Asaris

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• 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 effects, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 package 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 make breathing easier by improving 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 in relieving 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 monohydrated lactose, 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 a significant worsening
of asthma control. If symptoms of asthma worsen or are not adequately controlled after starting
treatment with Asaris, the patient should continue treatment and contact their doctor.
The doctor will closely monitor treatment in case of 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
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 these effects.
It is recommended that children's growth should be regularly monitored during long-term treatment with inhaled corticosteroids.
The doctor will reduce the dose of inhaled corticosteroid to the lowest dose providing 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, particularly those used in asthma treatment.
Asaris should not be used with certain medicines.
Before starting treatment with Asaris, inform your doctor if the patient is taking 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 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 (taken orally or by injection). 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 baby, 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 monohydrated lactose
Each dose of Asaris (100 μg + 50 μg) contains approximately 13.3 mg of monohydrated lactose.
Each dose of Asaris (250 μg + 50 μg) contains approximately 13.2 mg of monohydrated lactose.
Each dose of Asaris (500 μg + 50 μg) contains approximately 12.9 mg of monohydrated lactose.
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 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.
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 twice-daily use of Asaris, your 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 your doctor instructs you on 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.
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 situation, continue using the medicine, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. You should contact your doctor, as you may require additional treatment.
Do not use Asaris to relieve sudden asthma attacks. For this purpose, use a fast-acting medicine (e.g., salbutamol), which you should always carry with you. Be careful not to confuse Asaris with the fast-acting inhaled medicine.

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

2. Setting the dose:

• Hold the inhaler with the mouthpiece facing toward you. You may hold it with either your right or left hand.
• Slide the slider fully away from you until you hear a characteristic click.
• After sliding 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 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 your mouth. Be careful not to turn the inhaler with the mouthpiece facing downward, 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 through your mouth (not through your nose) from the inhaler.
• 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 toward you.
• Closing the inhaler is accompanied by a click 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 now 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 adverse effects may occur:

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

If higher doses have been 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.
Missed dose of Asaris
If you miss a dose of Asaris, take it as soon as possible, then continue using the medicine as prescribed. Do not take a double dose to make up for a missed dose.
Stopping Asaris treatment
It is very important to take Asaris every day until your doctor advises you to stop. Do not suddenly stop taking 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 lead to adverse 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 adverse 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
To reduce the risk of adverse symptoms, your doctor will prescribe the lowest dose of
Asaris that controls asthma or COPD.
Allergic reactions: The patient may experience sudden breathing difficulties after using
Asaris. Wheezing, coughing, itching, and 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 occur in less than 1 in 100 patients taking the medicine).

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

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

Common adverse 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 be helpful. Your doctor may prescribe an antifungal medicine to treat oral thrush.
• 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 while using fluticasone propionate and salmeterol (as salmeterol xinafoate); these may be signs of lung infection:
  • Fever or chills.
  • Increased mucus production or change in mucus color.
  • 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, or cramps).

Uncommon adverse effects (may occur in less than 1 in 100 patients):

• Very rapid heartbeat (tachycardia).
• Tremor and rapid 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 occur in less 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 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 prolonged period. These effects 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 for these adverse effects and ensure that you are using the lowest dose of Asaris that controls asthma.
• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medicines 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 of the adverse effects worsen 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, 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 authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the Asaris medicinal product

Keep the medicinal product out of the sight and reach of children.
Store below 25°C in the original packaging to protect from moisture.
Do not use this medicinal product 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 the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicinal products must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Asaris contains

• The active substances in Asaris are: salmeterol (as 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
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 further information, please contact the local representative of the Marketing Authorisation Holder.
Detailed instructions for using the inhalation device are available by scanning with a smartphone the QR code located below in the leaflet.