may be easier if someone else puts the drops in for you.

  1. Gently blow each nostril, in turn, to clear.
  2. Open the foil pack by tearing off one side.
  3. Detach one container and return the remaining containers, in the foil, to the carton.
  4. It is important to ensure that the contents of your Nasule are well mixed before use.
  5. While holding the container horizontally by the larger tab, flick the other end a few times and shake. Repeat this process several times until the entire contents of the container are completely mixed.
  6. Hold the lower tab of the container securely. Twist and remove the top, and discard the drops.
  7. To ensure the medicine treats the affected area, ideally you should position yourself as follows (see also the diagrams inside the pack):
    (a) Move into one of the following positions: kneeling, sitting, or standing. Bend forward until your head is at knee level
    OR
    (b) Lie on your back on a bed with your head supported but tilted backwards over the edge.
    Gently insert the opened nozzle of the container into one nostril. Squeeze the container to deliver 6 drops. This is approximately half the dose.
    NOTE: It is not always easy to count the drops. Make sure you hold the container by the dimpled sides. When the container is held just inside the nostril, squeeze until the dimpled sides meet. This delivers about half the dose.
  8. Transfer the container to the other nostril and squeeze it to deliver the remaining drops.
  9. Keep your head in this position for at least 1 minute. If you are lying down, rest your head to one side. After about half a minute rest your head to the other side, for a similar time.

How long to use the product

Flixonase Nasule Drops help control nasal polyps, but are not a cure. Continue to use Flixonase Nasule Drops regularly for as long as your doctor tells you to.

If you forget to use the product

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the product as soon as you remember, then go back to using the product as you would normally.

Do not use a double dose to make up for the dose that you missed.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have used too much Flixonase Nasule Drops, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

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

While you are using Flixonase Nasule Drops

Things you must do

Tell your doctor or pharmacist that you are using Flixonase Nasule Drops if you are about to be started on any new medicines.

Tell your doctor if you become pregnant or are trying to become pregnant.

Tell your doctor if, for any reason, you have not used your medicine exactly as prescribed.

Tell your doctor if you experience a change in your vision. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Use Flixonase Nasule Drops only in your nose.

Things you must not do

Do not stop using Flixonase Nasule Drops, or change the dose without first checking with your doctor.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use Flixonase Nasule Drops to treat any other complaints unless your doctor says to.

Avoid getting the drops in your eyes. Rinse the eyes with water if you do.

Side-Effects

Check with your doctor as soon as possible if you have any problems while using Flixonase Nasule Drops, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, Flixonase Nasule Drops can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side-effects are:

  • sneezing
  • irritation or dryness in the nose or throat
  • bad taste or smell
  • nose bleed
  • difficulty in breathing
  • allergic reactions

Very rare side effects include:

  • breakdown of tissue inside the nose (nasal septal perforation)
  • sores in the nose
  • cloudy lens in the eye (cataract), increased pressure of the eye that causes problems with vision (glaucoma). These eye problems occurred in people who used Flixonase Nasule Drops for a long time.

If any of these side effects persist, or are troublesome, see your doctor.

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

If you think you are having an allergic reaction to Flixonase Nasule Drops, TELL YOUR DOCTOR IMMEDIATELY or go to the emergency department at your nearest hospital. Symptoms usually include some or all of the following:

  • wheezing
  • swelling of the lips/mouth
  • difficulty in breathing
  • hay fever
  • lumpy rash ("hives")
  • fainting

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side-effects. You may not experience any of them.

After using Flixonase Nasule Drops

Storage

Keep this medicine where young children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Condensation may form on the inside of the foil pack during storage, but it is not a cause for concern.

Store your Flixonase Nasule Drops upright, at below 30°C.

Protect the drops from direct sunlight.

Do not freeze the drops.

Do not store the drops, or any other medicine, in a bathroom or near a sink.

Do not leave the drops in the car or on window sills. Heat and dampness can destroy some medicines.

Keep your product in its pack until it is time to use the drops. If you take the product out of its packaging it may not keep well.

Disposal

If your doctor tells you to stop using Flixonase Nasule Drops, or the product has passed its expiry date, ask your pharmacist what to do with any product left over.

Product description

What Flixonase Nasule Drops look like.

Flixonase Nasule Drops come in individual polyethylene 'bubbles', in strips of 7 units. Each 'bubble' holds a single dose of 400 micrograms of fluticasone propionate, in a volume of 400 microlitres. The complete strip of 7 is wrapped in foil. Packs contain 4 foil-wrapped strips, each of seven units.

