Airsus

Package leaflet: Information for the patient

Airsus 25 micrograms / 50 micrograms per dose, pressurised suspension for inhalation
Airsus 25 micrograms / 125 micrograms per dose, pressurised suspension for inhalation
Airsus 25 micrograms / 250 micrograms per dose, pressurised suspension for inhalation
Salmeterol (as xinafoate) / fluticasone propionate
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms appear to be the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Airsus is and what it is used for
2. What you need to know before using Airsus
3. How to use Airsus
4. Possible side effects
5. How to store Airsus
6. Contents of the pack and other information

1. What Airsus is and what it is used for

Airsus contains two active substances: salmeterol (as xinafoate) and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open, allowing air to flow in and out more easily. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Airsus every day as directed by your doctor. This will ensure effective control of your asthma.
Airsus helps prevent breathlessness and wheezing. However, Airsus must not be used to relieve a sudden attack of breathlessness or wheezing. If this occurs, you must use your fast-acting “reliever” inhaler (rescue inhaler), such as salbutamol. You must always carry your fast-acting “reliever” inhaler with you.

2. What you need to know before using Airsus

Do not use Airsus:

• If you are allergic (hypersensitive) to salmeterol, fluticasone propionate, or to the excipient norflurane (HFA 134a).

Warnings and precautions
Talk to your doctor or pharmacist before using Airsus. Your doctor will more closely monitor your
treatment if you have any of the following medical conditions:

• heart disease, including irregular or rapid heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (Airsus may increase blood sugar levels)
• low levels of potassium in the blood
• tuberculosis (TB), either currently or in the past, or other lung infections

If you have ever suffered from any of these conditions, inform your doctor before using Airsus.
For those engaged in sports: using this medicine without therapeutic need constitutes doping
and may lead to a positive result in anti-doping tests.

Other medicines and Airsus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines for asthma or any other medicines obtained without a prescription. This is because Airsus may not be suitable to take together with certain other medicines.
Before starting to use Airsus, inform your doctor if you are taking any of the following medicines:

• Beta-blockers (such as atenolol, propranolol, sotalol). Beta-blockers are mainly used for high blood pressure or other heart problems.
• Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole, and erythromycin). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase the risk of side effects with Airsus, including irregular heartbeat, or may worsen existing side effects.
• Corticosteroids (taken by mouth or by injection). If you have recently taken these medicines, this may increase the risk that this medicine will affect your adrenal gland.
• Diuretics, also known as "water pills", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
It is unlikely that Airsus will affect your ability to drive or operate machinery.

3. How to use Airsus

Always use Airsus exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• Use Airsus every day until your doctor tells you to stop treatment. Do not take a higher dose than recommended. If you are uncertain, consult your doctor or pharmacist.
• Do not stop taking Airsus or reduce the dose of Airsus without first speaking to your doctor.
• Airsus must be inhaled into the lungs through the mouth.
• Always keep track of the number of actuations when using Airsus. The inhaler is designed to deliver 120 actuations. However, it is not possible to determine when the inhaler is empty or when the 120 sprays have been used. There may still be a small amount of liquid remaining in the container. Make sure the inhaler is replaced after you have used 120 sprays, so you can be sure of receiving the correct amount of medication with each spray.

Adults and adolescents aged over 12 years

• Airsus 25/50 – 2 sprays twice daily
• Airsus 25/125 – 2 sprays twice daily
• Airsus 25/250 – 2 sprays twice daily

Children aged 4 to 12 years

• Airsus 25/50 – 2 sprays twice daily
• Airsus is not recommended for use in children under 4 years of age.

Your symptoms may be well controlled by using Airsus twice daily. If this occurs, your doctor may decide to reduce the dose to once daily. The dose may be adjusted as follows:

• once in the evening – if you have night-time symptoms
• once in the morning – if you have day-time symptoms

It is very important to follow your doctor’s instructions regarding the number of sprays and how often to take the medication. If you are using Airsus for asthma, your doctor will regularly monitor your symptoms.
However, if your asthma or breathing worsens, contact your doctor immediately. You may notice that your breathing becomes more laboured, that you experience chest tightness more frequently, or that you need to use your rapid-acting “reliever” medication more often. If any of these occur, continue taking Airsus but do not increase the number of actuations. Your respiratory condition may be worsening and you could become seriously ill. Contact your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use your inhaler. They should also check your inhaler technique at regular intervals. Incorrect or improper use of Airsus may result in the medication not working as intended for the treatment of your asthma.
• The medication is contained in a pressurized canister housed in a plastic inhaler with a mouthpiece.
• A new, full inhaler contains enough medication to deliver a minimum of 120 inhalations. After 120 sprays, the inhaler may no longer contain sufficient medication to deliver a complete dose.

Checking the inhaler function

1. When using the inhaler for the first time, check that it works. To test the inhaler, remove the protective mouthpiece cap by gently pressing the sides with your thumb and index finger and pulling it off.
2. To ensure the inhaler is working, shake it well, point the mouthpiece away from yourself, and press down firmly on the canister to release one spray into the air. Repeat this step, shaking the inhaler before releasing a second spray into the air. The total number of test sprays into the air before using the inhaler should be two.
3. After these two test sprays, you may begin using your inhaler.
4. If you have not used your inhaler for a week or more, check its function. To test the inhaler, shake it well, point the mouthpiece away from yourself, and press down firmly on the canister to release two sprays into the air.

Warnings
Never remove the metal canister from the inhaler.
If the inhaler becomes very cold (below 0°C), remove the metal canister from the plastic inhaler and warm it in your hands for a few minutes before use. Do not use any other method to warm it. After warming and before use, press down firmly on the canister to release two sprays into the air.

Ordering a new inhaler
Before your inhaler runs out of doses, you must order a new inhaler to ensure you do not run out of medication.

Using the inhaler
It is important to begin breathing in as slowly as possible just before using the inhaler.

1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cap (Figure A).
3. Check inside and outside to ensure the mouthpiece is clean and free of dust or foreign objects.
4. Shake the inhaler 4 or 5 times to ensure the contents are well mixed (Figure B).
5. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as much as possible (Figure C).
6. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.
7. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press down firmly on the top of the canister to release one spray of medication. Do this while continuing to inhale steadily and deeply (Figure D).
8. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as possible.
9. Wait about half a minute between taking one spray and the next, then repeat steps 4 to 8.
10. Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent the occurrence of oral candidiasis and hoarseness.
11. After use, always replace the mouthpiece cap to keep out dust (Figure E). When the mouthpiece cap is correctly positioned, it will click into place. Do not use excessive force.

Do not rush steps 5, 6, 7, and 8. It is important that you breathe in as slowly as possible before using the inhaler. Use your inhaler in front of a mirror the first few times.
If you see a “mist” coming from the top of the inhaler or from the sides of your mouth, go back to step 4.
As with all inhalers, caregivers must ensure that children prescribed Airsus use the correct inhalation technique as described above.
If you or your child finds it difficult to use the inhaler, your doctor or another healthcare professional may recommend using an AeroChamber Plus® spacer device with the inhaler. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the spacer with the inhaler, how to care for the spacer, and answer any questions you may have. It is important that if you are using a spacer with the inhaler, you do not stop using it without first discussing it with your doctor, nurse, or pharmacist. Other spacers are not recommended for use with Airsus, and you should not replace the AeroChamber Plus® spacer with another. It is also important that you do not change or stop using the spacer without discussing it with your doctor, who will advise you on how to adjust your therapy. Always speak with your doctor before making any changes to your asthma treatment.
People with weak hands may find it easier to hold the inhaler with both hands. Place your two index fingers on top of the inhaler and your thumbs below the mouthpiece.

Cleaning the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Never remove the metal canister from the plastic inhaler under any circumstances.
• Clean the outside and inside of the mouthpiece and the plastic housing with a dry cloth or tissue.
• Replace the mouthpiece cap. When correctly positioned, it will make a “click” sound. Do not use excessive force.
• Do not wash or immerse any part of your inhaler in water.

If you use more Airsus than you should
It is important to use the inhaler as instructed. If you accidentally use more than the recommended dose, consult your doctor or pharmacist. You may notice your heart beating faster than usual and feel tremors. You may also experience dizziness, headache, muscle weakness, and joint pain.
If you have used higher doses for a prolonged period, speak to your doctor or pharmacist for advice. This is because higher doses of Airsus may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to take Airsus
Do not take a double dose to make up for a forgotten dose. Take the next dose at your usual time.

If you stop treatment with Airsus
It is very important that you take Airsus every day as prescribed. Continue taking it until your doctor tells you to stop. Do not stop taking it or suddenly reduce your dose of Airsus. This could worsen your breathing.
Additionally, if you abruptly stop taking Airsus or reduce the dose, this could (very rarely) cause problems with the adrenal gland (adrenal insufficiency), which may sometimes lead to adverse effects.
These adverse effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Vomiting and diarrhoea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (fits)

When your body is under stress due to fever, trauma (such as after a car accident), infection, or surgery, adrenal insufficiency may worsen and you may experience some of the adverse effects listed above.
If you notice any of these adverse effects, contact your doctor or pharmacist. To prevent these symptoms from occurring, your doctor may prescribe additional corticosteroid tablets (such as prednisolone).

If you have any questions about using this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of Airsus capable of controlling your asthma.

Allergic reactions: You may notice that your breathing suddenly worsens after taking Airsus. You may experience severe shortness of breath, coughing, or difficulty breathing. You might also develop itching, a skin rash (urticaria), or swelling (typically of the face, lips, tongue, or throat), or you may suddenly feel your heart beating very fast, or feel weak or dizzy (which could cause you to collapse or lose consciousness). If you notice any of these effects, or if they occur suddenly after using Airsus, stop using Airsus immediately and contact your doctor without delay. Allergic reactions to Airsus are uncommon (affecting fewer than 1 in 100 people).

Other side effects are listed below:

Very common (may affect more than 1 in 10 people)

• Headache – this usually improves as treatment continues.
• In patients with COPD, an increased frequency of colds has been reported.

Common (may affect up to 1 in 10 people)

• Oral or throat candidiasis (raised, painful, yellow-cream coloured patches). Also, tongue pain, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out immediately and/or brushing your teeth after each dose of medicine may help. Your doctor may prescribe an antifungal medicine to treat the candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, chills, increased coughing, or worsening breathing problems.
• Throat irritation: rinsing your mouth with water and spitting it out immediately after each puff may help.
• Bruising and fractures.
• Sinus inflammation (a feeling of pressure or fullness in the nose, cheeks, and behind the eyes, sometimes accompanied by throbbing pain).
• Decreased potassium levels in the blood (may cause irregular heartbeat, muscle weakness, or cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood glucose monitoring may be needed, and your antidiabetic treatment may require adjustment.
• Cataract (clouding of the eye's lens).
• Very fast heartbeat (tachycardia).
• Trembling sensation (tremor) and rapid or irregular heartbeat (palpitations) – these effects are generally harmless and tend to decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (this effect occurs particularly in children).
• Disturbed sleep.
• Allergic skin rash.

Rare (may affect up to 1 in 1,000 people)

• Breathing difficulties or wheezing that worsens immediately after taking Airsus. If this occurs, stop using the Airsus inhaler. Use your fast-acting "reliever" medicine to help with breathing and contact your doctor immediately.
• Airsus may alter the normal production of steroid hormones in the body, especially if taken at high doses for a prolonged period. Effects may include: slowed growth in children and adolescents, bone thinning (osteoporosis), glaucoma, weight gain, or a rounded (moon-shaped) face (Cushing's syndrome).

Your doctor will monitor you regularly to check for any of these side effects and will ensure you are taking the lowest effective dose of Airsus to control your asthma.

• Behavioural changes such as unusual hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). Inform your doctor, but do not stop taking Airsus unless your doctor tells you to.
• Fungal infection of the oesophagus (gullet), which may cause difficulty swallowing.

Frequency not known (cannot be estimated from the available data):

• Depression or aggression. These effects are more likely to occur in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Airsus

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and packaging following EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Immediately after use, firmly replace the mouthpiece cap until it clicks into place. Do not apply excessive force. The canister contains a pressurised liquid. Do not expose to temperatures above 50°C; protect from direct sunlight. Do not pierce, break, or burn the canister, even if it appears to be empty.
• Like most pressurised inhalation medicines, the therapeutic effect of this medicine may decrease when the container is cold.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Airsus contains
Each metered dose (from the valve) contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and
50, 125 or 250 micrograms of fluticasone propionate. The other component is the propellant: norflurane (HFA
134a).
Description of the appearance of Airsus and contents of the pack

• Airsus is available as a metered-dose inhaler releasing its medicine as a pressurized suspension ready for inhalation through the mouth into the lungs.
• The pressurized canister contains a homogeneous inhalation suspension.
• The canister is placed in a plastic dispenser fitted with a mouthpiece and a blue dust-protective cap.
• Each pack contains 1 inhaler. Each inhaler contains 120 actuations.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Genetic S.p.A.
Via G. Della Monica 84083, Castel San Giorgio (SA), Italy
Manufacturer
Genetic S.p.A. Contrada Canfora Fisciano 84084, Salerno, Italy
This medicinal product is authorized in the European Economic Area member states under the following
names:
United Kingdom: Combisal
Italy: Airsus
Greece: Airsus
Poland: Fluticomb
This Patient Information Leaflet was last reviewed on: