Asaris

Patient Information Leaflet

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 this 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Asaris is and what it is used for
2. What you need to know 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, allowing 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 does not work for 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 using the medicine in case of an asthma attack or significant worsening
of asthma control. If, after starting treatment with Asaris, asthma symptoms worsen or
are not adequately controlled, the patient should continue treatment and contact
their doctor.
The doctor will closely monitor treatment in patients with the following conditions:

• heart diseases, 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 treatment with Asaris.

Children and adolescents
The medicine is not recommended for use in children under 4 years of age.
With prolonged use of high doses of inhaled corticosteroids such as Asaris,
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 monitored regularly
during long-term treatment with inhaled corticosteroids.
The doctor will reduce the dose of inhaled corticosteroid to the lowest dose that provides effective
control of asthma symptoms.
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 especially medicines used for asthma.
Asaris should not be used with certain medicines.
Before starting treatment with 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 drugs (e.g. ritonavir) and antifungal drugs (e.g. ketoconazole and itraconazole). Some of these drugs may increase the levels 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 become pregnant,
she should consult her doctor or pharmacist before using this medicine.
The doctor will assess whether the patient can take Asaris during this period.
Driving and operating machinery
It is unlikely that possible adverse effects associated with the use of Asaris
would 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
consult their doctor before taking this medicine.

3. How to use Asaris

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

• Asaris should be used daily until your doctor advises otherwise.
• Asaris should always be used according to your 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.
This medicine is not recommended for 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 twice-daily use of Asaris, your doctor may recommend reducing the frequency of Asaris 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 your doctor instructs you how many inhalations to take and how often.
If you are using Asaris for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, you should
contact your doctor immediately.
You may experience worsening of wheezing and need to use a higher dose of a fast-acting inhaled medicine to help breathing. In such a case, continue using the medicine, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.
Asaris should not be used to relieve sudden asthma attacks. For this purpose, use a fast-acting medicine (e.g. salbutamol) as needed, which you should always carry with you. Be careful not to confuse Asaris with your reliever inhaler.

Instructions for using the inhaler device

• Your doctor, nurse, or pharmacist should instruct you on how to properly use the inhaler device. They should periodically check whether you are using the inhaler correctly. Using Asaris incorrectly or improper use of the inhaler device may result in the medicine not producing the expected improvement in asthma or COPD.
• The inhaler device taken out of the Asaris medicine packaging for the first time is in the closed position.

• The inhaler device contains Asaris medicine in the form of individual doses of inhalation powder.
• The inhaler device is equipped with a dose counter indicating how many doses of medicine remain in the inhaler. 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 of medicine 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 your thumb with the other hand, slide the housing projection away from you until it stops, until you hear a click.

2. Setting the dose:

• Hold the inhaler with the mouthpiece facing towards you. You may hold it in either your right or left hand.
• Push the slider fully away from you until you hear a distinct click.
• After moving the slider, a small opening appears in the mouthpiece.
• The inhaler is now ready for use. Each time the slider is moved, the next dose of medicine is prepared for inhalation.

Do not move the slider unnecessarily,
as the next dose will be released and doses
of inhaled medicine will be wasted.

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

• Hold the inhaler at a certain distance from your mouth. Be careful not to turn the inhaler with the mouthpiece downwards, as this may cause the prepared powder dose to spill out. Breathe out calmly and deeply. Do not breathe out into the inhaler device.
• Place the mouthpiece in your mouth; 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 your 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 clicking sound. 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 ready for reuse.

Cleaning
To clean the inhaler mouthpiece, wipe it with a dry, soft cloth.
Use of a higher than recommended dose of Asaris
It is important to use Asaris exactly as prescribed by your doctor. If you accidentally use more than the recommended dose, inform your doctor or pharmacist.
After using a higher than recommended dose, the following side 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 reduce the production of steroid hormones by the adrenal glands.
Missing a dose of Asaris
If you miss a dose of Asaris, take it as soon as possible, then continue using the medicine as prescribed by your doctor. Do not take a double dose to make up for a missed dose.
Stopping use of Asaris
It is very important to use Asaris every day until your doctor advises you to stop. Do not suddenly stop using Asaris or reduce the dose on your own.
Very rarely, after long-term use of high doses of the medicine, sudden discontinuation or dose reduction may cause side effects such as:

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

Very rarely, similar side effects may also occur during infections or periods of severe stress (e.g. accident or surgery). To prevent these symptoms, your doctor may prescribe additional corticosteroids for use during this time.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
To reduce the risk of side effects, your doctor will prescribe the lowest dose of Asaris that controls your asthma or COPD.

Allergic reactions: The patient may experience sudden breathing difficulties after using Asaris.
Wheezing, cough, and itching or swelling (usually of the face, lips, tongue or throat) may occur.
If any of these symptoms occur suddenly after using Asaris, you must immediately inform your doctor.
Allergic reactions occur uncommonly (may occur in less than 1 in 100 patients taking the medicine).

Other side effects:

Very common side effects (may occur in more than 1 in 10 patients):

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

Common side effects (may occur in less than 1 in 10 patients):

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

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

• Pneumonia (lung infection) in patients with COPD. You should tell 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 (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon side effects (may occur in less 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 anxiety.
• Throat irritation. Rinsing the mouth with water and spitting it out immediately after each inhalation may help.

Rare side effects (may occur in less than 1 in 1000 patients):

• Wheezing or breathing difficulties that worsen immediately after taking the medicine. If such symptoms occur, you must stop using Asaris, use a fast-acting inhaled medicine to relieve breathing difficulties, and contact your doctor immediately.
• 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,
  • Reduced bone mass,
  • Cataracts and glaucoma,
  • Increased body weight,
  • Rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check whether you are experiencing any of these side effects and ensure that you are using the lowest dose of Asaris that controls your asthma.
• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood sugar levels and adjustment of previously used antidiabetic medicines may be necessary.
• Sleep disturbances and behavioural changes such as excessive excitability and irritability (these side effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). You should inform your doctor, but do not stop using Asaris unless your doctor advises you to do so.
• Rash.

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

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

If any of the side effects worsen or if any side effects not listed in this leaflet occur, you should inform your doctor or pharmacist.

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

5. How to store Asaris

Keep the 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: EXP followed by a date indicates the expiry date, and Lot followed by a number 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Asaris contains

• The active substances 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 monohydrate lactose, which contains milk proteins.

What Asaris looks like and contents of the pack
Asaris 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 in the leaflet below.