Airest 50/500 Mg N60 Cap

AIREST, 50/500 mcg powder for inhalation (in capsule)

AIREST composition

Active substance: The powder for inhalation contained in 1 capsule includes 50 mcg salmeterol (in the form of salmeterol xinafoate) and 500 mcg fluticasone propionate.

Indications for use

AIREST contains salmeterol and fluticasone as active substances. Salmeterol is a member of the group of medicines called bronchodilators (bronchial dilators) and reduces the tone of the muscles in the walls of the airways in the lungs, causing them to expand. Fluticasone belongs to the group of medicines called corticosteroids and, due to its anti-inflammatory effect, eliminates breathing problems by reducing swelling and sensitivity in the walls of the airways in the lungs. AIREST is used in the following cases • To relieve and control asthma symptoms.

It is given starting from step 3 in the phased treatment of asthma. • In regular treatment, in patients with moderate and severe COPD (chronic obstructive pulmonary disease), to reduce the frequency of symptoms and attacks. Contraindications: Allergy (hypersensitivity) to salmeterol or fluticasone or to the excipient lactose.

Use during pregnancy and lactation

Pregnancy Consult your doctor or pharmacist before you start using the medicine. If you are pregnant or planning to become pregnant, be sure to inform your doctor. The product may be used only if the expected benefit to the mother outweighs the potential risk to the fetus. If you feel you have become pregnant during treatment, consult your doctor or pharmacist immediately.

Lactation Consult your doctor or pharmacist before you start using the medicine. Since there is not enough experience with the use of salmeterol and fluticasone during lactation, use this product only if your doctor decides that its use during lactation is necessary. A decision should be made whether to stop lactation or stop treatment for the child, by assessing the likely benefit of treatment for the mother and the benefit of lactation for the child.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

The effect of AIREST on the ability to drive vehicles and operate other potentially dangerous machinery is not expected.

How to use AIREST and dosage

In the treatment of asthma: Adults and adolescents over 12 years old: 1 inhalation twice daily (inhalation into the lungs together with breathing) (50 micrograms salmeterol and 500 micrograms fluticasone). In chronic obstructive pulmonary disease (COPD): Adults: 1 inhalation twice daily (inhalation into the lungs together with breathing) (50 micrograms salmeterol and 500 micrograms fluticasone). How to use AIREST is used by oral inhalation. The medicine reaches your lungs when you inhale through the inhaler.

Therefore, it is important to inhale deeply and strongly through the mouthpiece of the device. The use of the inhalation device will be shown to you by your doctor or another healthcare professional. If AIREST is prescribed for a child, it should be used under the supervision of an adult who can use AIREST. Regular use of AIREST is required to obtain full benefit.

Do not stop your treatment even if you feel better. Do not change the dose of your medicine without your doctor’s instructions. Do not swallow the capsules. Capsules should be used only with the inhaler (device) inside the box.

This device is specifically designed for use with AIREST 50/500 mcg inhalation powder capsules. • The powder in the capsules is intended to be used only by inhalation (breathing). • Remove the capsules from the foil packaging before use. Make sure your fingers are dry to prevent the capsules from getting wet.

• After using the medicine, rinse your mouth with water and spit out the water after rinsing. Doing this reduces the risk of developing an oral fungal infection (candidiasis). • Do not use the capsules with any device other than the device inside the box. • Using AIREST at the same time every day will help you remember when to take the medicine.

• It is important to use AIREST regularly as instructed by your doctor. • If you have questions about how long you should use AIREST, ask your doctor or pharmacist. Detailed information about use is available in this package leaflet. Follow the rules below carefully for proper use of the inhalation device.

Instructions for using the inhaler Dear user, the inhaler is intended for you to inhale the medicine inside the AIREST inhalation capsule prescribed by your doctor because you have difficulty breathing. The inhaler (inhalation device) provided on the market in a cardboard box is placed in protective packaging for safety purposes. Remove the inhaler from the packaging as shown in the picture before using it. When using AIREST, remember to follow your doctor’s instructions carefully.

The inhalation device is an inhaler specifically designed for inhaling the AIREST inhalation capsule. It should not be used to obtain any other medicine. 1. Dust-protective cap 2.

Mouthpiece 3. Central chamber 4. Piercing button 5. Bottom of the chamber 1.

Pull the dust-protective cap upward and open it completely together with the mouthpiece. 2. Remove one AIREST inhaler capsule from the blister packaging (it must be removed immediately before use) and place it into the central chamber as shown in picture (2).

It does not matter in which direction the capsule is placed in the chamber. 3. Close the mouthpiece until you hear a “click” sound. Keep the dust-protective cap open.

4. Hold the inhaler with the mouthpiece facing upward and release the piercing button by pressing it firmly only once. This will open holes in the capsule and ensure the release of the medicine when you inhale.

NOTE: Do NOT use WATER to clean the inhaler. Capsules should not be exposed to excessive temperatures. AIREST inhaler capsules contain a small amount of powder and therefore the capsules are only partially filled. Questions and answers about use 1.

How can you prevent the capsules from breaking into small particles? During use, the capsules may break and small particles may fall into your mouth or throat when you breathe in. You can prevent this by doing the following: • Store the capsules in their original packaging (blister packs) before use. • Store the capsules at room temperature below 25°C.

• Protect the capsules from moisture. 6. Lift the inhaler up to your mouth and close your lips tightly around the mouthpiece. Keep your head upright, inhale slowly and deeply; adjust the inhalation rate so that you can hear or feel the capsule vibrating.

Inhale until your lungs are full; hold your breath for a period that will not cause you discomfort, and during this time remove the inhaler from your mouth. You can now start normal breathing in and out. Repeat steps 5 and 6 one more time to ensure the capsule is completely emptied. 5.

Breathe out completely. Important: Please never breathe out toward the mouthpiece. 7. Open the mouthpiece again.

Turn the device over, remove and discard the used capsule. Use a dry piece of paper and/or a soft brush to clean any remaining powder inside. Close the mouthpiece and the dust-protective cap and return the inhaler to its place. 2.

Are the capsule particles harmful? No. The capsule is made from harmless food-grade gelatin. You may swallow gelatin particles that fall into your mouth or throat.

3. How should you remove a capsule that is stuck in the capsule compartment? Open the device, turn it upside down, and gently tap the bottom. 4.

How can you tell whether the dose has really been taken? • While inhaling from inside the device, you will feel the capsule vibrating. • You will feel a “sweet taste” related to lactose in your mouth. You may feel powder in the back of your throat.

This is normal. • When the dose is taken, the capsule will be empty. 5. How should you clean the powder inside the device?

• Use a dry piece of paper or a soft brush. • Remember that you must not wash the device under any circumstances.