Aurodisc

Package leaflet: Information for the user

Aurodisc, (50 micrograms + 100 micrograms)/dose, inhalation powder, divided
Aurodisc, (50 micrograms + 250 micrograms)/dose, inhalation powder, divided
Salmeterolum + Fluticasoni propionas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Aurodisc is and what it is used for

Aurodisc 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 move 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.

Aurodisc is used to treat adults and adolescents aged 12 years and older.
Your doctor has prescribed this medicine to prevent breathing problems caused by:

• asthma.

To ensure proper asthma control, Aurodisc must be used every day as directed by your doctor.
Aurodisc helps prevent shortness of breath and wheezing. However, it must not be used to relieve sudden attacks of breathlessness or wheezing.
If such an attack occurs, a fast-acting bronchodilator, such as salbutamol, must be used immediately. You should always carry this medicine with you.

2. Important information before using Aurodisc

When not to use Aurodisc

• If the patient is allergic to salmeterol, fluticasone propionate, or lactose monohydrate, an excipient of the medicine.

Warnings and precautions
Before starting to use Aurodisc, talk to your doctor, pharmacist, or
nurse if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Aurodisc 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 vision disturbances, contact
a doctor.
Children
Do not use this medicine in children under 12 years of age.
Aurodisc 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. Aurodisc should not be used with
certain medicines.
Before starting to use Aurodisc, inform your doctor if the patient is taking
any of the following medicines:

• Medicines from the group of beta-blockers (e.g. atenolol, propranolol and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions such as angina.
• 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 experiencing side effects from Aurodisc, including irregular heartbeat, or may worsen existing side effects. Your doctor may wish to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction caused by Aurodisc.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, such as aminophylline and theophylline, 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 have
a child, she should consult her doctor before using this medicine.
Driving and operating machinery
It is unlikely that Aurodisc will affect the ability to drive
or operate machinery.
Aurodisc contains lactose
Aurodisc contains approximately 13 milligrams of lactose monohydrate in each dose. The amount of lactose in
this medicine usually does not cause problems in people who are lactose intolerant. The excipient
lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Aurodisc

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

• Aurodisc should be used daily until your doctor advises otherwise. Do not use more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop using Aurodisc or reduce the dose without first consulting your doctor.
• Aurodisc should be inhaled into the lungs through the mouth.

Recommended dose:
Adults and adolescents aged 12 years and older

• Aurodisc (50 micrograms + 100 micrograms)/dose: one inhalation twice daily.
• Aurodisc (50 micrograms + 250 micrograms)/dose: one inhalation twice daily.

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

• 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 your doctor instructs you on how many inhalations to use and how often.

If you are using Aurodisc for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or breathing becomes more difficult, contact your doctor immediately.
You may experience increased wheezing, more frequent chest tightness, or may need to use a higher dose of a fast-acting inhaled medicine to help breathing. In any of these situations, continue using Aurodisc, but do not increase the number of inhalations. Your symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for use

• Aurodisc may differ from inhalers you have used before, so it is very important to use it correctly. Your doctor, nurse, or pharmacist must train you in how to use the inhaler. This training is important to ensure you receive the required dose. If you have not received this training, ask your doctor, nurse, or pharmacist to show you how to use the inhaler correctly, especially before first use. They should also periodically check that you are using the inhaler correctly. Using Aurodisc incorrectly may mean the medicine does not provide the expected improvement in asthma.
• The inhaler contains blisters with salmeterol and fluticasone propionate in powder form.
• The inhaler is equipped with a dose counter that shows how many doses of medicine remain in the inhaler. The counter displays the dose number down to 0. Numbers from 5 to 0 appear in red as a warning that only a few doses of medicine remain in the inhaler. When the counter shows 0, the inhaler is empty.

Using the inhaler

1. To open the inhaler, hold it in one hand parallel to the floor. Press the red button with your thumb (see Fig. 1) and, using the other hand, rotate the light pink (for 50/100 micrograms strength) or pink (for 50/250 micrograms strength) mouthpiece cap away from you until it stops, until you hear a "click" (see Fig. 2). This opens a small hole in the mouthpiece and places a dose of powder into the mouthpiece.

Fig. 1 Fig. 2
Note: Each time the mouthpiece cover is opened with a "click", a blister inside opens and the next dose of powder is ready for inhalation. Therefore, do not open the mouthpiece cover unless you are ready to take your medicine, as this will open the next blister and waste medicine.

2. Hold the inhaler away from your mouth and breathe out calmly and fully. Do not breathe out into the inhaler.
3. Place the mouthpiece in your mouth (see Fig. 3). Breathe in deeply from the inhaler through your mouth, not through your nose. Remove the inhaler from your mouth. Hold your breath for about 10 seconds, or as long as is comfortable without causing discomfort. Then breathe out slowly.

Fig. 3
The inhaler delivers the medicine as a very fine powder. You may, but do not necessarily, feel the powder. Do not take an additional dose from the inhaler if you do not taste or feel the medicine.

4. Close the inhaler to keep it clean by rotating the light pink (for 50/100 micrograms strength) or pink (for 50/250 micrograms strength) mouthpiece cap back toward you as far as possible. You will hear a "click" (see Fig. 4). The mouthpiece cover is now returned to its original position. The inhaler is now ready for the next scheduled dose.
5. After inhaling the medicine, rinse your mouth with water and spit it out and (or) brush your teeth. This may help prevent hoarseness and oral thrush.

Fig. 4
Cleaning the inhaler
Keep the inhaler dry and clean.
If necessary, wipe the mouthpiece of the inhaler with a dry cloth or tissue.
Accidentally using more Aurodisc than recommended
It is important to use the inhaler as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist. Symptoms may include: faster than normal heartbeat, tremors, 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 Aurodisc may reduce the production of steroid hormones by the adrenal glands.
Missing a dose of Aurodisc
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Aurodisc
It is very important to take Aurodisc every day as directed. Continue taking the medicine until your doctor advises you to stop. Do not suddenly stop taking Aurodisc or reduce the dose, as your symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Aurodisc may (very rarely) lead to adrenal insufficiency, which can sometimes cause adverse effects.
These adverse effects may include any of the following:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhoea,
• weight loss,
• headache and drowsiness,
• low blood sugar,
• low blood pressure and seizures.

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, pharmacist, or nurse.

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 symptoms, your doctor will prescribe the lowest dose of this medicine
that provides asthma control.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Aurodisc medicine. Worsening of wheezing, cough, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may lead to falling or loss of consciousness). If any of these symptoms occur, including sudden onset after using Aurodisc medicine, stop using Aurodisc immediately and contact your doctor without delay. Allergic reactions to Aurodisc occur uncommonly (may occur in fewer than 1 in 100 people).

Very common adverse effects (may occur in more than 1 in 10 people)

• Headache – this adverse effect usually diminishes over time with continued treatment.

Common adverse effects (may occur in fewer than 1 in 10 people)

• Oral and pharyngeal candidiasis (painful, creamy-white lesions in the mouth and throat), as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

Uncommon adverse effects (may occur in fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of the dose of currently used antidiabetic medicines may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Sensation of trembling and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and diminish over time with continued treatment.
• Chest pain.
• Restlessness (this effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare adverse effects (may occur in fewer than 1 in 1000 people)

• Breathing difficulties or worsening wheezing occurring immediately after taking Aurodisc medicine. If such symptoms occur, stop using Aurodisc medicine, use a fast-acting inhaled medicine to relieve breathing difficulties, and contact your doctor immediately.

• Aurodisc may interfere with the body's normal production of steroid hormones, especially when high doses are used for a prolonged period. 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 for such adverse effects and ensure that you are using the lowest effective dose of this medicine to control asthma.

• Behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).

• Irregular, uneven heartbeat or extra beats (cardiac arrhythmias). Inform your doctor, but do not stop using Aurodisc unless instructed by your doctor.

• Fungal infection of the oesophagus, which may cause difficulty in swallowing.

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Depression or aggression (these effects are more likely 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 Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 to provide more information on the safety of this medicine.

5. How to store Aurodisc

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and inhaler label after: EXP. The expiry date (EXP) refers to the last day of the stated month.
• Do not store above 30°C.
• 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 Aurodisc contains
The active substances are salmeterol and fluticasone propionate.
Aurodisc, (50 micrograms + 100 micrograms)/dose
Each single inhalation delivers a dose (leaving dose) of
47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent to 50 micrograms of salmeterol (as
salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
Aurodisc, (50 micrograms + 250 micrograms)/dose
Each single inhalation delivers a dose (leaving dose) of
45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent to 50 micrograms of salmeterol (as
salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
The other ingredient is monohydrate lactose (see section 2 under “Aurodisc contains lactose”) (which
contains milk proteins).

What Aurodisc looks like and contents of the pack

• Aurodisc contains a strip of blisters filled with white or off-white powder. The foil protects the inhalation powder from atmospheric conditions.
• Each dose is pre-measured.
• White plastic devices with a light pink (for strength 50/100 micrograms) or pink (for strength 50/250 micrograms) mouthpiece are packed in cardboard boxes containing: 1, 2, 3 or 10 inhalers, each containing 60 doses of powder.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland

Manufacturer/Importer
Oy Medfiles Ltd.
Volttikatu 5, Volttikatu 8
70700 Kuopio
Finland
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far,
3000 Birzebbugia, BBG
Malta
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 – Anagni (FR)
Italy

This medicinal product is authorised for sale in the European Economic Area under the following names:
Belgium Aurocombo 50 microgram/100 microgram/dose, inhalation powder, pre-dispensed
Aurocombo 50 microgram/250 microgram/dose, inhalation powder, pre-dispensed
Aurocombo 50 microgrammes/100 microgrammes/dose, poudre pour inhalation en récipient unidose
Aurocombo 50 microgrammes/250 microgrammes/dose, poudre pour inhalation en récipient unidose
Aurocombo 50 Mikrogramm/100 Mikrogramm einzeldosiertes Pulver zur Inhalation
Aurocombo 50 Mikrogramm/250 Mikrogramm einzeldosiertes Pulver zur Inhalation
Republic of Aurasth
Czech Republic
France PROPIONATE DE FLUTICASONE/SALMETEROL ARROW 100 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
PROPIONATE DE FLUTICASONE/SALMETEROL ARROW 250 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
Germany Salmeterol/Fluticasonpropionat Zentiva Airmaster 50 Mikrogramm/100 Mikrogramm einzeldosiertes Pulver zur Inhalation
Salmeterol/Fluticasonpropionat Zentiva Airmaster 50 Mikrogramm/250 Mikrogramm einzeldosiertes Pulver zur Inhalation
Hungary Sirmin 50 mikrogramm/100 mikrogramm/adag adagolt inhalációs por
Sirmin 50 mikrogramm/250 mikrogramm/adag adagolt inhalációs por
Italy BISKUS
Netherlands Serair 50 microgram/100 microgram inhalatiepoeder, voorverdeeld
Serair 50 microgram/250 microgram inhalatiepoeder, voorverdeeld
Poland Aurodisc
Romania Aurospir 50 micrograme/100 micrograme Pulbere de inhalat unidoză
Aurospir 50 micrograme/250 micrograme Pulbere de inhalat unidoză
Sweden Campona Airmaster
United Kingdom Campona Airmaster