Asaris

Package leaflet: Information for the user

Asaris, (100 μg + 50 μg)/inhalation dose, powder for inhalation
Asaris, (250 μg + 50 μg)/inhalation dose, powder for inhalation
Asaris, (500 μg + 50 μg)/inhalation dose, powder for inhalation
Fluticasone propionate + Salmeterol
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm other people, 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.

Table of contents

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

1. What Asaris is and what it is used for

Asaris is a combination medicine containing two active substances: salmeterol and fluticasone propionate.
Salmeterol belongs to a group of medicines called long-acting bronchodilators (its effect lasts at least 12 hours). It helps to open the airways and allows easier airflow into and out of the lungs.
Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce swelling and irritation in the lungs.
Your doctor has prescribed this medicine to prevent breathing problems associated with:

• asthma,
• chronic obstructive pulmonary disease (COPD). Asaris at the dose of 500 μg + 50 μg reduces the number of exacerbations of COPD symptoms.

To ensure proper control of asthma or COPD, Asaris must be used every day as directed by your doctor.
Asaris is not intended for the relief of sudden attacks of breathlessness or wheezing; in such cases,
a fast-acting bronchodilator must be used immediately.

2. Important information before using Asaris

When not to use Asaris

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

Warnings and precautions
Before starting treatment with Asaris, discuss this with your doctor or pharmacist.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
Do not start treatment with Asaris during an acute asthma attack or significant worsening of asthma control. If symptoms worsen after starting Asaris or are not adequately controlled, the patient should continue treatment and contact their doctor.
The doctor will closely monitor treatment if the patient has any of the following conditions:

• heart disorders, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (the medicine may increase blood glucose levels),
• low blood potassium levels,
• active or previously treated tuberculosis. If the patient has ever had any of these conditions, they should inform their doctor before starting Asaris.

Children and adolescents
Asaris is not recommended for use in children under 4 years of age.
When high doses of inhaled corticosteroids such as Asaris are used long-term, systemic effects may occur. Children and adolescents under 16 years of age are particularly susceptible to such effects.
It is recommended that growth in children be regularly monitored during long-term treatment with inhaled corticosteroids.
The doctor will reduce the dose of inhaled corticosteroid to the lowest dose that maintains effective asthma control.

Asaris and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to use, including over-the-counter medicines and those used for asthma.
Asaris should not be used with certain medicines.
Before starting Asaris, 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.
• antiviral medicines (e.g. ritonavir) and antifungal medicines (e.g. ketoconazole and itraconazole). Some of these medicines may increase the concentration of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects, including irregular heartbeat, or may worsen existing adverse effects.
• corticosteroids (oral or injectable). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.

Some medicines may enhance the effect of Asaris, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

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 or pharmacist before using this medicine.
The doctor will assess whether she can take Asaris during this period.

Driving and operating machinery
It is unlikely that potential adverse effects associated with the use of Asaris will affect the ability to drive or operate machinery.

Asaris contains lactose monohydrate
Each dose of Asaris (100 μg + 50 μg) contains approximately 13.3 mg of lactose monohydrate.
Each dose of Asaris (250 μg + 50 μg) contains approximately 13.2 mg of lactose monohydrate.
Each dose of Asaris (500 μg + 50 μg) contains approximately 12.9 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Asaris

This medicine should always be used according to the instructions given by the doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Dosage

• Asaris should be taken daily until the doctor advises otherwise.
• Asaris should always be used according to the doctor's instructions. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist.

Bronchial asthma:
Adults and adolescents aged 12 years and older:
Asaris (100 μg + 50 μg): one inhalation twice daily.
Asaris (250 μg + 50 μg): one inhalation twice daily.
Asaris (500 μg + 50 μg): one inhalation twice daily.
Children aged 4 to 12 years:
Asaris (100 μg + 50 μg): one inhalation twice daily.
The medicine is not recommended for use in children under 4 years of age.

Chronic obstructive pulmonary disease (COPD):
Adults:
Asaris (500 μg + 50 μg): one inhalation twice daily.

If asthma symptoms are well controlled during treatment with Asaris twice daily, the doctor may recommend reducing the frequency of Asaris administration 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 doctor instructs the patient how many inhalations to take and how often.
If the patient is using Asaris for asthma, the doctor will regularly monitor symptoms.
If asthma symptoms worsen or asthma control deteriorates, you should
contact your doctor immediately.

An increase in wheezing or the need to use a higher dose of a fast-acting inhaled medicine to relieve breathing difficulties may occur. In such a case, continue using the medicine, but do not increase the number of inhalations. Symptoms of the disease may worsen and the patient's condition may deteriorate. Contact your doctor, as additional treatment may be needed.

Asaris should not be used to relieve sudden asthma attacks. For this purpose, a fast-acting medicine (e.g. salbutamol) should be used as needed, which the patient should always carry with them. Be careful not to confuse Asaris with the rescue inhaler medicine.

Instructions for using the inhaler device

• The doctor, nurse or pharmacist should instruct the patient on how to properly use the inhaler device. They should periodically check whether the patient is using the inhaler correctly. Incorrect use of Asaris or improper use of the inhaler device may result in the medicine not providing the expected improvement in asthma or COPD.
• The inhaler device, when first removed from the Asaris packaging, is in the closed position.

• The inhaler device contains Asaris in the form of individual powder doses for inhalation.
• The inhaler device is equipped with a dose counter indicating how many doses of medicine remain in the device. The counter displays the dose number down to 0. Numbers from 0 to 5 are marked in red to warn that only a few doses remain in the inhaler. When the counter shows 0, the inhaler is empty. The inhaler contains 60 doses of Asaris.

Using the inhaler device
To use the inhaler device, follow the steps below:
1. Opening:

• To open the inhaler device, hold the cover with one hand and, using the thumb of the other hand, slide the housing projection away from you until it stops and a click is heard.

2. Dose preparation:

• Hold the inhaler with the mouthpiece facing towards you. You may hold it in either your right or left hand.
• Slide the lever fully away from you until a characteristic clicking sound is heard.
• After sliding the lever, a small opening appears in the mouthpiece.
• The inhaler is now ready for use. Each time the lever is slid, the next dose of medicine is prepared for inhalation.

Do not slide the lever unnecessarily,
as the next dose will be released and the number of available doses will be reduced.

3. Performing inhalation:
Before starting inhalation, carefully read the instructions below.

• Hold the inhaler at a certain distance from the mouth. Be sure not to turn the inhaler with the mouthpiece facing downwards, as this may cause the prepared powder dose to spill out. Breathe out calmly and deeply. Do not exhale into the inhaler device.
• Place the mouthpiece in your mouth and inhale deeply from the inhaler through your mouth, not through your nose.
• Hold your breath, then remove the inhaler from your mouth. Hold your breath for several seconds, or as long as possible, then breathe out calmly.
• Rinsing the mouth with water and spitting it out after inhalation helps prevent hoarseness and oral thrush.

4. Closing:

• To close the inhaler, slide the housing projection towards you.
• Closing the inhaler is accompanied by a click. After closing, the dose-setting slider automatically returns to its original position, and the outer cover protects the device when not in use.
• The inhaler is now ready for reuse.

Cleaning
To clean the inhaler mouthpiece, wipe it with a dry, soft cloth.

Accidental overdose of Asaris
It is important to use Asaris exactly as prescribed by the doctor. If a larger than recommended dose is accidentally taken, inform your doctor or pharmacist.
After taking an overdose, the following adverse effects may occur:

• increased heart rate,
• tremors,
• headache,
• muscle weakness, joint pain.

If higher doses are used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of the medicine may cause reduced production of steroid hormones by the adrenal glands.

Missed dose of Asaris
If a dose of Asaris is missed, take it as soon as possible, then continue taking the medicine as prescribed. Do not take a double dose to make up for a missed dose.

Stopping treatment with Asaris
It is very important to take Asaris every day until the doctor advises otherwise. Do not suddenly stop taking Asaris or reduce the dose on your own.

Very rarely, when high doses of the medicine have been used for a long time, sudden discontinuation or dose reduction may lead to adverse effects such as:

• stomach pain,
• fatigue,
• loss of appetite,
• nausea, diarrhoea,
• weight loss,
• headache or drowsiness,
• low blood potassium levels,
• low blood pressure and seizures.

Very rarely, similar adverse effects may also occur during infections or periods of severe stress (e.g. accident or surgery). To prevent these symptoms, the doctor may prescribe additional corticosteroids to be taken during this time.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of
Asaris that controls your asthma or COPD.
Allergic reactions: Patients may experience sudden breathing difficulties after using
Asaris. Wheezing, cough, and itching with swelling (usually of the face, lips, tongue or throat) may occur. If such symptoms occur suddenly after using Asaris, inform your doctor immediately.
Allergic reactions occur uncommonly (may affect fewer than 1 in 100 patients taking the medicine).

Other adverse effects:
Very common adverse effects (may affect more than 1 in 10 patients):

• Headache – this adverse effect usually decreases with continued treatment.
• Increased incidence of colds has been reported in patients with COPD.

Common adverse effects (may affect fewer than 1 in 10 patients):

• Oral and pharyngeal candidiasis (painful, creamy-white lesions), tongue pain, hoarseness, and loss of voice. Rinsing the mouth with water and spitting it out immediately after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, swelling, and muscle pain.

The following adverse effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Pneumonia (lung infection) in patients with COPD. Inform your doctor if any of the following symptoms occur during treatment with fluticasone propionate and salmeterol (as salmeterol xinafoate); these may be signs of lung infection:
  • Fever or chills.
  • Increased mucus production or change in mucus colour.
  • Worsening cough or increased breathing difficulties.
• Easy bruising and traumatic fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (patients may experience irregular heartbeat, muscle weakness, cramps).

Uncommon adverse effects (may affect fewer than 1 in 100 patients):

• Very fast heartbeat (tachycardia).
• Tremor and fast or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease with continued treatment.
• Muscle cramps.
• Feeling of restlessness.
• Throat irritation. Rinsing the mouth with water and spitting it out immediately after each inhalation may be helpful.

Rare adverse effects (may affect fewer than 1 in 1000 patients):

• Wheezing or breathing difficulties worsening immediately after taking the medicine. If such symptoms occur, stop using Asaris immediately, use a fast-acting inhaled medicine to relieve breathing and contact your doctor without delay.
• Asaris may interfere with the body's normal production of steroid hormones, especially when high doses are used for a long time. Symptoms include:
  • Slowed growth in children and adolescents,
  • Decreased bone mass,
  • Cataracts and glaucoma,
  • Increased body weight,
  • Rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check for these adverse effects and ensure you are using the lowest effective dose of Asaris to control asthma.
• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of current antidiabetic medication doses may be necessary.
• Sleep disturbances and behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Asaris unless instructed by your doctor.
• Rash.

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

• Depression or aggression. These effects are more likely in children.
• Blurred vision.

If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 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 the Asaris medicinal product

Keep this medicine out of the sight and reach of children.
Store below 25°C in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Asaris contains

• The active substances in this medicine are: salmeterol (in the form of salmeterol xinafoate) and fluticasone propionate. Each inhalation dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and either 100, 250, or 500 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate, which contains milk proteins.

What Asaris looks like and contents of the pack
The medicine is a powder for inhalation.
Pack:
The medicine is supplied in an inhaler (inhalation device) equipped with a mouthpiece and a dose counter.
The inhalation device contains a blister with powder for inhalation divided into 60 doses.
The outer packaging is a cardboard box.
Each pack contains one or three inhalation devices.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]
For more detailed information, please contact the local representative of the Marketing Authorisation Holder.
A detailed instruction for use of the inhalation device is available by scanning with a smartphone the QR code located below in the leaflet.