Ingredients

Flixonase Nasule Drops contain the active ingredient fluticasone propionate. The product also contains the following inactive ingredients:

Polysorbate 20, sorbitan monolaurate, dibasic sodium phosphate, monobasic sodium phosphate, water for injection.

Supplier

Your Flixonase Nasule Drops are supplied by:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria 3067
Australia

Further Information

This is not all the information that is available on Flixonase Nasule Drops. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.

Do not throw this leaflet away. You may need to read it again.

This leaflet was prepared on 14 September 2018

The information provided applies only to: Flixonase Nasule Drops.

Trade marks are owned by or licensed to the GSK.

Flixonase Nasule Drops: AUST R 71294

©2018 GSK group of companies or its licensor.

Version 6.0

Published by MIMS January 2019

BRAND INFORMATION

Brand name

Flixonase Nasule Drops

Active ingredient

Fluticasone propionate

Schedule

S4

 

1 Name of Medicine

Fluticasone propionate.

6.7 Physicochemical Properties

The chemical name of fluticasone propionate is S-Fluoromethyl 6α, 9α-difluoro-11β-hydroxy- 16α-methyl-3-oxo-17 α-propionyloxy-androsta-1, 4-diene-17β-carbothioate.
The molecular formula of fluticasone propionate is C25H31F3O5S.

Chemical structure.


CAS number.

80474-14-2.

2 Qualitative and Quantitative Composition

Each ampoule of Flixonase Nasule Drops contains 400 microgram of fluticasone propionate in 400 microL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nasal drops.
White opaque, freely dispersed suspension free from any visible foreign matter.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Fluticasone propionate has potent anti-inflammatory activity but when used topically on the nasal mucosa has no detectable systemic activity. Fluticasone propionate causes little or no HPA axis suppression following intranasal or topical (dermal) administration and only causes overt HPA axis suppression after very high oral doses (10 mg four times a day, i.e. 40 mg daily, and above).

Clinical trials.

The clinical trials program evaluated the efficacy and safety of fluticasone propionate (FP) nasal drops in the treatment of nasal polyposis in patients ≥ 16 years old with mild to moderate polyps. Two main trials were conducted. Both studies were placebo controlled and consisted of 12 weeks randomised treatment followed by 12 weeks open treatment.
The first trial (FLTB3045) was double blind and compared 400 microgram fluticasone propionate once daily (od) with placebo for 12 weeks. A total of 104 patients were randomised to treatment, after which all received 400 microgram fluticasone propionate od for a further 12 weeks. Six patients (5 from the placebo group) were withdrawn from the randomised phase, while there were no withdrawals during the open label phase. At the end of the treatment period 27% of patients in the FP group showed a reduction in polyp size compared to 16% in the placebo group. This difference was not statistically significant. However, Peak Nasal Inspiratory Flow (PNIF) showed a significant improvement during FP treatment, as did all associated symptoms of rhinitis. The improvement in PNIF is particularly important as relief of nasal obstruction is a main benefit that patients require from treatment with topical steroids.
A second study (FLTB3046) compared 400 microgram fluticasone propionate once daily (od) and twice daily (bd) with placebo over 12 weeks, after which most received 400 microgram fluticasone propionate od for a further 12 weeks. A total of 142 patients were randomised to treatment, with 16 patients withdrawn after randomisation (10 from the placebo group). 107 patients entered the open label phase. At the end of the 12 week treatment period, 15% of patients in the placebo group showed an improvement in polyp size, 24% in the FP 400 microgram od group, and 41% in the 400 microgram bd group. The difference in improvement between FP 400 microgram bd and placebo was statistically significant. In addition, both doses of FP showed a significant improvement in PNIF, an improvement in the clinical assessment of nasal blockage and rhinitis and a reduction in nasal discomfort. FP 400 microgram bd showed greater improvements than 400 microgram od for all symptoms.
In both studies, serum cortisol concentrations were measured at baseline and at the end of the randomised phase to assess effects of treatment on the HPA axis. No significant differences were observed between the fluticasone and placebo groups.
Once daily (400 microgram/day) and twice daily (800 microgram/day) dosing has not been studied beyond 24 and 12 weeks respectively.

5.2 Pharmacokinetic Properties

Absorption.

After recommended doses of intranasal fluticasone propionate plasma levels are low. Systemic bioavailability for the nasal drop formula is extremely low (mean value 0.06%).
Following intravenous administration the pharmacokinetics of fluticasone propionate are proportional to the dose, and can be described by three exponentials.
Absolute oral bioavailability is negligible (< 1%) due to a combination of incomplete absorption from the gastrointestinal tract and extensive first pass metabolism.

