Airflusal Inhaler

Airflusal is indicated for the regular treatment of asthma when the administration of a combination (a long-acting β2 agonist and an inhaled corticosteroid) is appropriate:

• insufficiently controlled patients with inhaled corticosteroids and short-acting beta2-agonists that are administered “on-demand”.
• adequately controlled patients with a long-acting β2 agonist and with an inhaled corticosteroid.

Airflusal contains salmeterol and fluticasone propionate that have different mechanisms of action. The respective mechanisms of action of both active principles are set out below:

Salmeterol:

Salmeterol is a 12-hour long-acting selective agonist of β2 adrenergic receptors, with a long side chain that joins the outside of the receiver. Salmeterol results in longer bronchodilation, lasting at least 12 hours, in comparison with recommended doses for β2 adrenergic receptor agonists with a shorter duration of action.

Fluticasone propionate:

Fluticasone propionate administered by inhalation at the recommended doses has a glucocorticoid anti-inflammatory action at the pulmonary level, which results in a reduction of symptoms and exacerbations of asthma, with fewer adverse reactions than when corticosteroids are administered systemically.

Airflusal Inhaler uses include being indicated to treat:

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD).
• This disease is characterized by causing continuous respiratory difficulties by narrowing the airways, often accompanied by cough and phlegm. This medication reduces the number of exacerbations of COPD symptoms.

Always follow this medicine exactly as your doctor or pharmacist gives you. If in doubt, consult your doctor or pharmacist again.

Asthma

The recommended dose for adults and children over 12 years of age is:

• One inhalation twice a day.

Your doctor will want to monitor your symptoms regularly.

Chronic obstructive pulmonary disease

The recommended dose for adults is:

• One inhalation twice a day.

If your symptoms become well controlled using Airflusal twice a day, your doctor may decide to decrease your dose to once a day:

• once at night if you have nighttime symptoms,
• once in the morning if you have daytime symptoms.

How to use the Airflusal Inhaler

Use Airflusal every day as prescribed by your doctor, preferably just before meals in the morning or at night.

After use, rinse your mouth with water.

If you do not use Airflusal correctly or as prescribed, your breathing difficulties may worsen. For optimal treatment, you should use Airflusal daily, even if you have no symptoms.

Instructions for use

Your doctor, nurse, or pharmacist should teach you how to use your inhaler, and they should periodically check how you use it.

The inhaler contains 60 doses of powdered medicine in a rolled aluminum strip. It has a dose counter that tells you how many remaining doses are left in decreasing order from 60 to 0. When the last 10 doses are reached, the numbers appear on a red background.

The inhaler is not refillable, you must replace it when empty and replace it with a new one.

Before using the inhaler:

Open the clear side chamber of the inhaler.

Cut the aluminum strip protruding from the side chamber by carefully pulling the strip against the "teeth" of the side chamber as shown below. Do not pull or pull it hard.

Close the side chamber and discard the used strip.

Important: As the inhaler is used, the side chamber is gradually filled with the used aluminum strip. Aluminum strips with black lines do not contain medication. Eventually, the numbered sections of the strip will appear in the side chamber. There should never be more than 2 sections of the aluminum strip in the side chamber as this can cause the inhaler to jam. The excess strip should be carefully cut and left in a safe place.

Using the inhaler:

Hold the inhaler with your hands, as shown in the pictures.

Opening

Open the protective cap down to reveal the mouthpiece.

Check the dose counter to see how many doses are left.

Preparation of the dose

Pull up on the edge of the white lever. Check that the side chamber is closed.

Remember: You should only manipulate the white lever when you are ready to inhale your dose of medication. If you play with the white lever you will waste doses.

Opening: The white lever must be fully raised as far as its stop and until it clicks. This action moves a new dose into position with its corresponding number above on the counter.

Close: Next, close the white lever until it clicks back into its original position. In this way the inhaler is ready for immediate use.

Inhalation dose

• With the mouthpiece of the inhaler away from your mouth, exhale as much as you can or until you feel comfortable. You should never exhale directly on the inhaler as this may affect the dose.
• Hold the inhaler with the protective cap facing down.
• Close your lips tightly around the mouthpiece.
• Inhale deeply and continuously through the inhaler, not through the nose.
• Remove the inhaler from your mouth and hold your breath for 5 to 10 seconds or as long as possible without causing discomfort.
• Then start breathing slowly, but out of the inhaler.
• Close the mouthpiece's protective cap.
• Rinse your mouth with water and spit it out next. This can help you prevent fungal infections in your mouth and prevent hoarseness.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions: You may notice that your breathing suddenly worsens immediately after using Airflusal. You may have wheezing and coughing or shortness of breath. You may also notice itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel like your heart is beating very fast, feeling unconscious and dizzy (which can lead to collapse or loss of consciousness). If you experience any of these effects or appear suddenly after using Airflusal, notify your doctor immediately. Allergic reactions to Airflusal are rare (may affect up to 1 in 100 people).

Other adverse effects that can occur with the following frequencies are:

Very Common Airflusal Inhaler side effects (may affect more than 1 in 10 people)

• It usually improves with continuing treatment,
• increased number of colds in COPD patients.

Common Airflusal Inhaler side effects (may affect up to 1 in 10 people)

Canker sores (itching, creamy yellow ulcers) in the mouth and throat. Also sore tongue, hoarse voice, and sore throat. Rinsing your mouth with water and spitting it out and / or brushing your teeth immediately after each dose of medication can help.

For the treatment of canker sores, your doctor may prescribe antifungal medication,

• joint pain, swelling, and muscle pain,
• muscle cramps.

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

pneumonia (infection of the lungs),

Tell your doctor if you notice any of the following symptoms while inhaling Airflusal, they could be symptoms of a lung infection:

• increased sputum production,
• increased mucus production,
• change in sputum color,
• fever,
• shaking chills,
• increased cough,
• increased respiratory distress.
• bruises and fractures throughout the body,
• inflammation of the sinuses,
• low level of potassium in your blood (you may feel an irregular heartbeat, muscle weakness, or cramps).

Uncommon Airflusal Inhaler side effects (may affect up to 1 in 100 people)

• very fast heart rate (tachycardia),
• feeling tremors and fast or irregular heart rhythm (palpitations).
• These side effects are usually harmless and decrease with continued treatment,
• A feeling of concern This effect is more likely to appear in children,
• increased blood sugar levels.
• If you have diabetes, it will be necessary to monitor your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary,
• sleep disorders,
• chest pain,
• clouding of the lens of the eye (cataracts),
• allergic-type skin rash

Rare Airflusal Inhaler side effects (may affect up to 1 in 1,000 people)

• shortness of breath or wheezing that gets worse right after the use of Airflusal. If this happens to you, stop using Airflusal and use your quick-acting "rescue" inhaler to help you breathe. See your doctor immediately.
• delayed growth of children and adolescents,
• decreased bone mineral density,
• increased eye pressure (glaucoma),
• weight gain,
• rounded face in the shape of a full moon (Cushing's syndrome).
• Your doctor will regularly monitor any of these side effects and make sure that you are taking the lowest possible dose.
• changes in behavior, such as hyperactivity and irritability.
• irregular heartbeat or an extra beating heart.
• fungal infections in the esophagus (throat), which can cause difficulty swallowing.

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