Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium
Arquist is indicated for the treatment of asthma in adults and adolescents over 16 years of age. Arquist is also indicated for the treatment of severe COPD in conjunction with a long-acting beta agonist (such as salmeterol) for use in adults.
Arquist is for inhalation by oral inhalation only.
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 4 to 7 days, although some benefit may be apparent as soon as 24 hours for patients who have not previously received inhaled steroids.
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.
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 volumatic spacer may be used with Arquist inhaler.
The dosage of fluticasone propionate should be adjusted according to the individual response.
100 to 1000 micrograms twice daily.
Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease:
Mild asthma: up to 250 micrograms twice daily Moderate asthma: 250 to 500 micrograms twice daily.
Severe asthma: 500 to 1000 micrograms twice daily.
The dose may then be adjusted until control is achieved or reduced to the minimum effective dose, according to the individual response.
Alternatively, the starting dose of fluticasone propionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent as administered by metered-dose inhaler.
500 micrograms twice daily, in conjunction with a long-acting beta agonist (such as salmeterol).
Medication must be used daily for optimum benefit which may take three to six months. If there is no improvement after three to six months then the patient should undergo medical assessment.
Only the 250 microgram device is suitable for the administration of this dose.
There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.
Arquist are recommended for asthma in adults and adolescents over 16 years of age and Chronic Obstructive Pulmonary Disease (COPD) in adults only.
It is important to instruct the patient about correct inhalation technique (see package leaflet and instructions for use).
Testing your inhaler:
1. When using your inhaler for the first time, test it to ensure that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.
2. To make sure that it works, shake the inhaler well, point the mouthpiece away from you and press the canister to release four puffs into the air. If you have not used the inhaler for five days or more, release two puffs of medicine into the air.
Using your inhaler:
It is important to start to breathe as slowly as possible just before using your inhaler.
1. Stand up or sit upright when using your inhaler.
2. Remove the mouth piece cover. Check inside and outside to make sure that the mouthpiece is clean and free of objects.
3. Shake the inhaler 4 or 5 times to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable. Do not breathe in again yet.
5. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.
6. Breathe in through your mouth. Just after starting to breathe in, press down on the top of the canister to release a puff of medicine. Do this while still breathing in steadily and deeply.
7. Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable.
8. If your doctor has told you to take two puffs, wait about half a minute before you take another puff by repeating steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out.
10. After use always replace the mouthpiece cover straight away to keep out dust. Replace the cover by firmly pushing and clicking into position.
11. Practise in front of a mirror for the first few times. If you see’mist’coming from the top of your inhaler or the sides of your mouth you should start again.
12. Older children or people with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece. If this does not help, Volumatic spacer device may make it easier. Your doctor, nurse or pharmacist will be able to advise you.
Cleaning your inhaler:
To prevent your inhaler blocking, it is important to clean it at least once a week.
To clean your inhaler:
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) observed features included hypoglycaemia and sequelae of decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in dosage.
Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.
2 years.
In-use shelf-life: 3 months after opening the foil pouch.
Do not store above 30°C. Do not refrigerate or freeze.
Protect from direct sunlight.
As with most medicines in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold. If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands for a few minutes before use. Never use anything else to warm it up. Replace the mouth piece cover firmly and snap into position.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50ºC. Do not pierce the canister.
An inhaler comprising an aluminium alloy canister sealed with a metering valve, actuator and cap. Each canister contains 120 metered actuations.
Pack sizes: 1 or 2 canisters. Each canister contains 120 metered actuations.
Not all pack sizes may be marketed.
No special requirements for disposal.
Patients should be carefully instructed in the correct use of the inhaler (see section 4.2).
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