Aurospira

Package leaflet: Information for the patient

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 the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform 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 proper control of 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, a fast-acting bronchodilator, such as salbutamol, should be used immediately. You should always have such a medicine available.

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
  ingredients 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 develops blurred vision or other visual disturbances, contact a doctor.

Aurospira and other medicines
Tell the 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 the doctor if the patient is taking any of the following medicines:

• Medicines in the class of β-blockers (e.g. atenolol, propranolol, and sotalol). β-blockers are commonly used in the treatment of high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and 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. The doctor may wish to closely monitor the patient’s condition when such medicines are used.
• 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 in the treatment of high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, often 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 have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines
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 as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.

• Aurospira should be used daily 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 administered. A small amount of liquid may remain in the container. Ensure that the inhaler is replaced after 120 doses have been delivered to guarantee that the correct amount of medicine is administered with each inhalation.

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 use to once daily. The dose may be administered:

• once daily in the evening, if symptoms occur at night
• once daily in the morning, if 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 worsening 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. Your condition may worsen and lead to serious illness. 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 the inhaler vigorously, point the mouthpiece away from you, and press the canister to release a dose into the air. Repeat this step, shaking the inhaler immediately before releasing a second dose. In total, release two doses into the air before using the inhaler.
3. After releasing 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 a few minutes before use. Never use anything else to warm it. After warming, and before use, press the canister firmly to release two doses of medicine into the air.

Using the inhaler
It is important to begin breathing slowly and as steadily as possible even before using the inhaler.

1. When using the inhaler, stand or sit upright.
2. Remove the mouthpiece cap (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, 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 a few seconds or as long as comfortable.
9. Wait approximately 30 seconds before taking the next dose, then repeat steps 4 to 8.
10. Rinse your mouth with water and 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 through steps 5, 6, 7, and 8. It is important to breathe as slowly as possible immediately before inhalation. To ensure the inhalation is performed correctly, initially monitor 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 device, how to care for the spacer, and answer any related questions. If you use a spacer device, 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 discontinue use of 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 individuals with weak hands may find it easier to hold the inhaler with both hands. Hold the inhaler with both 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.
• Under no circumstances remove the metal canister from the plastic housing.
• Clean 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.

Accidental overdose of Aurospira
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 experience a faster than normal heartbeat and a trembling sensation. Other possible symptoms include dizziness, headache, muscle weakness, and joint pain.
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 production of steroid hormones by the adrenal glands.

Missed 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 daily as directed. Continue taking the medicine 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) lead to adrenal insufficiency (adrenal gland dysfunction), which may sometimes cause 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 the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse effects

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

Allergic reactions: The patient may experience a sudden worsening of breathing immediately after using Aurospira. Wheezing, cough, 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 a feeling of faintness and dizziness (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 effects are listed below:

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

Common adverse effects (may occur in up to 1 in 10 people)
Oral and throat thrush (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 thrush.
Joint pain, swelling, and muscle pain.
Muscle cramps.
The following adverse effects have been reported in patients with COPD:
Pneumonia (lung infection). Inform your doctor if any of the following symptoms occur: increased mucus production, change in mucus colour, 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 blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon adverse effects (may occur in up to 1 in 100 people)
Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medication doses 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 serious and decrease over time with continued treatment.
Chest pain.
Feeling of restlessness (this adverse effect occurs mainly in children).
Sleep disturbances.
Allergic skin rash.

Rare adverse effects (may occur in up to 1 in 1,000 people)
Breathing difficulties or wheezing worsening immediately after taking Aurospira. If such symptoms occur, stop using Aurospira, use a fast-acting inhaled medicine to relieve 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 long time. These effects 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 such adverse effects are occurring and ensure that you are using the lowest dose of Aurospira that controls asthma.
Behavioural changes such as excessive excitement and irritability (these effects occur mainly in children).
Irregular heartbeat or extra beats (arrhythmias). Inform your doctor about this, but do not stop taking Aurospira unless your doctor advises you to do so.
Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Aurospira

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 the outer cardboard
carton following: EXP. The expiry date refers to the last day of the stated month.
Medicines should 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 in this medicine 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\₂e (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 through 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 purple protective cap.
Or
The container is placed in a plastic housing incorporating a mouthpiece and fitted with a violet protective cap.
Or
The container is placed in a plastic housing incorporating a mouthpiece and fitted with a lilac protective 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.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

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

This medicine is authorised for sale in the European Economic Area countries under the following names:
Poland: Aurospira
Portugal: Fluticasona + Salmeterol Generis