Distribution.

Fluticasone propionate is extensively distributed within the body (Vss is approximately 300 litre). Plasma protein binding is 91%. After intravenous administration, fluticasone propionate has a very high clearance (estimated Cl 1.1 litre/min) indicating extensive hepatic extraction.
Peak plasma concentrations are reduced by approximately 98% within 3-4 hours and only low plasma concentrations are associated with the terminal half life, which is approximately 8 hours.

Metabolism.

Fluticasone propionate is extensively metabolised by CYP3A4 enzyme to an inactive carboxylic derivative.

Excretion.

Following oral administration of fluticasone propionate, 87-100% of the dose is excreted in the faeces as parent compound or as metabolites.

Other.

As fluticasone propionate is given at very low doses, any effect on co-administered drug is unlikely.
The data for paediatric pharmacokinetics show consistency with the adult findings.

5.3 Preclinical Safety Data

Genotoxicity.

Fluticasone propionate has no mutagenic effect in vivo or in vitro, no tumorigenic potential in rodents and is non-irritant and non-sensitising in animal models.

Carcinogenicity.

No evidence of a tumorigenic effect was observed in either a 2 year study in rats receiving doses of fluticasone propionate up to 57 microgram/kg/day by inhalation or in an 18 month study in mice receiving oral doses of fluticasone propionate up to 1 mg/kg/day. There was no evidence of a mutagenic potential in a standard battery of mutagenicity assays.

4 Clinical Particulars

4.1 Therapeutic Indications

Flixonase Nasule Drops are indicated for the treatment of mild to moderate nasal polyps and associated symptoms of nasal obstruction in adults and adolescents over 16 years of age.

4.3 Contraindications

Flixonase Nasule Drops are contraindicated in patients with a history of hypersensitivity to any components of the preparation.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Local infection. Infection of the nasal airways should be appropriately treated but does not constitute a contraindication to treatment with Flixonase Nasule Drops. After nasal surgery, healing must have occurred before use.
Care must be taken when withdrawing patients from systemic steroid treatment, and commencing therapy with Flixonase Nasule Drops, particularly if there is any reason to suspect that their adrenal function is impaired.
Systemic effects with nasal corticosteroids have been reported, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
The full benefit of Flixonase Nasule Drops may not be achieved until treatment has been administered for several weeks.
Rare instances of glaucoma and increased intra-ocular pressure have been reported following administration of intranasal corticosteroids, as a class effect. If a patient presents with a change in vision, 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).
Candidiasis of the throat can occur in patients treated with intranasal steroids. Special care should be taken when treating patients who may be susceptible to candida infections (e.g. diabetics).
A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

Adrenocortical function.

Intranasal steroid products are designed to deliver drug directly to the nasal mucosa in order to minimise overall systemic glucocorticoid exposure and side effects. However systemic effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression, reduction of bone density and retardation of growth in adolescents may occur with intranasal steroids, particularly at high doses prescribed for prolonged periods of time.
The lowest dose of Flixonase that causes suppression of the HPA axis, effects on bone mineral density or growth retardation has not yet been established. However, the systemic bioavailability of fluticasone propionate is low (estimated at 0.06%) when given as Flixonase Nasal Drops and this limits the potential for systemic side effects. Measurement of serum cortisol concentrations in the clinical studies did not suggest any HPA axis suppression with recommended doses.

Use in the elderly.

There are no special precautions for use in the elderly.

Paediatric use.

No data available.

Effects on laboratory tests.

Interactions with laboratory tests have not been established.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Under normal circumstances, very low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first-pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Studies have shown that other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and minor (ketoconazole) increases in systemic exposure to fluticasone propionate without notable reductions in serum cortisol concentrations. Nevertheless, care is advised when co-administering potent cytochrome P450 3A4 inhibitors (e.g. ketoconazole), as there is potential for increased systemic exposure to fluticasone propionate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

A fertility study in rats showed decreased mean fetal weight, retardation of ossification, and decreased postnatal viability at the dose of 50 microgram/kg/day subcutaneous (SC) fluticasone propionate.
(Category B3)
There is insufficient evidence of safety of fluticasone propionate in human pregnancy. Systemically absorbed corticosteroids are known to induce fetotoxic and teratogenic effects in rodent studies. However, equivalent effects have not been reported when these compounds have been given to humans during pregnancy. Reproductive toxicity studies with fluticasone propionate in mice and rats have shown the expected fetotoxic and teratogenic effects at SC doses of 100 to 150 microgram/kg/day and above. As with previous compounds of this class, these effects are unlikely to be relevant to human therapy. Direct intranasal application ensures minimal systemic exposure. As with other drugs, the use of Flixonase Nasule Drops during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
The excretion of fluticasone propionate into human breast milk has not been investigated. Subcutaneous administration of tritiated drug to lactating rats resulted in measurable radioactivity in both plasma and milk (levels in milk were 3-7 times plasma levels) 1-8 hours post-dosing. However plasma levels in patients following intranasal application of fluticasone propionate at recommended doses are low, and the amount of fluticasone ingested by the newborn is estimated to be very small as a consequence of very low maternal plasma concentration. As with other drugs, the use of Flixonase Nasule Drops during lactation requires that the benefits be weighed against possible risks associated with the product or with any alternative therapy.

4.8 Adverse Effects (Undesirable Effects)

Table 1 lists the drug related adverse events reported during the randomised treatment phase of the pivotal comparator trials (FLTB3045 and FLTB3046). These adverse events were considered by the investigator to be almost certainly, probably or possibly related to the study drug or of unknown or missing causality.
As with other intranasal products, dryness and irritation of the nose and throat may occur.
Unpleasant taste or smell, epistaxis and hypersensitivity reactions, including skin rash and oedema of the face and tongue, have been reported.
Following the use of intranasal corticosteroids there have been rare reports of anaphylaxis/ anaphylactoid reactions and bronchospasm. Cases of nasal septal perforation and nasal ulcers are very rare. There have also been very rare reports of glaucoma, raised intraocular pressure and cataract.

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 www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

For full therapeutic benefit regular usage is essential. Nasal polyps require regular medical assessment to monitor severity of the condition. The drops should be administered in a ‘head down’ position (see Section 4.2 Dose and Method of Administration, Instructions for use).

Adults and adolescents over 16 years old.

The contents of one container (400 microgram in 400 microL) to be instilled once or twice daily. The dose should be divided evenly between both affected nostrils.
Unilateral polyposis rarely occurs, and could be indicative of other conditions. Diagnosis should be confirmed by a specialist, and management individualised by them.

Elderly.

The normal adult dosage is applicable.

Children.

There are insufficient data at present to recommend the use of fluticasone propionate for the treatment of nasal polyps in children.

Instructions for use.

Gently blow each nostril, in turn, to clear. Open the foil pack by tearing off one side. Detach one Nasule and return the remaining containers, in the foil pack, to the carton. It is important to ensure that the contents of the container are well mixed before use. While holding the container horizontally by the larger tab, 'flick' the other end a few times and shake. Repeat this process several times until the entire contents of the container are completely mixed.
Hold the top of the container and flick or shake downwards with a quick motion. This will remove any liquid from the neck of the container. Hold then lower tab of the container securely and twist to remove the top.
The drops should be administered with the patient in the 'head down' position to ensure the medicine best reaches the affected area, as shown in the 'Instructions for use' leaflet inside the pack.
Flixonase Nasule Drops are for administration by the intranasal route only. Contact with the eyes should be avoided.
One Nasule holds enough drops for use in both nostrils.
Discard containers after use.

4.7 Effects on Ability to Drive and Use Machines

Fluticasone propionate is unlikely to produce an effect.

4.9 Overdose

There are no data available from patients on the effects of acute or chronic overdosage with Flixonase Nasule Drops. In healthy volunteers, intranasal administration of 2 mg fluticasone propionate twice daily for seven days had no effect on HPA axis function. Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function. In these patients, treatment with fluticasone propionate should be continued at a reduced dose sufficient to control symptoms; adrenal function generally recovers in a few days and can be verified by measuring plasma cortisol.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Special Precautions for Storage

Flixonase Nasule Drops should be stored below 30°C.
Condensation may form on the inside of the foil pack during storage, but it is not a cause for concern.
Store upright. Protect from direct sunlight. Do not freeze.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Flixonase Nasule Drops also contain the following excipients: polysorbate 20, sorbitan monolaurate, dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Flixonase Nasule Drops should be stored below 30°C.
Condensation may form on the inside of the foil pack during storage, but it is not a cause for concern.
Store upright. Protect from direct sunlight. Do not freeze.

6.5 Nature and Contents of Container

Flixonase Nasule Drops are packed as strips of seven polyethylene ampoules (Nasules) within foil wrapping. The Nasules are available in cartons containing 4 x strips of seven units.

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