Consumer medicine information

Tilade CFC-Free Inhaler

Nedocromil sodium

BRAND INFORMATION

Brand name

Tilade CFC-Free

Active ingredient

Nedocromil sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tilade CFC-Free Inhaler.

What is in this leaflet

This leaflet answers some common questions about Tilade CFC-Free Inhaler.

It does not contain all the information that is known about Tilade CFC-Free Inhaler. 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 using Tilade CFC-Free Inhaler against the benefits they expect it will 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 Tilade CFC-Free Inhaler is used for

Tilade CFC-Free Inhaler is inhaled into the lungs for the preventive treatment of mild to moderate asthma.

Asthma is a disease where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, pollens, smoke, air-borne pollution or other irritants.

Tilade CFC-Free Inhaler is used to prevent bronchial asthma due to allergy, exercise, cold air or irritants, in both adults and children over two years of age.

Tilade CFC-Free Inhaler works by reducing the inflammation of the airways which occurs in asthma.

With regular use, Tilade CFC-Free Inhaler will help prevent asthma symptoms from occurring.

Tilade CFC-Free Inhaler will not relieve the symptoms of an asthma attack once the attack has started.

You should follow your doctor's advice and prescribed treatment to get relief from a sudden asthma attack. Your doctor may have prescribed Tilade CFC-Free Inhaler for another reason.

Ask your doctor if you have any questions about why Tilade CFC-Free Inhaler has been prescribed for you. This medicine is only available with a doctor's prescription.

There is no evidence that Tilade CFC-Free Inhaler is addictive.

This product contains HFA-227, a non-ozone depleting propellant gas, which has been introduced as a replacement for the environmentally damaging chlorofluorocarbons (CFC's). This product contains no CFC's.

Before you use Tilade CFC-Free Inhaler

When you must not use it

Do not use Tilade CFC-Free Inhaler if you have an allergy to Tilade CFC-Free Inhaler or any of the ingredients listed at the end of this leaflet. If you have an allergic reaction you may get a skin rash, have difficulty in breathing, get symptoms of hayfever or feel faint.

Do not use Tilade CFC-Free Inhaler after the expiry date (EXP) printed on the pack. If you use this medicine after the expiry date has passed, it may not work as well.

Do not use Tilade CFC-Free Inhaler if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start using Tilade CFC-Free Inhaler, contact your doctor or pharmacist.

Before you use it

Ask your doctor to write an asthma management plan for you before you begin to use Tilade CFC-Free Inhaler. Tilade CFC-Free Inhaler is only one part of a general plan to help you manage your asthma.

You should discuss this plan regularly with your doctor to check your treatment. As part of your asthma management plan you will probably need to take another sort of medicine called a "reliever" to relieve the symptoms of an asthma attack which has started.

If you need treatment for a sudden asthma attack, use the "reliever" medicine your doctor has prescribed for you.

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed. Tilade CFC-Free Inhaler is not known to be harmful in pregnancy or while breast-feeding.

However, if you are pregnant or breast-feeding, you should discuss with your doctor the risks and benefits involved, before using Tilade CFC-Free Inhaler.

Taking other medicines

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

Tilade CFC-Free Inhaler can be used with most other medicines which are used to prevent or treat asthma.

How to use Tilade CFC-Free Inhaler

If you are not sure how to use an inhaler, ask your doctor or pharmacist.

Children should only use their inhaler on medical advice and with the help of an adult.

If the inhaler is new, it should be primed by pressing the inhaler 4 times before using. If the inhaler is not used for more than 3 days, prime it with 2 puffs before using.

It is important to use Tilade CFC-Free Inhaler exactly as your doctor or pharmacist has told you.

How much to use

Your doctor will tell you how many puffs to take each day. The usual dose is two puffs two to four times daily. Take Tilade CFC-Free Inhaler only as prescribed by your doctor and follow his or her directions carefully.

Do not use it more often than prescribed.

How to use it

It is important that these instructions are followed closely to make sure the correct dose of Tilade CFC-Free Inhaler reaches your lungs.

  1. Remove the cap from the plastic mouthpiece.

  1. Shake the inhaler well.
  2. Hold the inhaler well away from your mouth. Breathe out slowly. DO NOT BREATHE OUT THROUGH THE INHALER. It will clog the inhaler valve.

  1. Place the inhaler in your mouth and close your lips around it. While breathing in slowly and deeply, press the metal canister firmly and continue to breathe in.

  1. Remove the inhaler from your mouth. Hold your breath for 10 seconds, or for as long as is comfortable. Then breathe out slowly.

  1. Wait 1 minute then repeat steps 2 to 5 if another puff is required.
  2. After use, replace the cap on the mouthpiece.

This is one of several acceptable inhalation techniques for aerosols.

If your doctor or pharmacist has suggested another method, you should use that method. Good inhaler technique is essential and should be checked frequently.

When to use it

It is important that you continue taking Tilade CFC-Free Inhaler, even when you are feeling well, to achieve the best result from this medication.

If you are not sure when to use it, ask your doctor or pharmacist.

If you forget to use it

If you forget to use your Tilade CFC-Free Inhaler, just take the next dose when it is due, and then go back to using your medicine as you would normally.

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 doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

How long to use it

Tilade CFC-Free Inhaler helps control your condition. Therefore you must use Tilade CFC-Free Inhaler every day. Continue using the medicine for as long as your doctor or pharmacist tells you.

Do not stop using it unless your doctor or pharmacist tells you to - even if you feel better.

If you take too much (overdose)

Excessive inhalation of the aerosol should be avoided as large doses of the propellants may be hazardous.

In the case of accidental overdose immediately ask your doctor or Poisons Information Centre (Australia telephone 13 11 26 or New Zealand telephone 0800 764 766) for advice.

While you are using it

Things you must do

If you have an Asthma Action Plan that you have agreed with your doctor, follow it closely at all times.

Continue using Tilade CFC-Free Inhaler for as long as your doctor or pharmacist tells you.

Visit your doctor regularly to check on your asthma condition.

Good inhaler technique is very important and should be checked by your doctor regularly. Your doctor or pharmacist may suggest you use a spacer device to help you.

Tell any other doctors, dentists and pharmacists who are treating you that you are using Tilade CFC-Free Inhaler.

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using Tilade CFC-Free Inhaler.

If you become pregnant, while using Tilade CFC-Free Inhaler, tell your doctor or pharmacist.

Things you must not do

Do not take any other medicines for your breathing problems without checking with your doctor.

Do not give Tilade CFC-Free Inhaler to anyone else, even if they have the same condition as you.

Do not use Tilade CFC-Free Inhaler to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop using Tilade CFC-Free Inhaler or lower the dosage, without checking with your doctor or pharmacist.

Do not use Tilade CFC-Free Inhaler to relieve acute attacks of asthma. If you become wheezy or tight in the chest, use a 'reliever puffer' in the usual way.

Side Effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Tilade CFC-Free Inhaler. It helps most people with asthma, but it may have unwanted side effects in a few people.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • fever
  • headache
  • nausea
  • vomiting
  • stomach upset or stomach pains

These side effects are usually mild and short-lived.

The following side effects can occur with any inhaled medicine:

  • cough, sore throat
  • unpleasant taste in your mouth
  • breathing difficulties

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some people.

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

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

If you get any side effects, do not stop using Tilade CFC-Free Inhaler without first talking to your doctor or pharmacist.

After using it

Cleaning Instructions

This pack contains an extra mouthpiece which can be used while the other mouthpiece is being dried after washing.

Tilade CFC-Free Inhaler does not contain CFC, which harms the environment, and contributes to the depletion of the ozone layer. The propellant used is more environmentally friendly and is in keeping with our responsibility to support the phasing out of all CFC-containing products. Unfortunately, this propellant tends to result in some blockage in the mouthpiece which can only be prevented by daily cleaning and drying of the mouthpiece. It is therefore very important to keep Tilade CFC-Free Inhaler clean and dry to prevent the build up of excess powder in the mouthpiece which can then be difficult to remove and cause blockage to occur.

YOUR MOUTHPIECE MUST BE REGULARLY CLEANED AND DRIED.

FOR BEST RESULTS WASH MOUTHPIECE EVERY NIGHT TO PREVENT BUILD UP OF EXCESS POWDER WHICH CAN CAUSE A BLOCKAGE.

Follow Instructions Below

  1. Remove cap and metal canister from mouthpiece before washing.

  1. Wash the plastic mouthpiece in hand-hot water through the top for a minute.

  1. Wash through the bottom for a minute.

  1. Shake out excess water from inside by tapping the mouthpiece on a hard surface.

  1. Leave overnight or as long as possible to dry thoroughly. In humid conditions you may need to leave the mouthpiece to dry for a longer period of time.

  1. Before replacing the canister into the mouthpiece make sure that the white rubber cap firmly sits onto the metal canister.

  1. When the mouthpiece is completely dry replace the metal canister.

IMPORTANT:
Never try to unblock the mouthpiece with a pin - this will damage the inhaler. Never wash the metal canister.

If the inhaler is blocked you may wish to take the added step of soaking the mouthpiece in hot water for 20 minutes after removing the canister, then following steps 2 - 7 above.

For further instructions please call Australia 1800 818 806 or New Zealand 0800 283 684.

Storage

Keep your inhaler in a cool dry place where the temperature stays below 30°C. Do not freeze. Protect from light.

Do not leave Tilade CFC-Free Inhaler in the car on hot days or on window sills. Heat, light and dampness can destroy some medicines.

Do not store Tilade CFC-Free Inhaler or any other medicine in the bathroom or near a sink or stove.

Keep Tilade CFC-Free Inhaler where young children cannot reach it. A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop using Tilade CFC-Free Inhaler or it has passed its expiry date, ask your pharmacist what to do with any that are left over.

Do not puncture the container or throw it into a fire.

Product description

What it looks like

Tilade CFC-Free Inhaler is supplied in a canister containing 112 puffs and an additional mouthpiece.

Ingredients

Active ingredient:

  • 2mg nedocromil sodium per puff

Inactive ingredients:

  • apaflurane
  • povidone
  • macrogol 600
  • menthol.

Tilade CFC-Free Inhaler does not contain any chlorofluorocarbons (CFCs).

Sponsor

Distributed in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park, NSW 2113
Freecall No: 1800 818 806

Distributed in New Zealand by:

sanofi-aventis new zealand limited
Level 8, 56 Cawley Street
Ellerslie
Auckland
Freecall No: 0800 283 684

Tilade CFC-Free Inhaler is made in the United Kingdom.

This leaflet was revised April 2020.

Australian Register Number

AUST R 70238

tilade-ccdsv4-cmiv7-30apr20

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Tilade CFC-Free

Active ingredient

Nedocromil sodium

Schedule

S4

 

1 Name of Medicine

Nedocromil sodium.

2 Qualitative and Quantitative Composition

Each actuation contains nedocromil sodium 2 mg. Menthol flavoured.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pressurised inhalation.
Tilade CFC-Free contains nedocromil sodium as a suspension in a non-CFC propellant.

4 Clinical Particulars

4.1 Therapeutic Indications

Tilade CFC-Free is indicated for the prophylactic treatment of mild to moderate persistent asthma in adults and frequent episodic asthma in children aged over two years, and for the prevention of bronchospasm provoked by exercise, cold air, inhaled allergens, atmospheric pollutants and other irritants.

4.2 Dose and Method of Administration

Adults (including the elderly) and children over 2 years of age.

The recommended initial dosage is two actuations (each yielding 2 mg of nedocromil sodium) four times daily. Some patients who have demonstrated a good response to therapy and whose asthma is stable may be able to reduce the dose to two actuations twice daily. This may take more than one week of regular use.
The efficacy of Tilade CFC-Free in children under 2 years of age has not been established.
Tilade CFC-Free, in a single dose of two actuations (4 mg) a few minutes before exposure, affords protection for several hours against bronchospasm provoked by exercise, cold air, inhaled allergens, atmospheric pollutants and other irritants.
Most patients will benefit from the consistent use of a spacer device with their metered dose inhaler (MDI or puffer), particularly those with poor inhaler technique. Use of a spacer will also decrease the amount of drug deposited in the mouth and back of the throat, and therefore, reduce the incidence of local side effects such as mouth and throat irritation and hoarse voice.
In those people using a spacer, a change in formulation of the drug used, or a change in the make of spacer may be associated with alterations in the amount of drug delivered to the lungs. The clinical significance of these alterations is uncertain. However, in these situations, the person should be monitored for any loss of asthma control.
The patient should be instructed to closely follow the instructions for the proper use of the spacer.
Static on the walls of the spacer may cause variability in drug delivery. Patients should be instructed to wash the spacer in warm water and detergent and allow it to dry without rinsing or drying with a cloth. This should be performed before initial use of the spacer and at least monthly thereafter.

