AURODISC

Package leaflet: Information for the patient

Aurodisc, (50 micrograms + 100 micrograms/dose, powder for inhalation, divided
Aurodisc, (50 micrograms + 250 micrograms/dose, powder for inhalation, divided
Salmeterolum + Fluticasoni propionas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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 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.

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

• asthma.

To ensure proper control of asthma, Aurodisc must be used every day as directed by your doctor.
Aurodisc helps prevent shortness of breath 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. The patient should always have such a medicine available.

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 treatment with Aurodisc, speak with 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 visual disturbances, they should contact
their doctor.
Children
Do not use this medicine in children under 12 years of age.
Aurodisc and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. Aurodisc must not be used with certain medicines.
Before starting treatment with Aurodisc, inform your doctor if the patient is taking any of the following medicines:

• Medicines from the beta-blocker group (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 Aurodisc side effects, including irregular heartbeat, or may worsen existing side effects. The doctor may wish to closely monitor the patient taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal suppression 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, 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 per dose. The amount of lactose in this medicine usually does not cause problems in individuals with lactose intolerance. 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 prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Aurodisc should be taken every day until your doctor advises otherwise. Do not take a higher dose than prescribed. 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 taking Aurodisc twice daily, your doctor may recommend reducing the frequency of Aurodisc 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 your doctor instructs you on how many inhalations to take 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 previously, so it is very important to use it correctly. Your doctor, nurse, or pharmacist must train you in the proper use of the inhaler. This training is essential 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 result in the medicine not providing the expected improvement in asthma.
• The inhaler device 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 device. The counter displays the dose number down to 0. Numbers from 5 to 0 appear in red to warn that only a few doses remain in the inhaler. When the counter shows 0, the inhaler is empty.

Using the inhaler

1. To open the inhaler, hold the device 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 medicine 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 becomes ready for inhalation. Therefore, do not open the mouthpiece cover unless you intend to take a dose, as the next blister will open and medicine will be lost.

2. Hold the inhaler at a distance 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 through your mouth, not through your nose, from the inhaler. Remove the inhaler from your mouth. Hold your breath for about 10 seconds, or as long as is comfortable. Then breathe out calmly.

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 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 out the water 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 inhaler mouthpiece with a dry cloth or tissue.

Accidental overdose of Aurodisc
It is important to use the inhaler exactly as instructed. If you accidentally take more than the prescribed 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.

Missed dose of Aurodisc
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

Stopping treatment with Aurodisc
It is very important to take Aurodisc every day as prescribed. 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) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to adverse effects.
These adverse effects may include any of the following:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhea,
• 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 the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
To reduce the risk of adverse effects, 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. 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, 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 reactions (may occur in more than 1 in 10 people)

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

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

• Oral and pharyngeal candidiasis (painful, creamy-yellow 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 reactions (may occur in fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, 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 dangerous and tend to decrease with continued treatment.
• Chest pain.
• Restlessness (this reaction occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare adverse reactions (may occur in fewer than 1 in 1,000 people)

• Breathing difficulties or worsening wheezing occurring immediately after taking Aurodisc.
  If such symptoms occur, stop using Aurodisc, 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 may include:

  • Slowed growth in children and adolescents,
  • Decreased bone mass,
  • Glaucoma,
  • Increased body weight,
  • Facial rounding (moon-shaped face) (Cushing's syndrome). Your doctor will regularly check for these adverse effects and ensure that you are using the lowest effective dose of this medicine needed to control asthma.

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

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

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

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

• Depression or aggression (these 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: 22 49-21-301, Fax: 22 49-21-309, Website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 following 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Aurodisc contains
The active substances in this medicine are salmeterol and fluticasone propionate.
Aurodisc, (50 micrograms + 100 micrograms)/dose
Each single inhalation delivers a dose (leaving dose at the mouthpiece) of
47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent of 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 at the mouthpiece) of
45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent of 50 micrograms of salmeterol (as
salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate (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 inhaled powder from atmospheric conditions.
• Each dose is individually divided.
• White plastic devices with a light pink (for the 50/100 microgram strength) or pink (for the 50/250 microgram strength) 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 in the Member States of the European Economic Area under the following names:
Belgium Aurocombo 50 microgram/100 microgram/dose, inhalatiepoeder, voorverdeeld
Aurocombo 50 microgram/250 microgram/dose, inhalatiepoeder, voorverdeeld
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