Aurospira

Patient Information Leaflet

Aurospira, (50 micrograms + 25 micrograms)/metered dose, inhalation aerosol,
suspension
Aurospira, (125 micrograms + 25 micrograms)/metered dose, inhalation aerosol,
suspension
Aurospira, (250 micrograms + 25 micrograms)/metered dose, inhalation aerosol,
suspension
Fluticasone propionate + Salmeterol (as salmeterol xinafoate)
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:

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

1. What Aurospira is and what it is used for

Aurospira contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open. This makes it easier for air to flow into and out of the lungs. The effect lasts 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 prevent breathing problems such as asthma.
Aurospira should be used every day as directed by your doctor. This will ensure the medicine works properly to control asthma.
Aurospira helps prevent episodes of breathlessness and wheezing. However, it should not be used to relieve sudden attacks of breathlessness or wheezing.
If such an attack occurs, you must use a fast-acting bronchodilator immediately, such as salbutamol. You should always have this medicine with you.

2. Important information before using Aurospira

When not to use Aurospira:

• If the patient is allergic to salmeterol, fluticasone propionate, or any of the other
  components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting treatment with Aurospira if the patient has:

• Heart disease, including irregular or rapid heartbeat;
• Hyperthyroidism;
• High blood pressure;
• Diabetes (Aurospira may increase blood glucose levels);
• Low blood potassium levels;
• Active or previously treated tuberculosis, or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Aurospira and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including asthma medications and over-the-counter medicines. Aurospira should not be used with certain medicines.

Before starting Aurospira, inform your doctor if the patient is taking any of the following medicines:

• Beta-blockers (e.g. atenolol, propranolol, sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, drugs containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of Aurospira side effects, including irregular heartbeat, or may worsen existing side effects. Your doctor may wish to closely monitor the patient’s condition while taking these medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal gland dysfunction.
• Diuretics used to treat high blood pressure.
• Other bronchodilator medicines (such as salbutamol).
• Medicines containing xanthine derivatives, commonly used in the treatment of asthma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

It is unlikely that Aurospira will affect the ability to drive or operate machinery.

3. How to use Aurospira

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.

• Aurospira should be taken every day until your doctor advises otherwise. Do not take a higher dose than recommended. If in doubt, consult your doctor or pharmacist.

• Do not stop using Aurospira or reduce the dose without first consulting your doctor.

• Aurospira should be inhaled through the mouth into the lungs.

• Aurospira should always be used according to the number of actuations. The inhaler is designed to deliver 120 doses. However, it is not possible to precisely determine when the inhaler is empty or when 120 doses have been delivered. A small amount of liquid may remain in the container. You should ensure that the inhaler is replaced after 120 doses have been released, to ensure that each inhalation delivers the correct amount of medicine.

Adults and adolescents aged 12 years and older

• Aurospira 25 + 50 – two inhalations twice daily
• Aurospira 25 + 125 – two inhalations twice daily
• Aurospira 25 + 250 – two inhalations twice daily

Children aged 4 to 12 years

• Aurospira 25 + 50 – two inhalations twice daily
• Aurospira is not recommended for use in children under 4 years of age

If asthma symptoms are well controlled while using Aurospira twice daily, your doctor may recommend reducing the frequency of Aurospira to once daily. The dose may be administered:

• once daily in the evening, if the patient’s symptoms occur at night
• once daily in the morning, if the patient’s symptoms occur during the day

It is very important that the patient follows the doctor’s instructions regarding the number of inhalations and frequency of dosing.
If you are using Aurospira for asthma, your doctor will regularly monitor your symptoms. If asthma symptoms worsen or breathing becomes more difficult, contact your doctor immediately. This may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting inhaled medicine to help breathing. In such a case, continue using Aurospira, but do not increase the number of inhalations. Symptoms may worsen and serious illness may occur. Contact your doctor, as you may require additional treatment.
Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to properly use the inhaler. They should periodically check that you are using the inhaler correctly. Incorrect use of Aurospira or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma.
• The medicine is contained in a pressurized canister within a plastic housing with a mouthpiece.
• A new, full inhaler contains enough medicine for at least 120 inhalations. After 120 doses, the inhaler may no longer contain sufficient medicine to deliver a full dose.

Checking the inhaler

1. Before first use, check that the inhaler is working. Remove the mouthpiece cap by gently pressing the sides of the cap with your thumb and index finger and pulling it apart.
2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and press the canister to release a dose into the air. Repeat this, shaking the inhaler immediately before releasing a second dose. In total, release two doses into the air before using the inhaler.
3. After performing two test doses, you may begin using the inhaler.
4. If the inhaler has not been used for one week or longer, or if the inhaler is very cold (below 0°C), release two doses of medicine into the air.

Warnings
Never remove the metal canister from the inhaler.
Only if the inhaler is very cold (below 0°C), remove the metal canister from the plastic housing and warm it in your hands for several minutes before use. Never use anything else to warm it. After warming, and before use, firmly press the canister to release two doses of medicine into the air.
Using the inhaler
It is important to begin slow breathing, as slowly as possible, even before using the inhaler.

1. When using the inhaler, stand or sit upright.
2. Remove the mouthpiece cap from the inhaler (Figure A).
3. Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects.
4. Shake the inhaler 4 or 5 times to ensure the contents are evenly mixed (Figure B).
5. Hold the inhaler upright, with your thumb on the base of the inhaler, below the mouthpiece. Breathe out deeply as comfortably as possible (Figure C).
6. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite the mouthpiece.
7. Breathe in slowly and deeply through your mouth. Just after starting to inhale, press firmly on the top of the canister to release the dose. Do this while continuing a slow and deep inhalation (Figure D).
8. Hold your breath, remove the inhaler from your mouth, and remove your finger from the canister. Continue holding your breath for several seconds, or as long as comfortable.
9. Wait about half a minute before taking the next dose, then repeat steps 4 to 8.
10. Afterwards, rinse your mouth with water, spit it out, and (or) brush your teeth. This may help prevent the development of oral thrush and hoarseness.
11. After use, always immediately replace the mouthpiece cap to protect it from dust (Figure E). When properly replaced, the mouthpiece cap will snap into place. Do not use excessive force.

Do not rush steps 5, 6, 7, and 8. It is important to breathe as slowly as possible just before inhalation. To ensure the inhalation is performed correctly, initially check your technique in front of a mirror. If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth, repeat the steps starting from step 4.
As with all inhalers, caregivers should ensure that children prescribed Aurospira use the inhaler correctly, as described above.
If you or your child have difficulty using the inhaler, your doctor, nurse, or other healthcare professional may recommend using an AeroChamber Plus spacer device with the inhaler.
Your doctor, nurse, or pharmacist should instruct you on how to properly use the inhaler with the spacer, how to care for the spacer, and answer any related questions. If you use a spacer, it is important not to stop using it without first consulting your doctor or nurse. Other spacer devices are not recommended for use with Aurospira, so do not replace the AeroChamber Plus with another spacer. It is also important not to change or stop using the spacer without consulting your doctor, who will know how to adjust your therapy. Always consult 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. Hold the inhaler with two index fingers on top and both thumbs below the mouthpiece.
Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Never remove the metal canister from the plastic housing.
• Wipe the mouthpiece inside and outside and the plastic housing with a dry cloth or tissue.
• Replace the mouthpiece cap. When properly replaced, you will hear a click.
• Do not use excessive force.
• Do not immerse the metal canister in water.

Using more Aurospira than recommended
It is important to use the inhaler as directed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist. You may notice a faster heartbeat and a trembling sensation. Dizziness, headache, muscle weakness, and joint pain may also occur.
If higher doses have been used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Aurospira may reduce the adrenal glands’ production of steroid hormones.
Missing a dose of Aurospira
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
Stopping Aurospira
It is very important to take Aurospira every day as directed. Continue taking it until your doctor advises you to stop. Do not suddenly stop taking Aurospira or reduce the dose, as this may worsen breathing.
Additionally, abruptly stopping or reducing the dose of Aurospira may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may sometimes lead to adverse effects.
These adverse effects may include any of the following:
abdominal pain
fatigue and loss of appetite, nausea
nausea and diarrhoea
weight loss
headache and drowsiness
low blood sugar levels
low blood pressure and seizures (convulsions)
When the body is under stress due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.
If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).
If you have any further questions about using this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of Aurospira that
provides asthma control.

Hypersensitivity reactions: The patient may experience sudden worsening of breathing immediately
after using Aurospira. Wheezing, coughing, or shortness of breath may occur. Itching, rash (urticaria),
and swelling (usually of the face, lips, tongue, or throat) may also occur, as well as sudden rapid
heartbeat or feeling faint or dizzy (which may lead to collapse or loss of consciousness). If any of these
symptoms occur suddenly after using Aurospira, stop using Aurospira immediately and contact your
doctor without delay.
Allergic reactions to Aurospira are rare (may occur in less than 1 in 100 people).

Other adverse reactions are listed below:

Very common adverse reactions (may occur in more than 1 in 10 people)
Headache – this adverse reaction usually decreases over time with continued treatment.
In patients with chronic obstructive pulmonary disease (COPD), increased frequency of colds has
been reported.

Common adverse reactions (may occur in up to 1 in 10 people)
Oral and throat candidiasis (painful, creamy-white lesions), as well as tongue pain, hoarseness, and
throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing teeth
after each dose of medicine may be helpful. Your doctor may prescribe an antifungal medicine to treat
candidiasis.
Joint pain, joint swelling, and muscle pain.
Muscle cramps.
The following adverse reactions have been reported in patients with COPD:
Pneumonia (lung infection). Inform your doctor if you experience any of the following symptoms:
increased mucus production, change in mucus color, fever, chills, worsening cough, or worsening
breathing difficulties.
Bruising and fractures.
Sinusitis (feeling of pressure or fullness in the nose, cheeks, and behind the eyes, sometimes with
pulsating pain).
Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle
weakness, or cramps).

Uncommon adverse reactions (may occur in up to 1 in 100 people)
Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, more frequent blood
glucose monitoring and adjustment of currently used antidiabetic medications may be necessary.
Cataract (clouding of the eye lens).
Very rapid heartbeat (tachycardia).
Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not dangerous
and decrease over time with continued treatment.
Chest pain.
Feeling of anxiety (this adverse reaction occurs mainly in children).
Sleep disturbances.
Allergic skin rash.

Rare adverse reactions (may occur in up to 1 in 1,000 people)
Breathing difficulties or worsening wheezing occurring immediately after taking Aurospira. If such
symptoms occur, stop using Aurospira, use a fast-acting inhaled medicine to ease breathing, and
contact your doctor immediately.
Aurospira may interfere with the body's normal production of steroid hormones, especially when high
doses are used for a prolonged period. These effects may include:
Slowed growth in children and adolescents
Reduced bone mass
Glaucoma
Increased body weight
Rounded (moon-shaped) face (Cushing's syndrome)
Your doctor will regularly check whether you are experiencing such adverse reactions and ensure that
you are using the lowest effective dose of Aurospira to control asthma.
Behavioral changes such as excessive excitability and irritability (these symptoms occur mainly in
children).
Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop taking Aurospira
unless your doctor advises you to do so.
Fungal infection of the esophagus, which may cause difficulty swallowing.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)
Depression or aggression. These adverse reactions are more likely to occur in children.
Blurred vision

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al.
Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aurospira

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the cardboard
box after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aurospira contains
The active substances 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 ingredient is the propellant gas: norflurane (HFA-134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 0.75 g of nitrogen, equivalent to 0.107 tonnes of CO*2*e (global warming potential GWP = 1,430).

What Aurospira looks like and contents of the pack
Aurospira is supplied in a pressurised metered-dose inhaler containing a suspension for inhalation via the mouth into the lungs.
The pressurised container holds a white, homogeneous suspension for inhalation.
The container is placed in a plastic housing incorporating a mouthpiece and fitted with a protective lavender-coloured cap.
Or
The container is placed in a plastic housing incorporating a mouthpiece and fitted with a protective purple-coloured cap.
Or
The container is placed in a plastic housing incorporating a mouthpiece and fitted with a protective violet-coloured cap.
Each pack contains 1 inhaler. Each inhaler contains 120 doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer:
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy

This medicine is authorised in the Member States of the European Economic Area under the following names:
Poland: Aurospira
Portugal: Fluticasona + Salmeterol Generis