4.3 Contraindications

Known hypersensitivity to nedocromil sodium, or any of the other excipients.

4.4 Special Warnings and Precautions for Use

Tilade CFC-Free contains a hydrofluoroalkane propellant (apaflurane). In animal studies, narcosis and sensitisation to the arrhythmogenic effects of adrenaline were observed following inhalation of apaflurane at high exposure concentrations. The potency of the cardiac sensitisation was less than that of trichlorofluoromethane (CFC-11). In humans, apaflurane is absorbed into the circulation following inhalation administration, although the plasma concentrations are low and elimination is rapid. Excessive use of Tilade CFC-Free should be avoided as this carries a potential hazard, both from the propellant as well as from overdosage of the active drug in the formulation.
Tilade CFC-Free is intended for regular prophylactic treatment and not for symptomatic relief.
Tilade CFC-Free should not be used in preference to steroids in patients with severe rapidly worsening asthma. The role of Tilade CFC-Free in stable asthmatics controlled with inhaled steroids to enable a reduction of steroid dose is not clear and if this is planned, the steroid reduction should be gradual and the patient closely monitored. Tilade CFC-Free is not a bronchodilator and should not be used as an alternative to bronchodilator although its regular use may reduce the need for bronchodilators.

Information for patients.

Tilade CFC-Free should not be used for the relief of an acute attack of bronchospasm.
Regular use of Tilade CFC-Free is usually required. Patients should not stop Tilade CFC-Free treatment abruptly unless directed to by a doctor.
Good inhaler technique is essential and should be checked frequently. The use of a spacer device may be helpful to facilitate inhalation of the drug by those patients who are unable to use the metered dose inhaler efficiently.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Tilade CFC-Free has been used in association with numerous other drugs in man including beta-adrenergic agonists, inhaled and oral corticosteriods, theophylline and other methylxanthines, and ipratropium bromide. No harmful interactions have been observed in humans or in animals.
In patients already receiving treatment for their asthma, Tilade CFC-Free may be given in addition to existing therapies and will in many cases provide added therapeutic benefit. Having established this benefit of Tilade CFC-Free, it may be possible to eliminate or reduce concomitant therapy.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
Small amounts of nedocromil sodium are known to cross the placenta but without effect in animals. Animal studies have not shown any teratogenic or other adverse effects on reproductive parameters in mice, rats and rabbits dosed subcutaneously with nedocromil sodium at doses up to 100 mg/kg/day. However as with all new medicines, caution should be exercised, especially during the first trimester of pregnancy.
On the basis of animal studies and its physicochemical properties, it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. The concentrations of nedocromil sodium in milk of animals was very low but concentrations in human breast milk have not been established. Animal studies have indicated no adverse effect of nedocromil sodium in suckling newborn rats receiving the drug from the parent (dosed subcutaneously at 100 mg/kg/day) or directly by subcutaneous injection (100 mg/kg/day). There is no information to suggest that the use of nedocromil sodium by nursing mothers has any undesirable effects on the baby; however, the benefits to a nursing mother must be weighed against the potential risk to the child.

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.

4.8 Adverse Effects (Undesirable Effects)

Few side effects have been reported, principally headache (5%) and upper gastrointestinal symptoms (nausea, vomiting, dyspepsia and abdominal pain) (< 5%). These are usually mild and transient.
In common with other inhaled medications, Tilade CFC-Free may produce cough, pharyngitis or bronchospasm. Unusual or unpleasant taste may occur.
Adverse experiences reported among patients treated with Tilade or Tilade CFC-Free during comparative clinical trials in adults, or long-term treatment in children, are shown in Table 1. Included are all adverse experiences occurring with an incidence of 1% or greater in any treatment group, and judged to be treatment related.
The paediatric data presented in Table 1 have all been generated from a single uncontrolled open label long-term safety study. A comparison with the overall reporting in this trial shows that the percentage of adverse events rated as "related to test drug" is unusually high (approximately 30% of the total) compared to previous findings including paediatric studies on nedocromil sodium where this rate was 1-10%.

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 (Australia).

4.9 Overdose

Animal studies have not shown evidence of toxic effects of nedocromil sodium even at extremely high dosage, nor have extended human studies revealed any safety hazard with the drug.
Overdosage is therefore unlikely to cause problems. However, if overdosage is suspected, treatment should be supportive and directed to the control of the relevant symptoms.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs for obstructive airway diseases, Antiallergic agents, excluding corticosteroids, ATC code: R03BC.

Mechanism of action.

Nedocromil sodium inhibits the release of inflammatory mediators from a variety of cell types occurring in the lumen and in the mucosa of the bronchial tree. Laboratory experiments have shown that nedocromil sodium prevents the release of inflammatory chemotactic and smooth muscle contracting mediators which are preformed or derived from arachidonic acid metabolism by both the lipoxygenase and cyclo-oxygenase pathways in a range of human and animal leucocytes. In the Ascaris suum sensitised monkey subjected to bronchial challenge with specific antigen, nedocromil sodium provides protection against changes in airways resistance and lung compliance. Nedocromil sodium prevents the release of mediators such as histamine, LTC4 and PGD2 from the cellular population of the chronically inflamed bronchus. There is growing evidence that these mediators are important also in lung disease in man, and this additional activity may be expected to give nedocromil sodium extended scope in the management of bronchial asthma in which inflammation, allergy and bronchial hyper-responsiveness are significant physiological factors.

Clinical trials.

In the management of asthma, Tilade CFC-Free improves pulmonary function, reduces the frequency and severity of attacks and reduces bronchospasm, cough and bronchial hyper-reactivity.
In challenge studies, a single dose of Tilade CFC-Free afforded protection against bronchospasm provoked by exercise, inhaled allergens, cold air, atmospheric pollutants and other irritants. Continuous administration of Tilade CFC-Free reduces the bronchial hyper-reactivity seen in many patients with reversible obstructive airways disease.

5.2 Pharmacokinetic Properties

The pharmacokinetic profile of nedocromil is similar in healthy volunteers and in patients with bronchial asthma.

Absorption.

After inhalation, nedocromil sodium is deposited throughout the respiratory tract, from which about 5% of the dose is absorbed. By the nature of inhalation dosing, much of the delivered dose is swallowed directly or subsequently upon mucociliary clearance from the large airways. A small amount of nedocromil sodium is subsequently absorbed from the gastrointestinal tract. Since the absorption rate constant from the respiratory tract is slower than the elimination rate constant in bile and urine, the terminal half life (1.5-2 hours) reflects the rate of lung absorption. The drug is cleared sufficiently rapidly from the circulation so that successive doses according to the recommended regimen do not accumulate.

Distribution.

Nedocromil sodium is bound (up to 89%) reversibly to human plasma proteins and to a lesser extent in animals.

Metabolism.

It is not metabolised in man or in animals.

Excretion.

It is excreted unchanged in the urine (in man, approximately 70%) and in faeces (in man, approximately 30%). While the plasma concentration falls rapidly (i.e. to 10% of peak levels in 8 hours) and urinary excretion is 90% complete within 12 hours, faecal elimination may take up to 3 days to be completed.

5.3 Preclinical Safety Data

Genotoxicity.

Nedocromil showed no conclusive evidence of genotoxic activity in a standard battery of assays.

Carcinogenicity.

A two year inhalation study in rats and a 21 month dietary study in mice showed no evidence of carcinogenic activity of nedocromil sodium at doses up to 25 and 180 mg/kg/day respectively; systemic exposure at these doses (based on time weighted concentration of unbound drug in plasma) was about 20 times greater than that in humans receiving the maximum recommended dose.

6 Pharmaceutical Particulars

6.1 List of Excipients

Apaflurane, povidone, macrogol 600, and menthol.

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

Store below 30°C away from direct sunlight but do not freeze. The canister is pressurised and must not be punctured or burnt even when empty.

6.5 Nature and Contents of Container

Aerosol can. 112 metered doses. An additional mouthpiece has been supplied to assist in the cleaning and maintenance of the Tilade CFC-Free Inhaler.

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

Nedocromil sodium (disodium 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4H-pyrano-(3,2-g)quinoline-2,8-dicarboxylate).

Chemical structure.


CAS number.

69049-74-74.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes