SUMMARY CMI

AXOTIDE ACCUHALER, AXOTIDE JUNIOR ACCUHALER

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Axotide Accuhaler?

AXOTIDE ACCUHALER contains the active ingredient Fluticasone propionate. AXOTIDE ACCUHALERS are used reduce the swelling and irritation in the walls of the small air passages in your lungs.

For more information, see Section 1. Why am I using Axotide Accuhaler? in the full CMI.

2. What should I know before I use Axotide Accuhaler?

Do not use if you have ever had an allergic reaction to AXOTIDE ACCUHALER or any of the ingredients listed at the in the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Axotide Accuhaler? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AXOTIDE ACCUHALER and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Axotide Accuhaler?

• For adults: The usual dose is in the range of 100 to 1000 micrograms twice daily.
• For children: The usual dose is 100 micrograms twice daily.
• More instructions can be found in Section 4. How do I use Axotide Accuhaler? in the full CMI.

5. What should I know while using Axotide Accuhaler?

For more information, see Section 5. What should I know while using Axotide Accuhaler? in the full CMI

6. Are there any side effects?

If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. AXOTIDE ACCUHALER can cause eye problems (eg. cataract, glaucoma), loss of bone density, increase in the amount of sugar (glucose) in your blood and allergic reactions which may be severe. If you develop symptoms of an allergic reaction, call your doctor straight away or go straight to the Emergency Department at your nearest hospital. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

AXOTIDE ACCUHALER, AXOTIDE JUNIOR ACCUHALER

Active ingredient: Fluticasone propionate

Consumer Medicine Information (CMI)

This leaflet provides important information about using AXOTIDE ACCUHALER. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using AXOTIDE ACCUHALER.

Where to find information in this leaflet:

1. Why am I using Axotide Accuhaler?
2. What should I know before I use Axotide Accuhaler?
3. What if I am taking other medicines?
4. How do I use Axotide Accuhaler?
5. What should I know while using Axotide Accuhaler?
6. Are there any side effects?
7. Product details

1. Why am I using AXOTIDE ACCUHALER?

AXOTIDE ACCUHALER contains a steroid called fluticasone propionate which, reduces the swelling and irritation in the walls of the small air passages in your lungs.

AXOTIDE ACCUHALER contains the type of asthma medicine known as a 'preventer'. It does not give immediate relief from an asthma attack and may take up to a week to start to work. If your shortness of breath or wheeze does not get better after 7 days, tell your doctor. When used every day, your AXOTIDE ACCUHALER helps to ease breathing problems and prevent asthma attacks.

This medicine is only one part of a general plan to help you manage your asthma. You should discuss this plan with your doctor. You may also be using a 'reliever puffer'. Keep using it according to your doctor's advice. Ask your doctor to check your treatment regularly.

Ask your doctor if you have any questions about why AXOTIDE ACCUHALER has been prescribed for you.

The medicine in AXOTIDE ACCUHALER is not addictive.

2. What should I know before I use AXOTIDE ACCUHALER?

Warnings

Do not use AXOTIDE ACCUHALER if:

• you are allergic to fluticasone propionate, or any of the ingredients listed at the end of this leaflet.
• you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should. It is important that asthma is managed well during pregnancy and you should not stop your medicine without asking your doctor.
• the expiry date (EXP) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• have any other medical conditions.
• are taking other steroid medicines by mouth or inhalation. If you are already taking steroid tablets, you should carry a warning card about needing extra oral steroids during periods of stress e.g. worsening asthma attacks, chest infections, surgery, trauma and other major illnesses occurring at the same time.
• have ever had to stop taking other asthma medicines.
• have tuberculosis (TB) of the lung or other long term lung infection.
• are allergic to foods, dyes, preservatives or any other medicines.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Some medicines may interfere with AXOTIDE ACCUHALER and affect how it works.

For example, medicines like ketoconazole, used to treat fungal infection, and ritonavir used to treat HIV infection, may affect how AXOTIDE ACCUHALER works. If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.

Other types of asthma medicines

Your AXOTIDE ACCUHALER contains the kind of asthma medicine known as a 'preventer'. There are other types of inhalers that relieve your breathing problems when you are wheezing or your chest is tight. These medicines are called 'relievers'. Your doctor may tell you to use a 'reliever' in addition to your AXOTIDE ACCUHALER.

4. How do I use AXOTIDE ACCUHALER?

How to use it

Remember that the medicine in your AXOTIDE ACCUHALER is taken by inhalation only.

You will find the instructions on how to use your AXOTIDE ACCUHALER in the pack. Follow the instructions carefully.

How much to use

The pharmacist's label will usually tell you how many inhalations and how often to use your AXOTIDE ACCUHALER. If you are not sure, ask your doctor or pharmacist.

• For adults: The usual dose is in the range of 100 to 1000 micrograms twice daily.
• For children: The usual dose is 100 micrograms twice daily.
• Your doctor will decide what dose you should take, how often you should take it, and what strength of AXOTIDE ACCUHALER you should use.
• You should visit your doctor or pharmacist regularly to check that you are using your AXOTIDE ACCUHALER in the right way. If you are not breathing the medicine in correctly, the medicine may not be helping you as much as it could.

When not to use it

Do not use your AXOTIDE ACCUHALER to treat a sudden attack of breathlessness. You will need a different kind of medicine called a 'reliever' which your doctor will have told you to take.

How long to use AXOTIDE ACCUHALER

You must use your AXOTIDE ACCUHALER every day. Do not stop using it, even if you feel better, unless your doctor tells you.

If you forget to use AXOTIDE ACCUHALER

If it is almost time for your next dose, skip the dose you missed and take 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 take a double dose to make up for the dose you missed.

If you become wheezy or feel tight in the chest before the next dose is due, use a 'reliever puffer' in the usual way. You should get relief from your 'reliever puffer' within a few minutes

If you use too much AXOTIDE ACCUHALER

If you think that you have used too much AXOTIDE ACCUHALER, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using AXOTIDE ACCUHALER?

Things you should do

• Tell your doctor or pharmacist that you are using AXOTIDE ACCUHALER if you are about to be started on any new medicines.
• If you have to go into hospital for an operation, take your AXOTIDE ACCUHALER with you and tell the doctor what medicine(s) you are taking.
• 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.
• Use AXOTIDE ACCUHALER only in your nose.
  Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Call your doctor straight away if you:

• think you may be having an allergic reaction

Remind any doctor, dentist or pharmacist you visit that you are using AXOTIDE ACCUHALER.

Things you should not do

• Do not stop using AXOTIDE ACCUHALER 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 AXOTIDE ACCUHALER to treat any other complaints unless your doctor says to.
• Do not stop using this medicine suddenly.

Taking high doses of steroids for a long time this could affect the adrenal glands, which make the body's own steroid. Your doctor may do tests to check how the adrenal glands are working. Your doctor will be able to answer any questions you may have.

It is important that all doctors treating you are aware that you are on inhaled steroids. If your body is stressed by, for example, severe infection, surgical operation, an accident etc, you may need steroid tablets or injections for a time.

Driving or using machines

AXOTIDE ACCUHALER is unlikely to affect your ability to drive.

Looking after your medicine

• Store your AXOTIDE ACCUHALER upright, at below 30°C.
• Protect the drops from direct sunlight.
• Do not freeze.

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

• Do not leave in the car or on window sills.

Heat and dampness can destroy some medicines.

Store AXOTIDE ACCUHALER in the foil overwrap until you are ready to use it for the first time. Once opened the foil overwrap should be discarded.

Keep it 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.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

If your AXOTIDE ACCUHALER does not have the usual effect

If your chest condition gets worse, tell your doctor. Your doctor may tell you to take extra puffs of your AXOTIDE ACCUHALER or add another medicine (such as a 'reliever puffer') to your treatment.

IMPORTANT: IF YOUR BREATHING SUDDENLY BECOMES MORE DIFFICULT JUST AFTER YOU HAVE USED YOUR AXOTIDE ACCUHALER, YOU WILL NEED TO USE A 'RELIEVER PUFFER' AND TELL YOUR DOCTOR IMMEDIATELY.

Tell your doctor as soon as possible if:

• your 'reliever puffer' does not help your breathing as much as usual.
• the effect of your 'reliever puffer' does not last as long as usual.
• you need more puffs of your 'reliever puffer' than usual to get relief.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Less serious side effects

Serious side effects

There may be an increase in the amount of sugar (glucose) in your blood. If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetes treatment may be required.

It is possible that some people, particularly those taking higher doses of AXOTIDE ACCUHALER for a long time, may rarely suffer from the following side effects:

• rounded face
• loss of bone density
• eye problems (eg. cataract, glaucoma)
• slowing of growth in children. It is unclear what, if any, difference this makes to their final height
• Soreness in the food pipe.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What AXOTIDE ACCUHALER contains

Do not take this medicine if you are allergic to any of these ingredients.

What AXOTIDE ACCUHALER looks like

The AXOTIDE ACCUHALER is a plastic device which contains a foil strip inside. The foil strip has pockets (called blisters) which contain your medicine. The AXOTIDE ACCUHALER is packaged within a foil overwrap. The plastic device is labelled, "AXOTIDE ACCUHALER". Each device contains 60 blisters. Your AXOTIDE ACCUHALER has a dose counter which tells you how many doses are left. To let you know when you have reached the last five doses, the numbers appear in red.

JUNIOR ACCUHALER 100 micrograms of fluticasone propionate in a blister, 60 doses (AUST R 267493)

ACCUHALER 250 micrograms of fluticasone propionate in a blister, 60 doses (AUST R 267491)

Who distributes Axotide Accuhaler

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

This leaflet was prepared in November 2022.

Version 4.0

Published by MIMS February 2023

1 Name of Medicine

Fluticasone propionate.

2 Qualitative and Quantitative Composition

Axotide Accuhaler is a moulded plastic device containing a foil strip with regularly placed blisters each containing a mixture of microfine fluticasone propionate (100 micrograms or 250 micrograms) and larger particle size lactose monohydrate.
Axotide Inhaler contains a pressurised inhalation suspension, delivering either 50, 125 or 250 micrograms of fluticasone propionate per inhalation.

List of excipients with known effect.

3 Pharmaceutical Form

Axotide Accuhaler.

Axotide Inhaler.

4 Clinical Particulars

4.1 Therapeutic Indications

For use in the prophylactic management of asthma in adults and children of ages 1 year and older.

4.2 Dose and Method of Administration

Fluticasone propionate has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients receiving either no prophylactic treatment or other available anti-asthma therapy.
Axotide Accuhaler is administered via the inhaled route only.
Axotide Inhaler is administered via the inhaled route only. It is intended that each prescribed dose is given by a minimum of 2 inhalations.
In patients who find co-ordination of a pressurised metered-dose inhaler difficult, a spacer may be used with Axotide Inhaler.
Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. The onset of therapeutic effect is within 4 to 7 days.
If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
The dosage of fluticasone propionate should be adjusted according to the individual response.
See Section 6.5 Nature and Contents of Container for further information.
The Australian Asthma Handbook provides an additional source of reference information for prescribers.

Adults and children over 16 years.

Mild asthma.

Moderate asthma.

Severe asthma.

Children 1 year and older.

Special patient groups.

4.3 Contraindications

Axotide Accuhaler.

Axotide Inhaler.

4.4 Special Warnings and Precautions for Use

The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to increasing corticosteroid dosage. In patients considered at risk, daily peak flow monitoring may be instituted.
Lack of response or severe exacerbations of asthma may be an indication for review of the patient. Treatment options may include increasing the dose of inhaled fluticasone propionate and, if necessary, giving a systemic steroid and/or an antibiotic if there is an infection.
Axotide is not for use in acute attacks but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms.
Treatment with Axotide should not be stopped abruptly.
There have been very rare reports of increases in blood glucose levels (See Section 4.8 Adverse Effects (Undesirable Effects)) and this should be considered when prescribing to patients with a history of diabetes mellitus.
As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.
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.
As with other inhalation therapy, paradoxical bronchospasm may occur rarely, with an immediate increase in wheezing after dosing. This should be treated immediately with a fast and short-acting inhaled bronchodilator. Axotide should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted if necessary.

Axotide Inhaler.

Spacer devices.

Possible systemic effects, including adrenocortical function, bone density and growth.

Medical emergency.

Transfer of patients being treated with oral corticosteroids.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled 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.

4.7 Effects on Ability to Drive and Use Machines

Fluticasone propionate is unlikely to produce an effect.

4.8 Adverse Effects (Undesirable Effects)

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000) and very rare (< 1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.

Infections and infestations.

Immune system disorders.

Skin and subcutaneous tissue disorders.

Endocrine disorders.

Psychiatric disorders.

Metabolism and nutrition disorders.

Respiratory, thoracic and mediastinal disorders.

Reporting suspected adverse effects.

4.9 Overdose

Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action, as normal adrenal function typically recovers within a few days.
If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis occurring in children exposed to higher than approved doses (typically 1000 micrograms daily and above), over prolonged periods (several months or years). Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, hypoglycaemia, and seizures. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in dosage. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
It is not recommended that patients receive higher than approved doses. It is important to review therapy regularly and titrate down to the lowest dose at which effective control of disease is maintained (See Section 4.2 Dose and Method of Administration).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Fluticasone propionate inhaler and accuhaler.

Fluticasone propionate inhaler.

5.2 Pharmacokinetic Properties

Following inhaled doses of 2000 micrograms per day (1000 micrograms twice daily) for 14 days in healthy volunteers, peak plasma concentrations of about 0.3 nanogram/mL were observed at 30-60 minutes post-dosing.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Axotide Inhaler also contains the excipient norflurane which is a CFC-free propellant.
Axotide Accuhaler also contains the excipient lactose monohydrate (which contains milk protein).

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

Axotide Accuhalers and Junior Accuhalers should be stored below 30°C.
Store in a dry place.
Junior (CFC-Free) Inhalers and CFC-Free Inhalers should be stored between 2°C and 30°C. Protect from frost and direct sunlight. As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold. Warning: Do not expose to temperatures higher than 50°C. The canister should not be punctured, broken or burnt even when apparently empty.
Replace the mouthpiece cover firmly and snap it into position.

6.5 Nature and Contents of Container

1. Axotide Inhaler.

2. Dry powder inhalers.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical name: S-Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1, 4-diene-17β-carbothioate.
Molecular formula: C₂₅H₃₁F₃O₅S.

Chemical structure.

Description.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes