Asaris pmdi

Patient Information Leaflet

ASARIS pMDI, (50 μg + 25 μg)/inhalation dose, inhalation aerosol, suspension
ASARIS pMDI, (125 μg + 25 μg)/inhalation dose, inhalation aerosol, suspension
ASARIS pMDI, (250 μg + 25 μg)/inhalation dose, inhalation aerosol, suspension
Fluticasone propionate + Salmeterol
Please read this leaflet carefully before using this medicine, because 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 them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What ASARIS pMDI is and what it is used for

ASARIS pMDI 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.

Your doctor has prescribed this medicine to prevent breathing problems associated with asthma.
To ensure proper asthma control, ASARIS pMDI must be used every day as directed by your doctor.
ASARIS pMDI helps prevent episodes of breathlessness and wheezing. However, it must 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. You should always have such a
medicine available.

2. Important information before using ASARIS pMDI

When not to use ASARIS pMDI

• if the patient is allergic to salmeterol, fluticasone propionate, or to norflurane (HFA-134a), an excipient of the medicine.

Warnings and precautions
Before starting treatment with ASARIS pMDI, discuss with the doctor if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (ASARIS pMDI may increase blood glucose levels),
• low blood potassium levels,
• active or past treated tuberculosis, or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
ASARIS pMDI and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for use, including asthma medications and over-the-counter products. ASARIS pMDI should not be used with certain medicines.
Before starting ASARIS pMDI, inform the doctor if the patient is taking any of the following medicines:

• Medicines belonging to the β-blocker group (e.g. atenolol, propranolol, sotalol). β-blockers are commonly used in the treatment of high blood pressure or other heart conditions.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, erythromycin), including certain medicines used in HIV treatment (e.g. ritonavir, drugs containing cobicistat). 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 side effects. The doctor may wish to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (oral or injectable). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
• Diuretics used in the treatment of high blood pressure.
• Other bronchodilators (e.g. salbutamol).
• Medicines containing xanthine derivatives, commonly used in asthma treatment.

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 a doctor before using this medicine.
The doctor will assess whether the patient can use ASARIS pMDI during this period.
Driving and operating machinery
It is unlikely that ASARIS pMDI will affect the ability to drive or operate machinery.

3. How to use ASARIS pMDI

ASARIS pMDI should always be used as directed by your doctor. If in doubt,
consult your doctor or pharmacist.

• ASARIS pMDI should be used daily until your doctor advises otherwise.

• Do not take a higher dose than recommended. If in doubt, consult your
  doctor or pharmacist.

• Do not stop using ASARIS pMDI or reduce the dose without consulting your doctor.

• ASARIS pMDI should be inhaled into the lungs through the mouth.

Adults and adolescents aged 12 years and older:

• ASARIS pMDI, (50 μg + 25 μg)/inhalation dose: two inhalations twice daily.
• ASARIS pMDI, (125 μg + 25 μg)/inhalation dose: two inhalations twice daily.
• ASARIS pMDI, (250 μg + 25 μg)/inhalation dose: two inhalations twice daily.

Children aged 4 to 12 years:

• ASARIS pMDI, (50 μg + 25 μg)/inhalation dose: two inhalations twice daily.
• ASARIS pMDI is not recommended for use in children under 4 years of age.

If asthma symptoms are well controlled while using ASARIS pMDI twice
daily, your doctor may recommend reducing the frequency of ASARIS pMDI to once
daily.
The dose may be administered:

• once daily in the evening, if the patient experiences symptoms at night,
• once daily in the morning, if the patient experiences symptoms during the day.

It is very important that your doctor instructs you on how many inhalations to take and how often
to use the medicine.
If you are using ASARIS pMDI for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, you should
contact your doctor immediately. This may include worsening wheezing, more frequent
chest tightness, or the need to use a higher dose of a fast-acting, inhaled medicine to relieve breathing. In such a case, continue using ASARIS pMDI, 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.

Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler correctly. They should periodically check that you are using the inhaler properly. Incorrect use of ASARIS pMDI or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma.
• The medicine is contained in a pressurized canister within a plastic casing with a mouthpiece.

Checking the inhaler

1. Before first use, check that the inhaler is working. Remove the mouthpiece cap by gently pressing the sides of the cap with your thumb and index finger.
2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release two doses into the air. If the inhaler has not been used for one week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two doses into the air.

Using the inhaler
It is important to begin breathing slowly and as steadily as possible even
before using the inhaler.

1. Use the inhaler while standing or sitting.
2. Remove the mouthpiece cap. Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects (Figure A).
3. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and to evenly mix the contents (Figure B).
4. Hold the inhaler upright with your fingers, placing your thumb on the base of the inhaler, below the mouthpiece. Breathe out deeply, as fully as possible (Figure C).
5. Place the mouthpiece in your mouth and close your lips tightly around it. Do not bite the mouthpiece.
6. Begin a slow and deep inhalation. Immediately after starting to inhale through your mouth, press down on the inhaler to release the dose of ASARIS pMDI, then continue a steady, deep inhalation (Figure D).
7. Hold your breath, remove the inhaler from your mouth, and lift your finger from the top of the canister. Hold your breath for several seconds or as long as comfortable without causing discomfort, then breathe out slowly.
8. If your doctor has prescribed two inhalations, wait approximately 30 seconds before repeating steps 3–7.
9. Rinsing your mouth with water and spitting it out and/or brushing your teeth after inhalation helps prevent hoarseness and oral thrush.
10. After inhalation, always replace the mouthpiece cap to prevent dust from entering (Figure E). Push the cap firmly into place. If you do not hear a click when attaching the cap, remove it, turn it around, and try reattaching. Do not use excessive force.

Do not rush through steps 4, 5, 6, and 7. It is important to breathe as slowly as possible
immediately before inhalation. To ensure correct inhalation technique, initially practice
in front of a mirror. If a "mist" is seen escaping from the inhaler, mouth, or nose during inhalation,
this indicates incorrect technique. Repeat the steps starting from step 3.
As with all inhalers, caregivers should ensure that children prescribed ASARIS pMDI
use the inhaler correctly as described above.
If you have difficulty coordinating your breath with inhalation from the inhaler, your doctor may
recommend using the inhaler with a spacer device. Your doctor, nurse, or pharmacist should
instruct you on the correct use of the inhaler with a spacer, how to maintain the spacer, and answer
any related questions. If you use a spacer, it is important not to stop using it without consulting your
doctor or nurse. It is also important not to change the type of spacer without consulting your doctor.
If you stop using a spacer or change to a different type, your doctor may decide to adjust the dose
of medicine needed to control asthma symptoms. Always consult your doctor before making any
changes to your asthma treatment.
Older children or individuals with weak hands may find it easier to hold the inhaler with both
hands. Hold the inhaler with both index fingers on top and both thumbs underneath the base, below the mouthpiece.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Do not remove the metal canister from the plastic casing during cleaning or at any other time.
• Wipe the mouthpiece inside and outside and the outer surface of the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cap. When properly attached, you should hear a click. If you do not hear a click, remove the cap, turn it around, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Accidental overdose of ASARIS pMDI
It is important to use the inhaler as instructed. If you accidentally use more than the recommended 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 ASARIS pMDI may reduce steroid hormone production by the adrenal glands.

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

Stopping treatment with ASARIS pMDI
It is very important to take ASARIS pMDI every day as directed.
Continue taking the medicine until your doctor advises stopping.
Do not suddenly stop taking ASARIS pMDI or reduce the dose,
as symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of ASARIS pMDI 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 using this medicine, consult your
doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
To reduce the risk of side effects, your doctor will recommend the lowest dose of ASARIS pMDI that controls your asthma.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using ASARIS pMDI. Wheezing, cough, or shortness of breath may worsen, and itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat) may occur. 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 suddenly after using ASARIS pMDI, stop using ASARIS pMDI immediately and contact your doctor without delay. Allergic reactions to ASARIS pMDI are uncommon (may occur in 1 to 10 out of 1,000 patients taking the medicine).

Other side effects:
Very common side effects (may affect more than 1 in 10 people):

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

Common side effects (may affect 1 to 10 in 100 people):

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

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

• Pneumonia (lung infection). Inform your doctor if any of the following symptoms occur while taking ASARIS pMDI – they may be signs of lung infection: fever or chills, increased mucus production, 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 potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon side effects (may affect 1 to 10 in 1,000 people):

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of current antidiabetic medication may be necessary.
• Cataract (clouding of the eye lens).
• Very fast heartbeat (tachycardia).
• Tremor and fast or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, with symptoms such as chest pain and tightness, and shortness of breath.
• Sleep disturbances.
• Anxiety.
• Allergic skin rash.

Rare side effects (may affect 1 to 10 in 10,000 people):

• Wheezing or breathing difficulties worsening immediately after taking ASARIS pMDI. If such symptoms occur, stop using ASARIS pMDI immediately, use a fast-acting inhaled medicine to relieve breathing and contact your doctor immediately.
• ASARIS pMDI may interfere with the body's normal production of steroid hormones, especially when high doses are used for a long time. These effects include:
  • slowed growth in children and adolescents,
  • reduced bone mass,
  • glaucoma,
  • increased body weight,
  • rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check for these side effects and ensure you are using the lowest effective dose of ASARIS pMDI to control your asthma.
• 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 pMDI unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

Side effects 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of 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
Side effects can also be reported to the marketing authorisation holder or its representative.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store ASARIS pMDI

• Keep the medicine out of the sight and reach of children.
• Do not use ASARIS pMDI after the expiry date stated on the container. The expiry date (EXP) refers to the last day of the specified month. The Lot number indicates the batch number.
• Store below 25°C.
• As with most inhaled medicines in pressurized containers, the therapeutic effect of this medicine may be reduced when the container is cold.
• The metal container holds a pressurized suspension. Do not expose to temperatures above 50°C. Protect from direct sunlight. Do not pierce or burn the container, even if it seems empty.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ASARIS pMDI contains

• The active substances are: salmeterol and fluticasone propionate. Each metered dose contains 50, 125, or 250 μg (micrograms) of fluticasone propionate and 25 μg (micrograms) of salmeterol (as salmeterol xinafoate).
• The other ingredient is: norflurane, HFA-134a.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 11.2 g of HFA-134a (norflurane), equivalent to 0.0160 tonnes of CO\₂e (global warming potential GWP = 1430).

What ASARIS pMDI looks like and contents of the pack

• ASARIS pMDI is supplied in a pressurized inhaler containing a suspension for oral inhalation into the lungs.
• The pressurized container holds a homogeneous (uniform) suspension for inhalation.
• Pack contents: An aluminium container with a metering valve, mouthpiece made of PP, and a PP cap, all contained in a cardboard box. One pressurized container contains 120 doses.

Marketing Authorisation Holder and Manufacturer:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Manufacturer:
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy