AIRSALES 25 MICROGRAMS/50 MICROGRAMS Pressurized inhalation suspension

Зміст інструкції

1. AIRSALES 25 micrograms/50 micrograms/dose pressurized suspension for inhalation, 25 micrograms/125 micrograms/dose pressurized suspension for inhalation, 25 micrograms/250 micrograms/dose pressurized suspension for inhalation
   1. What is AIRSALES and what is it used for
   2. What you need to know before using AIRSALES
   3. How to use AIRSALES
   4. Possible side effects
   5. How to store AIRSALES
   6. Contents of the pack and other information

Equivalent medicinal product

AIRSALES 25 micrograms/50 micrograms/dose pressurized suspension for inhalation, 25 micrograms/125 micrograms/dose pressurized suspension for inhalation, 25 micrograms/250 micrograms/dose pressurized suspension for inhalation

Salmeterol xinafoate/fluticasone propionate
Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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 are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is AIRSALES and what is it used for

AIRSALES contains two active ingredients: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to enter and leave. 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 should use AIRSALES every day, as prescribed by your doctor. This ensures that the medicine works
correctly to control asthma.

AIRSALES helps to block the onset of shortness of breath and wheezing. However, AIRSALES
should not be used to treat a sudden attack of shortness of breath or wheezing. If this
happens, you should use your “reliever” (“rescue”) inhaler of rapid onset of action, such as
salbutamol. You should always have your “rescue” inhaler of rapid onset of action with you.

2. What you need to know before using AIRSALES

Do not use AIRSALES:

• If you are allergic to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using AIRSALES if you suffer from:

• heart disease, including irregular or fast heartbeat;
• hyperactivity of the thyroid gland;
• high blood pressure;
• diabetes mellitus (AIRSALES may increase blood sugar levels);
• low levels of potassium in the blood;
• tuberculosis (TB), now or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and AIRSALES
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine including medicines for asthma or any other medicine obtained without a prescription
medical prescription. This is because it may not be appropriate to take AIRSALES with other medicines.
Before starting to use AIRSALES, tell your doctor if you are taking the following medicines:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for the treatment of HIV (such as ritonavir and medicines containing cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the risk of experiencing unwanted effects with AIRSALES, which include irregular heartbeat, or may worsen unwanted effects. Your doctor may want to monitor you carefully if you are taking these medicines.
• Corticosteroids (by mouth or by injection). If you have taken one of these medicines recently, this may increase the risk that this medicine interferes with the adrenal gland.
• Diuretics, also known as “water tablets” used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine-based medicines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that AIRSALES will alter the ability to drive vehicles or use machinery.

For those who play sports
The use of the drug without therapeutic need constitutes doping and may still result in positive anti-doping tests.

3. How to use AIRSALES

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

• Use AIRSALES every day until your doctor tells you to stop therapy. Do not exceed the recommended dose. If you have any doubts consult your doctor or pharmacist.
• Do not stop using AIRSALES or reduce the dosage of AIRSALES without first consulting your doctor.
• AIRSALES must be inhaled into the lungs through the mouth.
• Use AIRSALES keeping track of the actuations. The inhaler is designed to deliver 120 actuations. However, it is not possible to determine when the inhaler is empty and when it has released 120 actuations. There may still be a small amount of fluid in the container. Make sure that the inhaler is replaced after releasing 120 actuations, so you can be sure to receive the correct amount of medicine in each actuation.

Adults and adolescents aged 12 years and over

• AIRSALES 25/50 - 2 inhalations twice a day
• AIRSALES 25/125 - 2 inhalations twice a day
• AIRSALES 25/250 - 2 inhalations twice a day

Children aged between 4 and 12 years

• AIRSALES 25/50 - 2 inhalations twice a day.
• AIRSALES is not recommended for use in children under 4 years of age.

Symptoms may be well controlled using AIRSALES twice a day. If this happens, your doctor
may decide to reduce the dose to once a day. The dose can be modified in this way:

• once, in the evening - if you have nighttimesymptoms.
• once, in the morning - if you have daytimesymptoms.

It is very important to follow your doctor's instructions on the number of inhalations to perform and how often
to take the medicine. If you are using AIRSALES for asthma, your doctor will regularly check your
symptoms.

However, if your asthma or breathing gets worse, tell your doctor immediately. It may happen that you
feel your breath more short of breath, that you experience chest tightness more frequently, or that you need
to use your fast-acting “rescue” medicine more often. If any of these conditions occur, you should continue to use AIRSALES but do not increase the number of doses you take. Your
breathing condition may worsen to become particularly serious. Consult your doctor because
additional treatment may be needed.

Instructions for use

• Your doctor, nurse or pharmacist will show you how to use your inhaler. They should also check at regular intervals how you use the inhaler. Incorrect or as prescribed use of AIRSALES may mean that it will not help you treat asthma as it should.
• The medicine is contained in a pressurized container housed in a plastic coating with a mouthpiece.
• A new inhaler contains enough medicine to deliver a minimum of 120 actuations. After 120 actuations, the inhaler may no longer have a sufficient amount of medicine to deliver a full dose of medication.

Checking the operation of the inhaler

• 1. When using the inhaler for the first time, you must verify that it works. To test the inhaler, remove the protective cap of the mouthpiece by gently pressing it on the sides with your thumb and index finger and pull it out.

• 2. To make sure the inhaler works, shake it well, point the mouthpiece away from yourself and firmly press the container to release a spray into the air. Repeat these steps, shaking the inhaler before releasing a second spray into the air. The total number of actuations released into the air, before using the inhaler, must be two.
• 3. After the first two test actuations, you can start using your inhaler.
• 4. If you have not used your inhaler for a week or more, or if the inhaler becomes very cold (below 0°C), release two sprays of the medicine into the air.

Warnings
Never remove the metal container from the inhaler at any time.
Only if the inhaler becomes very cold (below 0°C), remove the metal container from the plastic case
and warm it in your hands for a few minutes before use. Do not use anything else to heat it. After warming it
and before use, firmly press the container to release two sprays into the air.

Using the inhaler
It is important to start inhaling 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 make sure the mouthpiece is clean and free of dust or other particles deposited.
• 4. Shake the inhaler 4 or 5 times to make sure the contents of the inhaler are evenly mixed (Figure B).
• 5. Hold the inhaler in a vertical position with your thumb on the base, below the mouthpiece. Exhale as much as possible (Figure C).
• 6. Position the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite the mouthpiece. 7 Inhale through your mouth slowly and deeply. Immediately after starting to inhale, firmly press the top of the container to release a spray of medicine. Do so while still inhaling steadily and deeply (Figure D).
• 8. Hold your breath, remove the inhaler from your mouth and your finger from the top of the inhaler. Continue to hold your breath for a few seconds, or as long as possible.
• 9. Wait about half a minute between taking one spray of the medicine 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 can help prevent thrush and hoarseness. 11 After use, always replace the mouthpiece cap to prevent dust from entering (Figure E). When the mouthpiece cap is positioned correctly, you will hear a click. Do not use too much force.

Do not rush through steps 5, 6, 7 and 8. It is important that you inhale as slowly as possible
just before using the inhaler. You should use your inhaler while standing in front of a mirror for the first
few times. If you notice a leakage of product, which appears as a “mist” coming from the top
of your inhaler or from the sides of your mouth, you should start again from step 4.
As with all inhalers, those who care for children should make sure that those prescribed AIRSALES use the correct inhalation technique, as described above.
If you or your child find it difficult to use the inhaler, your doctor or other healthcare professional
may recommend using an AeroChamber Plus® spacer device with the inhaler. The
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 use a spacer with the inhaler, do not stop using it without first talking to your
doctor or nurse, or pharmacist. Other spacer devices are not recommended for use with
AIRSALES and you should not switch from the AeroChamber Plus® to another.It is also
important that you do not change or stop using the spacer without talking to your doctor, he will tell you
how to modify the therapy. Always talk to your doctor before making any changes to your asthma treatment.
Older children or people with weak hands may find it easier to hold the inhaler with both
hands. Place both index fingers on the top of the inhaler and both thumbs on the bottom 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.
• Do not remove the metal container from the plastic inhaler under any circumstances.
• Clean the outside and inside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Reposition the protective cap on the mouthpiece. If positioned correctly, it will click into place.
• Do not use excessive force.
• Do not put the metal container in water.

If you use more AIRSALES than you should
It is important to use the inhaler as instructed. If you accidentally took a dose higher than
recommended, consult your doctor or pharmacist. You may notice that your heart beats faster
than usual and experience tremors. You may also feel dizzy, have a headache, muscle weakness, and joint pain.
If you have taken higher doses for a long time, talk to your doctor or pharmacist for
advice. This is because higher doses of AIRSALES can reduce the amount of steroid hormones produced
by the adrenal gland.

If you forget to use AIRSALES
Do not take a double dose to make up for a missed dose. Just take the next dose at the usual time.

If you stop treatment with AIRSALES
It is very important to take AIRSALES every day, as prescribed by your doctor. Continue to take it
until your doctor tells you to stop treatment. Do not stop taking it and do not suddenly reduce
your dose of AIRSALES. This could worsen your breathing.
In addition, if you suddenly stop taking AIRSALES or reduce the dose of AIRSALES, this could
cause (very rarely) problems with the adrenal gland (adrenal insufficiency) which can sometimes
cause side effects.

• Stomach pain
• Fatigue and loss of appetite, feeling unwell
• Nausea and diarrhea
• Weight loss
• Headache or drowsiness
• Lowering of blood sugar levels
• Lowering of blood pressure and seizures (convulsions)

When your body is under stress, following a fever, trauma (such as after a car accident), infection,
or surgery, adrenal insufficiency can worsen and some of the above side effects may occur.
If you experience any of the side effects, see your doctor or pharmacist. To prevent
the occurrence of these symptoms, your doctor may prescribe you to take additional doses of corticosteroids
in tablets (such as prednisolone).
If you have any doubts about using this medicine, ask 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 possibility of side effects occurring, your doctor will prescribe the lowest dose of AIRSALES needed to control your asthma.

Allergic reactions:you may notice that your breathing gets worse suddenly after taking
AIRSALES.You may have wheezing and coughing or feel short of breath. You may also notice
itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat)
or you may suddenly feel your heart beating very fast or feel weak and dizzy (which may cause you to collapse or lose consciousness). If you notice any of these effects or if they occur suddenly after using AIRSALES, stop
using AIRSALES and tell your doctor immediately.Allergic reactions to AIRSALES are uncommon (affecting less than 1 in 100 people).
Other side effects are listed below:

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

• Headache - which usually gets better as treatment continues.
• In patients with Chronic Obstructive Pulmonary Disease (COPD) an increase in the number of colds has been reported.

Common (may affect up to 1 in 10 people):

• Thrush (painful, raised, creamy-yellow patches) in the mouth and throat. Also a sore tongue, hoarseness and irritation of the throat. Rinsing your mouth with water and spitting it out immediately

and/or brushing your teeth after taking each dose of medicine can help. Your doctor may
prescribe an antifungal medicine to treat thrush.

• Pain, swelling of the joints 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). Tell your doctor if you notice any of the following symptoms: increased production of sputum, change in the color of sputum, fever, chills, increased cough, increased breathing problems.
• Bruising and fractures.
• Inflammation of the sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes accompanied by a throbbing pain).
• Decreased potassium levels in the blood (irregular heartbeat, muscle weakness, cramps may be observed).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, you may need more frequent blood glucose checks and, possibly, adjustment of your antidiabetic therapy.
• Cataracts (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Shaking feeling (tremor) and fast or irregular heartbeat (palpitations) - these side effects are usually harmless and decrease as treatment continues.
• Chest pain.
• Feeling anxious (this effect occurs particularly in children).
• Disturbed sleep.
• Allergic skin rash.

Rare (may affect up to 1 in 1000 people)

• Difficulty breathing or wheezing that gets worse immediately after takingAIRSALES.If this happens, stop using theAIRSALES inhaler immediately.Use your “reliever” medicine that works quickly to help your breathing and tellyour doctor immediately.
• AIRSALES can alter the normal production of steroid hormones in the body, particularly if you have taken high doses for a prolonged period of time. The effects include: o slowed growth in children and adolescents o thinning of the bones o glaucoma o weight gain o a rounded (moon-shaped) face (Cushing’s syndrome)

Your doctor will check you regularly to check for any of these side effects and
make sure you are taking the lowest dose of AIRSALES to control your asthma.

• Changes in behaviour, such as unusual hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeat or presence of extra beats (arrhythmias). Tell your doctor but do not stop taking AIRSALES unless your doctor tells you to stop taking the medicine.
• Fungal infection in the esophagus (throat), which may cause difficulty swallowing.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store AIRSALES

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date indicated on the label and on the packaging after SCAD. The expiry date refers to the last day of that month.
• Do not store at a temperature above 25°C.
• The container contains a pressurized liquid. Do not expose to temperatures above 50°C, protect the medicine from direct sunlight. Do not puncture, break or burn the container even if it appears empty.
• Do not use this medicine if you notice visible signs of deterioration.
• As with most inhaled medicines in pressurized containers, the therapeutic effect of this medicine may decrease when the container is cold.

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

6. Contents of the pack and other information

What AIRSALES contains
The active ingredients are salmeterol and fluticasone propionate.
Each metered dose 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 AIRSALES and contents of the pack

• AIRSALES is available as a metered-dose inhaler that releases the medicine in a pressurized suspension ready for inhalation through the mouth into the lungs.
• The pressurized container contains a homogeneous suspension for inhalation.
• The container is placed in a plastic actuator equipped with a mouthpiece and a lilac-colored dust protective cap.
• The container is placed in a plastic actuator equipped with a mouthpiece and a purple-colored dust protective cap.
• The container is placed in a plastic actuator equipped with a mouthpiece and a violet-colored dust protective cap.
• Each pack contains 1 inhaler. Each inhaler contains 120 actuations.

Marketing authorization holder and manufacturer
Marketing authorization holder
ITALCHIMICI S.p.A. – Via Matteo Civitali, 1 – 20148 Milan (Italy).
Manufacturer
Genetic S.p.A. Contrada Canfora, Fisciano 84084, Salerno Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Portugal: Duobix
Italy: AIRSALES
Netherlands: Salmeterol/Fluticasonpropionaat Glenmark 25 microgram/50 microgram/dose aerosol, suspension
Salmeterol/Fluticasonpropionaat Glenmark 25 microgram/125 microgram/dose aerosol, suspension
Salmeterol/Fluticasonpropionaat Glenmark 25 microgram/250 microgram/dose aerosol, suspension