Aurodisc

Leaflet accompanying the packaging: patient information

Aurodisc, (50 micrograms + 100 micrograms)/dose, inhalation powder, divided

Aurodisc, (50 micrograms + 250 micrograms)/dose, inhalation powder, divided

Salmeterol + Fluticasone propionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Aurodisc and what is it 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 packaging and other information

1. What is Aurodisc and what is it used for

Aurodisc contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help maintain the patency of the airways. This facilitates the flow of air to and from the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.

Aurodisc is used in the treatment of adults and adolescents aged 12 years and older.

The doctor has prescribed this medicine to the patient to prevent breathing disorders occurring in:

• asthma.

In order to ensure proper control of asthma, Aurodisc must be used every day as recommended by the doctor.

Aurodisc prevents shortness of breath and wheezing in the airways. However, it should not be used to control sudden attacks of shortness of breath or wheezing in the airways.

If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always carry such a medicine with them.

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, the patient should talk to their doctor, pharmacist, or nurse if they have:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Aurodisc may increase blood glucose levels),
• low potassium levels in the blood,
• tuberculosis currently being treated or a history of tuberculosis or other lung infections.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

This medicine should not be used in children under 12 years of age.

Aurodisc and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Aurodisc should not be used with certain medicines.

Before starting to use Aurodisc, the patient should inform their doctor about taking the following medicines:

• Beta-adrenergic blockers (e.g., atenolol, propranolol, and sotalol). Beta-adrenergic blockers are most commonly used to treat high blood pressure or other heart diseases, such as angina pectoris.
• Medicines used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g., ritonavir, cobicistat-containing products). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects of Aurodisc, including irregular heartbeat, or may worsen existing side effects. The doctor may want to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (orally or by injection). If the patient has recently taken such medicines, it may increase the risk of adrenal gland disorders caused by Aurodisc.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, such as aminophylline and theophylline, often used to treat asthma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

It is unlikely that Aurodisc will affect the ability to drive and use machines.

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 for people 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 as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

• Aurodisc should be used every day, unless the doctor advises otherwise. The patient should not take a higher dose than recommended. In case of doubts, the patient should consult their doctor or pharmacist.
• The patient should not stop using Aurodisc or reduce the dose without consulting their 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 a day.
• Aurodisc (50 micrograms + 250 micrograms)/dose: one inhalation twice a day.

If the patient's asthma symptoms are well-controlled while using Aurodisc twice a day, the doctor may recommend reducing the frequency of Aurodisc use to once a day. The dose may be given:

• once a day, in the evening, if the patient's symptoms occur at night,
• once a day, in the morning, if the patient's symptoms occur during the day. It is very important that the doctor instructs the patient on how many inhalations and how often to use.

If the patient is using Aurodisc for asthma, the doctor will regularly check the patient's symptoms.

In case of worsening asthma symptoms or breathing difficulties, the patient should

contact their doctor immediately. There may be an increase in wheezing, more frequent chest tightness, or a need to use a higher dose of a fast-acting inhalation medicine to facilitate breathing. In any of these situations, the patient should continue using Aurodisc, but not increase the number of inhalations. The symptoms of the disease may worsen, and the patient's condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for use

• Aurodisc may differ from inhalers used by the patient in the past, so it is very important to use it correctly. The doctor, nurse, or pharmacist should train the patient in the use of the inhaler. This training is important to ensure that the patient receives the required dose. If the patient has not received this training, they should ask their doctor, nurse, or pharmacist to show them how to use the inhaler correctly, especially before the first use.They should also periodically check that the patient is using the inhalation device correctly. Using Aurodisc not in accordance with the doctor's recommendation may cause the medicine not to produce the expected improvement in asthma.
• The inhalation device contains blisters with salmeterol and fluticasone propionate in powder form.
• The inhalation device is equipped with a dose counter, which indicates how many doses of the medicine are left in the inhalation device. The counter indicates the dose number down to 0. The numbers from 5 to 0 appear in red to warn that there are only a few doses of the medicine left in the inhalation device. If the counter shows 0, it means that the inhalation device is empty.

Using the inhalation device

• 1. To open the inhalation device, the patient should hold the device with one hand in a horizontal position. They should press the red button with their thumb (see Figure 1) and turn the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover away from them with the thumb of the other hand until they hear a "click" (see Figure 2). This will open a small hole in the mouthpiece and place a dose of the medicine in the mouthpiece.

Figure 1
Figure 2
Note: Each time the mouthpiece cover is opened after the "click", the blister inside opens, and the next dose of powder is ready for inhalation. Therefore, the patient should not open the mouthpiece cover unless they need to take the medicine, as the next blister will open, and the medicine will be wasted.

• 2. The patient should hold the inhalation device at a distance from their mouth and perform a slow, deep exhalation. They should not exhale into the inhalation device.
• 3. The patient should put the mouthpiece into their mouth (see Figure 3). They should perform a deep inhalation from the inhalation device through their mouth, not through their nose. They should remove the inhalation device from their mouth. They should hold their breath for about 10 seconds or as long as it is comfortable. They should perform a slow exhalation.

Figure 3
The inhaler delivers a dose of the medicine in the form of a very fine powder. The patient may, but does not have to, feel the powder. The patient should not take an additional dose from the inhaler if they do not feel the taste of the medicine.

• 4. The patient should close the inhaler to keep it clean by turning the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover back to its original position as far as possible. The patient will hear a "click" (see Figure 4). The mouthpiece cover has now been restored to its original position. The inhaler is now ready for use at the next scheduled dose.

• 5. After inhaling the medicine, the patient should rinse their mouth with water and spit it out and (or) brush their teeth. This may help prevent hoarseness and thrush.

Figure 4

Cleaning the inhaler

The patient should keep the inhaler dry and clean.
In case of need, the patient can wipe the mouthpiece of the inhalation device with a dry cloth or tissue.

Using a higher dose of Aurodisc than recommended

It is important to use the inhalation device as directed. In case of accidental use of a higher dose than recommended, the patient should tell their doctor or pharmacist. The following may occur: faster than usual heartbeat, tremors, dizziness, headache, weakness, and joint pain.
In case of using higher doses for a long period, the patient should contact their doctor or pharmacist for advice, as high doses of Aurodisc may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Aurodisc

The patient should not take a double dose of the medicine to make up for a missed dose. They should take the next dose at the scheduled time.

Stopping the use of Aurodisc

It is very important to take Aurodisc every day as directed by the doctor. The patient should take the medicine until their doctor advises them to stop.The patient should not suddenly stop taking Aurodisc or reduce the dose, as the symptoms of the disease may worsen.
Additionally, sudden stopping or reducing the dose of Aurodisc may (very rarely) cause adrenal gland disorders (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• 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, such as due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen, and any of the above side effects may occur.
If the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in the form of tablets (e.g., prednisolone).
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Aurodisc can cause side effects, although not everybody gets them.
In order to minimize the risk of side effects, the doctor will recommend the smallest dose of this medicine that will control asthma.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after

using Aurodisc. There may be an increase in wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). The patient may also experience a feeling of a very fast heartbeat, weakness, dizziness (which may lead to falls or loss of consciousness). In case of any of these symptoms, including if they occur suddenly after using Aurodisc, the patient should stop using Aurodisc and contact their doctor immediately.Allergic reactions to Aurodisc are uncommon (they may occur less often than in 1 in 100 people).

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

• Headache - this side effect usually decreases over time while continuing treatment.

Common side effects (may occur less often than in 1 in 10 people)

• Thrush (painful, creamy-white patches) 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 the teeth after each inhalation may be helpful. The doctor may recommend an antifungal medicine to treat thrush.
• Pain, swelling of the joints, and muscle pain.
• Muscle cramps.

Uncommon side effects (may occur less often than in 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines being taken.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time while continuing treatment.
• Chest pain.
• Anxiety (this symptom occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare side effects (may occur less often than in 1 in 1000 people)

• Breathing difficulties or wheezing worsening immediately after taking

Aurodisc. In case of such symptoms, the patient should stop using Aurodisc, use a fast-acting inhalation medicine to facilitate breathing, and contact their doctor immediately.

• Aurodisc may disrupt the normal production of steroid hormones by the body, especially when taking high doses of the medicine for a long period. These symptoms include:
• slowed growth in children and adolescents,
• decreased bone mass,
• glaucoma,
• weight gain,
• rounding (moon-shaped face) of the face (Cushing's syndrome). The doctor will regularly check if the patient is experiencing such side effects and ensure that the patient is using the smallest dose of this medicine that will control asthma.
• Changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
• Irregular or extra heartbeats (arrhythmias). The patient should inform their doctor about this, but should not stop using Aurodisc unless the doctor advises them to do so.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

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

• Depression or aggression (the occurrence of these side effects is more likely in children).
• Blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aurodisc

• •The medicine should be stored 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) means the last day of the month stated.
• Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aurodisc contains

The active substances of the medicine are salmeterol and fluticasone propionate.
Aurodisc, (50 micrograms + 100 micrograms)/dose
Each single inhalation provides a delivered dose (dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. This is equivalent to a metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
Aurodisc, (50 micrograms + 250 micrograms)/dose
Each single inhalation provides a delivered dose (dose leaving the mouthpiece) of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. This is equivalent to a metered dose 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 foil with blisters filled with white or off-white powder. The foil protects the inhalation powder from the environment.
• Each dose is divided.
• A white plastic device with a light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover is packaged in a cardboard box, which contains: 1, 2, 3, or 10 inhalers, each containing 60 doses of powder.

Not all pack sizes may be marketed.

Marketing authorization holder

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

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 authorized in the Member States of the European Economic Area under the following names:

Data of the last revision of the leaflet: 10/2021